The FDA never inspected Johns Dental Laboratories during more than a decade in which it made the Anterior Growth Guidance Appliance, or \u201cAGGA,\u201d a dental device that has allegedly harmed patients and is now the subject of a criminal investigation.<\/p>\n

According to FDA documents obtained through the Freedom of Information Act, the agency \u201cbecame aware\u201d of the AGGA from a joint investigation<\/a> by KFF Health News and CBS News in March 2023, then responded with its first-ever inspection of Johns Dental months later.<\/p>\n

That inspection found that the Indiana dental device manufacturer didn\u2019t 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 investigate complaints and forward them<\/a> to the agency. Johns Dental had \u201cnever\u201d alerted the FDA to any such complaints, according to the documents.<\/p>\n

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 \u201cgrow\u201d or \u201cexpand\u201d an adult\u2019s jaw without surgery and treat common ailments like sleep apnea<\/a>. 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.<\/p>\n

Two former FDA officials said the AGGA was likely able to stay on the market \u2014 and off the FDA\u2019s radar \u2014 for so long because of the lack of inspections and investigations at Johns Dental. Madris Kinard, a former FDA manager who founded Device Events<\/a>, which analyzes FDA data, said it defies belief that Johns Dental never received a complaint worthy of relaying to the FDA.<\/p>\n

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\u201cThat\u2019s a red flag for me. If I don\u2019t see a single report to the FDA, I typically think there is something going on,\u201d Kinard said. \u201cWhen they don\u2019t report, what you have is devices that stay on the market much longer than they should. And patients get harmed.\u201d<\/p>\n
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, sells dozens of products<\/a> to dentists and makes hundreds of retainers and sleep apnea appliances each month, according to its website.<\/p>\n
The FDA never inspected Johns Dental Laboratories, in Terre Haute, Indiana, during more than a decade in which the lab made the Anterior Growth Guidance Appliance, or \u201cAGGA,\u201d according to FDA documents.(Samantha Liss\/KFF Health News)<\/span><\/figcaption><\/figure>\n
Twelve of Johns Dental\u2019s products are registered with the FDA as Class II<\/a> 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 screen captures<\/a> preserved by the Internet Archive.<\/p>\n
The AGGA, which was invented by Tennessee dentist Steve Galella in the 1990s, was not registered with the FDA like Johns Dental\u2019s other devices. Company owner Jerry Neuenschwander has said in sworn court depositions that Johns Dental started making the AGGA in 2012 and became Galella\u2019s exclusive manufacturer in 2015 and that at one point the AGGA was responsible for about one-sixth of Johns Dental\u2019s total sales revenue.<\/p>\n
In another deposition, Johns Dental CEO Lisa Bendixen said the company made about 3,000 to 4,000 AGGAs a year and paid Galella\u2019s company a \u201croyalty\u201d of $50 to $65 for every sale.<\/p>\n
\u201cWe are not dentists. We do not know how these appliances work. All we do is manufacture to Dr. Galella\u2019s specifications,\u201d she said, according to a deposition transcript.<\/p>\n
The FDA\u2019s 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 \u201ccontract manufacturer\u201d of other medical devices. Prior to 2018, the FDA was only aware of Johns Dental operating as a \u201cdental laboratory,\u201d which normally do not manufacture their own products and only modify devices made by other companies to fit dentists\u2019 specifications. The FDA does not regularly inspect dental labs, although it can if it has concerns or gets complaints, the agency said.<\/p>\n
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.<\/p>\n
\u201cThere hasn\u2019t been much attention to dental devices in the past,\u201d Kinard said. \u201cHopefully that\u2019s going to change because of dental implant failures, as well as this device, which has quite obviously had serious issues.\u201d<\/p>\n
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 KFF Health News-CBS News investigation revealed the AGGA was not backed by any peer-reviewed research and had never been submitted to the FDA for review. At the time, at least 20 patients had alleged in lawsuits that the AGGA had caused grievous harm to their teeth, gums, and bone \u2014 and some said they\u2019d 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.<\/p>\n
\u201cThe entire concept of this device, of this treatment, makes zero sense,\u201d said Kasey Li, a maxillofacial surgeon who published research on AGGA patients<\/a> that appeared on a National Institutes of Health website. \u201cIt doesn\u2019t grow the jaw. It doesn\u2019t widen the jaw. It just pushes the teeth out of their original position.<\/p>\n
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 KFF Health News-CBS News investigation. Johns Dental and Galella denied wrongdoing or have not yet responded to the allegations in the newer lawsuits.<\/p>\n
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 \u201cis safe and can achieve beneficial results\u201d when used properly.<\/p>\n
$\"A$
An Anterior Growth Guidance Appliance, or \u201cAGGA,\u201d is photographed before being used by Karan Gill, who wore the device for months and alleged in a lawsuit his teeth were left loose and sensitive. The AGGA\u2019s inventor, Steve Galella, and its manufacturer, Johns Dental Laboratories, settled the lawsuit after denying all liability.(Karan Gill)<\/span><\/figcaption><\/figure>\n
In the wake of the KFF Health News-CBS News report, Johns Dental abruptly stopped making the AGGA, according to the newly released FDA documents. The Department of Justice soon after opened a criminal investigation into the AGGA<\/a> that was ongoing as of December, according to court filings. No charges have been filed. A DOJ spokesperson declined comment.<\/p>\n
Spurred by the March 2023 news report, the FDA inspected Johns Dental in July. The FDA\u2019s website shows that Johns Dental was issued seven citations<\/a>, but the substance of the agency\u2019s findings was not known until the inspection report was obtained this year.<\/p>\n
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\u2019s complaint policies. Neuenschwander was told by his attorney not to talk to the inspector, the report states.<\/p>\n
\u201cHe asked if he could photograph my credentials,\u201d Gasparovich wrote in his report. \u201cThis was the last conversation I would have with Mr. Neuenschwander at the request of his attorney.\u201d<\/p>\n
The FDA requires device companies to investigate product complaints and submit a \u201cmedical device report\u201d to the agency within 30 days if the products may have contributed to serious injury or death. Gasparovich\u2019s inspection report states that Johns Dental had \u201cnot adequately investigated customer complaints,\u201d and its complaint policies were \u201cnot adequately established,\u201d allowing employees to not investigate if the product was not first returned to the company.<\/p>\n
Johns Dental received four complaints about the AGGA after the KFF Health News-CBS News report, including one that came after the FDA announced \u201csafety concerns\u201d<\/a> about the device, according to the inspection report.<\/p>\n
\u201cZero (0) out of the four (4) complaints were investigated,\u201d Gasparovich wrote in the report. \u201cEach complaint was closed on the same day it was received.\u201d<\/p>\n
In the months after Gasparovich\u2019s 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.<\/p>\n
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.<\/p>\n
Brooke said the AGGA is an example of how the FDA\u2019s oversight can be hamstrung by its reliance on device manufacturers to be transparent. If device companies don\u2019t report to the agency, it can be left unaware of patient complaints, malfunctions, or even entire products, he said.<\/p>\n
When a company \u201cdoesn\u2019t follow the law,\u201d Brooke said, \u201cthe FDA is in the dark.\u201d<\/p>\n
\u201cIf there aren\u2019t complaints coming from patients, doctors, competitors, or the company itself, then in a lot of ways, there\u2019s just a dearth of information for the FDA to consume to trigger an inspection,\u201d Brooke said.<\/p>\n
CBS News producer Nicole Keller contributed to this article.<\/em><\/p>\n
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