And then, just over a year after the ordeal, she read a Kaiser Health News investigation that described worse cases. KHN revealed that the Food and Drug Administration had allowed stapler maker Covidien to quietly file tens of thousands of reports of stapler malfunctions into a then-hidden database.

Alarmed that others had been harmed and reports had been hidden, Bonner, a retired Oakland, Calif., doctor, decided to go forward with a lawsuit against the stapler maker.

“If the information had been out there, then maybe Covidien would have changed the design of the staplers and made them safer,” she said, “and that would have obviated the problem in the first place.”

Bonner’s lawsuit is one example of how a vast cache of records that were released this summer are taking on a life of their own.

For almost 20 years, malfunctions and injuries linked to 108 medical devices, including dental implants and pacemaker leads, were funneled into an FDA database that few patients, doctors or even FDA officials knew existed.

In 2016, for example, Covidien reported 84 injuries or malfunctions in the public database known as MAUDE, while nearly 10,000 incidents flowed into the hidden database, KHN reported in March. A few MAUDE reports mentioned the existence of an “alternative summary reporting” program, but until this summer, the FDA made that internal data available only through the Freedom of Information process, which can take up to two years.

KHN’s investigation prompted then-FDA commissioner Scott Gottlieb to pledge in a tweet to open the hidden data to the public. The agency released all 5.7 million records in June.

Since then, researchers, lawyers and the FDA’s own officials have taken a closer look at the data to learn more about which devices malfunctioned, and how often.

Libbe Englander, the founder and CEO of Pharm3r, a medical data consulting firm, discovered that the devices in the hidden database were much riskier than other devices tracked by the FDA.

Her firm the hidden reports were “more likely to be associated with life-threatening devices and to contain potentially serious problems.”

For example, just 10% of the devices tracked in the MAUDE database are implanted in the body. But 44% of those in the hidden data are lodged in a patient’s body, including pacemakers and heart valves.

The Pharm3r report also found that the devices in the hidden data were more likely to be subject to a Class 1 recall, initiated when a device problem could cause serious injury or death. The report also underscored how vast the now-open data is ― accounting for about 40% of the total device-problem reports lodged with the FDA over the past two decades.

The once-hidden reports also figured into the ECRI Institute’s annual list of health technology hazards, a list circulated to hospitals and health systems.

ECRI found that this year’s No. 1 hazard was misuse of the surgical stapler ― which has been linked to 412 deaths, more than 11,000 serious injuries and nearly 100,000 malfunctions since 2011, according to the FDA.

“Most of these [stapler] reports had not previously been accessible to the public,” the notes. ECRI has advised doctors to have a backup plan in place in case a stapler malfunctions during surgery.

“If a hazard is getting a lot of attention, hospitals want to have a plan to address that,” said Rob Schluth, a senior project officer with the institute.

For Bonner, the problems with a surgical stapler became apparent just over a week after she had colon surgery in November 2017. Retired from a career as a hospital physician, she knew the steps to take toward recovery. But she felt nauseated all the time and could barely hold down water.

“I was trying to get up and walk,” she said. “I was doing everything, but I just got worse and worse.”

Doctors went in for a second surgery on Dec. 6 and found infected pus filling her abdomen. They routed her colon’s contents to be collected outside her body. It took additional surgeries to restore her colon function and address hernias caused by the procedures.

Bonner’s lawsuit alleges that a Covidien stapler caused her bowel leak and that the company, by not reporting malfunctions to the public database for years, “have hidden the true risks of using the device from surgeons and patients.”

In court records filed in the ongoing case, Covidien denied all of Bonner’s claims but did say that the FDA invited the company in 2001 to submit stapler malfunctions with quarterly “alternative summary” reports.

Medtronic spokesman John Jordan said the company does not have a comment on the pending legal case.

Other devices are under scrutiny. The once-hidden data showed more than 2 million problems with dental implants.

During an October on dental devices, an FDA official said her office was “taking a deeper dive and trying to identify lessons learned” from dental implant incidents.

Dr. Malvina Eydelman, of the Division of Dental Devices in the agency’s device branch, acknowledged that the number of events was “very high” and said her team was trying to develop a plan to share information with the public.

Also under scrutiny are the textured breast implants made by Allergan. The company’s Biocell implants, recalled in July, have 12 deaths and 481 of the 573 worldwide cases of “breast implant-associated” lymphoma, according to the FDA. Breast implant injuries and malfunctions accounted for nearly half a million reports in the hidden database, including implants that leaked, deflated or migrated.

Patients in Missouri, California, New York and Illinois have filed federal class action lawsuits against Allergan in recent weeks, each decrying the company’s heavy use of the “alternative summary reporting” program to file injury reports ― which were analyzed by the International Consortium of Investigative Journalists.

A class action case filed in Florida notes FDA rules say that alternative summary reports cannot include severe or unexpected events, “yet it is believed that these incidents were kept hidden in ASRs,” including at least one lymphoma case.

An ongoing federal securities lawsuit also alleges that Allergan used “inappropriately nonpublic” alternative summary reports, disregarding the “risk that some [lymphoma] cases would go undetected by the FDA.”

Allergan has not yet responded to the class action cases or to calls for comment. It denied the “threadbare” allegation in the securities lawsuit, citing the KHN article, which “makes clear that the filing of ASRs was permissible and even encouraged by the FDA to reduce ‘redundant paperwork.’”

While the FDA has ended the alternative summary reporting program, it opened the door for makers of more than 5,000 device types to file quarterly summaries of reported malfunctions. In each case, the device maker must file a public report to the MAUDE database noting how many reports were filed directly with the agency.

An FDA spokeswoman said the agency has stopped accepting summary reports of injuries cited in pelvic mesh lawsuits. The agency does continue to accept hundreds of death report summaries under a special exemption for devices tracked in a “registry” held by a specialty medical society.

“We are in the process of reviewing the effects of these changes and will continue working to improve the usability and transparency of information in the MAUDE database — whether that information was submitted as a summary or individual report,” FDA spokeswoman Stephanie Caccomo said in an email.

The release has not been as informative as Madris Tomes had hoped, she said, given that the FDA did not disclose data on how the devices harmed patients. Tomes is a former FDA manager who runs the company Device Events, which analyzes FDA data.

For instance, she said a breast implant injury report might say there was a “biocompatibility” problem, but it’s unclear what happened to the patient.

“Did it result in lymphoma or the patient needing a device replacement?” asked Tomes. “Without that outcome, we’re still a little bit in the dark on what this data means.”

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KHN had filed a series of FOIA requests, beginning in September 2018, seeking hidden reports of malfunctions or injuries tied to scores of medical devices. The FDA said fulfilling the requests would take up to 22 months and denied a KHN request for expediting the process because there was no “compelling need” to release the information.

In the meantime, KHN published a series of stories that showed more than a million reports had been filed to the hidden database, bypassing the public database known as MAUDE that doctors, researchers and patients rely on to spot problems with devices. Reports of malfunctioning surgical staplers, leaky breast implants and inaccurate blood glucose tests instead were sent to the agency as “alternative summary reporting” files.

In the wake of those news stories, the FDA announced it would shut down the alternative summary reporting program and release the data in the hidden reports, which it published online on June 21. In an emailed statement Wednesday morning, an FDA official said: “I believe this satisfies your FOIA request and the denial of expedited processing appeal, let me know if there are remaining issues to address, otherwise we will close your request and appeal.”

KHN had asked the FDA to expedite processing in April, citing a March 27 tweet by FDA Commissioner Scott Gottlieb, which stated, “It’s imperative that all safety information be available to the public. We’re now prioritizing making ALL of this data available.”

A FOIA officer responded a few days later to say KHN’s appeal fell under “unusual circumstances” and that the FOIA “office will need to consult with another office or agency that has substantial interest in the determination of the appeal.”

That was the last KHN heard from the FOIA office about this request until this week.

The hidden database released June 21 included 5.7 million incidents of malfunctions and injuries linked to medical devices over two decades. KHN analyzed this data and published five findings last week.

Read the original investigation:

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The newly acknowledged reports were detailed in an executive summary for FDA advisers. The agency convened a meeting of experts this week to help it determine whether surgical staplers should be moved out of its lowest-risk category — reserved for simple devices like tongue depressors and bandages — to a higher grade that may require testing and additional oversight. Surgical staplers are used to cut and seal vessels and tissues inside the body.

When the FDA initially announced the meeting in March, it acknowledged in that “many more device malfunction reports” were reported to the agency than it had publicly disclosed. The FDA executive summary published this week shows that the total reports more than doubled when the agency took nonpublic reports into account, totaling nearly 110,000 malfunctions or injuries from 2011 through 2018.

“It shocks the conscience,” said Chad Tuschman, a lawyer representing Mark Levering, 62, of Toledo, Ohio, who suffered a serious brain injury after a stapler malfunction caused massive bleeding in 2018. The surgeon, hospital and device maker Covidien, a division of Medtronic, have all denied allegations of wrongdoing in an ongoing legal case.

Surgical staplers have a unique ability to harm patients if they malfunction. Often used in minimally invasive surgeries, they are meant to both cut tissue and vessels and then quickly seal them. Patients have been gravely harmed when staplers have failed to fire or seal tissue, suffering from massive bleeding or infections if stomachs or intestines aren’t sealed properly.

The nonpublic reports were sent to the FDA as “alternative summary” reports, the topic of a recent Kaiser Health News investigation that focused on the agency accepting millions of hidden reports related to medical devices — including for surgical staplers.

The agency had previously acknowledged that in 2016, even as it posted fewer than 100 stapler-related injuries in a public database called MAUDE, it accepted nearly 10,000 reports into its little-known internal alternative summary reporting database. (The data in the FDA’s executive summary contains reports for staplers and staples, which experts have said were just different names for the same problem.)

Tuschman said he was stunned that there were more hidden reports than public ones in the executive summary. “The first question should be ‘Why?’ Why would they have the right to submit to a hidden database?”

Leading surgical stapler makers include divisions of Medtronic and Johnson & Johnson. Medtronic has said the FDA granted it exemptions for stapler-related malfunctions; Johnson & Johnson said it has not. (Ethicon is the name of its subsidiary medical devices company.)

On Thursday, the advisory panel recommended switching surgical staplers to a higher-risk classification with additional safety requirements, according to meeting attendee Jack Mitchell, director of health policy for the nonprofit National Center for Health Research. FDA spokeswoman Stephanie Caccomo declined to confirm this, citing a media office policy against telling reporters what happens at advisory committee meetings, which are open to the public.

“Every surgeon that I have ever worked with has had stapler failures,” said Dr. Doug Kwazneski, a Michigan surgeon who authored a survey in 2013 about “unacknowledged” stapler problems after searching the FDA’s public database of device incidents and coming up empty-handed.

“Going into something without data is dangerous,” Kwazneski said. “If the information exists, we should have access to it.”

More than 400 deaths have been reported since 2011 in the FDA’s public MAUDE database; fatalities can’t be reported to the alternative summary reporting database. Deaths were associated with Ethicon and Covidien products.

In recent communications about stapler safety to doctors, the FDA has advised against using the staplers on large blood vessels.

Kwazneski said surgical staplers are a time-saving tool, which lessens the risk of anesthesia complications during surgery, for example. But it’s important for physicians to remember they can fail.

Diana Zuckerman, president of the National Center for Health Research, said that alternative summary reports are “a well-kept secret” and that any reports related to their existence were “done in a way that was not understood as a repository for hundreds of thousands of serious adverse event reports.”

Mitchell said he was surprised the FDA didn’t reclassify surgical staplers “a long time ago,” considering the agency had the additional 56,000 alternative summary reports all along. “They were the only ones who had this information, and it was nonpublic.”

Kwazneski suspected that there were a high number of hidden reports for stapler malfunctions, but he said the numbers revealed in the FDA’s executive summary still came as a shock.

“The sheer magnitude of seeing it all at once kind of blew my mind,” he said.

Staplers lost their eligibility to report malfunctions through the hidden system in February 2019, and the FDA announced it would end the alternative summary reporting program earlier this month. It has promised to make that data public in the “coming weeks.”

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The Sprint Fidelis was prone to giving patients random electrical jolts — and sometimes failed to fire in genuine cardiac emergencies, according to manufacturer Medtronic’s .

What Sicklick and thousands of others in his position have not known is that the Food and Drug Administration quietly took steps to keep critical information out of the public light. Shortly after the recall, the FDA and Medtronic made a deal to keep reports about the widely used device’s malfunction incidents — now totaling 50,000 — shielded from public scrutiny.

The FDA has allowed device makers to file 1.1 million reports of injuries or malfunctions to a little-known internal FDA database since 2016, a recent Kaiser Health News investigation has found, spurring top FDA officials to pledge to open those records within weeks and shut down the “alternative summary reporting” program.

For the past two decades, the agency has granted various devices different types of so-called exemptions from reporting to their public-facing database, called MAUDE, KHN has found.

One of those exemptions covered the Sprint Fidelis. In May 2008, it was granted a “remedial action” exemption — allowed when “the manufacturer has initiated reasonable and appropriate actions to mitigate the problem(s)” and further reports of harm will not “provide any significant new data,” FDA spokeswoman Deborah Kotz said in an email. She said the FDA hasn’t granted such an exemption since 2015 and has “effectively ended the program,” and could not say whether that data would be opened to the public soon.

The logic of the FDA’s approach sits poorly with patients like Sicklick who have a Sprint Fidelis buried deep in their chests. “Worrying about it not working [has] caused a tremendous, tremendous amount of anxiety in me, and I’m not an anxious person,” said Sicklick, an allergy specialist from Long Island, N.Y. “I think the FDA should be making this information public.”

Six top cardiologists interviewed for this report said they weren’t aware the FDA had granted Medtronic such an exemption.

“Amazing. Really amazing,” said Dr. Robert Hauser, the Minnesota cardiologist whose research first brought the high rate of Sprint Fidelis failures to light. “It’s not in the best interest of the patients who have these devices.”

Hauser and other doctors have spent years helping patients navigate the risks of living with a cardiac implant that could harm them or undergoing a complicated device-removal surgery that could prove deadly.

The device is a pair of wires tied to a defibrillator designed to shock the heart back into a normal rhythm. By the time it was recalled in late 2007, the Sprint Fidelis had been implanted in the heart tissue of 268,000 patients.

While doctors and patients can voluntarily report problems with the device, the FDA requires device makers to report to MAUDE the injuries they become aware of — unless they have an exemption.

Through March, Medtronic says, it logged more than 50,000 instances of harm or malfunction, with more than one problem reported for some of the 35,000 cases.

While a few in the MAUDE database refer to the existence of an exemption for the Sprint Fidelis, the FDA has said these “remedial action” reports are filed internally and available to the public through a Freedom of Information Act request, which can take nearly two years to process.

Medtronic, which supplied data on the exemption for this story, said that its Independent Physician Quality Panel has been reviewing data on the device since 2007 and that the information has been periodically reported to physicians. “Patient safety is our top priority,” spokesman Jeffrey Trauring said in an email.

Trauring said his company operates the “most comprehensive [defibrillator] lead surveillance program in the industry.” He also said Medtronic has about the lead’s performance with the “most reliable data,” as compared with the FDA’s open MAUDE database and its “significant and well-established limitations.”

Kotz said via email that the FDA has “worked closely with Medtronic” to monitor the performance of the recalled leads and “ensure appropriate patient management recommendations are available to clinicians” in twice-yearly .

“[Medtronic provides] additional information on product performance and safety in a more comprehensive format than what we receive in summary reports,” Kotz said.

None of the Medtronic publications, though, offer details about the 50,000 malfunction and harm reports the company lodged with the FDA over 10 years. Those until-now-unacknowledged reports define the number of lead fractures or instances of inappropriate shocks.

The Medtronic reports less specific “advisory related events.” They also track more detailed malfunctions for a smaller number of devices either shipped back to the company or enrolled in a study.

Detective Work

A dozen years ago, before Sprint Fidelis was recalled, Hauser was a practicing cardiologist at the Minneapolis Heart Institute when two patients in one weekend arrived with fractured Sprint Fidelis leads. Hauser said he looked at the center’s files and found five similar cases.

Then he delved into MAUDE and found even more cases. He called Medtronic. He published a paper about what he had found, which he said “went viral.”

On Oct. 15, 2007, Medtronic issued a recall, saying the device gave some patients inappropriate shocks and was a “possible or likely” contributing factor in five patient deaths. The company later revised the death count to 13.

The thinnest defibrillator lead marketed to date, researchers said the Sprint Fidelis wires were prone to send faulty signals to the defibrillator, causing patient injuries.

In its 2007 , Medtronic advised against surgically removing the lead, citing rates of major complications, including death, ranging from 1% to 7%.

The recall was big news. Patients would testify to Congress or tell journalists about unexpected shocks that felt like a cannon to the chest or being kicked by a horse.

Then-House oversight committee chairman Henry Waxman fired off a week after the recall, in part asking about the company’s reporting of adverse events.

The agency acknowledged in a Dec. 13 response letter that Medtronic was reporting “the majority of adverse events” on their implantable defibrillators to the FDA “in aggregate electronically, via compact discs.”

Medtronic’s Trauring said at the time the company had an “alternative summary reporting” exemption for cases of lead infections or erosion, which meant the wires had moved out of position inside the body.

Six months later, on May 8, 2008, the FDA gave Medtronic a second exemption, allowing the company to report problems central to the recall outside of public scrutiny.

Trauring said in an email that under that second “remedial action” reporting exemption, Medtronic reported a total of 36,914 cases with 50,205 complications.

They include more than 22,000 instances of lead fracture and nearly 2,900 incidents of inappropriate shocks. Trauring said the company discontinued the summary reporting on Nov. 1, 2018, due to low volumes of issues.

Death cases were not filed with the reports granted exemptions. Since the 2007 recall, more than 2,300 reports of deaths in which the device was suspected to have played a role were filed with the FDA and are publicly available, records filed in MAUDE show. A 2009 report says one patient had 13 painful shocks and then bleeding during a surgery to remove his faulty lead. An attorney reported to the FDA that within months that patient died.

In 2012, a patient with a faulty device died after a major vessel was torn during a surgery to remove the lead. In 2015, a patient went to the emergency room after getting five shocks, was deemed to be in heart failure “exacerbation” and died in the hospital four days later, reports in MAUDE show.

Meanwhile, researchers trying to measure the harm resulting from the faulty device were reaching different conclusions. While Medtronic-backed studies were reporting a three-year lead survival rate of 95% to 97%, Hauser and his colleagues found a lower rate, 88%, according to in the Netherlands Heart Journal.

Dr. John Mandrola, a cardiologist at Baptist Medical Associates in Louisville, Ky., said the Sprint Fidelis was the “worst cardiac device problem” he has seen in 22 years of practice. He said some of his patients were traumatized by unexpected shocks and the repercussions went on for years. That the FDA did not publicly report ongoing harm “seems problematic to me,” he said. “What is the benefit to the public of an exemption?”

Dr. Frederic Resnic, cardiovascular medicine division chairman at Lahey Hospital & Medical Center in Burlington, Mass., and a Tufts University medical school professor, has testified to Congress about device safety. He said in an email that he commends the FDA for recent work to modernize safety surveillance for medical devices, but the “lack of communication and transparency” over the Sprint Fidelis exemption “challenges the FDA’s unique role as the primary, trusted, information source regarding medical device safety.”

Dr. Rita Redberg, a University of California-San Francisco cardiology professor and editor of JAMA Internal Medicine, said the FDA has acknowledged that device-related problems are woefully under-reported.

“Now the FDA is making it worse intentionally,” she said. “I can’t think of a justification for it, and I think it’s a dangerous practice.”

KHN data correspondent Sydney Lupkin contributed to this report.

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The agency said it will open past records to the public within weeks.

A Kaiser Health News investigation in March revealed that the obscure program was vast, collecting 1.1 million reports since 2016. The program, which began about 20 years ago, was so little-known that forensic medical device experts and even a recent FDA commissioner were unaware of its existence.

Former FDA official Dr. S. Lori Brown said ending the program now is a “victory for patients and consumers.”

“The No. 1 job of the FDA — it shouldn’t be ‘buyer beware’ — is to have the information available to people so they can have information about the devices they are going to put in their body,” Brown said.

FDA principal deputy commissioner Dr. Amy Abernethy and its device center director, Dr. Jeff Shuren, announced the decision to terminate the program in a statement on increasing transparency about the safety of breast implants.

The agency has for years allowed makers of breast implants to report hundreds of thousands of injuries and malfunctions out of the public eye, federal records show.

“We believe these steps for more transparent medical device reports will contribute to greater public awareness of breast implant adverse events,” Abernethy and Shuren said in a Thursday statement. “This is part of a larger effort to end the alternative summary reporting program for all medical devices.”

FDA spokeswoman Angela Stark said the agency will also end “alternative summary reporting” exemptions still in place for makers of implantable cardiac defibrillators, pacemakers and tooth implants. The FDA has said the program was originally designed to allow for more efficient internal review of well-known risks.

The agency said it began winding down the program in mid-2017, revoking many reporting exemptions, including those for saline breast implants and for balloon pumps used inside patients’ blood vessels.

At that point, the agency required device makers with ongoing exemptions to file quarterly reports in its public device-harm database known as MAUDE, short for the Manufacturer and User Facility Device Experience.

Still, FDA data provided to KHN shows that during the first nine months of 2018 the FDA continued to accept more than 190,000 injury reports and 45,000 malfunction reports under the hidden “alternative summary reporting” program.

Ronni Solomon, vice president and chief policy officer of the ECRI Institute, which studies device safety, said the staff uses the FDA’s open data on a daily basis to look for signals that might show heightened risks with a particular device.

“We think it’s really vital for the sake of transparency, for the sake of policy, for sake of science,” she said. “We’re really glad to see this, the sooner the better.”

The agency said its forthcoming data release will be for the alternative summary reports filed before mid-2017. The FDA for years reached agreements with makers of about 100 devices, allowing them to cease public reports of certain types of problems. The agency previously said the agreements and resulting records were available only by filing a Freedom of Information Act request, a process that can take months or even years.

Going forward, device makers will be required to file individual reports describing each case of patient harm related to a medical device.

The FDA has not said it will stop allowing device makers to file other types of device-harm exemption reports that are withheld from the public, such as when there is mass litigation over a device or when a company is submitting reports from an independent device-tracking registry. Nor has a plan been announced to open those records, which contain reports of harm related to pelvic mesh and surgical robots and reports of deaths related to several cardiac devices.

The FDA had granted Covidien, now a division of Medtronic, a long-standing “alternative summary reporting” exemption for its surgical staplers, a device used to cut tissues and vessels and quickly seal them during a variety of surgeries.

In 2016, when just 84 reports of stapler-related harm were disclosed in the FDA’s MAUDE database, almost 10,000 more malfunction reports were sent directly to the FDA’s in-house database, the agency acknowledged.

The device has been subject to numerous lawsuits over patient deaths and grave harm.

Doris Levering alleged in court that a stapler malfunction during liver surgery caused profuse bleeding that left her husband, Mark, 62, with serious brain damage and unable to walk. She applauded the agency’s decision to open the database. “It’s just wonderful to know that this information is going to be out in the open and not covered up,” she said. “Now doctors who need to find the information will be able to find it.”

The surgeon, hospital and device maker have all denied wrongdoing in an ongoing legal case.

The FDA a May 30 advisory board meeting to review the agency’s oversight of surgical staplers.

The FDA will leave in place a newer summary-reporting program that allows makers of more than 5,500 types of devices to send the agency spreadsheets logging device malfunctions. Unlike the “alternative summary reporting” program, device makers will not be allowed to report serious injuries using that approach.

Over the years, the FDA has had an uneven record of disclosing its “exemption” reports to advisers who review the safety of individual devices.

In February, FDA officials presented an advisory panel on gynecological devices with data showing 476 adverse events in 2017 related to a certain type of pelvic mesh. That panel was not briefed on nearly 12,000 reports filed by eight mesh makers in 2017, under a special exemption for lawsuit-related reports, according to an agency spokeswoman and a review of public records.

FDA spokeswoman Deborah Kotz said in an email that those “litigation” summary reports did not contain enough detail for the FDA to determine whether they shed any light on the safety question at hand.

The FDA ultimately took decisive action, though, ordering makers of the type of mesh under review to stop marketing those products, which were used to support sagging pelvic organs.

In late March, after KHN’s investigation landed, the FDA convened another panel to review breast implant-related injuries and a rare form of lymphoma. For that meeting, the agency did provide a full tally of previously unreported injury and malfunction reports related to breast implants.

As of Thursday, though, the agency said it would leave the textured breast implants linked to a rare lymphoma on the market.

Matt Baretich, a Denver-area biomedical engineer who advises health systems on device safety, is eager to examine the hidden reports as they’re released by the FDA.

“I’m really interested to see what information has been hidden so I can go back,” Baretich said. “I may have been looking for that information and not found anything and thought there was not a problem.”

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“We’re now prioritizing making ALL of this data available,” Gottlieb tweeted.

A recent Kaiser Health News investigation revealed the scope of a hidden reporting pathway for device makers, with the agency accepting more than 1.1 million such reports since the start of 2016.

Device makers for nearly 20 years were able to quietly seek an “exemption” from standard, public harm-reporting rules. Devices with such exemptions have included surgical staplers and balloon pumps used in the vessels of heart-surgery patients.

Gottlieb’s tweet also referenced the challenge in opening the database, saying it “wasn’t easily accessible electronically owing to the system’s age. But it’s imperative that all safety information be available to the public.”

The agency made changes to the “alternative summary reporting” program in mid-2017 to require a public report summarizing data filed within the FDA. But nearly two decades of data remained cordoned off from doctors, patients and device-safety researchers who say they could use it to detect problems.

Gottlieb’s announcement was welcomed by Madris Tomes, who has testified to FDA device-review panels about the importance of making summary data on patient harm open to the public.

“That’s the best news I’ve heard in years,” said Tomes, president of Device Events, which makes the FDA device-harm data more user-friendly. “I’m really happy that they’re taking notice and realizing that physicians who couldn’t see this data before were using devices that they wouldn’t have used if they had this data in front of them.”

Since September, KHN has filed Freedom of Information Act requests for parts or all of the “alternative summary reporting” database and for other special “exemption” reports, to little effect. A request to expedite delivery of those records was denied, and the FDA cited the lack of “compelling need” for the public to have the information. Officials noted that it might take up to two years to get such records through the FOIA process.

As recently as Friday, though, the agency began publishing previously undisclosed reports of harm, suddenly updating the numbers of breast implant malfunctions or injuries submitted over the years. The new data was , which is reviewing the safety of such devices. The panel, which met Monday and Tuesday, saw a chart showing hundreds of more accounts of harm or malfunctions than had previously been acknowledged.

Dr. Michael Carome, director of Public Citizen’s health research group, said his initial reaction to the news is “better late than never.”

“If [Gottlieb] follows through with his pledge to make all this data public, then that’s certainly a positive development,” he said. “But this is safety information that should have been made available years ago.”

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A recent Kaiser Health News investigation revealed that the FDA granted device makers numerous “exemptions” from the standard rules of publicly reporting harm related to devices.

One such program began about 19 years ago and allowed companies to file alternative summary reports about injuries or malfunctions into a database not visible to doctors, medical researchers or the public.

While the FDA pledged quickly to review the safety of one such device — the surgical stapler — researchers say the agency needs to open the data on scores of other devices, which have included mechanical ventilators and pacemaker electrodes.

“The FDA absolutely should be making all of this information available,” said Diana Zuckerman, president of the National Center for Health Research, who has testified to Congress and the FDA about device safety.

During a recent interview, FDA Commissioner Scott Gottlieb said that he had no immediate plans to release the device-safety reports, but that the matter is under review. In an updated statement Tuesday, he added that “we are looking at ways to make ASR [alternative summary reporting] data received prior to 2017 more easily accessible.”

“I think that the imperative of the agency is to make as much of this information available to the public as possible,” Gottlieb said during the interview last week. “I think these databases by and large should be searchable to the public.”

An agency spokeswoman said the FDA revoked most of the “alternative summary reporting” exemptions in mid-2017 and asked device makers who kept their exemptions to file a public report summarizing what information they’d send in a spreadsheet directly to the agency. That new approach doesn’t affect the hidden reports dating to 2000.

Agency data show that more than 2 million alternative summary reports have been filed since the start of 2014.

In a February for device makers, the FDA said summary reporting can streamline reporting for the industry and simplify the agency’s review process “while maintaining or enhancing the quality, utility, and clarity of MDRs [device reports] through a more holistic view of reportable event trends.”

Makers of about 100 devices filed reports that way over the years, and the FDA has not disclosed the reports’ content beyond responding to KHN’s questions about specific devices. Among the devices involved are implantable defibrillators and the staplers, which in 2016 were linked to under 100 public reports of harm, even as nearly 10,000 malfunction reports were filed discreetly within the FDA.

Asked for more detail on staplers and other devices with exemptions, the agency referred to the Freedom of Information Act process, which can take nearly two years.

That’s not soon enough for organizations like the ECRI Institute. Chief policy officer Ronni Solomon said the nonprofit does device-safety analyses for the government and evidence-based reports for hospitals and performs device-related accident investigations.

Having thorough data on device-related harm is key on all fronts, she said, noting that the organization is exploring ways to get access to more FDA data.

Dr. Alan Shapiro, an associate professor at the New York University School of Medicine who has used the agency’s public device-safety database, called MAUDE, in his research, said paring down patient-safety data and keeping it in-house is the wrong move in the current era of artificial intelligence and automation.

He noted that an important safety tenet in hospitals is: the more eyes on the patient the better. He said there’s a clear parallel to the work researchers do with agency data to identify device-safety lapses.

“The FDA isn’t so capable that they can afford to hide data,” he said.

Hani Elias, chief executive of Lumere, said his consulting company uses the open FDA device data to advise health systems across the nation on device safety for purchasing decisions. He co-founded the company after seeing hospitals make device-buying decisions based on the effectiveness of the sales force rather than on quality and safety.

“There’s a lot of benefit in opening up this data,” Elias said.

Among the benefits of greater transparency would be the peer pressure among device makers — stripped of reporting exemptions — to make their products safer.

“You don’t want to be the people known for the products known for hurting people,” said Alan Card, an assistant professor and patient-safety researcher at the University of California-San Diego School of Medicine.

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In 2018, the FDA approved a new pathway for makers of 5,600 device types to file malfunction reports in summary format. That program relieves the device makers of seeking a special exemption. It requires one public report detailing a novel or unique type of malfunction. Information about subsequent, similar malfunctions can be sent straight to the FDA in a spreadsheet.

The agency has also quietly granted device makers other summary-reporting exemptions for injury information gleaned from litigation and from device-specific registries used for research. Device makers filing such reports also have to file a public report summarizing the data that is sent directly to the FDA and isn’t readily available to the public.

Agency records show that some cardiac device makers have filed hundreds of death reports under the registry exemption. The FDA confirmed that nearly 12,000 litigation summary reports related to injuries associated with pelvic mesh were filed in 2017 alone.

Prior to the KHN investigation, Zuckerman said she was aware the FDA granted reporting exemptions but the sheer number of reports “takes my breath away.”

In the interview, Gottlieb said he “wasn’t aware of the full scope of the reports that weren’t going into MAUDE.” Gottlieb has announced his resignation; his last day will be April 5.

Card also said the KHN report was a surprise, but now that it’s out, it’s time for the FDA to open the records to help doctors and patients make the safest choices. “There are a lot of people out there who are trying to make reasonable decisions on data that isn’t what it was purported to be,” he said.

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In a letter sent to Friday, the FDA said it will convene an advisory meeting on the safety of the devices and signaled that it might reclassify surgical staplers to put them under tighter control. The agency also said it plans to issue proposed recommendations to companies that make the devices, which are used in countless surgeries.

The FDA also acknowledged in its letter that “we are aware that many more device malfunction reports during this time frame” were submitted as “summary reports,” which go to the FDA but are not included in the public database known as MAUDE (the Manufacturer and User Facility Device Experience). The agency said it “is conducting an analysis” of those summary reports and the results will be made available to the public.

The KHN investigation found that in 2016 alone nearly 10,000 surgical stapler malfunction reports flowed into the internal FDA database that few patient-safety experts who were contacted knew existed. The public database that year disclosed fewer than 100 injuries or malfunctions.

The secretive reports on staplers were part of a much broader FDA program, collectively called “alternative summary reporting.” Since the start of 2016, more than 1.1 million serious injury or malfunction reports went into the internal database instead of being disclosed in detail in MAUDE, which is widely used by doctors and researchers to track problems.

The FDA has said “about 100” devices have had special exemptions to report incidents that way but confirmed the identity of only a few devices to KHN. The agency said it revoked most of the reporting exemptions in 2017 as a new summary-reporting program took shape and asked device makers to file reports noting publicly that summary data was being submitted in addition to data that would be kept inside the agency.

The news report highlighted the work of Dr. Douglas Kwazneski, who experienced a stapler malfunction then turned to FDA data and saw “there was nothing” — a surprise that at the time “seemed like a cover-up,” Kwazneski said.

Surgical staplers cut and seal blood vessels and tissue, often during minimally invasive surgeries. When the staplers fail to fire, patients have bled profusely and suffered dire injuries or death. The FDA said stapler malfunctions or misuse can lead to “bleeding, sepsis, tearing of internal tissues and organs, increased risk of cancer recurrence, and death.”

The FDA has granted reporting exemptions over the years for both surgical staplers and staples, agency records show.

Stapler maker Medtronic confirmed that its reporting exemption for surgical staples ended in mid-2017. FDA records show that its public reports of injuries and malfunctions soared, from about 1,000 in 2015 to 11,000 last year. Ethicon, which also makes staplers, said it has not used the reporting exemption.

In the agency’s Friday announcement, Dr. William Maisel, chief medical officer in the FDA’s Center for Devices and Radiological Health, said the agency’s review of stapler incidents is ongoing. “But we know these devices provide important benefits for patients undergoing surgery, so it’s important for us to continue to educate providers about the devices’ safety and risk.”

“Improving the safety of surgical staplers and implantable staples is a top priority for the FDA, and we believe our forthcoming draft guidance to industry and planned advisory committee meeting will advance those efforts,” Maisel said.

The agency’s announcement said that public reports of harm by staples and staplers show “that from January 1, 2011 to March 31, 2018, the FDA received more than 41,000 individual medical device reports for surgical staplers and staples for internal use, including 366 deaths, more than 9,000 serious injuries, and more than 32,000 malfunctions.”

The agency also said that changing the classification of surgical staplers could allow the agency to require “performance testing of various mechanical features” and special labeling.

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Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up.

Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and “there was nothing,” he said. Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. Such failures can have deadly consequences.

Kwazneski had no idea the FDA had quietly granted the makers of surgical staplers a special “exemption” allowing them to file reports of malfunctions in a database hidden from doctors and from public view.

“I don’t want to sound overdramatic here, but it seemed like a cover-up,” said Kwazneski, who practiced in Pasco County, Fla., from 2016 through earlier this year.

The FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions, a Kaiser Health News investigation shows. Since 2016, at least 1.1 million incidents have flowed into the internal “alternative summary reporting” repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could put patients in jeopardy.

Deaths must still be reported in MAUDE. But the hidden database has included serious injury and malfunction reports for about 100 medical devices, according to the FDA, many implanted in patients or used in countless surgeries. They have included surgical staplers, balloon pumps snaked into vessels to improve circulation and mechanical breathing machines.

An FDA official said that the program is for issues that are “well-known and well-documented with the FDA” and that it was reformed in 2017 as a new voluntary summary reporting program was put in place for up to 5,600 devices.

Yet the program, in all its iterations, has been so obscure that it is unknown to many of the doctors and engineers dedicated to improving device safety. Even a former FDA commissioner said he knew nothing of the program.

KHN pored over reams of public records for oblique references to reporting exemptions. After months of questions to the FDA, the agency confirmed the existence of reporting-exemption programs and thousands of never-before-acknowledged instances of malfunctions or harm.

Amid the blackout in information about device risks, patients have been injured, hundreds of times in some cases, lawsuits and FDA records show.

“The public has a right to know about this,” said Dr. S. Lori Brown, a former FDA official who accessed the data for her research. She said doctors relying just on the public reports — and unaware that many incidents may be omitted — can easily reach the wrong conclusion about the safety record of a particular device.

The FDA has also opened additional — and equally obscure — pathways for device makers to report thousands of injuries brought to light by lawsuits or even deaths that appear in private registries that medical societies use to track patients. Those exemptions apply to risky and controversial products, including pelvic mesh and devices implanted in the heart.

FDA spokeswoman Deborah Kotz confirmed that the “registry exemption” was created without any public notice or regulations. “Any device manufacturer can request an exemption from its reporting requirements,” she said in an email.

Agency records provided to KHN show that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017 alone.

Alison Hunt, another FDA spokeswoman, said the majority of device makers’ “exemptions” were revoked that year as a program took shape that requires a summary report to be filed publicly.

More than a million reports of malfunctions or harm spanning about 15 years remain in a database accessible only to the FDA. But with the agency’s new transparency push, the public may find a public report and submit a Freedom of Information Act request to get information about incidents. A response can take up to two years.

The long-standing exemption program “has allowed the FDA to more efficiently review adverse events … and take action when warranted without sacrificing the quality of our review or the information we receive,” Hunt said in an email.

To those outside the agency, though, the exceptions to the reporting rules are troubling. They strike Madris Tomes, a former FDA manager, as the agency surrendering some of the strongest oversight and transparency powers it wields.

“The FDA is basically giving away its authority over device manufacturers,” said Tomes, who now runs Device Events, a website that makes FDA device data user-friendly. “If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of these devices.”

Doctors, like Kwazneski, who have turned to the public data to gauge the risks of surgical staplers have seen little. He the “unacknowledged” problem of stapler malfunctions in a 2013 article in the journal Surgical Endoscopy. In 2016, while reports of 84 stapler injuries or malfunctions were openly submitted, nearly 10,000 malfunction reports were included in the hidden database, according to the FDA.

Device maker Medtronic, which owns stapler maker Covidien, as the market leader in surgical staplers. A company spokesman said that the firm has used reporting exemptions to file stapler-related reports through July 2017. Ethicon, the other major stapler maker, said it has not.

The public database shows that Medtronic has reported more than 250 deaths related to staplers or staples since 2001.

Mark Levering, 62, nearly lost his life after a stapler malfunction early last year, according to a lawsuit filed by his family. His surgeon has testified that a surgical stapler misfired during his liver surgery at ProMedica Toledo Hospital in Ohio.

Staff performed CPR for 22 minutes while surgeons rushed to suture the severed vein. He emerged from a coma unable to walk or consistently recognize his wife and son. The surgeon, hospital and device maker Covidien have denied allegations of wrongdoing in an ongoing legal case.

Told of the reporting “exemption” for surgical staplers, his wife, Doris Levering, was incredulous.

“Why would this information not be made available to doctors? The true information — I mean the actual numbers …” she said. “People’s lives are at stake. Mark’s life will never be the same.”

The Stapler Problem

The sheer number of malfunctions made surgical staplers an easy pick for the new alternative summary reporting program at its inception nearly 20 years ago, according to Larry Kessler, a former FDA official and now a University of Washington health services professor.

Surgical staplers have a unique ability to help — or harm — patients. The device is designed to cut and seal tissues or vessels quickly, often during minimally invasive surgeries. When it fails to seal a major blood vessel, medical staff can quickly shift into “code blue” mode to rescue a patient from bleeding to death.

The severity of some of the injuries caught former FDA official Brown’s attention in the early years of its reporting exemption. Her on stapler mishaps, published in the Journal of the American College of Surgeons, accounts for one of the few places in public records where an FDA authority mentions the “alternative summary” program. She found that in the first 28 months of filing to the hidden database, stapler makers filed more than 5,100 reports of malfunctions or injuries.

She also noted that the publicly reported 112 stapler-related deaths in patients aged 22 to 91 from 1994 to 2001 were a “reason for concern.”

In the public data filed since, it would appear that the staplers rarely misfire. In 2011, only 18 injury or malfunction reports were filed publicly. Last year, the number was 79.

Lawsuits detail how quickly a stapler failure can turn a smooth surgery into a catastrophe.

In Michigan, Eugene Snook’s surgeon was in the process of removing part of his lung when he cut but couldn’t seal a major vessel due to a “stapler malfunction,” the surgeon said in sworn court testimony. Snook, then 59, had no detectable blood pressure for four minutes during the 2012 surgery.

The damage to Snook’s artery was so great, his surgeon decided to remove his lung completely, medical records filed in court say. Snook sued stapler maker Covidien, which in court records said there was no proof the stapler was unsafe when it left Covidien’s control and also that the surgeon used it improperly. The case reached a confidential settlement in 2017.

Another surgeon attempting to remove a benign liver growth from April Strange, 33, in 2013, testified that a stapler malfunction caused the woman to bleed to death. Strange, of central Illinois, left behind a husband and two daughters, then 6 and 8.

The stapler was thrown out after surgery, court records say. Covidien argued in court records that Ryan Strange couldn’t prove that the stapler had a specific defect.

Covidien reached an agreement to settle the family’s claims for $250,000, part of a larger settlement in the case.

Doctors initially thought Mark Levering had liver cancer. So when the diagnosis came back as an abscess that needed to be surgically removed last February, it came as a relief to his wife, Doris.

That relief turned to dread the day of surgery. The procedure was supposed to last two hours, she said. But the surgery hit a snag when the stapler “misfired,” according to the surgeon, causing so much bleeding that the minimally invasive procedure was converted to an open procedure so the doctor could suture the vein.

Levering underwent CPR for 22 minutes. A code blue was called, a nurse testified. Levering lost 3 quarts of blood — about half the blood in his body. He was put on life support and would remain in a coma for weeks.

After Levering reopened his eyes, it was clear that the man who used to tend to stray cats and enjoy dinner out with his family was gone. Levering could no longer walk, comb his hair or recognize the letters of the alphabet.

Doris and Mark Levering have sued the doctor, hospital and surgical stapler maker, alleging that the device caused Mark’s bleeding and brain injury. The surgeon has acknowledged in sworn testimony that the stapler malfunctioned, but denied other wrongdoing. The hospital said in a legal filing that its actions were “prudent, proper” and “lawful.”

Covidien denies any defect with the stapler or that it caused Levering’s injuries. A spokesman for parent company Medtronic declined to comment further on any lawsuit but said that “we always make patient safety our top priority” and that the company complies with FDA requirements.

The company’s reports of stapler problems in the public database remain relatively low. But in 2018, with the reporting exemption gone, a spike of reports emerged for Covidien’s staples — not to be confused with staplers. While Medtronic reported 1,000 staple malfunctions or injuries in 2015, the number soared to 11,000 for 2018.

Rolling Out The Program

The alternative summary reporting program started two decades ago with a simple goal: to cut down on redundant paperwork, according to officials who were at the FDA at the time.

Kessler, the former FDA official, said the program took shape after scandals over under-reporting of device problems spurred changes allowing criminal penalties against device companies.

Soon, thousands of injury and malfunction reports poured into the agency each month, with about 15 staff members dedicated to reviewing them, Kessler said. Many reports were so similar that reviewing them individually was “mind-numbing.” Kessler went to the FDA’s legal department and to device manufacturers to propose a solution.

Device makers would be able to seek a special “exemption” to avoid reporting certain complications to the public database. The manufacturers would instead send the FDA a spreadsheet of injury or malfunctions each quarter, half-year or year.

That way, Kessler said, reviewers could quickly look for new problems or spikes in known issues. When the program launched in 2000, the list of exempted devices was made public and only a few devices were involved, Kessler said.

“I don’t know why it’s not [made public] now,” he said. “I’m surprised about that.”

Starting in September, KHN filed Freedom of Information Act requests for “exemption” agreements and reports for several medical devices. Health and Human Services officials denied an appeal to provide some of the records quickly, concluding there was no “compelling need” for haste. For one request, the records were estimated to arrive in 22 months.

The FDA did provide some top-level data. It shows that from 2014 through 2017, the overall number of alternative summary reports filed by device makers rose from 431,000 to 481,000.

The FDA declined to provide a complete list of “about 100” devices that have been granted reporting exemptions over the years, but confirmed that exemptions have been used for mechanical breathing machines and balloon pumps, known as intra-aortic balloon pumps, inserted in the vessels of people with circulation problems.

An FDA spokeswoman said “alternative summary” exemptions remain in place for pacemaker electrodes and implantable defibrillators.

Matthew Baretich, a biomedical engineer in the Denver area, said he helps several area health systems analyze device-related patient injuries and make equipment-purchasing decisions.

He said he regularly scans the FDA’s public device-injury reports. Asked about “alternative summary” reports, he said, “I’ve got to tell you, that’s a new term to me.”

Bruce Barkalow, president of a Michigan-based biomedical engineering firm, said he’s the guy government officials, attorneys or device makers call if someone gets a pacemaker and dies in the shower three days later.

In an interview, he said he was not aware of the reports, either. He said they may appear to the FDA to be a “nothing burger,” but the data would be meaningful to his forensic investigations.

The ECRI Institute, a nonprofit leader in medical device safety, declined to provide an engineer for an interview. Educating hospital leaders and health providers, the institute issues an annual “Top 10” in medical technology hazards. Its tagline: “Separating fact from fiction in healthcare.”

Among the institute’s “top medical device subject matter experts,” spokeswoman Laurie Menyo said in an email, “none of them had any familiarity with FDA’s Alternative Summary Reporting Program.”

Even Dr. Robert Califf, former FDA deputy commissioner and commissioner from 2015 to 2017, said in an interview that he was unaware of the program. “Never heard anything about it,” he said. “It’s interesting.”

Companies that get the exemptions tend to be very “tight-lipped” about them, said Christine Posin, a former device firm manager and consultant to device companies.

The relative secrecy around the program can give them an advantage, she said. For instance, sales representatives can print out only the public reports of device problems, ignoring what’s buried elsewhere.

That creates a business opportunity to persuade a doctor to try a different device. “‘We have a good product that does the same thing,’” Posin said a sales representative might tell a physician.

Exemptions Multiply

The FDA has spent millions, convened experts and pledged to improve its work in device safety in recent years. All the while, it has quietly opened new avenues for the makers of controversial and risky devices to file injury and even death reports with little public review.

Pelvic mesh is one example. The fabric-like device has long been used to hold up pelvic organs in women experiencing organ prolapse. In 2011, the FDA issued a “” saying “serious complications” like pain or infection were “not rare.”

The agency soon reclassified the device, ordered safety studies and saw most mesh makers remove the device from the market.

Behind closed doors, though, the agency has since granted pelvic mesh makers a special exemption from reporting injuries to the public, according to the FDA and mesh makers who were asked about the practices.

Under what the FDA calls the “litigation complaint summary reporting” exemption, device makers can file a single “injury” report. Attached to the summary report, device makers have sent the FDA a spreadsheet with as many as 1,175 reports of patient injuries, based on allegations in lawsuits.Ìý

To someone tallying the overall number of injuries related to pelvic mesh, the report would appear as a single injury. It would take a sharp eye to find the summary report and a special request — taking up to two years to be filled — to get the details cases submitted directly to the FDA.

According to the FDA, in 2017 alone, eight mesh makers used their exemptions to send nearly 12,000 injury reports to the FDA.

Dr. M. Tom Margolis, a urogynecologist in the San Francisco Bay Area and an expert medical witness for those who are suing mesh makers, said a program that might hinder doctors relying on open FDA data to assess the risks of mesh is “horrible” and “unethical.”

“We need to know the good and the bad,” said Margolis, who treats patients in his urogynecology practice. “If you’re trying to hide complications from me, well that’s … wrong, my God, it’s heinous.”

The FDA issued the same kind of exemption to the makers of da Vinci surgical robots months after Johns Hopkins University School of Medicine that the company was filing a notably small number of injury reports in the public database. Johns Hopkins professor Dr. Marty Makary noted in 2013 that the handful of reports sent to the FDA at the time were signs of a “haphazard” system that is “not independent and not transparent.”

Within months, the FDA allowed the makers of the robots to , noting that a spreadsheet sent straight to the FDA summarizes about 1,400 injuries alleged in lawsuits, with some injuries dating to 2004. Since then, the device maker has reported smaller batches and 130 injuries at a time.

“This is very frustrating,” said Homa Alemzadeh, an assistant professor of computer engineering at the University of Virginia who is working with MAUDE data to create software to identify errors in real time or before they happen in surgeries performed by robots. She said she was not aware of the reporting exemption.

Under another reporting exemption, the FDA is allowing device makers to report hundreds of death cases in spreadsheets sent directly to the agency.

Under the “registry exemption,” device makers can summarize what they learn from registries that tend to be held by specialty medical societies, and track the use of a certain kind of device, according to FDA spokeswoman Kotz.Ìý

Kotz said the data in registries often falls short of the level of detail that the FDA seeks for the more thorough death reports that device makers are required to file.

Device makers filing such reports include Edwards Lifesciences, which makes the Sapien 3 valve that’s snaked through a vessel and implanted in the heart. Some hail the device as a breakthrough for saving patients from the trauma of open-heart surgery to replace a valve. Others raise concerns over limited data showing how long the valve .

The summary reports offer potential patients few answers. Such reports document as many deaths or in a single filing, with virtually no detail readily available to the public. In all, Edwards has filed more than 1,800 Sapien 3 valve patient deaths as summaries since 2016.

Edwards spokeswoman Sarah Huoh said in an email that the FDA mandated the tracking of every patient who has the valve in the registry to provide “comprehensive evidence for device safety.”

“The approval of alternative reporting protects against duplicate reports coming from multiple sources,” Huoh said.

Another device, the MitraClip, is used to attach two flaps in the heart that are allowing blood to flow backward. The device has been controversial, with some scientists saying it is crucial for a certain subset of patients, and others pointing to the to the heart.

The FDA has allowed Abbott Vascular, which makes the MitraClip, to report as many or in a single filing, also shipping the details straight to the agency, FDA records show.

An Abbott spokesman said in an email that the company has done clinical trials with thousands of patients to establish the MitraClip’s safety. He said the exemption was granted because data in the registry was stripped of patient identifiers, making it hard to know whether the company would be filing redundant reports to the FDA.

Last year, the FDA finalized regulations for yet another summary reporting program. Under the newest system, device makers do not have to seek an exemption or notify the FDA that they’ll be filing a public summary report in MAUDE.

The FDA has deemed the makers of more than 5,600 types of devices eligible to file “voluntary malfunction summary reports.” Among them are some of the riskiest devices the agency oversees, including cardiac stents, leadless pacemakers and mechanical heart valves.

The growing cadre of exceptions to the injury- and death-reporting rules strikes Dr. Michael Carome, director of the Public Citizen Health Research Group, as a retreat by the FDA from making crucial information available for researchers and patients.

“It’s just another example of a flawed oversight system,” he said, “bent toward making it easier for industry rather than making protection of public health the primary goal.”

California Healthline reporter and producer Heidi de Marco contributed to this report.

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