The FDA said it never inspected the dental lab that manufactured the controversial AGGA device.

Aug. 9 — The Food and Drug Administration (FDA) failed to conduct any inspections of Johns Dental Laboratories for more than a decade while it manufactured the Anterior Growth Guidance Appliance, or “AGGA,” a dental device that allegedly harmed patients and is now the subject of a criminal investigation.

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

That review found that the Indiana-based dental device maker failed to investigate all customer complaints and that the company failed to investigate some complaints about people harmed by its products, including AGGA, according to FDA documents. The FDA requires device companies to investigate complaints and forward them to the agency. Johns Dental “never” notified the FDA of such complaints, according to the documents.

AGGA, which its inventor testified had been used on more than 10,000 patients, was promoted by dentists across the country, some of whom claimed it could “unfold” or “expand” an adult’s jaw without surgery and treat common ailments such as sleep apnea. But those claims were not supported by peer-reviewed studies, and Johns Dental settled lawsuits from 20 patients who claimed AGGA had caused them serious harm. The company did not admit liability.

Two former FDA officials said AGGA likely was able to stay on the market — and off the FDA’s radar — for so long because of the lack of inspections and investigations into Johns Dental. Madris Kinard, a former FDA executive who founded Device Events, an FDA data analysis firm, said it’s unbelievable that Johns Dental never received a complaint worth reporting to the FDA.

“That’s a red flag to me. If I don’t see a single report to the FDA, I usually think something’s going on,” Kinard said. “When they don’t report, you have devices that are sitting on the market much longer than they should be. And patients are being harmed.”

Johns Dental Laboratories declined to comment when reached by phone, and its attorneys did not respond to interview requests. The family-owned company, which has been in operation since 1939 in the western Indiana city of Terre Haute, sells dozens of products to dentists and makes hundreds of orthodontic 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 moderate risk. Some of them have been featured on the company’s website for at least two decades, according to screenshots preserved on the Internet Archive.

AGGA, invented by Tennessee dentist Steve Galella in the 1990s, is not registered with the FDA like other Johns Dental devices. Company owner Jerry Neuenschwander testified in a sworn deposition that Johns Dental began producing AGGA in 2012 and became the exclusive manufacturer of Galella in 2015, and at one point AGGA accounted for about one-sixth of Johns Dental’s total sales.

In another deposition, Johns Dental CEO Lisa Bendixen said the company made about $3,000 to $4,000 a year and paid Galella a “royalty fee” of $50 to $65 on each sale.

“We are not dentists. We do not know how these devices work. All we do is manufacture them to Dr. Galella’s specifications,” she said, according to a transcript of her testimony.

The FDA’s lack of knowledge about AGGA likely contributed to its lax oversight of Johns Dental. Asked to explain the lack of inspections, 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. Before 2018, the FDA only knew that Johns Dental operated as a “dental laboratory,” which typically does not manufacture its own products and merely modifies devices made by other companies to fit dentists’ specifications. The FDA does not regularly inspect dental laboratories, although it can do so if it has concerns or receives 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 played a role in the lack of scrutiny at Johns Dental.

“In the past, there hasn’t been a lot of attention paid to dental devices,” Kinard said. “I hope that changes because of the dental implant failures and this device, which apparently had some serious problems.”

AGGA resembles a retainer and uses springs to apply pressure to the front teeth and upper palate, according to the patent application. Last year, a KFF Health News-CBS News investigation found that AGGA was not supported by any peer-reviewed studies and was never submitted to the FDA for review. At the time, at least 20 patients claimed in lawsuits that AGGA caused serious damage to their teeth, gums and bone — and some said they lost teeth. Several dentists said in interviews that they had studied AGGA patients whose teeth had been pushed out of position by the device, sometimes causing tens of thousands of dollars in damage.

“The whole concept of this device, this treatment, makes no sense,” said Kasey Li, an oral and maxillofacial surgeon who published research on AGGA patients that appeared on the 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.