Then Carroll saw a TV commercial for another path: ClearChoice Dental Implant Centers. The company advertises that it can give patients “” by surgically replacing teeth instead of fixing them.

So Carroll saved and borrowed for the surgery, she said. In an interview and a lawsuit, Carroll said that at a ClearChoice clinic in New Jersey in 2021, she agreed to pay $31,000 to replace all her natural upper teeth with pearly-white prosthetic ones. What came next, Carroll said, was “like a horror movie.”

Carroll alleged that her anesthesia wore off during implant surgery, so she became conscious as her teeth were removed and titanium screws were twisted into her jawbone. Afterward, Carroll’s prosthetic teeth were so misaligned that she was largely unable to chew for more than two years until she could afford corrective surgery at another clinic, according to a sworn deposition from her lawsuit.

ClearChoice has denied Carroll’s claims of malpractice and negligence in court filings and did not respond to requests for comment on the ongoing case.

“I thought implants would be easier, and all at once, so you didn’t have to keep going back to the dentist,” Carroll, 52, said in an interview. “But I should have asked more questions … like, Can they save these teeth?”

Dental implants have been used for more than half a century to surgically replace missing or damaged teeth with artificial duplicates, often with picture-perfect results. While implant dentistry was once the domain of a small group of highly trained dentists and specialists, tens of thousands of dental providers now offer the surgery and place millions of implants each year in the U.S.

Amid this booming industry, some implant experts worry that many dentists are losing sight of dentistry’s fundamental goal of preserving natural teeth and have become too willing to remove teeth to make room for expensive implants, according to a months-long investigation by Â鶹ŮÓÅ Health News and CBS News. In interviews, 10 experts said they had each given second opinions to multiple patients who had been recommended for mouths full of implants that the experts ultimately determined were not necessary. Separately, lawsuits filed across the country have alleged that implant patients like Carroll have experienced painful complications that have required corrective surgery, while other lawsuits alleged dentists at some implant clinics have persuaded, pressured, or forced patients to remove teeth unnecessarily.

The experts warn that implants, for a single tooth or an entire mouth, expose patients to costs and surgery complications, plus a new risk of future dental problems with fewer treatment options because their natural teeth are forever gone.

“There are many cases where teeth, they’re perfectly fine, and they’re being removed unnecessarily,” said William Giannobile, . “I really hate to say it, but many of them are doing it because these procedures, from a monetary standpoint, they’re much more beneficial to the practitioner.”

Giannobile and nine other experts say they are combating a false public perception that implants are more durable and longer-lasting than natural teeth, which some believe stems in part from advertising on TV and social media. Implants require upkeep, and although they can’t get cavities, that patients can be susceptible to infections in the gums and bone around their implants.

“Just because somebody can afford implants doesn’t necessarily mean that they’re a good candidate,” said George Mandelaris, a Chicago-area periodontist and member of the American Academy of Periodontology Board of Trustees. “When an implant has infection, or when an implant has bone loss, an implant dies a much quicker death than do teeth.”

In its simplest form, implant surgery involves extracting a single tooth and replacing it with a metal post that is screwed into the jaw and then affixed with a prosthetic tooth commonly made of porcelain, also known as a crown. Patients can also use “full-arch” or “All-on-4” implants to replace all their upper or lower teeth — or all their teeth.

For this story, Â鶹ŮÓÅ Health News and CBS News sought interviews with large dental chains whose clinics offer implant surgery — ClearChoice, Aspen Dental, Affordable Care, and Dental Care Alliance — each of which declined to be interviewed or did not respond to multiple requests for comment. The Association of Dental Support Organizations, which represents these companies and others like them, also declined an interview request.

ClearChoice, which specializes in full-arch implants, did not answer more than two dozen questions submitted in writing. In an emailed statement, the company said full-arch implants “have become a well-accepted standard of care for patients with severe tooth loss and teeth with poor prognosis.”

“The use of full-arch restorations reflects the evolution of modern dentistry, offering patients a solution that restores their ability to eat, speak, and live comfortably — far beyond what traditional dentures can provide,” the company said.

Carroll said she regrets not letting her dentist try to fix her teeth and rushing to ClearChoice for implants.

“Because it was a nightmare,” she said.

‘They Are Not Teeth’

Dental implant surgery can be a godsend for patients with unsalvageable teeth. Several experts said implants can be so transformative that their invention should have contended for a Nobel Prize. And yet, these experts still worry that implants are overused, because it is generally better for patients to have their natural teeth.

Paul Rosen, a Pennsylvania periodontist who said he has worked with implants for more than three decades, said many patients believe a “fallacy” that implants are “bulletproof.”

“You can’t just have an implant placed and go off riding into the sunset,” Rosen said. “In many instances, they need more care than teeth because they are not teeth.”

Generally, a single implant costs a few thousand dollars while full-arch implants cost tens of thousands. Neither procedure is well covered by dental insurance, so many clinics partner with credit companies that offer loans for implant surgeries. At ClearChoice, for example, loans can be , according to the company’s website.

Despite the price, implants are more popular than ever. Sales increased by more than 6% on average each year since 2010, culminating in more than 3.7 million implants sold in the U.S. in 2022, according to a 2023 report produced by iData Research, a health care market research firm.

Some worry implant dentistry has gone too far. In 10 interviews, dentists and dental specialists with expertise in implants said they had witnessed the overuse of implants firsthand. Each expert said they’d examined multiple patients in recent years who were recommended for full-arch implants by other dentists despite their teeth being treatable with conventional dentistry.

Giannobile, the Harvard dean, said he had given second opinions to “dozens” of patients who were recommended for implants they did not need.

“I see many of these patients now that are coming in and saying, ‘I’ve been seen, and they are telling me to get my entire dentition — all of my teeth — extracted.’ And then I’ll take a look at them and say that we can preserve most of your teeth,” Giannobile said.

Tim Kosinski, who is a representative of the and said he has placed more than 19,000 implants, said he examines as many as five patients a month who have been recommended for full-arch implants that he deems unnecessary.

“There is a push in the profession to remove teeth that could be saved,” Kosinski said. “But the public isn’t aware.”

Luiz Gonzaga, a periodontist and prosthodontist at the University of Florida, said he, too, had turned away patients who wanted most or all their teeth extracted. Gonzaga said some had received implant recommendations that he considered “an atrocity.”

“You don’t go to the hospital and tell them ‘I broke my finger a couple of times. This is bothering me. Can you please cut my finger off?’ No one will do that,” Gonzaga said. “Why would I extract your tooth because you need a root canal?”

Jaime Lozada, director of an elite dental implant residency program at Loma Linda University, said he’d not only witnessed an increase in dentists extracting “perfectly healthy teeth” but also treated a rash of patients with mouths full of ill-fitting implants that had to be surgically replaced.

Lozada said in August that he’d treated seven such patients in just three months.

“When individuals just make a decision of extracting teeth to make it simple and make money quick, so to speak, that’s where I have a problem,” Lozada said. “And it happens quite often.”

When full-arch implants fail, patients sometimes don’t have enough jawbone left to anchor another set. These patients have little choice but to get implants that reach into cheekbones, said Sohail Saghezchi, an oral and maxillofacial surgeon at the University of California-San Francisco.

“It’s kind of like a last resort,” Saghezchi said. “If those fail, you don’t have anywhere else to go.”

‘It Was Horrendous Dentistry’

Most of the experts interviewed for this article said their rising alarm corresponded with big changes in the availability of dental implants. Implants are now offered by more than 70,000 dental providers nationwide, two-thirds of whom are general dentists, according to the iData Research report.

Dentists are not required to learn how to place implants in dental school, nor are they required to complete implant training before performing the surgery in nearly all states. This year, Oregon started of hands-on training before placing any implants. Stephen Prisby, executive director of the Oregon Board of Dentistry, said the requirement — the first and only of its kind in the U.S. — was a response to dozens of investigations in the state into botched surgeries and other implant failures, split evenly between general dentists and specialists.

“I was frankly stunned at how bad some of these dentists were practicing,” Prisby said. “It was horrendous dentistry.”

Many dental clinics that offer implants have consolidated into chains owned by private equity firms that have bought out much of implant dentistry. In health care, private equity investment is sometimes criticized for overtreatment and prioritizing short-term profit over patients.

Private equity firms have spent about $5 billion in recent years to buy large dental chains that offer implants at hundreds of clinics owned by individual dentists and dental specialists. ClearChoice was bought for an estimated $1.1 billion in 2020 by , which is owned by three private equity firms, according to , a research firm focused on the private equity industry. Private equity firms also bought Affordable Care, whose largest clinic brand is , for an estimated $2.7 billion in 2021, according to PitchBook. And the private equity wing of the Abu Dhabi government bought , which offers implants at many of its affiliated clinics, for an estimated $1 billion in 2022, according to PitchBook.

ClearChoice and Aspen Dental each said in email statements that the companies’ private equity owners “do not have influence or control over treatment recommendations.” Both companies said dentists or dental specialists make all clinical decisions.

Private equity deals involving dental practices increased ninefold from 2011 to 2021, according to an published in August. The study also said investors showed an interest in oral surgery, possibly because of the “high prices” of implants.

“Some argue this is a negative thing,” said Marko Vujicic, vice president of the association’s Health Policy Institute, who co-authored the study. “On the other hand, some would argue that involvement of private equity and outside capital brings economies of scale, it brings efficiency.”

Edwin Zinman, a San Francisco dental malpractice attorney and former periodontist who has filed hundreds of dental lawsuits over four decades, said he believed many of the worst fears about private equity owners had already come true in implant dentistry.

“They’ve sold a lot of [implants], and some of it unnecessarily, and too often done negligently, without having the dentists who are doing it have the necessary training and experience,” Zinman said. “It’s for five simple letters: M-O-N-E-Y.”

Hundreds of Implant Clinics With No Specialists

For this article, journalists from Â鶹ŮÓÅ Health News and CBS News analyzed the webpages for more than 1,000 clinics in the nation’s largest private equity-owned dental chains, all of which offer some implants. The analysis found that more than 70% of those clinics listed only general dentists on their websites and did not appear to employ the specialists — oral surgeons, periodontists, or prosthodontists — who traditionally have more training with implants.

Affordable Dentures & Implants listed specialists at fewer than 5% of its more than 400 clinics, according to the analysis. The rest were staffed by general dentists, most of whom did not list credentialing from implant training organizations, according to the analysis.

ClearChoice, on the other hand, employs at least one oral surgeon or prosthodontist at each of its more than 100 centers, according to the analysis. But its new parent company, Aspen Dental, which offers implants in many of its more than 1,100 clinics, does not list any specialists at many of those locations.

Not everyone is worried about private equity in implant dentistry. In interviews arranged by the , which trains dentists to use implants, two other implant experts did not express concerns about private equity firms.

Brian Jackson, a former academy president and implant specialist in New York, said he believed dentists are too ethical and patients are too smart to be pressured by private equity owners “who will never see a patient.”

Jumoke Adedoyin, a chief clinical officer for Affordable Care, who has placed implants at an Affordable Dentures & Implants clinic in the Atlanta suburbs for 15 years, said she had never felt pressure from above to sell implants.

“I’ve actually felt more pressure sometimes from patients who have gone around and been told they need to take their teeth out,” she said. “They come in and, honestly, taking a look at them, maybe they don’t need to take all their teeth out.”

Still, lawsuits filed across the country have alleged that dentists at implant clinics have extracted patients’ teeth unnecessarily.

For example, in Texas, a patient alleged in a 2020 lawsuit that an Affordable Care dentist removed “every single tooth from her mouth when such was not necessary,” then stuffed her mouth with gauze and left her waiting in the lobby as he and his staff left for lunch. In Maryland, a patient alleged in a 2021 lawsuit that ClearChoice “convinced” her to extract “eight healthy upper teeth,” by “greatly downplay[ing] the risks.” In Florida, a patient alleged in a 2023 lawsuit that ClearChoice provided her with no other treatment options before extracting all her teeth, “which was totally unnecessary.”

ClearChoice and Affordable Care denied wrongdoing in their respective lawsuits, then privately settled out of court with each patient. ClearChoice and Affordable Care did not respond to requests for comment submitted to the companies or attorneys. Lawyers for all three plaintiffs declined to comment on these lawsuits or did not respond to requests for comment.

Fred Goldberg, a Maryland dental malpractice attorney who said he has represented at least six clients who sued ClearChoice, said each of his clients agreed to get implants after meeting with a salesperson — not a dentist.

“Every client I’ve had who has gone to ClearChoice has started off meeting a salesperson and actually signing up to get their financing through ClearChoice before they ever meet with a dentist,” Goldberg said. “You meet with a salesperson who sells you on what they like to present as the best choice, which is almost always that they’re going to take out all your natural teeth.”

Becky Carroll, the ClearChoice patient from New Jersey, told a similar story.

Carroll said in her lawsuit that she met first with a ClearChoice salesperson referred to as a “patient education consultant.” In an interview, Carroll said the salesperson encouraged her to borrow money from family members for the surgery and it was not until after she agreed to a loan and passed a credit check that a ClearChoice dentist peered into her mouth.

“It seems way backwards,” Carroll said. “They just want to know you’re approved before you get to talk to a dentist.”

CBS News producer Nicole Keller contributed to this report.

Â鶹ŮÓÅ Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at Â鶹ŮÓÅ—an independent source of health policy research, polling, and journalism. Learn more about .

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Nothing has helped. Tallant, 51, of Knoxville, Tennessee, said she lives in agony and cannot eat any food that must be chewed. Despite spending a small fortune on treatment, she can barely open her mouth enough to squeeze in a toothbrush.

Tallant estimates she has paid at least $200,000 for TMJ care. She provided medical records showing more than $60,000 in out-of-pocket spending in just the past decade. She has exhausted her savings and borrowed money, she said, and her family sold a plot of land to help pay the bills.

Tallant will need another jaw surgery later this year, which could cost as much as $75,000. Her insurance is unlikely to pay for any of it, she said.

“It’s a bottomless pit,” Tallant said, choking up, as she leafed through a pile of medical records splayed on her dining table. “It has consumed so much of my life that there is not much left.”

Temporomandibular joint disorders, known as TMJ or TMD, cause pain and stiffness in the face and jaw and are believed to afflict as many as 33 million Americans. Scientific studies have found that women experience TMJ disorders as men, and while minor symptoms may not require treatment, severe symptoms can include disabling pain that makes it challenging to eat, work, talk, or sleep.

Despite the commonness of TMJ disorders, treatments are often not covered by medical or dental insurance, leaving patients with out-of-pocket bills that can range from a few hundred dollars to tens of thousands of dollars. Many medical insurers consider TMJ treatment too dental-focused for medical insurance, while dental insurers consider it too medical for dental insurance, leaving patients stuck in a “medical-dental divide” that hinders care and increases cost, according to the National Academies of Science, Engineering, and Medicine.

Worse still, researchers warn that the meager insurance coverage available for TMJ often excludes the safest forms of care while steering patients toward surgery — a riskier and irreversible option that the National Institutes of Health .

Terrie Cowley, a longtime TMJ patient who leads the , an advocacy group, has spoken with patients who refinanced their homes and cashed out retirement accounts to afford the out-of-pocket costs for their care.

“It bankrupts them,” Cowley said. “But it isn’t nearly as horrible as when the treatments go wrong.”

Insurance woes are just one facet of the problems with TMJ care in the United States. In April, a joint investigation by Â鶹ŮÓÅ Health News and CBS News found that TMJ disorders have been widely misunderstood by many dentists for decades, so some patients fall into a spiral of ineffective care and futile surgeries that do more harm than good. Dentistry has tried to correct course in recent years with the promising new specialty of orofacial pain, which treats TMJ disorders with a more conservative approach, but these specialists are few and rarely covered by insurance, so their services remain beyond the reach of many patients.

Tony Schwartz, president of the American Board of Orofacial Pain, said the specialty is still fighting for widespread acceptance from insurance companies and some dentists, who cling to “old, debunked theories” that TMJ disorders are caused by misaligned teeth or a bad bite.

“This is the basis for why insurance companies have been so reluctant to, over the years, pay for any treatment,” Schwartz said. “Because there has been so much controversy about what works and what doesn’t work.”

For this article, Â鶹ŮÓÅ Health News and CBS News interviewed 10 patients with severe TMJ disorders who have been in treatment for years, if not decades. Almost all the patients described spending thousands of dollars out-of-pocket at every stage of their care, usually because treatment fell outside their medical and dental insurance coverage. Some patients said their medical bills mounted just as debilitating pain forced them to leave jobs or abandon careers. Some underwent expensive TMJ surgeries offered by only a small group of surgeons who generally do not accept insurance.

Kyra Wiedenkeller, 45, of New York state, said she worked as a manager in the music industry, including on “American Idol,” before her “unrelenting pain” became too great.

Wiedenkeller, who is now on disability, said she’s spent at least $100,000 out-of-pocket on TMJ treatment and provided medical documents showing she had been billed for at least that much.

“Every doctor I’ve seen has made me progressively worse,” Wiedenkeller said. “I paid an exorbitant amount of money. I wiped out my 401(k) for these treatments in hopes of getting better time and time again. And just get worse and worse. I feel like there is no end.”

Wiedenkeller’s story echoes findings of the national academies, which conducted a that included input from more than 110 patients. The study found that TMJ patients are “often harmed” during “overly aggressive” treatment, which frequently falls into a chasm between medical and dental insurance, leaving most bills paid out-of-pocket at costs of up to tens of thousands of dollars.

As an example, the study describes how dental splints — a common TMJ treatment — have been considered to be medical care by some dental insurers and considered dental care by some medical insurance programs, and are “therefore not covered” by either.

And when TMJ is covered by insurance, it tends to exclude “low-risk, effective treatments,” like those used by orofacial pain specialists, but covers “higher-risk” options, like jaw surgery, according to the national academies study. This leads to patients receiving “the care that is best reimbursed, rather than the care that is best,” the study said.

Other researchers have come to the same conclusion.

James Fricton, an orofacial pain specialist who , said that even though surgery is appropriate for few patients, it is the only treatment covered by most insurance plans in most states.

“Patients will assume that insurance companies know what they’re doing,” Fricton said. “If that’s all that’s covered, what do you think they are going to get? Surgery.”

In contrast, insurance coverage appears to be weakest at the other end of the treatment spectrum.

“Orofacial pain,” in 2020, is now taught in residency programs at a dozen U.S. colleges at least, including the universities of Michigan, Minnesota, and North Carolina. The specialty avoids making irreversible changes to the bite or jaw and instead treats TMJ disorders with tools like counseling, dietary changes, medication, physical therapy, and removable dental splints. Many TMJ patients can be treated by orofacial pain specialists for a few thousand dollars.

The national academies study describes this approach as one of the few promising options for TMJ patients, citing studies that who are taught how to manage their pain. But the national academies also said it is a “particular challenge” that this treatment is “often not considered reimbursable by insurance.”

In separate interviews, six orofacial pain specialists with clinics around the country said insurance coverage for this specialty care is patchy, poor, or nonexistent. Several said their specialty is often absent from dropdown menus on standard insurance forms. Most said the insurance industry had fallen behind on the evolving science of TMJ, missing a chance to help patients and cut costs.

“It’s a no-brainer,” said Jeffrey Okeson, dean of the University of Kentucky’s College of Dentistry. “If I was an insurance person, I’d want to supply $1,000 to a patient to do conservative treatment … instead of $15,000 or $30,000 for surgery. Think of the money that can be saved there.”

Okeson and the other orofacial pain specialists said unreliable insurance coverage has hamstrung the specialty by making it less attractive to the next generation of dentists.

Currently there are fewer than 300 certified orofacial pain specialists in the United States, according to a database maintained by the American Board of Orofacial Pain. At least 20 states have no certified specialists, and eight other states have only one or two.

Deepika Jaiswal, the only certified specialist in Iowa, said some patients with TMJ disorders drive across the state to see her.

However, most of her patients — and many of her fellow dentists — remain unaware of the orofacial pain specialty, Jaiswal said, so insurance companies likely feel little pressure to include it in their coverage.

“People don’t even know around the area that we exist,” Jaiswal said. “When there are more providers providing this service, I think at that point there will be more insurance.”

CBS News producer Nicole Keller contributed to this article.

Â鶹ŮÓÅ Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at Â鶹ŮÓÅ—an independent source of health policy research, polling, and journalism. Learn more about .

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According to FDA documents obtained through the Freedom of Information Act, the agency “became aware” of the AGGA from a joint investigation by Â鶹ŮÓÅ 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 — and off the FDA’s radar — 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 Â鶹ŮÓÅ 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 — 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 Â鶹ŮÓÅ 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 Â鶹ŮÓÅ 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 Â鶹ŮÓÅ 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.

Â鶹ŮÓÅ Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at Â鶹ŮÓÅ—an independent source of health policy research, polling, and journalism. Learn more about .

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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 … 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 Â鶹ŮÓÅ 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” — not compelling scientific evidence nor consistent results — 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 Â鶹ŮÓÅ 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… 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.”

‘Not 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… If I could go back in time and go talk to younger Lisa, I would say ‘Run!’

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 ‘Run!’”

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. … 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 — like installing braces or crowns or grinding teeth down — 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, ‘We 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 Â鶹ŮÓÅ 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.

Â鶹ŮÓÅ Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at Â鶹ŮÓÅ—an independent source of health policy research, polling, and journalism. Learn more about .

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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 Â鶹ŮÓÅ 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” — 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 Â鶹ŮÓÅ 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 Â鶹ŮÓÅ 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 Â鶹ŮÓÅ 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 Â鶹ŮÓÅ 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 Â鶹ŮÓÅ 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.

Â鶹ŮÓÅ Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at Â鶹ŮÓÅ—an independent source of health policy research, polling, and journalism. Learn more about .

USE OUR CONTENT

This story can be republished for free (details).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Collectively, the lawsuits allege that Profemur artificial hips broke or corroded at the neck in about 7½ years, on average. Profemur necks made from titanium broke on average in about 10 years while necks made from the cobalt-chromium alloy broke or corroded in just six years, the lawsuits allege.

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

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

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

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

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

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

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

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

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

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

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

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

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

‘Like a Black Hole Developed Under Their Foot’

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

New Metal, New Complications

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

“That was a big mistake,” Fokter said.

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

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

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

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

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

Kristin Biorn had one.

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

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

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

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

She now walks with a cane.

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

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

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

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

Â鶹ŮÓÅ Health News data editor Holly K. Hacker and CBS News producer Nicole Keller contributed to this report.

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The controversy centered on how doctors are paid for a type of breast reconstruction known as DIEP flap, in which skin, fat, and blood vessels are harvested from a woman’s abdomen to create a new breast.

Last year, the Centers for Medicare & Medicaid Services a trio of medical billing codes for breast reconstructive surgery that enabled doctors to collect much more money for DIEP flap operations than for simpler types of breast reconstruction. Some plastic surgeons said the government’s move would limit access and make DIEP flaps available only to those who could afford to pay tens of thousands of dollars out-of-pocket.

Through its coding decisions, the federal government can influence the medical options available to patients, even those with private insurance.

In an Aug. 22 memo, that it received a “substantial number of responses” verbally and in writing asking regulators to keep the “S” billing codes that reimburse doctors more for the surgery. “The majority of the commenters feel their accessibility will be, or has already been, impacted by the decision to eliminate the S codes,” the agency wrote in reversing its earlier plan.

Supporters praised CMS’ latest action. “I’m so grateful to CMS for this decision that is really meaningful,” Elisabeth Potter, a plastic surgeon who specializes in DIEP flap surgeries, said in a .

The agency’s announcement came after it convened a public hearing in June, during which several patients, physicians, and representatives of breast cancer advocacy organizations implored CMS officials to scrap their original plan. Otherwise, they said, access to DIEP flap surgery would diminish.

The DIEP flap procedure has potential benefits over implants and operations that take muscle from the abdomen. For example, although implants are less costly and less time-intensive to perform, they generally need to be replaced every 10 years or so. But DIEP flap surgery is also more expensive. If patients go outside an insurance network for the operation, it can cost more than $50,000. A plastic surgeons’ group argued some in-network doctors would stop offering the surgery if insurers paid significantly less.

“This decision is monumental for breast cancer patients and breast reconstruction,” Christy Huling, who had a double mastectomy and DIEP flap surgery, said during CMS’ June 1 meeting. Through tears, Huling said she is an avid outdoors person and that her life would have changed “drastically” if she’d instead had reconstruction surgery that removed muscle from her abdomen. “This procedure has allowed me to continue to maintain my quality of life,” she said of DIEP flap.

The government’s initial plan was driven by the Blue Cross Blue Shield Association, a major lobbying organization for health insurance companies. In 2021, the group asked CMS to discontinue the three S codes, arguing they were no longer needed, according to a .

CMS initially decided the codes would expire at the end of 2024; however, even with the delayed effective date, physicians said, the decision was starting to hinder access to DIEP flap surgery and create anxiety for patients. At least two major insurance companies told doctors they would no longer reimburse them under the higher-paying codes.

A bipartisan group of lawmakers , including Rep. Debbie Wasserman Schultz (D-Fla.) and Sen. Amy Klobuchar (D-Minn.), who have both had breast cancer; Rep. James Comer (R-Ky.); and Sen. Marsha Blackburn (R-Tenn.). “This latest CMS decision will provide women with more certainty, and help ensure fair and equitable access to their choice of breast reconstruction techniques,” Wasserman Schultz said in a statement following CMS’ change.

Codes don’t dictate the amounts private insurers pay for medical services; those reimbursements are generally worked out between insurance companies and medical providers. However, using the targeted S codes, doctors and hospitals have been able to distinguish DIEP flap surgeries, which require complex microsurgical skills, from other forms of breast reconstruction that take less time to perform and generally yield lower insurance reimbursements.

CMS’ initial plan would have made it “impossible to continue doing high-volume, high-quality complex breast microsurgery for breast cancer patients,” Dhivya Srinivasa, a plastic surgeon in California who specializes in breast reconstruction, said during CMS’ June 1 hearing. “I am already seeing it, patients who are good candidates who were told ‘no.’ Why were they told no when they’re a good candidate? To say that it has nothing to do with reimbursement, I think, would be foolish.”

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On June 1, the Centers for Medicare & Medicaid Services plans to for a type of breast reconstruction known as DIEP flap, in which skin, fat, and blood vessels are harvested from a woman’s abdomen to create a new breast.

The procedure offers potential advantages over implants and operations that take muscle from the abdomen. But it’s also more expensive. If patients go outside an insurance network for the operation, it can cost more than $50,000. And, if insurers pay significantly less for the surgery as a result of the government’s decision, some in-network surgeons would stop offering it, a plastic surgeons group has argued.

The DIEP flap controversy, , illustrates arcane and indirect ways the federal government can influence which medical options are available — even to people with private insurance. Often, the answers come down to billing codes — which identify specific medical services on forms doctors submit for reimbursement — and the competing pleas of groups whose interests are riding on them.

Medical coding is the backbone for “how business gets done in medicine,” said , a physician at Washington University School of Medicine in St. Louis who researches health economics and policy.

CMS, the agency overseeing Medicare and Medicaid, maintains a list of codes representing thousands of medical services and products. It regularly evaluates whether to add codes or revise or remove existing ones. Last year, it decided to eliminate a code that has enabled doctors to collect much more money for DIEP flap operations than for simpler types of breast reconstruction.

In 2006, CMS established an “S” code — S2068 — for what was then a relatively new procedure: breast reconstructions with deep inferior epigastric perforator flap, or DIEP flap. S codes temporarily fill gaps in a parallel system of billing codes known as CPT codes, which are maintained by the American Medical Association, a physician group.

Codes don’t dictate the amounts private insurers pay for medical services; those reimbursements are generally worked out between insurance companies and medical providers. However, using the narrowly targeted S code, doctors and hospitals have been able to distinguish DIEP flap surgeries, which require complex microsurgical skills, from other forms of breast reconstruction that take less time to perform and generally yield lower insurance reimbursements.

CMS announced in 2022 that it planned to eliminate the S code at the end of 2024 — a move some doctors say would slash the amount surgeons are paid. (To be precise, CMS announced it would eliminate a series of three S codes for similar procedures, but some of the more outspoken critics have focused on one of them, S2068.) The agency’s decision is already changing the landscape of reconstructive surgery and creating anxiety for breast cancer patients.

Kate Getz, a single mother in Morton, Illinois, learned she had cancer in January at age 30. As she grappled with her diagnosis, she said, it was overwhelming to think about what her body would look like over the long term. She pictured herself getting married one day and wondered “how on earth I would be able to wear a wedding dress with only having one breast left,” she said.

She thought a DIEP flap was her best option and worried about having to undergo repeated surgeries if she got implants instead. Implants generally need to be replaced every 10 years or so. But after she spent more than a month trying to get answers about how her DIEP flap surgery would be covered, Getz’s insurer, Cigna, informed her it would use a lower-paying CPT code to reimburse her physician, Getz said. As far as she could see, that would have made it impossible for Getz to obtain the surgery.

Paying out-of-pocket was “not even an option.”

“I’m a single mom. We get by, right? But I’m not, not wealthy by any means,” she said.

Cost is not necessarily the only hurdle patients seeking DIEP flaps must overcome. Citing the complexity of the procedure, Getz said, a local plastic surgeon told her it would be difficult for him to perform. She ended up traveling from Illinois to Texas for the surgery.

The government’s plan to eliminate the three S codes was driven by the Blue Cross Blue Shield Association, a major lobbying organization for health insurance companies. In 2021, the group asked CMS to discontinue the codes, arguing that they were no longer needed because the American Medical Association had updated a CPT code to explicitly include DIEP flap surgery and the related operations, according to a .

For years, the American Medical Association advised doctors that the CPT code was appropriate for DIEP flap procedures. But after the government’s decision, at least two major insurance companies told doctors they would no longer reimburse them under the higher-paying codes, prompting a backlash.

Physicians and advocacy groups for breast cancer patients, such as the nonprofit organization , have argued that many plastic surgeons would stop providing DIEP flap procedures for women with private insurance because they wouldn’t get paid enough.

Lawmakers from both parties have asked the agency to keep the S code, including Rep. Debbie Wasserman Schultz (D-Fla.) and Sen. Amy Klobuchar (D-Minn.), who have had breast cancer, and Sen. Marsha Blackburn (R-Tenn.).

CMS will consider whether to keep the three S codes or delay their expiration.

In a May 30 statement, Blue Cross Blue Shield Association spokesperson Kelly Parsons reiterated the organization’s view that “there is no longer a need to keep the S codes.”

In a profit-driven health care system, there’s a tug of war over reimbursements between providers and insurance companies, often at the expense of patients, said Joynt Maddox, the Washington University physician.

“We’re in this sort of constant battle” between hospital chains and insurance companies “about who’s going to wield more power at the bargaining table,” Joynt Maddox said. “And the clinical piece of that often gets lost, because it’s not often the clinical benefit and the clinical priority and the patient centeredness that’s at the middle of these conversations.”

Elisabeth Potter, a plastic surgeon who specializes in DIEP flap surgeries, decided to perform Getz’s surgery at whatever price Cigna would pay.

According to Fair Health, a nonprofit that provides information on health care costs, in Austin, Texas — where Potter is based — an insurer might pay an in-network doctor $9,323 for the surgery when it’s billed using the CPT code and $18,037 under the S code. Those amounts are not averages; rather, Fair Health estimated that 80% of payment rates are lower than or equal to those amounts.

Potter said her Cigna reimbursement “is significantly lower.”

Weeks before her May surgery, Getz received big news — Cigna had reversed itself and would cover her surgery under the S code. It “felt like a real victory,” she said.

But she still fears for other patients.

“I’m still asking these companies to do right by women,” Getz said. “I’m still asking them to provide the procedures we need to reimburse them at rates where women have access to them regardless of their wealth.”

In a statement for this article, Cigna spokesperson Justine Sessions said the insurer remains “committed to ensuring that our customers have affordable coverage and access to the full range of breast reconstruction procedures and to quality surgeons who perform these complex surgeries.”

Medical costs that health insurers cover generally are passed along to consumers in the form of premiums, deductibles, and other out-of-pocket expenses.

For any type of breast reconstruction, there are benefits, risks, and trade-offs. paper published in JAMA Surgery found that women who underwent DIEP flap surgery had higher odds of developing “reoperative complications” within two years than those who received artificial implants. However, DIEP flaps had lower odds of infection than implants.

Implants carry risks of additional surgery, pain, rupture, and even an uncommon type of immune system cancer.

Other flap procedures that take muscle from the abdomen can leave women with weakened abdominal walls and increase their risk of developing a hernia.

Academic research shows that insurance reimbursement affects which women can access DIEP flap breast reconstruction, creating a two-tiered system for private health insurance versus government programs like Medicare and Medicaid. Private insurance generally pays physicians more than government coverage, and Medicare doesn’t use S codes.

Lynn Damitz, a physician and board vice president of health policy and advocacy for the American Society of Plastic Surgeons, said the group supports continuing the S code temporarily or indefinitely. If reimbursements drop, some doctors won’t perform DIEP flaps anymore, she said.

A study found that, of patients who used their own tissue for breast reconstruction, privately insured patients were more likely than publicly insured patients to receive DIEP flap reconstruction.

To Potter, that shows what will happen if private insurance payments plummet. “If you’re a Medicare provider and you’re not paid to do DIEP flaps, you never tell a patient that it’s an option. You won’t perform it,” Potter said. “If you take private insurance and all of a sudden your reimbursement rate is cut from $15,000 down to $3,500, you’re not going to do that surgery. And I’m not saying that that’s the right thing to do, but that’s what happens.”

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Multiple lawsuits allege the device has caused grievous harm to at least 20 patients and the FDA is now investigating its safety, Â鶹ŮÓÅ 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 Â鶹ŮÓÅ 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 Â鶹ŮÓÅ Health News-CBS News investigation of the AGGA involved interviews with 11 patients who said they were hurt by the device — plus attorneys who said they represent or have represented at least 23 others — 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 Â鶹ŮÓÅ Health News and CBS News. His attorney, Alan Fumuso, previously said in a written statement that the AGGA, “when properly used, is safe and can achieve beneficial results.”

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

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

CBS News producer Nicole Keller contributed to this article.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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