According to FDA documents obtained through the Freedom of Information Act, the agency “became aware” of the AGGA from a joint investigation by 蘑菇影院 Health News and CBS News in March 2023, then responded with its first-ever inspection of Johns Dental months later.

That inspection found that the Indiana dental device manufacturer didn’t require all customer complaints to be investigated and the company did not investigate some complaints about people being hurt by products, including the AGGA, the FDA documents state. The FDA requires device companies to to the agency. Johns Dental had “never” alerted the FDA to any such complaints, according to the documents.

The AGGA, which its inventor testified has been used on more than 10,000 patients, was promoted by dentists nationwide, some of whom said it could “grow” or “expand” an adult’s jaw without surgery and treat common ailments like sleep apnea. But these claims were not backed by peer-reviewed research, and Johns Dental has settled lawsuits from 20 patients who alleged the AGGA caused them grievous harm. The company has not admitted liability.

Two former FDA officials said the AGGA was likely able to stay on the market 鈥� and off the FDA’s radar 鈥� for so long because of the lack of inspections and investigations at Johns Dental. Madris Kinard, a former FDA manager who founded , which analyzes FDA data, said it defies belief that Johns Dental never received a complaint worthy of relaying to the FDA.

“That’s a red flag for me. If I don’t see a single report to the FDA, I typically think there is something going on,” Kinard said. “When they don’t report, what you have is devices that stay on the market much longer than they should. And patients get harmed.”

Johns Dental Laboratories declined to comment when reached by phone and its lawyers did not respond to requests for an interview. The family-owned company, which has operated since 1939 in the western Indiana city of Terre Haute, to dentists and makes hundreds of retainers and sleep apnea appliances each month, according to its website.

Twelve of Johns Dental’s products are registered with the FDA as medical devices, meaning they carry at least a moderate risk, and some have been featured on the company website for at least two decades, according to preserved by the Internet Archive.

The AGGA, which was invented by Tennessee dentist Steve Galella in the 1990s, was not registered with the FDA like Johns Dental’s other devices. Company owner Jerry Neuenschwander has said in sworn court depositions that Johns Dental started making the AGGA in 2012 and became Galella’s exclusive manufacturer in 2015 and that at one point the AGGA was responsible for about one-sixth of Johns Dental’s total sales revenue.

In another deposition, Johns Dental CEO Lisa Bendixen said the company made about 3,000 to 4,000 AGGAs a year and paid Galella’s company a “royalty” of $50 to $65 for every sale.

“We are not dentists. We do not know how these appliances work. All we do is manufacture to Dr. Galella’s specifications,” she said, according to a deposition transcript.

The FDA’s lack of knowledge about the AGGA likely contributed to its loose oversight of Johns Dental. When asked to explain the lack of inspection, the FDA said that, based on what it knew at the time, it was not required to inspect Johns Dental until 2018 when the company registered as a “contract manufacturer” of other medical devices. Prior to 2018, the FDA was only aware of Johns Dental operating as a “dental laboratory,” which normally do not manufacture their own products and only modify devices made by other companies to fit dentists’ specifications. The FDA does not regularly inspect dental labs, although it can if it has concerns or gets complaints, the agency said.

Kinard said that based on her experience at the FDA she believes the agency prioritizes medical devices over dental devices, which may have contributed to the lack of inspections at Johns Dental.

“There hasn’t been much attention to dental devices in the past,” Kinard said. “Hopefully that’s going to change because of dental implant failures, as well as this device, which has quite obviously had serious issues.”

The AGGA resembles a retainer and uses springs to apply pressure to the front teeth and upper palate, according to a patent application. Last year, the 蘑菇影院 Health News-CBS News investigation revealed the AGGA was not backed by any peer-reviewed research and had never been submitted to the FDA for review. At the time, at least 20 patients had alleged in lawsuits that the AGGA had caused grievous harm to their teeth, gums, and bone 鈥� and some said they’d lost teeth. Multiple dental specialists said in interviews that they had examined AGGA patients whose teeth had been shoved out of position by the device, sometimes causing tens of thousands of dollars in damage.

“The entire concept of this device, of this treatment, makes zero sense,” said Kasey Li, a maxillofacial surgeon who that appeared on a National Institutes of Health website. “It doesn’t grow the jaw. It doesn’t widen the jaw. It just pushes the teeth out of their original position.

Johns Dental and Galella have negotiated out-of-court settlements with the original 20 AGGA plaintiffs without publicly admitting fault. At least 13 more AGGA patients have filed similar lawsuits since the 蘑菇影院 Health News-CBS News investigation. Johns Dental and Galella denied wrongdoing or have not yet responded to the allegations in the newer lawsuits.

Galella declined to be interviewed in 2023 and neither he nor his attorneys responded to recent requests for comment. One of his attorneys, Alan Fumuso, said in a 2023 statement that the AGGA “is safe and can achieve beneficial results” when used properly.

In the wake of the 蘑菇影院 Health News-CBS News report, Johns Dental abruptly stopped making the AGGA, according to the newly released FDA documents. The Department of Justice soon after opened a criminal investigation into the AGGA that was ongoing as of December, according to court filings. No charges have been filed. A DOJ spokesperson declined comment.

Spurred by the March 2023 news report, the FDA inspected Johns Dental in July. The FDA’s website shows that Johns Dental was , but the substance of the agency’s findings was not known until the inspection report was obtained this year.

FDA investigator David Gasparovich wrote in that report that he arrived unannounced at Johns Dental last July and was met by five attorneys who instructed employees not to answer any questions about the AGGA or the company’s complaint policies. Neuenschwander was told by his attorney not to talk to the inspector, the report states.

“He asked if he could photograph my credentials,” Gasparovich wrote in his report. “This was the last conversation I would have with Mr. Neuenschwander at the request of his attorney.”

The FDA requires device companies to investigate product complaints and submit a “medical device report” to the agency within 30 days if the products may have contributed to serious injury or death. Gasparovich’s inspection report states that Johns Dental had “not adequately investigated customer complaints,” and its complaint policies were “not adequately established,” allowing employees to not investigate if the product was not first returned to the company.

Johns Dental received four complaints about the AGGA after the 蘑菇影院 Health News-CBS News report, including one that came after the about the device, according to the inspection report.

“Zero (0) out of the four (4) complaints were investigated,” Gasparovich wrote in the report. “Each complaint was closed on the same day it was received.”

In the months after Gasparovich’s inspection, Johns Dental sent letters to the FDA saying it revised its complaint policies to require more investigations and hired a consultant and an auditor to address other FDA concerns, according to the documents obtained through FOIA.

Former FDA analyst M. Jason Brooke, now an attorney who advises medical device companies, said the FDA uses an internal risk-based algorithm to determine when to inspect manufacturers and he advises his clients to expect inspections every three to five years.

Brooke said the AGGA is an example of how the FDA’s oversight can be hamstrung by its reliance on device manufacturers to be transparent. If device companies don’t report to the agency, it can be left unaware of patient complaints, malfunctions, or even entire products, he said.

When a company “doesn’t follow the law,” Brooke said, “the FDA is in the dark.”

“If there aren’t complaints coming from patients, doctors, competitors, or the company itself, then in a lot of ways, there’s just a dearth of information for the FDA to consume to trigger an inspection,” Brooke said.

CBS News producer Nicole Keller contributed to this article.

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The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories. The devices are not currently being removed from the market. In an emailed response, Abbott said it had communicated the risk to customers this year.

The delayed action raises questions for some safety advocates about how and when issues with approved medical devices should be reported. The heart devices in question have been associated with thousands of reports of patients’ injuries and deaths, as described in a 蘑菇影院 Health News investigation late last year.

“Why doesn’t the public know?” said , a cardiologist and an expert in medical device safety and regulation at the University of California-San Francisco. Though some surgeons may have been aware of issues, others, particularly those who do not implant the device frequently, may have been in the dark. “And their patients are suffering adverse events,” he said.

The recall involves a pair of mechanical pumps that help the heart pump blood when it can’t do so on its own. The devices, small enough to fit in the palm of a hand, are implanted in patients with end-stage heart failure who are waiting for a transplant or as a permanent solution when a transplant is not an option. The recall affects nearly 14,000 devices.

Amanda Hils, an FDA press officer, said the agency is working with Abbott to investigate the reported injuries and deaths and determine if further action is needed.

“To date, the number of deaths reported appears consistent with the ,” Hils said in an email.

According to the FDA’s recall notice, the devices can cause buildup of “biological material” that reduces their ability to help the heart circulate blood and keep patients alive. The buildup accumulates gradually and can appear two years or more after a device is implanted in a patient’s chest.

Doctors were advised to watch out for “low-flow alarms” on the devices and, if they do diagnose the obstruction, to either monitor the patient or perform surgery to implant a stent, release the blockage, or replace the pump. “Rates of outflow obstruction are low,” Abbott spokesperson Justin Paquette said in an email, adding that patients whose devices are functioning normally “have no reason for concern.”

A review of the FDA device database shows at least 130 reports related to HeartMate II or 3 that mention the complication reported by regulators. The earliest such report filed with the FDA dates to at least 2020, according to a 蘑菇影院 Health News review of the database.

Monday’s alert is the second Class 1 recall of a HeartMate device this year.

In January, Abbott issued an urgent “” to hospitals about in which the HeartMate 3 unintentionally starts and stops due to the pump’s communication system, which cardiologists use to assess patients’ status. The FDA in March.

In February, Abbott issued to hospitals about the blockage problem, asking them to inform physicians, complete and return an acknowledgment form, and pay attention to low-flow alarms on the device’s monitor that may indicate an obstruction. The company said in the letter that it is working on “a design solution” to prevent the blockages.

A in the Journal of Thoracic and Cardiovascular Surgery reported the obstruction in about 3% of cases, though the incidence rate was higher the longer a patient had the device.

The only other Class 1 was in May 2018, when the company issued corrective action notices to hospitals and physicians warning that the graft line that carries blood from the pump to the aorta could twist and stop blood flow.

The FDA recall notice issued Monday includes to diagnose the blockage using an algorithm to detect obstructions and, if needed, a CT angiogram to verify the cause.

At present, the HeartMate 3, which was first approved by the FDA in 2017, is the only medical option for many patients with end-stage heart failure and who do not qualify for a transplant. The HeartMate 3 has supplanted the HeartMate II, which received FDA approval in 2008.

If the new recall leads to the device being removed from the market, end-stage heart failure patients could have no options, said , a cardiothoracic surgeon at the University of Michigan who also oversees a proprietary database of HeartMate II and HeartMate 3 implants.

If that happens, “we are in trouble,” Pagani said. “It would be devastating to the patients to not have this option. It’s not a perfect option 鈥� no pump ever is 鈥� but this is as good as it’s ever been.”

It’s not known precisely how many patients have received a HeartMate II or HeartMate 3 implant. That information is proprietary. The FDA recall notices show worldwide distribution of more than and more than .

The blockage complication may have gone unreported to the public for so long partly because physicians are not required to report adverse events to federal regulators, said Madris Kinard, a former FDA medical device official and founder of , a company that makes FDA device data more user-friendly for hospitals, law firms, and investors.

Only device manufacturers, device importers, and hospitals are to report device-related injuries, deaths, and significant malfunctions to the FDA.

“If this is something physicians were aware of, but they weren’t mandated to report to the FDA,” Kinard said, “at what point does that communication between those two groups need to happen?”

Dhruva, the cardiologist, said he is looking for transparency from Abbott about what the company is doing to address the problem so he can have more thorough conversations with patients considering a HeartMate device.

“We’re going to expect to have some data saying, 鈥楬ey we created this fix, and this fix works, and it doesn’t cause a new problem.’ That’s what I want to know,” he said. “There’s just a ton more that I feel in the dark about, to be honest, and I’m sure that patients and their families do as well.”

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The 68-year-old Wisconsin farmer chose the pump, called a HeartMate 3 鈥� currently the only FDA-approved device of its kind in use. Instead of extending his life, though, the device led to his death, according to a lawsuit filed in December 2020 by his daughter Jamie Edwards.

The lawsuit alleged that Herrman died because a defect in the locking mechanism of the HeartMate 3 prevented the device from sealing, causing multiple strokes and leading to a severe brain injury and multiorgan failure. Herrman “could not have anticipated the danger this defect 鈥� created for him,” the lawsuit said.

Herrman’s death to a Food and Drug Administration database where the public can learn about device-related deaths, serious injuries, and malfunctions. The in the peer-reviewed Journal of Heart and Lung Transplantation.

In September 2021, Ramon Flores Sr. had at Methodist Hospital of San Antonio. A lawsuit his family filed in August alleges that the locking mechanism defect led to air embolism strokes. Flores died eight days after surgery, at age 76.

“How many other people is this going to happen to?” said his daughter, Alanna Flores Blanco, 52. “We never, ever were explained that the device could malfunction and this could happen.”

After the deaths of Herrman and Flores, Thoratec Corp., the device’s manufacturer, evaluated the pumps involved. In , Thoratec, a subsidiary of Abbott Laboratories, confirmed a bent locking arm. But “a direct correlation” between the HeartMate 3 and the deaths “could not conclusively be established,” the manufacturer reported to the FDA.

Abbott did not respond to questions about the deaths or the alleged defects. The manufacturer denied liability in both cases. It settled Herrman’s lawsuit this fall, and the Flores case is ongoing.

The men’s deaths are among more than 4,500 reports since August 2017 in which the HeartMate 3 may have caused or contributed to a patient’s death, according to a 蘑菇影院 Health News analysis of the FDA’s database of medical device incidents, known as the , or MAUDE. Hospitals, doctors, and others report device-related deaths, serious injuries, and malfunctions to manufacturers, who are and report cases to the FDA.

In nearly 90% of those 4,500-plus reports, Thoratec said it found no problem with the device or how it was used, according to a 蘑菇影院 Health News review of the FDA database.

In cases where Abbott finds the HeartMate 3 did not cause or contribute to a death or serious injury, the company files “corrective reports,” said Justin Paquette, an Abbott public affairs director.

He added, “The complexity of the device – combined with patients battling late stage heart failure and associated comorbidities – creates very dynamic clinical care situations.”

Abbott said the HeartMate 3 is the safest iteration yet of any left ventricular assist device, or LVAD, a type of mechanical heart pump and refined over the last six decades.

The HeartMate 3 was first approved by the FDA, for use in patients awaiting a heart transplant, in August 2017, and one year later it was approved as a long-term therapy. The device is often considered only for patients with end-stage heart failure, and even then it is a last resort.

HeartMate 3 has “dramatically improved the safety of LVADs by reducing rates of complications that had historically challenged heart pump technology, including clotting, stroke and bleeding,” Paquette said.

As recently as August, the FDA also expressed support for the device. “The FDA believes the benefits of HeartMate 3 continue to outweigh the risks for this vulnerable patient population with few available alternatives,” said Jeremy Kahn, an agency spokesperson.

Others aren’t so sure. Former FDA medical device official Madris Kinard sees the high number of death reports as a warning.

“To me this is a safety signal and it’s hard to know if the FDA is working on something to address it,” said Kinard, founder of , a company that makes FDA device data more user-friendly for hospitals, law firms, investors, and others. “You have to wonder why [death reports are] still happening, and at the same rate.”

, a former director in the FDA’s medical device office, agrees the death reports for HeartMate 3 need more study. “The FDA may be missing some signals,” he said. Perhaps “there’s a little more here than meets the eye.”

Not all device problems are reported to MAUDE, and submitting a report is not necessarily an admission that a device caused a death or a serious injury. Device problem reports can be inaccurate or incomplete, or lack verification, and a single incident may be reported more than once 鈥� or not at all.

Those limitations ultimately can leave patients and their caregivers uninformed about risks associated with a device such as the HeartMate 3, said , a cardiologist and expert in medical device safety and regulation at the University of California-San Francisco.

“They’re making perhaps the biggest decision of their lives: Do I proceed with an LVAD or not? And even if I proceed, what are the risks I’m facing?” he said. “And they are left with incomplete data and uncertainty about how to make that determination.”

Even doctors cannot use the FDA database as a tool to effectively counsel patients, Dhruva added.

“lf you don’t know what is a real safety signal and what’s not,” he said, “then how can that information help us to calibrate our benefits-and-risks discussion with patients?”

Tracking Incident Reports

The HeartMate 3 is not the only device whose safety profile is hard to ascertain in MAUDE, Dhruva said. The information in the FDA database is insufficient to give patients an adequate understanding of any medical device’s safety risks and reflects “the overall weakness of postmarket surveillance” after a device has been approved for sale, he said.

Under federal regulations, device manufacturers typically adverse events to the FDA within 30 days of learning about them, and that data is often used by researchers and regulators to identify potential safety concerns. Reports also can be by doctors, patients, or others. The FDA says that reports if the manufacturer determines that a device did not cause or contribute to an adverse event.

More from the series

• Patients Expected Profemur Artificial Hips to Last. Then They Snapped in Half. Dec 5, 2023
• Thousands Got Exactech Knee or Hip Replacements. Then, Patients Say, the Parts Began to Fail. Oct 10, 2023
• This Dental Device Was Sold to Fix Patients’ Jaws. Lawsuits Claim It Wrecked Their Teeth. Mar 1, 2023

But with millions of reports for thousands of devices, it can be difficult to detect and prevent problems that put patients at risk.

Hospitals and surgeons also might self-censor what they report to manufacturers due to concerns about being sued, said Kessler, now a professor at the University of Washington.

“Health care facilities, and risk managers in particular, they aren’t always forthcoming with detailed data about events,” he said.

Reports in MAUDE show that patients with a HeartMate 3 have experienced adverse events, such as bleeding, infection, and respiratory failure, that the manufacturer warned were possible in its .

About 400 reports cited infusion or flow problems with the HeartMate 3. In thousands of other cases, the manufacturer said it did not observe any problems with the device, making it even more difficult for a doctor or a patient’s family to understand the safety history of the product.

Reports in MAUDE also describe fatal incidents due to complications not mentioned in the manufacturer’s instructions, such as the locking mechanism malfunction. In one report, a patient after an external battery charger caught fire.

Each report in MAUDE has dozens of data points and summaries describing what happened. What’s lacking in the database: context and details that would be useful for patients and doctors, such as the total number of devices in use and the name of the hospital where the event occurred.

Flores Blanco had never heard of MAUDE before her father’s surgery. Even if she had, it’s unlikely she would have found a locking mechanism issue amid the morass of records, much less anticipated what might happen.

Missed Signals?

A routine FDA inspection of Abbott’s manufacturing plant in 2017 showed that Thoratec had fallen behind schedule reporting adverse events, according to agency records obtained by 蘑菇影院 Health News under a Freedom of Information Act request.

The company updated training and hired additional staff to handle complaints submitted by hospitals, doctors, patients, and others, according to an inspection report. It provided the FDA inspector with “quantitative evidence” that late reporting to the FDA had decreased.

By October 2020, during a follow-up inspection, Thoratec was using a database to enter and process complaints and submit device reports electronically, according to an inspection report.

FDA inspectors did not cite any deficiencies with how Thoratec handled complaints after the visit. Inspectors noted the company had received 8,115 complaints related to the HeartMate 3 during the 12 months prior to the inspection in October 2020, the records show.

It’s not clear what the complaints concerned. Abbott did not respond when asked how many of the complaints led to an adverse event report to the FDA.

In Kinard’s view, device-makers in general often take longer than 30 days to investigate the root cause of an incident and frequently conclude that an adverse event was due to user error.

“They are using this regularly to downplay the problems with the device,” she said.

In Herrman’s case, a Thoratec representative was in the operating room and witnessed the incident, according to a deposition in the lawsuit. The company submitted a report to the FDA about Herrman’s injury within 30 days of the June 2019 incident.

Herrman’s surgeon, , was experienced at implanting the device, according to the lawsuit, and he was also a principal investigator on the clinical trial that brought the HeartMate 3 to market. Stulak did not respond to interview requests. But, in 2020, he and two Mayo Clinic colleagues described Herrman’s case in The Journal of Heart and Lung Transplantation, where they noted the locking mechanism malfunction. “The lack of a tight seal from this defect resulted in the multiple subsequent air embolism events and irrecoverable neurological damage,” they wrote.

The article describes how Stulak replaced the device with a new one, but it was too late to prevent the injuries to Herrman. Thoratec submitted at least three follow-up reports to the FDA about the incident and said its investigation could not determine whether the HeartMate 3 caused Herrman’s death.

Herrman’s death certificate cites complications of ischemic heart disease. Flores’ death certificate says he died of cardiac arrest and hypoxic ischemic encephalopathy, or brain damage.

The FDA has had its own problems keeping the MAUDE database up to date.

The agency is years behind schedule on anonymizing and releasing adverse event reports for all medical devices.

Kinard said the FDA has yet to publicly release “millions” of follow-up reports that manufacturers have filed after their initial adverse event report for a medical device.

The FDA acknowledged that the agency is not up to date on public reporting but could not say how many reports are pending 鈥� for the HeartMate 3 or any device.

“We are currently working on redaction for public posting in MAUDE, of all supplemental reports dated 2021-2023,” said Kahn, the FDA spokesperson. “It is difficult to determine how many of those – pending redaction of supplemental reports – pertain to the subject device.”

FDA press officer Lauren-Jei McCarthy noted that, besides adverse event reports, the agency also monitors published literature, patients, patient advocacy groups, professional societies, individual health care providers, and other sources to determine whether further action is warranted.

“We review and take seriously all reports of adverse events associated with medical devices,” McCarthy said. She said patients and providers who use the HeartMate 3 “remain a high priority” and that the agency cannot comment on investigations.

A Last-Resort Treatment

Before he got a HeartMate 3 implanted in January 2022, Sid Covington, of Austin, Texas, said he had researched the device during years of medication therapy and cardiac rehabilitation to treat his congestive heart failure.

“I looked at case studies. I looked at a number of the different heart studies,” Covington said. “I looked at their marketing brochures and all that stuff, just whatever I could find.”

Covington, 76, said he was familiar with MAUDE and Intermacs, a private registry that tracks LVAD patients, but didn’t consult them. When he had to decide whether to get the device, he was in the hospital with chest pain, shortness of breath, and fatigue from advanced heart failure. Covington said his only option was the HeartMate 3.

“When it comes down to the moment, you really don’t have much choice,” he said. “It’s any port in the storm at that point.”

The HeartMate 3 requires constant attention and care from patients, who must keep the external parts of the device dry at all times and avoid jumping and contact sports. Patients must also ensure that it always has an external source of power, which is supplied through a cord attached to the pump that exits the body through a surgical opening.

Patients who get the device are often out of options to treat their end-stage heart failure, said , a cardiologist with the University of Colorado and member of a multidisciplinary medical team that cares for heart failure patients.

“We wouldn’t proceed with an LVAD unless we think the risk of death is really high and we’ve tried everything else,” he said.

That informs the regulatory view, too, Kessler said.

“When you’re talking about people who are seriously ill, then the FDA will accept a potentially higher risk,” he said, “but not an irresponsible one, and certainly not one that couldn’t be communicated to clinicians and the public.”

Allen, who helped for patients considering an LVAD, said reliable data on safety and risks to patients is key.

“It’s about as high-risk, high-reward a choice as there can be,” Allen said. “It’s a really complicated decision to make and I think standard informed consent approaches are really inadequate for fully understanding that.”

Data Exists but Is Confidential

Long-term data for the HeartMate 3 鈥� including performance metrics for the certified to implant the device 鈥� are kept in Intermacs, managed by , which has promised to provide transparency but has yet to deliver.

The registry tracks mortality and injury rates for patients with an LVAD and logs the number of devices implanted each year.

But Intermacs is proprietary, and access at hospitals requires a principal investigator and at least one trained staff member, who can use the data to evaluate their facility’s performance against an aggregate from their peers across the nation.

, a heart transplant and LVAD surgeon at University of Michigan Health, leads a medical society task force that oversees Intermacs. He said 12,000 to 14,000 HeartMate 3 implants have been recorded in Intermacs since 2017. The HeartMate 3 has “the best outcomes of any other LVAD, ever,” he said.

Over the years, federal regulators have made it easier for patients to access LVADs, for implant centers and to be on a transplant waiting list to receive one of the pumps.

Though the HeartMate 3 is presently the only LVAD being implanted in the United States, it once had a competitor, Medtronic’s HeartWare, which the manufacturer in June 2021, citing a high risk of stroke and pumps failing to restart if stopped.

While the FDA provides consumers with about key clinical trials supporting the approval of new drugs, the agency provides no comparable data for medical devices. And though Medicare reimburses hospitals nearly $200,000 for most HeartMate 3 implants, federal administrators do not track patient outcomes or enforce performance standards for the heart pumps.

, a cardiac surgeon and researcher, was the principal investigator for Intermacs when the FDA, Centers for Medicare & Medicaid Services, and National Heart, Lung, and Blood Institute awarded a contract to the University of Alabama at Birmingham to .

Federal agencies paid about $15 million over 10 years for Intermacs, Kirklin said, because they wanted to better understand the risk factors for death and other adverse events with so-called mechanical circulatory support devices, including LVADs, as well as the factors that indicated a higher likelihood of patients doing well on the pumps.

The FDA monitors annual reports of Intermacs data, including adverse events, and allows companies to use the registry’s data to analyze their devices’ performance and to fulfill reporting requirements after a device enters the market.

LVAD implant centers are required to report their data to Intermacs in order to be certified by the accrediting nonprofit The Joint Commission. And while CMS requires that centers implant at least 10 devices every three years to continue receiving Medicare reimbursement, there are no requirements for outcomes or other quality metrics. CMS does not track LVAD patient outcomes at individual facilities, said Sara Lonardo, CMS press secretary at the time.

Kirklin said he is working with The Society of Thoracic Surgeons to create a risk model that would allow the public to see quality scores for individual hospitals that implant LVADs, a need the group has . But it will be a year before the tool is ready.

Kirklin and Pagani said the number of death reports for the HeartMate 3 in the FDA’s MAUDE database can be misleading without the outcome and longitudinal perspective that Intermacs provides.

“When you see a lot of deaths it means, 鈥楲et’s investigate.’ I couldn’t agree more,” Kirklin said. “But it’s rather limited. It’s not time-related and you don’t know the denominator. If you look up Intermacs, it’s all there.”

The families of Herrman and Flores filed lawsuits, in part, to find out what went wrong. Herrman’s family settled the lawsuit and agreed to confidentiality. Thoratec has filed a motion to dismiss the ongoing Flores case based on the FDA’s approval of the device.

Alanna Flores Blanco said she and her father were aware of the HeartMate 3’s positive outcomes, including that shows those who receive the device have a better than 50% chance of living five years or more.

“That’s why he took the chance to do it,” she said.

Flores Blanco said her father was a model patient, meeting regularly with cardiologists and other specialists, attending classes to learn how to live with the device, and receiving approval for surgery from the medical review board at Methodist Hospital in San Antonio.

The family felt informed and her father was prepared, she said.

“He did everything he was supposed to do,” she said. “What failed him ultimately was that device.”

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A student ran for help. Firefighters arrived and hoisted Little onto a gurney. At the hospital, an X-ray revealed that the artificial hip implant in Little’s right leg had “suddenly and catastrophically structurally failed,” according to a lawsuit Little would later file in federal court. The implant severed at its “neck” 鈥� a 2-inch-long titanium part linking Little’s thigh to his torso.

“It looked like a laser went through it,” Little said in an interview. “It was like someone just went in there and cut it right in the middle.”

Profemur artificial hips were once considered innovative for a feature known as a “dual modular neck,” intended to modernize total hip replacement surgery. Hundreds of thousands of Americans undergo hip implant surgery each year and devices are expected to last at least 20 years, according to the American College of Rheumatology. The Profemur necks, available in an array of lengths and angles, made it easier to customize the hip implants for patients.

But the neck also proved to be a weak point. Over the past two decades, more than 750 Profemur hips like Little’s have fractured at the neck, an attorney for the manufacturer once said in court while defending the device as not defective. In interviews, patients said they were left unable to walk and in need of emergency surgery. Reports submitted to the FDA describe Profemur patients stranded in the midst of routine life, while hiking, golfing, bowling, mowing the lawn, lifting a potted plant, getting out of a chair, putting on pants, and leaning over to pick up a key.

After each break, patients endure an hours-long repair surgery that can be traumatic because the broken implant is embedded in their bone and difficult to remove, according to three orthopedic surgeons who’ve performed such a procedure. The repair surgery, which can cost tens of thousands of dollars and may not be fully reimbursed by insurance, often requires a patient’s femur to be cracked open to extract a metal stem that was inserted down its length. Lawsuits have likened removing the bone around the stem to peeling a banana.

“It’s gruesome,” said Lee E. Rubin, an orthopedic surgeon and expert on prosthetic hips at Yale School of Medicine. “There’s no way around the fact that there’s a failed or broken implant in that patient’s thigh. We have to remove it.”

Many Profemur fractures in patients’ bodies could have been avoided if the manufacturer or the FDA responded to early signs of failure with more urgency, according to a months-long investigation by 蘑菇影院 Health News and CBS News. An FDA database shows reports of Profemur’s titanium modular necks breaking inside U.S. patients since at least 2005, but the corresponding parts were not recalled until 15 years later, if at all. Ten sizes of the titanium neck eventually were recalled in 2020 after being identified in more than 650 reports of fractures submitted to the FDA. Six other sizes of titanium necks, identified in about 75 additional fracture reports, have not been permanently recalled.

Aidin Eslam Pour, another Yale orthopedic surgeon , said the manufacturer “waited too long.”

“This implant should have been pulled out of the market earlier,” he said.

Profemur’s original manufacturer, Wright Medical Technology, in 2009 switched the metal of the modular neck from titanium to a stronger cobalt-chromium alloy, FDA documents show. Then, after some of those necks also began to break, the company recalled one size but left 11 others on the market despite reports of corrosion causing the implants to fail, FDA documents show.

In total, at least 28 sizes of the Profemur artificial hips with a dual modular neck have allegedly fractured or corroded, but just 11 sizes have been permanently recalled, according to FDA data and records.

Wright Medical, a Tennessee company founded in 1950, has made implantable medical devices since at least the 1970s, according to . Wright sold its hip and knee implant division, including the Profemur, to Chinese company MicroPort for $285 million in 2013, according to the . Stryker Corp., one of the nation’s largest device companies, paid about $4 billion for the rest of Wright in 2020.

Wright Medical declined to comment in an email from Stryker spokesperson Jon Zimmer. MicroPort did not respond to more than a dozen requests for comment sent to its attorneys, public relations firm, and U.S. offices. MicroPort still on its website, where the devices are listed as “not marketed/registered in United States.”

The FDA declined to provide an official for an interview and did not answer written questions about why some Profemur sizes were not permanently recalled. In an email, FDA spokesperson Audra Harrison said medical device manufacturers are largely responsible for deciding which products to recall and when to do so, while the agency “monitors” this process and requests recalls only in “urgent situations.” In the case of the Profemur modular necks, all recalls were initiated by MicroPort, and the FDA “took action accordingly,” the agency said.

For this investigation, journalists with 蘑菇影院 Health News and CBS News analyzed thousands of reports of Profemur complications submitted over the past two decades to the , which catalogs reports of medical device problems and malfunctions. MAUDE is unverified, incomplete, and imperfect 鈥� for example, not all device problems are properly submitted to the database, and a single issue may be reported more than once. However, the database still offers the best available perspective on medical device complications in the United States. The FDA has used MAUDE to identify device problems since the early ’90s.

蘑菇影院 Health News and CBS News also reviewed about 180 lawsuits filed in federal court in the past decade alleging Profemur modular necks broke or corroded. Plaintiffs have alleged severe pain, swelling, a “debilitating lack of mobility,” and, in at least a few cases, nerve damage and neurological issues from cobalt and chromium ions leaking into their bloodstream.

Most of the lawsuits have been resolved through out-of-court settlements without Wright Medical or MicroPort publicly admitting fault, according to court filings. The remainder of the lawsuits are ongoing.

Wright Medical has denied liability in some lawsuits before settling them and has defended Profemur implants in court in the years before some of the implants were recalled for fracturing.

“A device fracture does not mean it is defective,” Wright Medical attorney Tiffany Carpenter said in federal court in 2018, according to . “Devices fracture all the time.”

Collectively, the lawsuits allege that Profemur artificial hips broke or corroded at the neck in about 7陆 years, on average. Profemur necks made from titanium broke on average in about 10 years while necks made from the cobalt-chromium alloy broke or corroded in just six years, the lawsuits allege.

Some plaintiffs say they got Profemur implants in both legs 鈥� then they both ended up breaking.

Mark Feld, 75, of New Hampshire, who was an avid runner, said he was implanted with Profemur artificial hips in his right and left legs in 2005 and 2008, then the right hip fractured within 10 years, according to a lawsuit he filed. Wright Medical denied liability in court filings and settled out of court for an undisclosed amount.

Feld said that because he surrendered all claims against Wright in the settlement, he could not sue again when his left implant broke in 2020 as he was walking across a bridge near his apartment.

He crawled home to call 911, he said, and was rushed to the hospital.

“I couldn’t walk across that bridge for a year,” Feld said. He now has new hip implants made by another company, but his fear lingers. “To this day, I still feel like a ticking time bomb. 鈥β� Nobody could confirm for me that it can’t happen again.”

Little, the Arizona teacher, also suffered a second Profemur break, four years after his first, according to his lawsuit, in which Wright Medical denied liability and settled out of court. Little said in an interview that this time he was teaching class on a tennis court when he felt a sensation in his left leg that reminded him of crushing an aluminum can. He said he narrowly avoided tumbling onto his students.

After his two broken hip implants and replacement surgeries, Little said, he had to stop coaching basketball and will retire from teaching at the end of this school year 鈥� four years earlier than planned. He still feels unsteady and is afraid to climb a stepladder to change a lightbulb, he said.

“I’ve been robbed of some things,” Little said. “There should be accountability for it.”

It is not publicly known how many Profemur hips have failed. According to , Carpenter, the attorney for Wright Medical, said in court in 2018 that the company was aware of 768 fractures among about 353,000 Profemur necks sold. That’s a fracture rate of about 0.2%.

Other sources report a much higher rate. The Profemur devices that were permanently recalled in 2020 had a U.S. fracture rate of 2.2% 鈥� 11 times what was described in court 鈥� according to FDA documents. Peer-reviewed studies estimate fracture rates as and as for some Profemur models.

Even the lowest estimates are “unacceptable,” said Samo Fokter, an orthopedic surgeon and Profemur expert at University Medical Center Maribor in Slovenia.

Fokter has co-authored more than 10 peer-reviewed studies on the Profemur, , and said he implanted about 50 of them before they were known to fracture.

“This should not happen,” Fokter said. “If you put too much force on any implant, it can fracture, of course, but this is very, very rare. Not approaching 1%. It should be less than one in 100,000, let’s say.”

鈥�Like a Black Hole Developed Under Their Foot’

The Profemur’s problems originate from its “neck,” which is a metal connector between the upper components in the hip socket to a lower “stem” that is inserted into a patient’s thigh bone, according to peer-reviewed studies, court records, and expert interviews.

Historically, an artificial hip’s stem and neck were a single piece of metal. The Profemur line added a junction at the top of the stem so the neck was separate. Because these dual modular necks detached on both ends, the size and angle could be changed to better fit a patient.

But the Profemur’s additional junction was also its downfall. Rubin, one of the Yale experts, who also maintains at the university, said in some patients tiny cracks formed on the portion of the neck that slotted into the socket of the stem. Patients had no idea their implant was cracking until the neck snapped, he said.

“From a patient’s perspective, they’re walking around on what otherwise would seem like a successful hip implant,” Rubin said. “And all of a sudden, as they took a step, they could not bear weight 鈥� like a black hole had developed under their foot.”

The dual modular neck was developed by a European company, Cremascoli Ortho Group, in the ’80s, then purchased by Wright Medical in 1999 to be introduced as the Profemur in the United States. The Profemur was cleared for sale by the FDA in 2000 through the , which permits new medical devices to be sold without extensive testing if they are deemed to have “substantial equivalence” to other devices already on the market. Through this process, new medical devices can piggyback on a single approval for decades.

Wright Medical told the FDA that the Profemur was substantially equivalent to five existing artificial hip systems, and the agency agreed, according to FDA documents obtained through a Freedom of Information Act request. However, of those five hip systems, at least three had significantly different necks than the Profemur, Rubin said. And one was later recalled because of its high failure rate, according to the FDA.

The FDA documents state that although the Profemur is different from the older hip implants that its approval was based on, those differences were “not expected to affect the device’s safety and effectiveness.” Spokesperson Harrison said in an email that the FDA “followed the statutory framework” when the Profemur was reviewed and cleared.

Once it was cleared by the FDA, Wright touted the Profemur’s dual modular neck as a feature.

In a 2004 promotional document obtained by 蘑菇影院 Health News and CBS News, Wright guaranteed the “structural reliability” and “absence of fretting corrosion” at the junction of the stem and neck. Then Wright marketed the Profemur to people with an “active lifestyle,” saying the product was for patients who wanted to return to activities like golf, tennis, karate, and wrestling after their hip replacements, according to at least two dozen lawsuits filed against the company.

Wright also hired Jimmy Connors, who was the world’s top-ranked tennis player in the 鈥�70s, as a spokesperson.

“This hip has given me back my quality of life. It’s allowed me to do anything I did before,” Connors said on JimmysNEWHip.com, a website launched by Wright in 2006, according to preserved by the Internet Archive.

When the website launched, Wright Medical knew of at least some reports of modular neck fractures. Multiple lawsuits allege the company was aware as of 2000 that some Cremascoli hips had fractured at the modular neck, and then became aware of more fractures in 2003 and 2004. The FDA database shows Wright was also aware of two Profemur implants that allegedly fractured at the neck and were returned to Wright in spring 2005.

In 2006, FDA data showed six reports of Profemur fractures that identified the neck as the part that allegedly broke. By 2007, there were 11 such reports. By 2008, there were 30.

Connors, reached on his cellphone, said Wright Medical did not inform him of Profemur fractures at the time of his endorsement or since. Connors said his own hip implant did not fracture but had to be replaced in 2012 because of other complications.

If he had been told about a fracture risk, Connors said, he might have chosen another implant.

“If I was going through it now, I’d know a lot more to ask than I did back in the first time,” Connors said.

Perry Parks, 79, who played football for the Los Angeles Rams in the ’60s, said Connors’ endorsement persuaded him to get a Profemur hip in 2007. His implant snapped six years later during a bike ride, according to his lawsuit. Wright Medical denied liability and settled out of court.

In an interview, Parks said he was lucky to be biking at the beach at the time of the break, where he tumbled into sand, instead of in traffic.

“The thing that incenses me more is that they knew this,” Parks said. “There was some intentionality here to put 鈥� profits over the health of people.”

New Metal, New Complications

In 2009, Wright Medical introduced a new version of the Profemur modular neck that once again was cleared for sale by the FDA. Agency documents show that the neck material was switched from titanium to a cobalt-chromium alloy, a stronger metal.

“That was a big mistake,” Fokter said.

While the cobalt-chromium necks were less susceptible to fracture, they created a new problem at the same junction between the neck and stem, said Fokter and the two Yale experts. Once implanted, the cobalt-chromium neck could rub against the stem’s titanium socket, leading to a form of bimetallic corrosion that can cause pain and swelling and leak small amounts of metal ions into a patient’s bloodstream, potentially causing a long list of complications, the three experts said.

Robert Rembisz, 75, a retiree in Vero Beach, Florida, alleged in an ongoing lawsuit that Profemur corrosion in his right leg caused elevated metal levels in his blood and “neurologic symptoms” including nerve damage, tinnitus, and balance and coordination problems. Wright Medical has not yet responded to the allegations in Rembisz’s lawsuit.

Rembisz added in an interview that he believes the implant hindered his memory and cognition, leading him to question whether he was suffering early signs of dementia. He provided to 蘑菇影院 Health News and CBS News lab reports showing the metals in his blood rising over years, with cobalt levels peaking at nearly 12 times the normal range. Rembisz said most of the symptoms faded after his implant was removed in 2021.

“The problems I developed weren’t even close to my hip,” Rembisz said. “This problem could be occurring in [other people’s] bodies as well. And they don’t even know it.”

Six years after Profemur switched metals, MicroPort recalled one size of the cobalt-chromium neck affecting about 10,500 implants, citing an “,” according to FDA records. But it is unknown how many could not be returned because they’d already been implanted.

Kristin Biorn had one.

Biorn, 74, of Pasadena, California, alleged in a lawsuit that this particular size of Profemur neck was implanted in her left leg in 2013 and broke within two years 鈥� four months before the recall. Wright Medical and MicroPort denied liability in her lawsuit, then settled out of court.

In an interview, Biorn said the break occurred as she was working at her burgeoning home-staging business. While putting final touches on a client’s home with her teenage son, she fell to the floor, unable to stand or crawl, she said.

“Honestly, it gives me nightmares about what could have happened had my son not been there,” Biorn said. “My phone was downstairs and there was no way I could have gotten down the stairs alone. No one was scheduled to come in for four days.”

Biorn said in her interview that it took three surgeries to fix her hip after the Profemur fracture and she was ultimately forced to close her business and retire.

She now walks with a cane.

Although MicroPort recalled one cobalt-chromium size in 2015, the company did not recall 11 other sizes made of the same metal with the same design, and some lawsuits have faulted the company for leaving “interchangeable” products on the market. MicroPort also did not at that time recall any of the titanium necks, which as of 2015 were identified in more than 500 fracture reports in FDA’s database. MicroPort recalled 10 titanium sizes in 2020.

Finally, also in 2020, MicroPort issued a sweeping recall for all available Profemur modular necks, regardless of whether they were made of titanium or cobalt-chromium, according to FDA records.

The recall was temporary so MicroPort could included in the packaging of Profemur implants. The revised documents added a “general precaution” that doctors should consider a patient’s activity level and weight before implanting them with a Profemur, and said that patients should not have “unrealistic” expectations that include “substantial walking, running, lifting, or muscle strain.”

Afterward, the recall was lifted, and the FDA once again allowed the implants to be put up for sale.

蘑菇影院 Health News data editor Holly K. Hacker and CBS News producer Nicole Keller contributed to this report.

蘑菇影院 Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at 蘑菇影院鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

USE OUR CONTENT

This story can be republished for free (details).

Yet in just three years, the Optetrak implant manufactured by Exactech in Gainesville, Florida, had worn out and had to be replaced 鈥� a painful and debilitating operation.

“The surgery was a huge debt of pain paid over months,” said Irby, 71, a Gainesville resident and retired medical technologist with the Department of Veterans Affairs.

Irby is one of more than 1,100 patients suing Exactech after it began recalling artificial knees, hips, and ankles, starting in August 2021. Exactech sent to surgeons blamed a packaging defect dating back as far as 2004 for possibly causing the plastic in a knee component to wear out prematurely in about 140,000 implants. Many patients argue in hundreds of lawsuits that they have suffered through, or could soon face, challenging and risky operations to replace defective implants that failed.

Although Exactech does not offer an express warranty on its products, the company stresses the durability of its implants in advertising, even suggesting they likely will outlive their human recipients.

Exactech, which grew over three decades from a mom-and-pop device manufacturer into a global entity that sold for $737 million in 2018, declined comment, citing the “ongoing litigation,” said company spokesperson Tom Johnson. In court filings, Exactech has argued that its products are not defective and have “an excellent history.”

A 蘑菇影院 Health News review of thousands of pages of court filings in patient lawsuits, a pending whistleblower lawsuit, and other government records shows that the company is being accused of downplaying or concealing evidence of product failures from patients and federal regulators for years. In hundreds of instances, according to government records, the company took years to report adverse events to a federal database that tracks device failures.

In his suit, Irby alleges that Exactech “knew or should have known” that the Optetrak “had an unacceptable failure and complication rate.” He said Exactech used packaging materials of “an inferior grade or quality.”

“I think they were cutting corners to improve their bottom line,” Irby told 蘑菇影院 Health News.

Exactech denied the allegations in a legal filing in Irby’s suit, in which it described the Optetrak device as “safe and effective.”

A Family Affair

Surgeon William “Bill” Petty chaired the orthopedics department at the University of Florida in Gainesville, when he, his wife, Betty, and Gary Miller, a biomedical engineer and fellow faculty member, formed Exactech in November 1985. The Pettys served in corporate roles until retiring in early 2020. Their first hire was their son David in 1988, who remains on Exactech’s board of directors.

Exactech’s fortunes started to take off in 1994, when it inked a major deal to license and market the Optetrak knee implant based on designs by surgeons and engineers at the prestigious Hospital for Special Surgery in New York City. That alliance won Exactech instant credibility in the fiercely competitive device industry.

So did its pedigree as a “surgeon-focused” business with a family-run vibe, small enough that surgeons considering its wares could meet the owners and tour its Florida plant.

Building on that goodwill, Exactech’s sales shot past $124 million in 2007, about half generated by the Optetrak knee system.

“It’s not just a road we’re on, it’s a trail we’re blazing,” the company boasted in sales literature aimed at surgeons.

Exactech’s corporate confidence belies years of warnings and doubts about the durability of the Optetrak, according to whistleblowers 鈥� one whistleblower called it an “open secret” inside the company. Notably, there were concerns about the fragility of a finned tibial tray, one of the four pieces of the knee replacement that fits into the shin bone, according to the whistleblower lawsuit.

For starters, several surgeons complained that the knee implants loosened prematurely, causing patients pain and limiting their ability to move around, court records allege.

While 95% of artificial knees should last at least a decade, surgeons had to pull out and replace many Optetrak components 鈥� a complex operation known as revision surgery 鈥� much sooner, according to allegations in patient lawsuits.

Christopher Hutchins, a Connecticut orthopedic surgeon who relied on the Optetrak finned devices for more than 350 knee surgeries, said in a court deposition that some loosened in as little as two to three years. He called that “awfully premature” and “extraordinary.”

Hutchins vented his frustrations in a brief meeting with Exactech co-founder Bill Petty at a Rhode Island hospital in either 2006 or 2007, according to his deposition. Petty told him at the meeting he “realized that it was a problem” with the device, according to Hutchins.

“I was somewhat struck that if they knew there was a problem why it wasn’t being addressed and why the product wasn’t being pulled from the market,” Hutchins testified in the November 2021 deposition.

“There was no disclosure or transparency.”

Older patients not only suffered physical pain, but also felt an “emotional burden” from facing revision surgery in which results often are “not as good as the first go around,” Hutchins explained during his deposition testimony.“I’m in the business to try to make people better, and when things fail, I take it to heart.”

Hutchins was not the only surgeon alarmed by what he says were early failures of the Optetrak devices and the company’s tepid response.

鈥楶opping Out’

In August 2005, Maine orthopedic surgeon Wayne Moody told company officials that Optetrak had loosened and needed to be revised in 25 out of 385 operations he had performed over the previous four years, according to meeting minutes filed in court.

One knee implant gave out in just nine months, Moody told the group, according to the minutes.

In a deposition, Robert Farley, a former Exactech sales agent who filed a whistleblower lawsuit in 2018 alleging fraud by the company, alleged that he heard two colleagues joke about Moody’s tribulations at a national sales conference.

Moody “probably had 50-something revisions. 鈥� They’re just popping out right and left,” the sales agent said, according to Farley’s suit.

Fellow whistleblower Manuel Fuentes, a former Exactech senior product manager, testified in a deposition that pulling the product off the market around 2008 “would have been the ethical and moral thing to do.”

At a meeting in early 2008 attended by the company’s top brass, including Bill Petty, the company’s marketing director at the time, Charley Rye, floated the idea of a recall, Fuentes said. Company executives shot that down as “financially detrimental,” Fuentes testified in a sworn declaration filed with the court.

Asked about the meeting during a December 2021 deposition, Petty replied, “I don’t recall that anyone suggested a recall.”

鈥楽ilent Recall’

Exactech discussed the loosening problem in an internal memo that said between 2006 and 2009 the company “began to get some negative feedback” about the Optetrak “that was at times confounding and difficult to process,” court records show.

The discouraging reports ranged from complaints of early revisions from at least 10 U.S. surgeons and surgery practices in several of the more than 30 countries where Exactech sold the implant, court records show.

The results did little to dim Exactech’s prospects. From 1994 through April 2022, Exactech sold 58,763 Optetrak devices with finned trays for use by 514 surgeons nationwide, according to an affidavit by a company official.

Many lawsuits argue that instead of warning patients and surgeons about the loosening problem, Exactech replaced the finned tray component in its newest products, a strategy device industry critics refer to as a “silent recall.” Exactech denies that and said in a court filing that design changes it made were part of a “natural evolution” of the Optetrak.

Even as Exactech rolled out newer generations of the Optetrak, the company faced lawsuits and other criticism alleging it had failed to come clean about unusually high surgical revision rates.

Late Notices

The Food and Drug Administration runs a massive, public, called MAUDE to warn the public of dangers linked to medical devices and drugs.

Manufacturers must advise the FDA when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm.Those reports must be submitted within 30 days unless a special exemption is granted.

But court and government records show that reports of adverse reactions tied to Exactech’s implant sometimes took years to show up in the government database 鈥� if they were reported at all.

Exactech failed to advise the FDA of dozens of Optetrak early revision complaints lodged by orthopedic surgeons Moody and Hutchins, a company representative acknowledged in a court filing.

蘑菇影院 Health News downloaded the FDA data and found about 400 examples in which Exactech reported adverse events to the MAUDE database two years or more after learning of them.

FDA inspectors who combed through Exactech’s internal files in 2017 cited the company for failing to undertake an “adequate investigation” of complaints, according to FDA records cited in court filings.

In court filings, Exactech steadfastly denied Optetrak has any defects. Instead, it blamed the loosening problem on surgeons, saying they had failed to cement the knee implants into place correctly or misaligned them.

The company said it had no obligation to report poor outcomes tied to mistakes by surgeons 鈥� even though the FDA requires companies to report injuries involving “user error.” In 2022, a federal judge in the whistleblower case, in denying a motion to dismiss, found that Exactech was “hard-pressed” to claim it was not obligated to report the adverse events.

The three whistleblowers are accusing Exactech of fraud for allegedly selling defective products to Medicare and other federal health care programs. The case is pending in federal court in Alabama and Exactech has denied any wrongdoing. Exactech in mid-August filed a motion to dismiss the case.

Lawyers for more than 300 injured patients suing in Alachua County Circuit Court in Florida are pressing for full disclosure of 2,435 complaints to the company alleging deficiencies with Exactech knee products, which the company admits receiving as of the end of April.

In other pending lawsuits, patients argue the company pointedly ignored evidence of chronic safety issues to fuel profits.

Keith Nuzzo, of Litchfield, Maine, is one. He alleged that Exactech “cut corners, utilized inferior manufacturing practices 鈥� [and] only disclosed information or took corrective action if contacted by regulatory authorities.”

Nuzzo had a right knee replacement done by orthopedic surgeon Moody in February 2012 and a left knee implanted a week afterward.

His right knee became painful and wobbly about four years later and a second surgeon replaced it in August 2016. The left knee gave out in November 2020, also requiring replacement, according to the suit.

Despite the revisions, Nuzzo lives with “daily knee pain and discomfort,” which limits his “activities of daily living and recreation,” according to the suit. The case is pending. As of mid-September, Exactech had not filed an answer.

No Guarantees

In advertising directed at surgeons, Exactech boasts about the long life of its implants.

One sales brochure states that the Optetrak “demonstrated 91-99 percent implant survival rates” over just under a decade. That is consistent with, if not superior to, industry standards, though as a rule of thumb many surgeons expect implants to last 15 to 20 years, sometimes longer.

The mounting legal claims allege many Exactech knee and hip implants have worn out well before their time.

The 蘑菇影院 Health News analysis of more than 300 pending cases in Alachua County found that surgeons removed about 200 implants after less than seven years. Some people in the sample, whose surgeries spanned more than two dozen states, were awaiting revision procedures. In the federal court sample, patients alleged that half of the 400 implants that were removed lasted less than six years.

Advertising materials aside, Exactech is circumspect in describing the reliability of its implants when it speaks to courts. In a 2021 filing, the company noted that the Optetrak comes with no express warranty.

How long it lasts “depends on a multitude of factors, including those pertaining to surgical technique and the particular patient,” the company said.

Promoting the Products

Exactech’s focus on its surgeon customers includes paying handsome consulting fees to some orthopedists who have used the company’s implants in the operating room or promoted them in advertising.

Exactech paid surgeon consultants $23.2 million combined from the start of 2013 through the end of 2022, the most recent year available, according to a government database called Open Payments.

In promoting the Optetrak , Exactech touted “excellent results” achieved by orthopedic surgeon Raymond Robinson. Left unsaid: Exactech paid Robinson more than $900,000 in consulting fees and other payments from 2013 through 2022. In a court filing, Exactech denied any consultants “were compensated in exchange for product promotion.” Robinson could not be reached for comment.

Exactech’s sales brochures also boast that surgeons “around the world have documented excellent results with the Optetrak knee system.”

Yet Exactech bottled up a succession of sharply negative reports from other countries, while working to discredit others, according to internal company records filed in court by the whistleblowers.

One in 2012 that nine of 110 Optetrak procedures required revision due to loosening in under three years, for instance. Exactech disputed the findings in a , and in a court filing said the conclusions were “based on incorrect information and a flawed understanding of the true causes.”

A hospital in Buenos Aires, Argentina, reported that 25% to 30% of Optetrak knees required revisions in under two years, according to whistleblower Fuentes.

The Australian implant registry criticized Optetrak’s reliability as early as 2007 and in several later years. In response, Exactech executives said in depositions and court filings that they traced many of the poor results to a single hospital and three surgeons who failed to align the implants correctly.

The Australian registry pegged Exactech’s revision rate at 19.4% at seven years and 22% at 10 years, the worst of any knee implant on the market, which led the government health system to stop purchasing it, court records allege. Exactech denied the allegations in a court filing.

James Brooks, a retired Texas orthopedic surgeon, said in a court affidavit that he believed Exactech had an obligation to tell surgeons about the poor outcomes overseas rather than touting rosy results tied to doctors on its payroll.

In the 2021 affidavit, Brooks recalled implanting the Optetrak knee in a Dallas man in 2011, only to confirm from X-rays that it was failing in 2017 and needed to be replaced two years later. Brooks said he would have steered clear of Optetrak had he known of its “much higher failure rate than comparable products.”

Clicking Sounds

Laura Grandis is suing Ohio orthopedic surgeon and Exactech consultant Ian Gradisar, who received $132,720 from the company, including research payments, from 2013 through 2022, according to government records.

Gradisar’s father, Ivan, also an orthopedic surgeon, served on the original Optetrak design team. In 2008, Ian Gradisar helped his father with an audit of “patient outcomes” commissioned by Exactech. The audit showed that 12 of 47 Optetrak patients operated on over the course of 15 months required revisions, giving the son “first-hand knowledge of the failing and defective Optetrak,” Grandis alleges in her suit.

Ian Gradisar put an Exactech implant in Grandis’ left knee in Akron, Ohio, in November 2020.

In early 2021, she had “severe” pain in her knee and needed a cane or a walker to get around, according to the suit.

Gradisar told her the knee had failed, which he said was “very rare and only happened 5% of the time,” according to the suit.

Grandis had revision surgery in July 2021 with an Optetrak implant. Some seven months later, she felt pain that worsened throughout the day. She tried ice and rest, but that did not work. Her knee hurt when she put weight on it and started making a clicking sound when she moved, according to the suit.

In June 2022, Grandis received a “Dear Patient” form letter from the hospital where her surgery was performed notifying her of the Exactech recall.

Gradisar’s office told her the surgeon could not see her until October 2022 “as he was inundated with phone calls from patients about the Exactech recall,” according to the suit.

In response to the suit, Exactech denied the allegations, including that its knee implants had “increased failure rates.” The case is pending. Gradisar and his lawyer did not respond to requests for comment.

But in a court filing, Gradisar denied any defects in the implant and said he “provided quality care and treatment” to Grandis.

In December 2022, Grandis ended up having a second revision operation that kept her hobbling around on crutches for six weeks, according to her suit.

Total Recall

Two years after the initial recall, Exactech and its owners 鈥� past and present 鈥� face a rush of lawsuits demanding accountability for alleged patient injuries.

Most of the suits in the Alachua County group name Bill, Betty, and David Petty and Miller as defendants for their roles at Exactech. Their attorney did not respond to requests for comment, but in May, the defendants jointly filed a motion to dismiss, arguing that the suits fail “to allege sufficient facts to impose liability.”

Many suits in the federal court cluster also name as a defendant TPG Capital, a Texas-based private equity firm that paid $737 million to acquire Exactech in February 2018. TPG declined to comment but has filed a motion to dismiss the cases.

In one recall letter sent to surgeons, Exactech acknowledged that the data from the Australian registry confirmed that Optetrak had “statistically significant” higher rates of revisions than knee implants made by other companies 鈥� a conclusion it had previously disputed.

The letter adds that Exactech is “uncertain” if the packaging defect is the “root cause” of Optetrak’s poor performance. An issued in March said the agency is working with Exactech to assess whether other implants packaged in the defective bags pose similar risks.

Exactech lawyers say the company may not be to blame for every implant that wears out unexpectedly.

In a November 2022 hearing, Exactech attorney Michael Kanute said wear of polyethylene implant components is a “known risk no matter who makes them.” He said the patient’s size and activity level as well as the technique of the surgeons could also be factors.

“So every case is different,” he said.

蘑菇影院 Health News data editor Holly K. Hacker and reporter Megan Kalata contributed to this report.

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A needle inserted into her arm had fallen loose, breaking a circuit that the machine used to clean her blood. It was still pumping, drawing and filtering blood as designed, but the blood was now spilling into her bed instead of returning to her body.

Gedney, a leader of the , knew what to do. Armed with a decade of experience with hemodialysis, she calmly applied pressure to her arm and pressed a red button that turned off the pump. Her blood loss stopped. In the seconds her needle was loose, Gedney’s blood had soaked through her pajamas, bedsheets, and quilt.

“I sat up and looked down, and I was literally covered in blood,” said Gedney, 71. “It was a bloodbath.”

On that frightful night last year, Gedney survived a rare and very dangerous complication of hemodialysis 鈥� a venous needle dislodgment, or VND. About 500,000 Americans with kidney failure rely on hemodialysis to mimic the function of healthy kidneys by pumping their blood through an external cleaning machine. If the venous needle dislodges, the machine continues to pump and clean blood, but the blood escapes. The patient is methodically drained and, unless someone intervenes, can die in minutes.

By some estimates, at least one American is killed this way every week.

A relatively simple solution is available in Europe: An alarm detects blood loss with a disposable sensor patch, then automatically shuts off the dialysis pump. Dialysis companies in the United States have not embraced this fail-safe technology, so it is largely unavailable to Americans. The alarm costs $649 and each patch about $2.25. Neither is covered by Medicare, which insures most dialysis patients.

“That’s the ugly side of dialysis,” said Debbie Brouwer-Maier, a 40-year dialysis nurse and member of the American Nephrology Nurses Association’s VND task force. She said the dialysis industry resists “any item that’s going to improve care if there is added cost.”

“The patch is the problem,” Brouwer-Maier said. “It’s a disposable you have to buy without being reimbursed for every single treatment the patient does.”

Currently, most American dialysis treatment occurs in a nationwide network of clinics where patients sit in rows of chairs for hours at a time about three times a week. Only about 2% of patients undergo hemodialysis at home, sometimes with the aid of family or a caregiver.

But hemodialysis is changing: The Trump and Biden administrations promoted home dialysis with increased Medicare payments. A new generation of portable machines offer better results, more independence, and a lower overall cost to the government and insurers. Home patients can be treated more often or for longer periods, putting less stress on their bodies, and may find it easier to travel or keep a day job.

Dialysis experts and patient advocates interviewed for this article agreed that many hemodialysis patients, if carefully selected and thoroughly trained, would benefit greatly from the momentum toward home care. Some also worry that no amount of training could erase the increased threat of needle dislodgment for those who dialyze at home while alone or asleep.

“It is the widowmaker heart attack of dialysis,” said Ankur Shah, a Brown University nephrologist. “If you have a VND at home, and you go one or two minutes before you recognize it, you are now trying to intervene while you are physically going into shock.”

Shah’s concerns are shared by others. In 2020, the nurse association task force found that patients who do hemodialysis at home or while asleep “may be at higher risk.” ECRI, a nonprofit focused on health care safety, named needle dislodgments with a “particular concern” for patients at home. Both organizations said dialysis machines don’t reliably detect dislodgments, so blood pumps cannot be counted on to turn themselves off.

Ismael Cordero, an ECRI engineer who evaluates medical devices, said the absence of an automatic shut-off may also endanger patients in dialysis clinics, where a patient’s blanket could obscure a loose needle or staff members may not react in time.

Decades ago, Cordero witnessed a few dislodgments while working his way through college at a clinic in Pennsylvania. It was his job to mop up the blood.

“If that needle slips out, and no alarm goes off, and nobody notices, then within 10 minutes that patient would lose all of their blood,” he said.

Two companies make hemodialysis machines that the FDA has approved for home use.

Outset Medical, whose resemble a mini-fridge and were approved for home use in 2020, said in response to emailed questions that it has received no reports of VNDs among Tablo patients at home. The company said it believes VNDs may be more common or dangerous in a clinical setting than at home because staffers monitor multiple patients who are “frequently sleeping under blankets” and “completely disengaged from their treatment.”

“At home, a patient has been trained to manage themselves, including this rare event,” the company said in an email. “And despite the potential severity of the event, the treatment is simple and a procedure the patient performs every time they dialyze. Stop the blood pump.”

Fresenius, one of the world’s largest dialysis companies, which has sold for home use in the U.S. since 2005, declined to comment.

Despite the lethality of venous needle dislodgments, there is no accounting of how often they occur. The National Institutes of Health maintains but does not track VND events in clinics or at home. The Centers of Medicare & Medicaid Services requires dialysis companies to log them internally but not to report them to the government or the public.

But research shows they do happen. A 2017 study by researchers in Portugal reported among about 733,000 dialysis sessions in one year. A 2012 survey of more than 1,100 dialysis nurses reported that 76% witnessed a dislodgment in the prior five years, and 8% said they had seen five or more. A 2008 study of dialysis clinics run by the Veterans Health Administration found among 2.5 million sessions over a six-year span, including many that required hospitalization and some that were fatal.

, a Swedish company that makes dialysis safety products, estimates that needle dislodgment kills three Americans and 21 people globally each week. But these estimates are extrapolated from a mid-2000s study from a single Pittsburgh hospital 鈥� one of the few efforts in the U.S. to count them.

Redsense’s signature product is a stand-alone alarm system, used by some clinics and home patients in the U.S., Canada, Europe, and Australia. The system detects a needle dislodgment with a blood sensor patch, then sounds an alarm and flashes red lights to alert someone to turn off the pump.

But these alarms could be doing more. Since 2017, some Redsense alarms have also been able to send a signal that will automatically turn off a blood pump without human intervention. This fail-safe was requested by dialysis clinics in Europe, said Redsense CEO Pontus Nobréus, but it has never been submitted to the FDA for approval because no companies showed interest in using it in the United States.

Currently, no hemodialysis machine used in the U.S. is programmed to respond to the shut-off signal, Nobréus said.

“It hasn’t been used to its full potential, which is a pity,” Nobréus said. “We can send a signal to the machine, but the manufacturer has to have the software integrated to actually tell the machine to stop.”

Although Redsense alarms are not covered by Medicare, new legislation could change that. In May, Rep. Adrian Smith (R-Neb.) and Rep. Melanie Stansbury (D-N.M.) introduced the “,” which would extend Medicare coverage to VND alarms and related supplies for home patients only.

The bill was motivated in part by rural constituents who drive hours to dialysis clinics, Smith said, and he believes Medicare coverage lags far behind the latest dialysis technology.

“We want our public policy to be parallel with what technology can deliver,” Smith said, “and more than that, encourage innovation and more technology that will ultimately help patients.”

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Multiple lawsuits allege the device has caused grievous harm to at least 20 patients and the FDA is now investigating its safety, 蘑菇影院 Health News and CBS News have reported.

The AGGA is a retainer-like device promoted by some dentists as an option for expanding adult patients’ jawbones, beautifying their faces, and curing common ailments like sleep apnea. The lawsuits have alleged patients suffered damaged gums, eroded bone, and, in some cases, lost teeth.

The criminal investigation of the use of the AGGA was revealed in a court motion that seeks to delay the largest of the lawsuits “pending the outcome of any criminal proceedings.” The motion was filed this month by attorneys for AGGA inventor Dr. Steve Galella, his company, the Facial Beauty Institute, and AGGA manufacturer Johns Dental Laboratories, who said the investigation is being conducted “for the purpose of potentially bringing criminal charges” against their clients.

The attorneys said in their court filing that there is “no doubt” the investigation arose from the 蘑菇影院 Health News-CBS News coverage of the AGGA.

“The U.S. Attorney’s Office for the Western District of Tennessee and the U.S. Department of Justice is currently conducting a criminal investigation which, it is anticipated, will ultimately result in the presentation of evidence to a grand jury relating to the facts in this case,” the attorneys state in the court filing in support of the motion.

None of the court records suggests what criminal charges could result from the investigation.

The U.S. Attorney’s Office in Memphis, which generally does not discuss ongoing investigations, declined to comment. Scott Charnas, an attorney representing many AGGA patients, also declined to comment. Attorneys for Galella, the Facial Beauty Institute, and Johns Dental did not respond to requests for comment on Tuesday.

The AGGA, which was recently rebranded as the Osseo-Restoration Appliance, uses springs to apply pressure to the front teeth and upper palate, according to a patent application filed in 2021. Galella has said pressure from the device causes an adult’s jaw to “remodel” forward, which he described, in training footage produced in discovery in an AGGA lawsuit, as the key to possibly “curing” patients and making them more beautiful.

“You can sell good health. You can help people and at the same time you’re going to make a wheelbarrow full of money,” Galella tells dentists in the video footage. “And it’s all OK, and it’s all fair. We’re not cheating anybody and we’re not being greedy, but that just comes with the territory.”

The 蘑菇影院 Health News-CBS News investigation of the AGGA involved interviews with 11 patients who said they were hurt by the device 鈥� plus attorneys who said they represent or have represented at least 23 others 鈥� and dental specialists who said they’d examined patients who had experienced severe complications using the AGGA. The investigation also found no record of the AGGA being registered with the FDA, despite the agency’s role in regulating medical and dental devices. Galella has said in a that the device was never submitted to the FDA, which he believes wouldn’t have jurisdiction over it.

The FDA announced late last month that it is “evaluating safety concerns” about the AGGA and other similar devices.

Galella has declined to be interviewed by 蘑菇影院 Health News and CBS News. His attorney, Alan Fumuso, previously said in a written statement that the AGGA, “when properly used, is safe and can achieve beneficial results.”

All the AGGA lawsuits are ongoing. Galella and the other defendants have denied liability in court filings.

The plaintiffs do not allege in their lawsuits that Galella treated them but allege he or his company consulted with each of their dentists about their AGGA treatment.

CBS News producer Nicole Keller contributed to this article.

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The federal agency told the public in a “safety communication” posted on that it is looking not only at that product, the Anterior Growth Guidance Appliance, or AGGA, but other similar dental devices as well, including the Anterior Remodeling Appliance, or ARA, identified in a recent KHN and CBS News article.

The FDA said it is “aware of reports of serious complications with use of these devices” and asked that patients and health care providers report any complications experienced with them to the agency.

The agency said it is aware the devices have been used to treat conditions including sleep apnea and temporomandibular joint disorder of the jaw, also known as TMD or TMJ, but noted that “the safety and effectiveness of these devices intended for these uses have not been established.”

The AGGA device alone has been fitted on more than 10,000 dental patients, according to court records.聽

The KHN-CBS News investigation of the AGGA involved interviews with 11 patients who said they were hurt by the device 鈥� plus attorneys who said they represent or have represented at least 23 other patients 鈥� and dental specialists who said they’d examined patients who had experienced severe complications using the AGGA. The investigation found no record of the AGGA being registered with the FDA, despite the agency’s role in regulating medical and dental devices. The FDA confirmed Thursday that the devices “are not cleared or approved by the FDA.”

The AGGA’s inventor, Tennessee dentist Dr. Steve Galella, has said in a that the AGGA was never submitted to the FDA, which he believes wouldn’t have jurisdiction over it.

At least 20 AGGA patients have in the past three years filed lawsuits against Galella and other defendants claiming the AGGA did not 鈥� and cannot 鈥� work. Plaintiffs allege that instead of expanding their jawbones, the AGGA left them with damaged gums, loose teeth, and eroded bone.

Additionally, KHN and CBS News reported that the Las Vegas Institute, a company that previously taught dentists to use the AGGA, now trains dentists to use another device its CEO has described as “almost exactly the same appliance.” That one is called the Anterior Remodeling Appliance, or ARA.

KHN and CBS News reached out Thursday to attorneys for Galella, the Las Vegas Institute, and the manufacturers of the AGGA and the ARA but received no immediate response.

Galella has declined to be interviewed by KHN and CBS News. His attorney, Alan Fumuso, previously said in a written statement that the AGGA “is safe and can achieve beneficial results.”

All the AGGA lawsuits are ongoing. Galella and the other defendants have denied liability in court filings. Cara Tenenbaum, a former senior policy adviser in the FDA’s device center, said reports of complications from these devices are of critical importance and can be .

“Whether that’s a dentist, an orthodontist, a surgeon, a patient, family member, or caregiver,” Tenenbaum said in a recent interview, “anyone can and should submit these reports so the FDA has a better understanding of what’s happening.”

In a court deposition, Galella said he personally used the AGGA on more than 600 patients and has for years trained other dentists how to use it. In video footage of one training session, produced in discovery in an AGGA lawsuit, Galella said the device puts pressure on a patient’s palate and causes an adult’s jaw to “remodel” forward, making them more attractive and “curing” common ailments, such as sleep apnea and TMJ.

“It’s OK to make a crapload of money,” Galella told dentists in the video. “You’re not ripping anybody off. You’re curing them. You’re helping them. You’re making their life totally beautiful forever and ever.”

In its Thursday announcement, the FDA said it is aware the devices have been used “to remodel the jaw in adults” but pointed out that devices like these called “fixed (non-removable) palatal expanders” are generally used on children and adolescents, “whose upper jaw bones are not yet fused.” By contrast, the FDA said, “an adult’s upper jaw bones are fused, and when a fixed palatal expansion device applies force, the palate is resistant to expansion. If forces are applied incorrectly to the teeth, serious complications can occur including chronic pain, tooth dislocation, flared teeth, uneven bite, difficulty eating, damaged gums, exposed roots, bone erosion, and tooth loss.”

Patients interviewed by KHN and CBS News described experiencing many of those problems. One patient who has sued, former professional clarinetist Boja Kragulj, said specialists later had to pull her four front teeth. She now wears false teeth.

Reached Thursday, Kragulj said: “While it’s too late for me and many others, there is some comfort in knowing the FDA is investigating the AGGA/ARA/ORA product and its claims. I hope other patients are spared the injuries and lost years that many of us have now suffered.”

The FDA said it plans “to investigate potential violations” in connection with the use of the devices, and that it is “identifying and contacting responsible entities to communicate [its] concerns.”

The American Dental Association, which has 159,000 dentist members, said it “will inform dentists of the FDA’s evaluation, and will continue to monitor for FDA updates regarding these devices and issues.”

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Additionally, KHN and CBS News have learned that the Las Vegas Institute, a training company that previously taught dentists to use the AGGA, now trains dentists to use another device it has described as “almost exactly the same appliance.” That one is called the Anterior Remodeling Appliance, or ARA.

The FDA’s interest in the AGGA was revealed by Cara Tenenbaum, a former senior policy adviser in the agency’s device center who has said the FDA should investigate the product, which has been fitted on more than 10,000 dental patients, according to court records.

Tenenbaum said that after KHN and CBS News published their report, she was contacted by “very concerned” FDA officials who said they have begun “looking into” the AGGA but have yet to determine how much legal authority the agency has to regulate it.

“The FDA is looking at what authorities they may have around this device 鈥� what they may be able to do,” Tenenbaum said. “Now, of course, whether or not this device is FDA regulated, it still needs to be safe.”

KHN and CBS News have reviewed online messages verifying that an FDA official has communicated with Tenenbaum about the AGGA. The FDA declined to comment on the AGGA or confirm whether it was evaluating the device.

The KHN-CBS News investigation of the AGGA involved interviews with 11 patients who said they were hurt by the device 鈥� plus attorneys who said they represent or have represented at least 23 others 鈥� and dental specialists who said they’d examined patients who had experienced severe complications using the AGGA. The investigation also found no record of the AGGA being registered with the FDA, despite the agency’s role in regulating medical and dental devices.

The AGGA’s inventor, Tennessee dentist Dr. Steve Galella, has said in a that the device was never submitted to the FDA, which he believes doesn’t have jurisdiction over it. Tenenbaum has said the lack of registration is “incredibly problematic” because that is one method by which the FDA collects reports of a device’s negative effects.

She encouraged anyone who has witnessed complications from the AGGA to assist the FDA by .

“Whether that’s a dentist, an orthodontist, a surgeon, a patient, family member, or caregiver,” Tenenbaum said, “anyone can and should submit these reports so the FDA has a better understanding of what’s happening.”

Victor Krauthamer, a former FDA official who worked in a division regulating medical devices at the agency for three decades, said it was normal for an FDA probe of a device to begin by researching the boundaries of the agency’s authority, ensuring any future action has a solid legal foundation.

Krauthamer said he expects the FDA to take regulatory action against the AGGA, including to the manufacturer and potentially taking custody of the devices.

“At this point, I would be surprised if there wasn’t some sort of compliance action, such as a seizure,” Krauthamer said, adding later, “I think that’s probably where the FDA is 鈥� trying to make a case that will hold in court and won’t be thrown out.”

Jeffrey Oberlies, an attorney for AGGA manufacturer , said in an email that the company “looks forward to resolving the allegations against it” and declined to comment on the AGGA or the FDA’s interest in the device.

Galella said in his deposition he personally used the AGGA on more than 600 patients and has for years trained other dentists how to use the appliance. In video footage of one training session, produced in discovery in an AGGA lawsuit, Galella said the device puts pressure on a patient’s palate and causes an adult’s jaw to “remodel” forward, making them more attractive and “curing” common ailments like sleep apnea and temporomandibular joint disorder, or TMJ.

“It’s OK to make a crapload of money,” Galella told dentists in the video. “You’re not ripping anybody off. You’re curing them. You’re helping them. You’re making their life totally beautiful forever and ever.”

Dentists across the country have drawn from Galella’s teachings on their websites, often saying the AGGA can “grow,” “remodel,” or “expand” an adult’s jaw without surgery. At least 11 of those dentists’ websites appear to have removed any mention of the AGGA since the KHN-CBS News investigation was published March 1.

“I think that’s good to hear,” said Boja Kragulj, a former professional clarinetist who has that the AGGA did catastrophic harm to her teeth. “I think when you take away this information from patients that are searching for the appliance and seeing these claims, that’s generally a good thing.”

Kragulj is one of at least 20 AGGA patients who have in the past three years filed lawsuits against Galella and other defendants claiming the AGGA did not 鈥� and cannot 鈥� work. The plaintiffs allege that instead of expanding their jawbones, the AGGA left them with damaged gums, loose teeth, and eroded bone.

Some allege in lawsuits they will lose teeth because of the device and added in interviews that they no longer have enough healthy bone to replace those teeth with dental implants.

“I can take my finger now and I can literally wiggle my front teeth,” said Melanie Pappalardi, 28, who said she wore an AGGA for a year and filed a lawsuit in Indiana. “I can’t bite into absolutely anything.”

The plaintiffs do not allege in their lawsuits that Galella treated them but that he or his company consulted with each of their dentists about their AGGA treatment.

Galella has declined to be interviewed by KHN and CBS News. His attorney, Alan Fumuso, has said in a written statement that the AGGA “is safe and can achieve beneficial results.”

All the AGGA lawsuits are ongoing. Attorneys for Galella and his company, , have denied liability in court filings. Johns Dental Laboratories settled one lawsuit for an undisclosed amount but continues to fight allegations in the other cases. The , which previously held AGGA classes for dentists and , denied liability in court and has a to end claims in one lawsuit in which it is named as a defendant.

In a sworn deposition filed in that lawsuit, Las Vegas Institute CEO Dr. Bill Dickerson said that in 2020 he began to question the claims about what the AGGA could accomplish, then severed all ties with Galella.

However, that same year the Las Vegas Institute pivoted to the Anterior Remodeling Appliance, or ARA, according to by Dickerson. Dickerson has said in multiple Facebook posts over the past three years that the AGGA and ARA are very similar, including in a June 2021 post that described ARA as “almost exactly the same appliance.” He also said that most dentists associated with the Las Vegas Institute have switched to the ARA, which is made by a different dental laboratory than AGGA’s manufacturer.

“Different lab. Same thing,” Dickerson said in .

The Las Vegas Institute did not respond to requests for comment on the ARA. Institute attorney William Schuller has previously declined to discuss the ARA.

Dental specialists who have warned about the AGGA said they are also alarmed by the ARA.

Dr. Kasey Li, a California maxillofacial surgeon, and Dr. George Mandelaris, a Chicago-area periodontist, each of whom have said they’ve examined multiple patients harmed by the AGGA, said after looking at a photo of the ARA from the manufacturer’s website, it appears to be very similar to the AGGA.

“It is very similar to the AGGA,” Mandelaris said in an email. “Almost identical.”

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Five years ago, seeking to correct her bite and improve her breathing, Kragulj tried a dental device that she was told would put pressure on her upper palate, lengthening her jawbone to fix her issues without surgery, according to . Kragulj said she discovered the device through Facebook, and it sounded “miraculous.”

What she said happened next was ghastly. Kragulj alleged in her lawsuit that instead of changing her jaw, the device pushed her teeth forward through the bone that anchors their roots in place, which put her front teeth in jeopardy. Dozens of photos provided by her attorney show that over time her teeth bulged out of her mouth, warping her smile into a twisted mess. In the three years since filing her suit, Kragulj has had four unsalvageable teeth removed and two others ground to nubs, she said.

Now Kragulj’s only option is to undergo far more extensive surgeries than she faced before, according to her lawsuit. She described pain when eating anything that must be chewed and sometimes struggles to speak clearly through false teeth. And her livelihood is lost: Despite decades of training, Kragulj recently said she can no longer play clarinet well enough to perform or teach.

So now something I had only seen in very old studies that were published in black and white, on animals, I saw in my patients with 3D X-rays.

Dr. Marianna Evans, orthodontist and periodontist

More than 10,000 dental patients have been fitted with an Anterior Growth Guidance Appliance, or “AGGA,” according to court records. But the unproven and unregulated dental device, often costing patients about $7,000, has not been evaluated by the FDA, according to a months-long joint investigation by KHN and CBS News. The FDA relies on device companies to submit new products for evaluation, and because the AGGA was never submitted, it has been sold to patients without that government review.

“They’re still selling it. And still teaching classes. And still putting it in people’s mouths,” Kragulj, 42, said in an interview.

Dentists across the country promote the AGGA on their websites, often claiming it can “grow,” “remodel,” or “expand” an adult’s jaw without surgery, sometimes saying it has the potential to make patients more attractive and treat common ailments like sleep apnea and TMJ. However, after reviewing dental scans that the AGGA inventor submitted in court to prove the device works, eight experts told KHN and CBS News the scans show signs of the AGGA displacing teeth instead of expanding the jaw. Some experts said, based on their experience with former AGGA patients, the device caused tens of thousands of dollars in damage to the patient’s mouths.

Dr. Marianna Evans, a Philadelphia orthodontist and periodontist who has examined multiple AGGA patients experiencing pain or complications, said she was reminded of gruesome, decades-old experiments that intentionally displaced the teeth of monkeys and dogs to test the limits of orthodontia.

“These studies could not be done on humans because it was ethically wrong,” Evans said. “So now something I had only seen in very old studies that were published in black and white, on animals, I saw in my patients with 3D X-rays.”

At least 20 AGGA patients, including Kragulj, have in the past three years filed lawsuits detailing their complaints about the device, claiming it left them with flared teeth, damaged gums, exposed roots, or erosion of the bone that holds teeth in place. Some plaintiffs said in lawsuits they would lose teeth and added in interviews that they no longer have enough healthy bone to replace their teeth with dental implants.

Most of their lawsuits do not name the dentists who installed the device as defendants, but are filed against the AGGA’s inventor, its manufacturer, and companies that train dentists to use it, alleging they profit from false claims about a device that does not 鈥� and cannot 鈥� work.

All the AGGA lawsuits are ongoing. Attorneys for the inventor, , and the company he leads, , have in court filings denied liability and argued that plaintiffs were appropriately , including “teeth dying” or “removal of teeth.” The , which previously held AGGA classes for dentists and , denied liability in court and has a to end claims in one lawsuit in which it is named as a defendant. And the AGGA’s manufacturer, , has settled one lawsuit for an undisclosed amount but continues to fight allegations in the rest of the cases.

Galella, 70, a Tennessee dentist who invented the AGGA in the 1990s, declined to be interviewed after being contacted by phone, email, and in person. His attorney, Alan Fumuso, said in a written statement that Galella “had not been made aware of any complaints” about the device prior to the recent lawsuits.

“The [AGGA], when properly used, is safe and can achieve beneficial results for the patient,” Fumuso said. “This is not only the personal observation and experience of Dr. Galella, but also the experience of other dentists as well.”

The plaintiffs do not allege in their lawsuits that Galella treated them but that he or his company consulted with each of their dentists about their AGGA treatment.

For this article, KHN and CBS News journalists interviewed 11 dental patients who said they were harmed by the AGGA 鈥� eight of whom have active lawsuits concerning the device 鈥� plus attorneys who said they represent or have represented at least 23 others. In every case, the patients said in lawsuits or interviews that they were convinced the device would expand their jaws or improve their breathing and mistakenly assumed the AGGA would not be for sale unless it was proven safe and effective.

None of their jawbones expanded, the patients alleged in lawsuits and interviews.

The entire concept of this device, of this treatment, makes zero sense. 鈥� It doesn’t grow the jaw. It doesn’t widen the jaw. It just pushes the teeth out of their original position.

Dr. Kasey Li, maxillofacial surgeon and sleep apnea specialist

Leigh Peterson, 47, of Ohio, spent $7,000 on AGGA treatment in hopes of alleviating her TMJ, or temporomandibular joint disorder, which had caused her pain since she was a teen.

Within months of AGGA use, Peterson said, her teeth were so loose she could feel them move when rubbing moisturizer on her cheeks. Kissing her boyfriend became uncomfortable.

Peterson, who does not have an active lawsuit, said that according to a dental specialist she will need at least one round of bone grafts to stabilize her teeth.

“I feel like all I have to look forward to now is treatment and pain and fear and debt,” Peterson said. “And I just regret it. I wish I’d never done any of this.”

The AGGA, which was recently rebranded as the Osseo-Restoration Appliance, resembles a retainer and uses springs to apply pressure to the front teeth and upper palate, according to a patent application filed in 2021. The version of AGGA intended for adults is affixed to a patient’s molars, typically worn for several months, and must be removed by a medical professional. Galella said pressure from the device causes an adult’s jaw to “remodel” forward “to where the body really wants it to be,” according to video footage from one of his dentist trainings produced in discovery in an AGGA lawsuit. In the video, Galella describes this transformation as the key to “curing” patients and making them more beautiful.

“We fix the facial biology,” Galella said in the video.

However, in a series of interviews with orthodontists, periodontists, and maxillofacial surgeons 鈥� all of whom have more training than the average dentist 鈥� these experts said that while it is possible to expand the jaws of children without surgery, jawbones stop growing forward as people mature into adulthood. Experts who have examined patients fitted with an AGGA said the device aggressively moved teeth, sometimes creating an illusion of jaw growth by tilting some teeth forward and forcing gaps between others. In the worst cases, those experts have seen teeth shoved so far out of position that their roots are pushed free of the bone and into the gums.

Dr. Kasey Li, a California maxillofacial surgeon and sleep apnea specialist, last year published a study 鈥� the 鈥� describing loose teeth and bone loss among AGGA patients he has examined.

In an interview, Li described the AGGA device as “medieval” and said using it to try to expand a jaw is not unlike trying to make your house bigger by simply pushing on the wooden framing in the walls.

“The entire concept of this device, of this treatment, makes zero sense,” Li said. “It doesn’t grow the jaw. It doesn’t widen the jaw. It just pushes the teeth out of their original position.”

Rolling Out the AGGA

The AGGA device has been used on patients for about 15 years. Its biggest promoter is Galella, who operates out of a small, unremarkable clinic in a strip mall in the Memphis suburbs.

Galella said in a 2021 sworn deposition in one of the lawsuits that he has applied the AGGA to about 600 patients and prepared treatment plans for patients getting an AGGA from another dentist on about 9,800 occasions, collecting a “royalty” of $50 to $65 each time the device is made.

The Facial Beauty Institute has also taught an undisclosed number of dentists to use the device during three-day courses costing about $5,000, according to the company’s website. The Las Vegas Institute, also known as LVI Global, offered similar AGGA classes for years and lists on its website about 75 dentists across the U.S. and Canada who have taken that class.

Dave Hornblower, 36, of Ontario, who was fitted with an AGGA in 2019 by a dentist who trained at the Las Vegas Institute, , according to his lawsuit against the company, the inventor, and other defendants.

Hornblower said in an interview the AGGA did not improve his breathing and he now feels pain whenever he makes a “TH” sound, brushing his tongue against the back of his front teeth.

“My dentist said he’d went to courses, seen the evidence, and he seemed very sure of himself, so I was sure of him,” Hornblower said. “He told me it would do all that magical stuff, and I believed him.”

William Schuller, an attorney for the Las Vegas Institute, said in a phone interview that the Institute disputes claims the AGGA is “inherently dangerous” or “has no utility to adults.” Schuller said AGGA training is no longer offered at the institute and disputed that the institute ever taught dentists to use the device.

“I wouldn’t go so far as to say that LVI directly taught dentists to use the AGGA device ever,” he said. “LVI is a campus that provides the ability to teach courses in a variety of procedures and techniques. The doctors who taught the courses were associated with Dr. Galella. It was his course and his course materials that he prepared.”

However, according to , the AGGA training at the Las Vegas Institute was for years taught by the company’s “co-orthodontic directors,” Dr. David Buck and Dr. Timothy Gross. Buck said in that deposition he created lectures and wrote materials for the course, which were approved by Galella and the leadership of the institute, which kept 70% of the tuition paid for the trainings. A slideshow presentation from one of these training sessions, filed as an exhibit in another AGGA lawsuit, identifies Buck and Gross as “clinical instructor[s]” at the institute.

We are not aware of any peer-reviewed articles regarding AGGA working and we’re not aware of any peer-reviewed articles regarding AGGA not working.

William Schuller, attorney

When pressed during his deposition, Galella said he was or clinical trials demonstrating that the AGGA works as claimed on patients whose jaws have finished growing. Galella said his confidence in the device comes from years of using it on patients and dental scans he had not published.

“It proved it to me,” Galella said. “But for the rest of the world, I hadn’t posted anything. Sorry.”

Galella’s company has posted a that summarizes the theory behind the AGGA and contains one image from a dental scan of an unidentified, presumably adult patient that describes 1 to 3 millimeters of “outward relocation” of the upper jawbone after wearing an AGGA for four months. The paper says research on the AGGA “takes some time” and “we have begun this research in earnest.”

Schuller acknowledged the lack of peer-reviewed evidence behind the AGGA.

“We are not aware of any peer-reviewed articles regarding AGGA working,” he said in an interview, “and we’re not aware of any peer-reviewed articles regarding AGGA not working. So my understanding is that there is no literature to speak to it one way or the other.”

Faced with the lack of professional studies, a federal judge last year ordered Galella to turn over a sample of his dental scans. Galella was required to provide the plaintiffs with before-and-after scans from five patients over age 30 that demonstrate the AGGA is effective.

Those scans offer no proof, according to an expert witness enlisted by the plaintiffs. In a sworn affidavit filed with the court, , who leads the residency program at the Georgia School of Orthodontics, said Galella’s dental scans “” of the adult jawbones.

KHN and CBS News had those scans reviewed by eight independent experts, including orthodontists, periodontists, maxillofacial surgeons, and faculty from dental colleges at Columbia, Harvard, and the University of Florida. None of these experts was involved in any of the AGGA lawsuits at the time of their interviews.

Every expert had the same response: Galella’s scans showed patients’ teeth had moved but their jaws remained unchanged.

“It is proof,” said Dr. Richard Roblee, an Arkansas orthodontist who reviewed the scans. “Proof that the [AGGA] is not working correctly, not doing what they say. That is the proof that he has given.”

Roblee said he has examined at least 15 people he said were harmed by the AGGA and has never seen another dental technique cause “this much damage” to so many patients.

Dr. George Mandelaris, a Chicago-area periodontist and member of the American Academy of Periodontology Board of Trustees, said Galella’s dental scans show “harm” to the bone that holds teeth in place. Mandelaris said he has consulted with 11 AGGA patients, including Kragulj, who looked as if “a bomb went off in her mouth.”

Dr. Sercan Akyalcin, the head of orthodontics at Harvard, said the scans showed the patients’ upper frontmost teeth were pushed forward but did not show that their jawbones expanded.

Dr. Millie Embree, a professor of orthodontics at Columbia, and Dr. Anita Gohel, the head of oral radiology at the University of Florida, each said they saw that patients were losing teeth in the scans that Galella chose to validate the AGGA’s effectiveness.

“I’m a little surprised that this was the best evidence,” Gohel said. “I wonder what the rest is.”

The AGGA appears to be off the radar of the FDA, which is responsible for regulating medical and dental devices in the United States. Device manufacturers are supposed to register new products with the agency, and any devices that pose even a moderate risk to a patient can be required to go through a pre-market review to check if they are safe and effective.

In an emailed statement, the FDA confirmed it had no record of the AGGA being registered in its device database but would not comment on whether the device should have been registered or if it would be investigated. The agency would not say if it was aware of the AGGA prior to being contacted by KHN and CBS News.

The AGGA’s exclusive manufacturer, Johns Dental Laboratories, located in Indiana, said in a court document it has no record of communicating with the FDA about the AGGA before beginning to make or sell it. Johns Dental said in court the AGGA falls into the FDA’s least-risky classification for devices, similar to a dental retainer, and is exempt from a pre-market clearance under a statutory exemption for dental labs. Johns Dental attorney Jeffrey Oberlies declined to comment.

Galella said in his deposition that he believed the AGGA was outside of the FDA’s jurisdiction.

Cara Tenenbaum, a former senior policy adviser in the FDA’s device center, said the AGGA is within FDA jurisdiction and it was “incredibly problematic” that it was not registered, at least in part because that is how the FDA collects reports of negative effects.

If properly registered, Tenenbaum said, the AGGA might be classified with devices that reposition the jaw or prevent snoring, which are in a more tightly regulated category than what Johns Dental cited in court. Tenenbaum said the FDA was most likely unaware of the AGGA and she suspects it will investigate once alerted to allegations of patient harm.

Scott Charnas, a New York attorney who represents numerous AGGA patients, said he believed a more proactive FDA would have discovered and investigated the device years ago.

“It’s just going to go on and on unless someone does something about it,” Charnas said. “Somebody needs to step up.”

AGGA Inventor: 鈥業t’s OK to Make a Crapload of Money’

Both Galella and the Las Vegas Institute have said in dentist trainings that the AGGA can “cure” TMJ and sleep apnea, according to the AGGA training video footage and a slideshow presentation obtained from the ongoing lawsuits.

Galella is heard in the video telling dentists that customers are “gonna beat your door down” because the AGGA can cure patients instead of merely treating their symptoms. He says some patients who want to lessen their pain or improve their looks will “pay anything 鈥� anything! 鈥� to have that problem resolved.”

“It’s OK to make a crapload of money,” Galella tells dentists in the video. “You’re not ripping anybody off. You’re curing them. You’re helping them. You’re making their life totally beautiful forever and ever.”

Beauty was also a focal point of AGGA classes at the Las Vegas Institute, where the slideshow presentation features photos of celebrities and models. Images of decorated Olympic swimmer Michael Phelps and Princess of Wales Kate Middleton are shown as examples of the kind of unattractive, “underdeveloped midface” that the AGGA is claimed to correct. Middleton is specifically described as “remarkably not” beautiful.

“Why are we here?” reads the first page of the slideshow. “To treat ugly faces.”

The Las Vegas Institute frequently promoted the AGGA in where many of the patients interviewed for this story say they were first persuaded to use the device. The group outwardly appears to be a discussion space for people with jaw problems, and membership is controlled by the Las Vegas Institute.

“We were looking for this holy grail type of deal,” said Karan Gill, who wore an AGGA for months and alleges in a lawsuit his teeth were left loose and sensitive. “The people who were promoting the AGGA in these Facebook groups and such 鈥� that’s the way they were talking about it.”

Five former members described the Facebook group as a pro-AGGA echo chamber, where anyone who asked for proof that the AGGA works was hushed or banned.

“If you seek the truth outside, you will be excommunicated,” said Nick Hamilton, 40, a former member of the Facebook group who has . “I was asking too many questions. And I started talking openly with other people that were having issues. And they kicked us all out.”

A KHN-CBS News review of the Facebook group postings the past six years uncovered at least five posts in which Las Vegas Institute CEO Bill Dickerson said that the AGGA is “growing bone” or can “grow the maxilla,” which is another name for the upper jaw.

“[I]nstead of just moving teeth 鈥� we are growing bone 鈥� it’s awesome,” Dickerson wrote in a 2017 post about the AGGA in the Facebook group.

Dickerson has since changed his view. Last year, in a sworn deposition filed in an ongoing lawsuit, Dickerson said and agreed it would be misleading to say it could. Dickerson said in the deposition he began to question the claims of what the AGGA could do in 2020, and after reviewing some patients’ dental scans, he severed ties with Galella and the Facial Beauty Institute.

Kragulj, the clarinetist from the beginning of this article, said she discovered the AGGA through a Facebook video from Galella’s Facial Beauty Institute. According to her lawsuit, she got a device in 2018 and wore it for about 14 months, by which point she had sustained “irreversible” damage to the bone that holds her teeth in place.

Eventually, Kragulj sought help from the man who knew the AGGA better than anyone: Galella. She said she traveled to his Facial Beauty Institute for a consultation, expecting an elite academic facility but finding only a small clinic with aging wallpaper and broken equipment.

Kragulj said Galella looked in her mouth and, after an audible sigh, offered to fix her for $15,000 鈥� plus as much as $15,000 more per tooth. Galella confirmed that meeting and approximate cost in his deposition.

After the meeting, Kragulj decided she was done with Galella, according to her lawsuit. She said she returned to the traditional surgeons and specialists she once eschewed, and the first orthodontist she saw described her teeth as “the worst thing he’d ever seen.”

“They were hanging on by a thread, and the bone was gone,” Kragulj said in an interview. “So it was an extravagant process to get to a place where I could even have fake teeth.”

Kragulj said that since abandoning the AGGA treatment she had to remove four front teeth and was fitted with a dental bridge of false teeth. She said she will need surgery to fix the underlying problems in her jaw and will likely need to replace her upper teeth with prosthetics.

Her entire treatment will cost, by her estimate, a minimum of $150,000, followed by a lifetime of maintaining and replacing dental implants, she said.

Kragulj said it is unlikely she will ever play the clarinet professionally again and as of now she cannot play properly for even a minute without pain.

“My inner world is very silent,” Kragulj said. “It was my voice.”

CBS News producer Nicole Keller contributed to this article.

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