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FDA said it never inspected dental lab that made controversial AGGA device

Brett Kelman, Anna Werner, CBS News, KFF Health News on

Published in Health & Fitness

The FDA never inspected Johns Dental Laboratories during more than a decade in which it made the Anterior Growth Guidance Appliance, or “AGGA,” a dental device that has allegedly harmed patients and is now the subject of a criminal investigation.

According to FDA documents obtained through the Freedom of Information Act, the agency “became aware” of the AGGA from a joint investigation by KFF Health News and CBS News in March 2023, then responded with its first-ever inspection of Johns Dental months later.

That inspection found that the Indiana dental device manufacturer didn’t require all customer complaints to be investigated and the company did not investigate some complaints about people being hurt by products, including the AGGA, the FDA documents state. The FDA requires device companies to investigate complaints and forward them 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 Device Events, 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, sells dozens of products 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 Class II 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 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.

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©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

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