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.

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).

A new regulation聽聽allows states to include adult dental care as a benefit that health insurers must cover under the Affordable Care Act. Following聽, the proposal represents an election-year aspiration for the future of Obamacare: It doesn’t require states to do anything, even as it shows off聽President Biden’s intention to make the ACA a more robust safety net.

“It’s huge, really significant,” said聽Colin Reusch, director of policy at聽Community Catalyst, a health coverage advocacy group. He said the new Biden administration rule represents “one of the first real changes” to coverage provisions of the law since it passed in 2010.

But like so much in health care, expanding access to dental services is a lot more complicated than it sounds.

An estimated聽68.5 million聽U.S. adults lacked dental insurance in 2023, according to the nonprofit聽CareQuest Institute for Oral Health. That’s more than聽2.5 times聽the roughly聽26 million聽Americans of all ages聽.

And millions of Americans lost dental coverage in the past year as part of the Medicaid “unwinding” that dropped low-income people who had been covered by the program during the pandemic.

At the same time,聽聽more than聽$45 billion聽in lost productivity annually, according to the聽Centers for Disease Control and Prevention, and it’s linked to a long list of even more serious health problems, including heart disease and diabetes.

Still, efforts to expand U.S. dental coverage have long foundered on the shoals of cost. When people have dental insurance, they tend to use it. So including the coverage in a health insurance policy can raise overall premiums.

That’s one reason traditional Medicare coverage explicitly excludes most dental care. (Many private Medicare Advantage plans offer some dental coverage as an enticement for seniors to join.)

An effort to add a dental benefit to Medicare聽was stripped聽from Biden’s “Build Back Better” legislation before it was passed in 2022 as the Inflation Reduction Act. Instead, the administration聽in which Medicare can cover dental care. Any progress on oral health 鈥� including giving states the option to require coverage for adults 鈥� is seen by advocates as a victory. Dental coverage for children is already an essential benefit under the ACA.

But whether they actually get coverage depends on states affirmatively adding dental benefits to benchmark plans in the ACA’s insurance marketplaces. Those plans not only determine what services Affordable Care Act insurance has to cover, but also set parameters for state-employee and many private-employer health plans.

Reusch said a few states are considering the change, but it will be a while until anything is certain. States have until May 2025 to decide whether to add dental care to benchmark ACA plans; the benefit wouldn’t be effective until the 2027 plan year.

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org.

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).

Temporomandibular joint disorders, known as TMJ or TMD, cause pain in the jaw and face that can range from discomfort to disabling, with severe symptoms far more common in women. Despite its prevalence, TMJ remains under-researched and ineffectively treated, an investigation by 蘑菇影院 Health News and CBS News found.

The NIH recently doubled annual funding for TMJ research, to $34 million, and in 2023 funded a new collaborative to better understand and treat the disorders.

Rena D’Souza, director of the National Institute of Dental and Craniofacial Research, said she’s “hopeful” the lives of future TMJ patients will be made “bearable.” But the millions of Americans suffering from the disorder must tread carefully when seeking care, she warned.

“I would say that the treatments overall have not been effective, and I can understand why,” D’Souza said. “We don’t understand the disease.”

The increased NIH funding is a direct response to a comprehensive 2020 study of TMJ by the National Academies of Sciences, Engineering and Medicine.

The study found that most health-care professionals, including dentists, have received “” on TMJ disorders and common treatments are not backed by compelling scientific evidence or consistent results. Because of the lack of proven treatments, TMJ patients are “often harmed” by “overly aggressive” care, the national academies found.

The NIH echoes these findings on its website, warning that some common from any treatment that permanently changes their teeth, bite or jaw 鈥� including surgery.

Some TMJ patients have the same advice, learned the hard way.

“The grand irony to me is that I went to the doctor for headaches and neck pain, and I’ve had 13 surgeries on my face and jaw, and I still have even worse neck pain,” said Tricia Kalinowski, 63, of Old Orchard Beach, Maine. “And I live with headaches and jaw pain every day.”

One reason treatment options for TMJ aren’t better, multiple experts said, is because the disorders predominantly affect women. Their complaints were historically dismissed as neither serious nor complex, and therefore TMJ was not a priority for research.

“That has been a bias that is really long-standing,” D’Souza said. “And it’s certainly affected the progress of research.”

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org.

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).

“We’re seeing more oral disease than the general population. There is a bigger need,” Braun said of the patients she treats at Bernard F. Gipson Eastside Family Health Center, which is part of Denver Health, the largest safety-net hospital in Colorado, serving low-income, uninsured, and underinsured residents.

Braun is part of a trend across the United States to integrate oral health into medical checkups for children, pregnant women, and others who cannot afford or do not have easy access to dentists. With federal and private funding, these programs have expanded in the past 10 years, but they face socioeconomic barriers, workforce shortages, and the challenge of dealing with the needs of new immigrants.

With a five-year, $6 million federal grant, Braun and her colleagues have helped train 250 primary care providers in oral health in Colorado, Montana, Wyoming, and Arizona. Similar projects are wrapping up in Illinois, Michigan, Virginia, and New York, funded by the federal Health Resources and Services Administration’s Maternal and Child Health Bureau. Beyond assessment, education, and preventive care, primary care providers refer patients to on- or off-site dentists, or work with embedded dental hygienists as part of their practice.

“Federally qualified health centers have a long history of co-locating dental services within their systems,” Braun said. “We’re taking that next step where care is not just co-located, meaning, say, we’re upstairs and dental is downstairs, but we’re integrated so that it becomes part of the same visit for the patient.”

Having doctors, nurses, and physician assistants who assess oral health, make referrals, and apply fluoride at community health centers is critical for the many children who lack access to dental care, said Tara Callaghan, director of operations for the Montana Primary Care Association, which represents 14 federally qualified health centers and five Urban Indian organizations.

“Providing these services during medical visits increases the frequency of fluoride application,” Callaghan said, and “improves parents’ knowledge of caring for their child’s teeth.” But obstacles remain.

Because of Montana’s large geographic area and small population, recruiting dental professionals is difficult, Callaghan said. Fifty of the state’s 56 counties are designated dental shortage areas and some counties don’t have a single dentist who takes Medicaid, she added. Montana ranks near the bottom for residents having access to , which can prevent cavities and strengthen teeth.

Pediatric dental specialists, in particular, are scarce in rural areas, with families sometimes driving hours to neighboring counties for care, she said.

Embedding dental hygienists with medical doctors is one way to reach patients in a single medical visit.

Valerie Cuzella, a registered dental hygienist, works closely with Braun and others at Denver Health, which serves nearly half of the city’s children and has embedded hygienists in five of its clinics that see children.

State regulations vary on which services hygienists can provide without supervision from a dentist. In Colorado, Cuzella can, among other things, independently perform X-rays and apply silver diamine fluoride, a tool to harden teeth and slow decay. She does all this in a cozy corner office.

Braun and Cuzella work so closely that they often finish each other’s sentences. Throughout the day they text each other, taking advantage of brief lulls when Cuzella can pop into an exam room to check for gum disease or demonstrate good brushing habits. Braun herself takes similar opportunities to assess oral health during her exams, and both focus on educating parents.

Medical and dental care have traditionally been siloed. “Schools are getting better at interprofessional collaboration and education, but by and large we train separately, we practice separately,” said Katy Battani, a registered dental hygienist and assistant professor at Georgetown University.

Battani is trying to bridge the divide by helping community health centers in nine states 鈥� including California, Texas, and Maryland 鈥� integrate dental care into prenatal visits for pregnant women. Pregnancy creates opportunities to improve oral health because some women gain dental coverage with Medicaid and see providers at least once a month, Battani said.

In Denver, housing instability, language barriers, lack of transportation, and the “astronomical cost” of dentistry without insurance make dental care inaccessible for many children, the migrant community, and seniors, said Sung Cho, a dentist who oversees the dental program at STRIDE Community Health Center, serving the Denver metro area.

STRIDE tries to overcome these barriers by offering interpretation services and a sliding pay scale for those without insurance. That includes people like Celinda Ochoa, 35, of Wheat Ridge, who waited at STRIDE Community Health Center while her 15-year-old son, Alexander, had his teeth cleaned. He was flagged for dental care during a past medical checkup and now he and his three siblings regularly see a dentist and hygienist at STRIDE.

One of Ochoa’s children has Medicaid dental coverage, but her three others are uninsured, and they couldn’t otherwise afford dental care, said Ochoa. STRIDE offers an exam, X-rays, and cleaning for $60 for the uninsured.

In the past year, Cho has seen an influx of migrants and refugees who have never seen a dentist before and need extensive care. Medical exams for refugees at STRIDE increased to 1,700 in 2023 from 1,300 in 2022, said Ryn Moravec, STRIDE’s director of development. She estimates the program has seen 800 to 1,000 new immigrants in 2024.

Even with growing needs, Cho said the Medicaid “unwinding” 鈥� the process underway to reexamine post-pandemic eligibility for the government program that provides health coverage for people with low incomes and disabilities 鈥� has created financial uncertainty. He said he worries about meeting the upfront costs of new staff and of replacing aging dental equipment.

At STRIDE’s Wheat Ridge clinic, two hygienists float between dental and pediatrics as part of the medical-dental integration. Yet Cho said he needs more hygienists at other locations to keep up with demand. The pandemic created bottlenecks of need that are only now being slowly cleared, particularly because few dentists take Medicaid. If they do accept it, they often limit the number of Medicaid patients they’ll take, said Moravec. Ideally, STRIDE could hire two hygienists and three dental assistants, Moravec said.

In 2022, Colorado enacted a law to alleviate workforce shortages by allowing 鈥� midlevel providers who do preventive and restorative care 鈥� to practice. But Colorado does not have any schools to train or accredit them.

Before age 3, children are scheduled to see a pediatrician for 12 well visits, a, particularly for at-risk children. As part of Braun’s program in the Rocky Mountain region, providers have applied more than 17,000 fluoride varnishes and increased the percentage of children 3 and younger who received preventive oral health care to 78% from 33% in its first 2陆 years.

Callaghan, at the Montana Primary Care Association, witnesses that on the ground at community health centers in Montana. “It’s about leveraging the fact that kids see their medical provider for a well-child visit much more often and before they see their dental provider 鈥� if they have one.”

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).

Another woman in California, desperate for relief, used a screwdriver to lengthen her jawbone daily, turning screws that protruded from her neck.

A third in New York had bone from her rib and fat from her belly grafted into her jaw joint, and twice a prosthetic eyeball was surgically inserted into the joint as a placeholder in the months it took to make metal hinges to implant into her jaw.

“I feel like Mr. Potato Head,” said Jenny Feldman, 50, of New York City, whose medical records show she’s had at least 24 TMJ-related surgeries since she was a teenager. “They’re moving ribs into my face, and eyeballs, and I feel like a toy 鈥� put together [by] somebody just tinkering around.”

These are some of the horrors of temporomandibular joint disorders, known as TMJ or TMD, which afflict up to 33 million Americans, according to the National Institutes of Health. Dentists have attempted to heal TMJ patients for close to a century, and yet the disorders remain misunderstood, under-researched, and ineffectively treated, according to an investigation by 蘑菇影院 Health News and CBS News.

Dental care for TMJ can do patients more harm than good, and a few fall into a spiral of futile surgeries that may culminate in their jaw joints being replaced with metal hinges, according to medical and dental experts, patients, and their advocates speaking in interviews and video testimony submitted to the FDA.

TMJ disorders cause pain and stiffness in the jaw and face that can range from discomfort to disabling, with severe symptoms far more common in women. Dentists have commonly treated the disorder with splints and orthodontics. And yet these treatments are based on “strongly held beliefs” and “inadequate research” 鈥� not compelling scientific evidence nor consistent results 鈥� according to the National Academies of Sciences, Engineering, and Medicine, which reviewed decades of research on the topic. The NIH echoes this message, warning that there is “” that splints reduce pain and recommends “staying away” from any treatment that permanently changes the teeth, bite, or jaw.

“I would say that the treatments overall have not been effective, and I can understand why,” said Rena D’Souza, director of the NIH’s National Institute of Dental and Craniofacial Research. “We don’t understand the disease.”

For this investigation, journalists with 蘑菇影院 Health News and CBS News interviewed 10 TMJ patients with severe symptoms who said they felt trapped by an escalating series of treatments that began with splints or dental work and grew into multiple surgeries with diminishing returns and dwindling hope.

In every interview, the patients said the TMJ pain worsened throughout their treatment and they regretted some, if not all, of the care they received.

“The grand irony to me is that I went to the doctor for headaches and neck pain, and I’ve had 13 surgeries on my face and jaw, and I still have even worse neck pain,” said Tricia Kalinowski, 63, of Old Orchard Beach, Maine. “And I live with headaches and jaw pain every day.”

TMJ has become an umbrella term for about 30 disorders that afflict roughly 5% to 10% of Americans. Minor symptoms may not require treatment at all, and many cases resolve by themselves over time. Severe symptoms include chronic pain and may limit the ability to eat, sleep, or talk.

In a by the national academies, including input from more than 110 patients, experts found that most health care professionals, including dentists, have received “” on TMJ disorders and patients are “often harmed” by “overly aggressive” care and the lack of proven treatments.

Almost 100 years this has been in dentistry, and look at what we have鈥� A whole ton of people pretending they know everything, and we don’t know anything.

Terrie Cowley, TMJ patient

The , which represents about 160,000 dentists nationwide and establishes guidelines for the profession, declined an interview request. In a written statement, ADA President Linda Edgar said that TMJ disorders are “often managed rather than cured” and that it sees “great potential” in new efforts to research more treatment options.

Terrie Cowley, a longtime TMJ patient who leads the TMJ Association, an advocacy group that has spoken with tens of thousands of patients, said she was so disillusioned with dental care for TMJ that she advises many patients to avoid treatment entirely, potentially for years.

“Almost 100 years this has been in dentistry, and look at what we have,” Cowley said. “A whole ton of people pretending they know everything, and we don’t know anything.”

鈥楴ot Taken Seriously’

Scientific studies have found that TMJ disorders arise , particularly those in their 20s and 30s, leading to theories that the cause may be linked to reproductive hormones. But a true understanding of TMJ disorders remains elusive.

Kyriacos Athanasiou, a biomedical engineering professor at the University of California-Irvine, said it was because TMJ disorders are more prevalent among women that they were historically dismissed as neither serious nor complex, slowing research into the cause and treatment.

The resulting dearth of knowledge, which is glaring when compared with other joints, has been “a huge disservice” to patients, Athanasiou said. In a 2021 study he co-authored, researchers found that the knee, despite being a much simpler joint, was the subject of about six times as many research papers and grants in a single year than the jaw joint.

D’Souza agreed that TMJ disorders were “not taken seriously” for decades, along with other conditions that predominantly affect women.

“That has been a bias that is really long-standing,” she said. “And it’s certainly affected the progress of research.”

Patients have felt the effect too. In interviews, female patients said they felt patronized or trivialized by male health care providers at some point in their TMJ treatment, if not throughout. Some said they felt blamed for their own pain because they were viewed as too stressed and clenching their jaw too much.

“We desperately need research to find the reasons why more women get TMJ disease,” wrote Lisa Schmidt, a TMJ Association board member, in . “And surgeons need to stop blaming this condition on women.”

Every time you have a surgery, your pain gets worse鈥� If I could go back in time and go talk to younger Lisa, I would say 鈥楻un!’

Lisa Schmidt, TMJ patient

Schmidt, 52, of Poway, California, said she was diagnosed with TMJ disorder in 2000 due to headaches, and an orthodontist immediately recommended her for a splint, braces, and surgery.

After wearing the splint for only three days, Schmidt said, she was in “excruciating pain” and could no longer open her mouth far enough to eat solid food. Schmidt said she spent the next 17 years stuck on a “surgery carousel” with no escape, and eventually was in so much pain she abandoned her career as an aerospace scientist who worked alongside NASA astronauts.

Schmidt said her low point came in 2016. In an attempt to restore bone that had been cut away in prior surgeries, a surgeon implanted long screws into Schmidt’s jaw that protruded downward out of her neck. Schmidt said she was instructed to tighten those screws with a screwdriver daily for about 20 days, lengthening the corners of her jaw to restore the bone that had been lost. It didn’t work, Schmidt said, and she was left in more pain than ever.

“Every time you have a surgery, your pain gets worse,” Schmidt said. “If I could go back in time and go talk to younger Lisa, I would say 鈥楻un!’”

Lack of Sufficient Evidence

Many of the shortcomings of TMJ care were laid bare in the published by the national academies in March 2020 that received limited public attention amid the coronavirus pandemic. The report’s 18 authors include medical and dental experts from Harvard, Duke, Clemson, Michigan State, and Johns Hopkins universities.

Sean Mackey, a Stanford professor who co-led the team, said it found that patients were often steered toward costly treatments and “pathways of futility” instead of being taught to manage their pain through strategies and therapies with “good evidence.”

“We learned it’s a quagmire,” Mackey said. “There is a perverse incentive in our society that pays more for things we do to people than [for] talking and listening to people. 鈥� Some of those procedures, some of those surgeries, clearly are not helping people.”

Among its many findings, the national academies said it has been widely assumed in the field of dentistry that TMJ disorders are caused by a misaligned bite, so treatments have focused on patients’ teeth and bite for more than 50 years. But there is a “” that a misaligned bite is a cause of TMJ disorders, and the belief traces back to “inadequate research” in the 1960s that has been repeated in “poorly-designed studies” ever since, the report states.

Therefore, TMJ treatment that makes permanent changes to the bite 鈥� like installing braces or crowns or grinding teeth down 鈥� has “no supporting evidence,” according to the national academies report. The that these TMJ treatments “don’t work and may make the problem worse.”

Dental splints, the most common TMJ treatment, also known as night guards or mouth guards, are removable dental appliances that are molded to fit over the teeth and can cost hundreds or even thousands of dollars out-of-pocket, according to the TMJ Association. Like most medical devices, splints generally go through the FDA’s 510(k) clearance process, which does not require each splint to be proven effective before it can be sold, according to the agency.

The national academies’ report states that splints produce “mixed results” for TMJ patients, and even when splints succeed at reducing jaw pain it is not understood why they work. Hundreds of splint designs exist, the report states, and some dentists reject research that challenges the use of splints unless it focuses on the specific design they prefer.

“Because of the hundreds of variations in [splint] design, it is unlikely that any study could ever be conducted that will be considered sufficient to a particular dentist with a pre-existing belief about the effectiveness of one appliance,” the report states.

Other treatments fare no better. The FDA has not labeled any drugs specifically for TMJ disorders, and to be a long-term solution, according to the TMJ Association. Botox injections may ease pain but have during animal testing. The NIH warns that minor surgeries that flush the jaw with liquid bring only temporary pain relief and that more complex surgeries should be reserved for severe cases because they have yet to be proved safe or effective in the long term.

To improve care, the national academies called for better education about TMJ disorders across medicine and dentistry and more research funding from the NIH, which has a “ripple effect” on research and training across the nation.

Since the 2020 report, the NIH has launched a and increased annual research funding from about $15 million to about $34 million, D’Souza said. TMJ care was added to must teach to be accredited in 2022. The national academies launched an last year.

But TMJ funding still pales in comparison to other ailments. The NIH spends billions each year to research deadly diseases, like cancer and heart disease, that also afflict large numbers of Americans. It spends millions more on research of non-life-threatening conditions like arthritis, back pain, eczema, and headaches.

Mackey noted that much of the NIH’s spending is allocated by Congress.

“If Congress comes in and says, 鈥榃e want to devote X amount of money to [TMJ],’ all of the sudden you will see an increase in money,” Mackey said. “So that’s my message to people out there: Raise your voices. Write your legislator.”

Total Jaw Replacements

Plagued by TMJ symptoms, and after failed treatments, some patients turn to a last resort: replacing their jaw joint with synthetic implants. Surgeons might replace the cartilage disk at the core of the joint or use “total joint replacement surgery” to fasten a metal hinge to the bones of the skull.

But the implants have a harrowing history: Several disk implants were recalled or discontinued in the ’90s due to dangerous failures. The FDA now classifies TMJ implants among its because the products on the market today can cause “adverse health consequences” if the devices fail, according to the agency’s website.

Two companies, Zimmer Biomet and Stryker, make the only total jaw replacement implants currently sold in the U.S.

Zimmer Biomet, which has made its implant for more than two decades, described it in email statements as “a safe and efficacious solution” for patients who need their jaw joint replaced, either due to TMJ disorders, failed surgeries, injuries, or other ailments. An FDA-mandated study completed in 2017 found about 14% of patients who get the Zimmer Biomet implant require additional surgery or removal within 10 years, said agency spokesperson Carly Pflaum.

Stryker, which in 2021 bought a company that made a total jaw replacement implant and now makes the implant itself, declined to comment. Although the NIH has advised TMJ patients to avoid surgery since at least 2022, Stryker launched a “” for the implant last year and is recruiting surgeons to be added to a “surgeon locator” feature on the site, according to posts on Facebook and .

A study of the Stryker implant’s success rate was mandated by the FDA and completed in 2020, but the agency has yet to make the results public.

D’Souza, the NIH official, said that based on her professional experience, she estimates that most total jaw replacement surgeries are ultimately ineffective.

“The success rate is low,” D’Souza said. “It is not very encouraging.”

Multiple patients provided 蘑菇影院 Health News and CBS News with medical records showing their total jaw replacement implants had to be removed due to malfunction, infection, or previously unknown metal allergies. Several patients said that since their implants were removed months or years ago, they have lived with no hinge in their jaw at all.

Kalinowski, the TMJ patient in Maine, has had portions of her jaw joint replaced six times, including receiving four implants. Her medical records show that the cartilage disk on her right side was replaced in 1986 with an implant that was later recalled and again in 1987 with another that was later discontinued. Her left and right disks were replaced in 1992 with a muscle flap and rib graft, respectively, and her entire right joint was replaced with yet another implant that was later discontinued in 1998. Both joints were replaced again in 2015, her records show.

Since then, Kalinowski said, her artificial jaw has functioned properly, although she remains in pain and cannot move her jaw from side to side. Her mouth hangs open when her face is at rest, and she drinks protein shakes for lunch because it’s easier than struggling with solid food.

But the “worst part,” Kalinowski said, is that her surgeries caused nerve damage on her lower face, and so she has not felt her husband’s kisses since the ’90s.

“If there was one moment in my life I could take back and do over again, it would be that first surgery. Because it set me on a trajectory,” Kalinowski said. “And it never goes away.”

CBS News producer Nicole Keller contributed to this article.

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).

Related Articles

• This Dental Device Was Sold to Fix Patients’ Jaws. Lawsuits Claim It Wrecked Their Teeth. Mar 1, 2023
• Watch: Dental Device at Center of Lawsuits Was Used on Patients Without FDA Review Mar 2, 2023
• Feds Launch Criminal Investigation Into 鈥楢GGA’ Dental Device and Its Inventor Apr 12, 2023

Steve Galella, the inventor of the Anterior Growth Guidance Appliance, or “AGGA,” has said in court depositions that his device had been used on about 10,000 patients, and that he trained many dentists to use the AGGA in classes around the U.S. and overseas.

At least 23 patients, some of whom described being desperate for relief from sleep apnea or temporomandibular joint disorder (TMJ), have sued Galella in recent years claiming that the AGGA damaged their mouths and, in some cases, caused tooth loss. Galella denied wrongdoing in those lawsuits and has settled almost all of them within the past few months.

Galella was deposed before he settled the largest of those lawsuits. According to a recently obtained by 蘑菇影院 Health News and CBS News, Galella said under oath that he had not represented that the AGGA could treat or cure TMJ or sleep apnea.

Video footage tells a different story.

Galella repeatedly references treating TMJ and sleep apnea patients with the AGGA, sometimes in conjunction with other devices, in footage from a training session he led with Australian dentists in 2017, which was produced in discovery in an AGGA lawsuit.

At one point in the footage, Galella can be seen displaying two versions of the AGGA to the dentists, pointing to one he says is preferred by “TMJ and sleep patients” 鈥� and then saying, “And I give it to them.”

“Can you cure TMJ? Yes,” Galella , according to the footage. “Can you cure mild to moderate sleep apnea? Yes.”

The AGGA, which Galella 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. This year, after a joint investigation by 蘑菇影院 Health News and CBS News reported allegations of patients harmed by the AGGA, the FDA and the Department of Justice opened investigations into the device.

Dentists across the country have promoted 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 to treat common ailments like TMJ and sleep apnea, which afflict millions of Americans. Galella has said in depositions and video footage that the AGGA causes the bones in an adult’s jaw to “remodel” forward, reshaping their face.

The 2017 video footage contains other examples of Galella teaching dentists to treat TMJ and sleep apnea patients with the AGGA, which he sometimes calls a “growth appliance.” In one segment, he describes using a growth appliance on “nine out of 10” of his TMJ patients. In another instance, Galella presents photos of what he says is a TMJ patient, then proceeds to describe how he treated them with an AGGA while showing photos of the patient’s device and saying: “It’s easy with this appliance.” The footage also shows Galella calling a growth appliance “the cure” for sleep apnea, and he later says in reference to sleep apnea that “with a growth appliance, yeah, you can fix it.”

When Galella was confronted with this video footage during his recent deposition, he said his statements had been taken “out of context,” according to the deposition transcript.

The AGGA plaintiffs alleged in their lawsuits not that Galella treated them directly but instead that he or his company consulted with their dentists and prepared AGGA “treatment plans” for each patient.

Galella said during his deposition he had reviewed more than 12,000 treatment plans but said he’d never seen one that used the AGGA to treat TMJ or sleep apnea, according to the transcript. In the AGGA lawsuits, about a , and some of those plans list the patient’s “chief complaint” as TMJ or sleep apnea.

Galella’s attorneys did not respond to multiple recent requests for comment, and Galella declined to be interviewed when approached in person in February. One of Galella’s attorneys, Alan Fumuso, said in a written statement in February that the AGGA “is safe and can achieve beneficial results” when used properly.

The 蘑菇影院 Health News-CBS News investigation of the AGGA was based on interviews with 11 people who said they were hurt by the device and dental specialists who said they’d witnessed severe complications in AGGA patients. The investigation found no record of the AGGA being registered with the FDA and no peer-reviewed evidence showing the device “expands” or “remodels” the jaw as Galella and other dentists have claimed.

“The entire concept of this device, of this treatment, makes zero sense,” said Kasey Li, a maxillofacial surgeon and sleep apnea specialist who has . “It doesn’t grow the jaw. It doesn’t widen the jaw. It just pushes the teeth out of their original position.”

In the wake of the 蘑菇影院 Health News-CBS News investigation, the FDA announced it was “” about the AGGA and a similar device, the Anterior Remodeling Appliance. The agency said the devices had been used to treat TMJ and sleep apnea even though they were not cleared by the FDA and their safety and effectiveness had not been established.

Weeks later, the criminal investigation into the AGGA was disclosed in court filings by Galella and device manufacturer Johns Dental Laboratories, who said the U.S. attorney’s office in Memphis, Tennessee, was “potentially bringing criminal charges” against them. In another court filing, Johns Dental provided a copy of a grand jury subpoena seeking a wide variety of AGGA documents, including “any complaints received from any source whatsoever regarding the AGGA.”

Since then, Galella has resolved lawsuits from at least 19 AGGA plaintiffs through out-of-court settlements without any public admission of fault. Additional AGGA lawsuits were filed in Indiana, Pennsylvania, and Washington, with all plaintiffs alleging they were harmed while being treated for TMJ or sleep apnea.

Alice Runion, a 30-year-old IT consultant living outside Indianapolis, alleged in one of those lawsuits that wearing an AGGA as part of her TMJ treatment resulted in “permanent impairment and disfigurement” and “caused severe damage to the roots of [her] teeth.”

In an interview, Runion added that the AGGA caused lingering migraines that have left her unable to work on a computer for long stretches, forcing her out of her job. Runion said that even after corrective jaw surgery that cost tens of thousands of dollars, some of her teeth may still be at risk.

“My surgeon and my health care providers have told me that it is possible that I could lose teeth in the future still because of the treatment I received,” Runion said.

The AGGA is also being studied by orthodontists Neal Kravitz and Jeffrey Miller, who said they intend to publish a research paper next year on how the device hurts patients. Miller, who has been a paid consultant for some AGGA plaintiffs, said he has examined dental scans from at least 30 patients who were “damaged” by the AGGA.

“It’s not difficult to see the pattern,” Miller said. “The patients lose bone that supports the housing of their teeth.”

Miller and Kravitz said that they bought an AGGA in May for their research and that the Department of Justice sent an official to photograph the unboxing of the device for the criminal investigation.

Miller and Kravitz added that Johns Dental was willing to sell them the AGGA only if they did not refer to the device by name while purchasing it. They provided 蘑菇影院 Health News and CBS News with a copy of an email in which a Johns Dental employee writes: “To order the growth appliances from here on out, you’ll need to avoid using the names of those appliances or Dr. Galella’s name.”

A Johns Dental facility was inspected by the FDA in July, according to online inspection records. Those records show the company was pertaining to medical devices, but do not specifically mention the AGGA or any specific device. One citation was for an unspecified device whose “design history file does not demonstrate that the design was developed following the requirements” of federal law. Johns Dental declined to comment through its attorney, Jeffrey Oberlies.

Ten days after that FDA inspection, Johns Dental owner Jerry Neuenschwander was deposed in an AGGA lawsuit, court records show. He pleaded the Fifth in response to every question, according to a obtained by 蘑菇影院 Health News and CBS News.

Spokespeople for the Justice Department and the FDA declined to comment on the AGGA. Attorneys for Neuenschwander did not respond to requests for comment.

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).

Htwe, 38, is from Myanmar and worked as an OB-GYN there until a military coup overthrew the government in February 2021. Alongside other medical workers, she against the military, and, fled the country with her husband and young daughter.

Htwe and her family spent six months in Thailand before they resettled in Missoula as refugees early last year. That move around the globe took less time than the eight months she waited to get a dental appointment after arriving in Montana.

“In my country, dental care is not like it is here,” said Htwe, who is now a community health worker at Partnership Health Center in Missoula. “Here we need to wait for dental care. In Myanmar, it’s not like that. We can go at any time when we need a consultation or something.”

Refugee advocates in Montana hear stories like Htwe’s often. And these stories are similar to what low-income people can contend with across the U.S. Long wait times for dental appointments, high costs, and finding dentists willing to take new Medicaid patients make access to dental care difficult.

Refugees in the U.S. getting dental care because of cultural differences, and language and transportation issues, but their specific circumstances vary widely depending on where they resettle, and if the state offers dental coverage for refugees.

The flow of refugees admitted to the U.S. is growing since the Biden administration set the annual cap for the fiscal year that began in October to 125,000, . More than 24,000 refugees arrived between October and April, . The state and country are on pace to welcome more refugees .

“It’s a health equity issue when patients have an array of barriers to getting care,” said Jane Grover, a dentist and the director of the Council on Access, Prevention, and Interprofessional Relations for the American Dental Association.

She added that dental pain complicates a person’s ability to eat, work, and do daily tasks. When oral health is suboptimal, the risk for gum and periodontal disease increases. That can then lead to like heart disease and diabetes.

“Often, refugees come to us with some or very little previous dental care,” said Bonnie Medlin, health and education programs coordinator for the International Rescue Committee in Missoula.

Refugees spend an average of about 10 years in refugee camps before resettlement, and those camps may or may not have dental services, said Medlin.

When refugees arrive in Montana, they are enrolled in the state’s Medicaid program and are eligible for most like exams, teeth cleanings, and X-rays. State Medicaid programs decide the level of adult dental benefits to offer, and Montana is among 18 states, plus Washington, D.C., that . But having health coverage doesn’t guarantee a person can see a dentist quickly or at all.

Montana health department spokesperson Jon Ebelt said private practice dentists are not required to have a certain percentage of their patients covered by Medicaid. They can choose whether to accept Medicaid or any other insurance.

A run by the Department of Health and Human Services provides short-term medical coverage to refugees for Medicaid, but are covered.

In Missoula, three private dental clinics frequently work with refugees who are on Medicaid. One is strictly a pediatric dental office, however, and the other two perform only surgical procedures.

States set Medicaid reimbursement rates for dental care and Montana’s rates . Despite this, the numbers don’t always add up. “Dentists in private practice want to help and accept Medicaid patients when they can, but the margin just makes it impossible for them,” said Lara Salazar, CEO of , a community health clinic based in Missoula.

“We see patients regardless of their socioeconomic status, offer a sliding scale fee, and accept all insurance for the 65,000 visits we get across our clinics per year,” said Salazar.

PHC’s dental clinics provide comprehensive and emergency dental care for adults and children and see around 975 patients a month. Most mornings 10 to 20 people line up for urgent, same-day appointments at the center’s downtown clinic. Some of the patients needing urgent dental care are part of Missoula’s refugee population.

“People are dealing with abscesses, root canals and suddenly they’re in a dental chair and things are happening. It’s especially scary when they haven’t been to a dentist before,” said Helen Maas, a senior community health specialist who works on PHC’s refugee-focused health team with Htwe. “Trying to explain how the health care system works gets very complicated,” she said.

require providers serving Medicaid patients to offer interpretation services when needed, but Medicaid reimbursement doesn’t cover all the costs, said Maas. “I know this is an issue for providers in town and a reason they are not able to accommodate everyone.”

Patients and providers at PHC connect with via phone and video chat. Maas said the translation service is great, but sometimes it can take up to an hour to find an appropriate interpreter for less common languages, like Dari and Pashto.

According to Maas, limited transportation is an additional obstacle for refugee families and can make getting to scheduled appointments particularly hard once they start working.

Another challenge is appointment wait times. New patient appointments for refugee children happen soon after arrival. But adults on Medicaid often wait up to nine months for an initial dental exam at PHC or another clinic in Missoula unless they are in acute pain that prohibits eating or causes major health concerns. “Timing depends on if providers outside of Partnership are accepting new Medicaid patients, and many are not,” said Maas.

To help accommodate the need, some dentists in the community donate services to refugee patients. Maas hopes to see more of this in the future.

In the meantime, outcomes look promising for refugees like Htwe who needed dental care after resettlement. “When I went to my appointment, the dentist set up a long-term plan for my teeth,” she said. “I’ve had two cleaning appointments and I now have a habit of flossing.”

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).

They couldn’t find a dentist near their home in Wilkin County, Minnesota, who accepted Medicaid. When a mobile clinic that would treat Medicaid patients drove nearly 200 miles from Minneapolis to the rural county on Minnesota’s western border, appointments that fit her family’s schedule were “hit-or-miss,” she said.

That all changed when Ehlert’s family found a clinic in neighboring Otter Tail County run by Apple Tree Dental, where dental therapists, who prioritize treating Medicaid recipients, provide much of the clinic’s care.

Now, “we actually go to the dentist like we’re scheduled to,” Ehlert said. “It really is indescribable how much of a difference it’s made.”

Dental therapists are licensed providers who offer basic care traditionally provided by dentists, including fillings and simple tooth extractions. Over a dozen states have turned to them to increase access to oral health care, and at least eight more are considering doing the same. Like Minnesota, some states have deployed therapists specifically to benefit underserved populations, such as rural residents, Medicaid recipients, and Native American tribes.

Still, dental therapists are not universally supported or available to most rural Americans, despite inadequate access to oral health services in many nonurban communities.

Karl Self, director of dental therapy at the University of Minnesota School of Dentistry, said that recruiting these midlevel providers is a cost-effective way to expand care in rural Minnesota.

Self has led the university’s program since the outset, after surveying schools in Canada, New Zealand, and the United Kingdom for examples of how to teach the new degree. Dental therapy has existed abroad since 1921 but was first practiced in the U.S. in 2004 within the Alaska Tribal Health System. Today, only five college programs offer dental therapy training.

Dental therapists deliver a slice of specialized care that helps fill gaps, Self said.

“Dental therapists are sort of the restorative experts,” he said. “They spend the vast majority of their time doing a very small segment of dentistry as a whole. But it’s a very high percentage of the primary care needs of patients.”

Under the supervision of a dentist, dental therapists can complete oral evaluations, fill cavities, and extract children’s baby teeth. In Minnesota, dental therapists with advanced training can treat patients without having a dentist on-site.

That flexibility enables those therapists to provide care in communities without full-time dentists.

Self said dental practices can deploy therapists to satellite offices, offering basic care multiple days per week and reserving more complicated procedures for occasional visits from a dentist.

When Katy Leiviska graduated from the University of Minnesota School of Dentistry as part of the school’s first class of dental therapists in 2011, she couldn’t find a job.

It was two years after Minnesota became the first state to license dental therapists. The new licensure came with strings attached, requiring the therapists to practice in areas that didn’t have enough dentists to serve the population, or to primarily treat low-income, uninsured, and underserved patients.

Leiviska called clinics almost daily looking for a job but found that most operators and owners didn’t know what dental therapy was.

“It took me almost a year to get in,” she said. In the meantime, “I was working at Applebee’s.”

Once she did join a clinic, Leiviska said, more than 90% of her patients were uninsured or on Medicaid. She has used her advanced dental therapy training to practice solely in urban areas since, but providers like her have become an integral part of Minnesota’s effort to fill dental care gaps in rural areas.

The same can’t be said for all states.

Across the border in Wisconsin, a bipartisan group of lawmakers introduced bills in 2017 and 2019 to create the license class. The Wisconsin Dental Association opposed the measures, arguing that the state should invest in its existing workforce rather than create another profession. Marquette University and the Academy of General Dentistry joined the association in its objection.

Since the first iteration of the bill required only that dental therapists attend a technical college for three years without prior training as a dental hygienist, the Wisconsin Dental Association was concerned that dental therapists could then extract teeth without dentist supervision, and that the bill didn’t require a dentist to examine a patient before a dental therapist worked on them. The association contended the bill should require candidates to attend a program certified by the Commission on Dental Accreditation.

During a 2021 attempt to pass a dental therapy bill, sponsors came to an agreement with the dental association that led it to a neutral position rather than opposition. The compromise would have made the Wisconsin law more closely resemble Minnesota’s approach. For example, dental therapists would be required to work in dental health professional shortage areas or have at least half their patients be from underserved communities.

The bill ultimately failed, but Democratic Gov. Tony Evers has reintroduced dental therapy in his proposed budget for 2023-25.

If a bill were to pass, said Matt Crespin, executive director of the Children’s Alliance of Wisconsin, it would be a “commonsense solution” to the state’s oral health crisis.

“In Wisconsin, it is very challenging if you are covered by Medicaid to get access to dental care 鈥� even privately insured or uninsured patients have a challenge in accessing providers, in particular in rural parts of the state,” he said. “Adding dental therapists to the dental team to work in collaboration with a dentist would increase access to care.”

Crespin, whose organization is part of a coalition that supports bringing dental therapy to Wisconsin, said one way he imagines increasing care options is by having dental therapists provide preventive care to students in public schools.

Access to care is a key issue in Wisconsin, where have shortages of dental professionals, according to the Rural Health Information Hub. In Minnesota, are listed as having such shortages.

Pinpointing dental care deserts takes only dentists into account; those numbers do not reflect whether counties in Minnesota have dental therapists.

According to Minnesota’s latest workforce report, as of 2018, the state had 92 dental therapists, including 25 working in rural areas. That same year, there were 5,683 hygienists and 4,140 dentists 鈥� most of them practicing in the Twin Cities area.

Neal Irion is one of those dental therapists. He treats patients at the nonprofit Apple Tree Dental clinic in Fergus Falls, a town of about 14,000 in western Minnesota.

“I’m delivering 鈥� like, me personally 鈥� close to $1 million a year of dental care,” he said. “That’s a lot of fillings; that’s a lot of exams.”

Over the years, Irion has watched as Apple Tree struggled to recruit dentists to serve the rural community. His clinic employs one part-time dentist, a full-time dentist, and two full-time dental therapists. And, like Irion, the other midlevel provider on staff, Alyssa Klugman, is an advanced dental therapist and licensed hygienist.

Klugman said her hourlong commute to work reminds her of patients’ having to travel sometimes hours for their appointments at the clinic. Those patients are often low-income and at high risk for dental disease.

“I see thousands of patients every year,” she said. “Being able to help that many people get out of pain or treat disease, it’s just incredible that I can have the opportunity to do that.”

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).

Marked in painful abscesses, dangerous infections, and missing molars are tales of unequal access to care.

All of these ailments 鈥� which keep patients out of work because of pain or social stigma, and children out of school because they can’t concentrate with rotting roots 鈥� are preventable.

Annual dental checks are essential to overall health. But of the 67 counties in Florida, experts say, only one has enough dentists to treat all patients. Nine counties in Florida have fewer than three practicing dentists apiece. Lafayette County, in north Florida, doesn’t have a single one.

“It’s a social injustice,” said Grimmett, director of dental services at the not-for-profit, which serves Medicaid and uninsured patients in the Tampa Bay region.

“You will never be totally well if you don’t have oral health,” she said.

In Florida and across the nation, vulnerable and marginalized communities 鈥� already prone to higher rates of chronic disease and limited access to health care 鈥� are left behind in these dental deserts. There, patient volume exceeds the capacity of providers, or too few dentists are willing to serve those on Medicaid or the uninsured.

Constricting the pool of dentists are low 鈥� or nonexistent 鈥斅爎eimbursement rates for services paid through the state’s Medicaid programs. Meanwhile, costly dental education can make dentists reluctant to work in more rural areas.

About 6 million Floridians , according to data from the U.S. Department of Health and Human Services. That’s the largest state population living without basic dental care in the U.S.

The consequences can be catastrophic, as people try to navigate a health system with few providers willing to serve them and costs that make services unattainable.

They’re people like Mark Maggs, a 54-year-old Pinellas Park resident diagnosed with cancer last year. He delayed treatment because doctors said he needed to have teeth pulled first. His daughter started a GoFundMe to raise the $3,000 for the extractions.

They’re people like Lisa Lambros, a 40-year-old New Port Richey resident who drives 90 minutes to Tampa for appointments at the county health department. She lost her teeth due to cancer three years ago and desperately needs dentures, but hasn’t been able to afford them. She feels bad for her kids, embarrassed when they bring friends home to meet her.

“I had perfect teeth until I got sick,” Lambros said. “Now people treat me different. They look at me like I’m a bad person.”

Lambros and Maggs both live with daily pain that could be relieved with dental care.

Health equity advocates are fighting for long-term investments in oral health at the local, state, and federal levels to close gaps in care.

Where Are All the Dentists?

Poor dental access is not the result of too few dental school graduates.

Enrollment has been ticking up nationally, with more than 26,000 students in school last year. That’s about a tenth the number of working dentists in the U.S., according to the American Dental Association.

But the majority of those graduates aren’t practicing in underserved communities and don’t accept uninsured patients or those enrolled in federal health insurance plans.

The issue is uneven distribution, said Joe Anne Hart, who’s worked for the for nearly two decades.

Recruiting dentists to rural communities, where public infrastructure is typically worse, can be a challenge, Hart said.

And often, she added, there’s a financial reason why dentists choose to practice in more affluent regions: student loan debt.

As of 2020, new graduates left dental school with an , according to the American Dental Education Association.

With fewer patients in mostly poorer rural communities, graduates flock to private practices elsewhere, seeking financial stability. But it’s not just rural residents who struggle to access care. Because Medicaid reimbursements for dental care are paltry, even in urban areas, most dentists opt not to serve Medicaid patients.

Nearly 8 in 10 Florida dentists reported they did not accept Medicaid patients, according to the most recent from the state Department of Health. More than 70% of respondents cited low Medicaid reimbursement rates as the main reason why.

In Florida, fewer than 5% of dentists work in publicly funded dental offices and community clinics. The survey found the majority work in private practices.

“When you look at our dental Medicaid funding, we haven’t had an increase since 2012,” said Christopher Bulnes, who practices in Hillsborough County. “We’re at the bottom of the nation.”

In 2020, the Medicaid reimbursement rate for child dental services in Florida was of what private insurance reimbursed on average, according to the American Dental Association. That’s one of the lowest reimbursement rates in the country. In Texas, for example, the rate is 70.3%. Arizona’s reimbursement rate is nearly double that of Florida’s.

For standard adult services, such as preventive cleanings and imaging, there is no benefit in the Sunshine State.

Kimme Heller is a 38-year-old St. Petersburg mom who lost her teeth after pregnancy as she battled infection after infection, a product of unlucky genetics and lack of access to preventive care. Her jawbone is so deteriorated from decay that her face is starting to change shape. It hurts to eat. She’s been looking for a dental surgeon, but availability is limited. Even if she could get in, she couldn’t afford the procedures.

“The rich get their smiles. The poor get disease,” she said.

Representatives of the Florida Dental Association said the state 鈥� which controls how much dental coverage is offered under Medicaid 鈥� should promote oral health care and increase coverage for vulnerable patients.

Additionally, the organization is lobbying for programs that would encourage dentists to care for underserved communities. One initiative they’ve floated would offer dentists up to $50,000 a year in student loan relief for efforts such as serving Medicaid patients or working in areas without enough providers.

As lawmakers convene in Tallahassee, the association has asked the state to set aside $1.8 million per year to support the Dental Student Loan Repayment Program. But with days to go, lawmakers have yet to act.

A Costly Toll

The percentage of adults and kids who have visited a dentist in the past year is lower in Florida than in any other state.

“We’re talking about quality-of-life issues,” said Grimmett, of Evara Health. “Every day we see patients who weren’t able to move forward with cancer treatment because they needed and they weren’t able to get it. We’ve seen patients who have been in pain for long periods of time who can’t sleep or eat and need treatment. We see people without teeth who need dentures.”

Each year, more than $45 billion is lost from the U.S. economy 鈥斅爐allied in work missed and job opportunities lost 鈥斅燽ecause of untreated oral disease, according to the U.S. Centers for Disease and Control and Prevention. Nearly 1 in 5 adults reported that oral disease affected their appearance and hampered their ability to get work. Some struggle to eat through the pain.

Children, meanwhile, miss class.

“I can’t tell you how many times I’ve received calls from a parent or school nurse because a child cannot focus or learn because they are in pain,” said , who serves Medicaid patients near Pensacola.

In 2020, of people ages 1 through 20 on Medicaid received preventive dental care, such as an annual screening. In Florida, about 67% of kids on Medicaid went without.

Black and Hispanic children are to have untreated oral illness.

For people 65 or older who use Medicare, dental care can also remain out of reach. Medicare does not cover standard services such as cleanings and fillings.

is a founding member of Floridians for Dental Access and former dean of the University of Florida College of Dentistry. His organization is a partnership between nonprofits, individual dentists, and medical centers working to improve health access in the state.

He’s motivated to close disparities 鈥� and not just those directly related to health. Oral pain can affect children’s educational outcomes too.

“The literature now documents very clearly that if you are in pain, you’re going to miss school more often than other kids, you’re not going to learn as well,” Catalanotto said. “You’re going to have social issues, because if you’ve got broken-down front teeth, kids are going to make fun of you.”

Catalanotto said there’s also a financial toll. When people don’t have access to local providers and are in pain, they often go to the emergency room.

In 2020, Florida hospitals billed roughly $330 million for more than 100,000 emergency room visits that stemmed from preventable oral health problems, according to analysis of hospital data by CareQuest Institute for Oral Health, a national nonprofit that focuses on health equity.

Much of that burden falls on taxpayers.

And while health care access is limited across medicine 鈥斅爊ot just in dentistry 鈥斅燙atalanotto stressed that teeth don’t fix themselves.

Some minor ailments, such as colds and viral infections, can simply run their course. A minor dental ailment, he said, does no such thing.

Oral disease is progressive and ongoing and ultimately leads to severe infections.

Until more people have access to preventive care, the most vulnerable are going to continue to get unnecessarily sick.

“We have a crisis in Florida,” Catalanotto said. “That is abundantly clear.”

This article was produced in partnership with the聽.

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).

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.

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).