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 ºÚÁϳԹÏÍø 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, ºÚÁϳԹÏÍø 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 ºÚÁϳԹÏÍø 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.

ºÚÁϳԹÏÍø News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—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 ºÚÁϳԹÏÍø 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, ºÚÁϳԹÏÍø 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.

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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 ºÚÁϳԹÏÍø 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 ºÚÁϳԹÏÍø 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 ºÚÁϳԹÏÍø 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 ºÚÁϳԹÏÍø 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 ºÚÁϳԹÏÍø 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.

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

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This story can be republished for free (details).

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

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

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

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

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

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

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

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

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

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

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

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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 ºÚÁϳԹÏÍø 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 ºÚÁϳԹÏÍø 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 ºÚÁϳԹÏÍø 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.

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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 ºÚÁϳԹÏÍø 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 ºÚÁϳԹÏÍø 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 ºÚÁϳԹÏÍø 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 ºÚÁϳԹÏÍø 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 ºÚÁϳԹÏÍø 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 ºÚÁϳԹÏÍø 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.

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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, ºÚÁϳԹÏÍø 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 ºÚÁϳԹÏÍø 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 ºÚÁϳԹÏÍø 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 ºÚÁϳԹÏÍø 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.”

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

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

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

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

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

Dr. Marianna Evans, orthodontist and periodontist

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Dr. Kasey Li, maxillofacial surgeon and sleep apnea specialist

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

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

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

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

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

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

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

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

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

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

Rolling Out the AGGA

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

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

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

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

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

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

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

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

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

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

William Schuller, attorney

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

AGGA Inventor: ‘It’s OK to Make a Crapload of Money’

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

CBS News producer Nicole Keller contributed to this article.

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