Dangerous Non-FDA Approved Medical Devices: A Consumer Warning

By Aitken Aitken Cohn

Recently a promising young clarinetist, Boja Kragulj, shared her harrowing story with CBS News about a disastrous dental treatment with an unproven, unregulated device that upended her career.

Kragulj had breathing issues—the placement of her jaw constricted her airway—and she’d been told that only surgery could correct it.

Then, on social media, she saw an advertisement for the Anterior Growth Guidance Appliance, or “AGGA.”

AGGA is a pricey (typically around $7000) dental device, advertised as a way to “grow,” “expand,” or “remodel” the jaw, treat problems like sleep apnea and TMJ, and even enhance facial beauty. Dentists around the country who have attended AGGA training sessions promote it on their websites as an alternative to surgery. AGGA’s inventor, Dr. Steve Galella of Tennessee, claims the device spurs jaw growth, even in adults. According to court records, over 10,000 patients have been treated with the device.

Kragulj began treatment five years ago with a dentist who said she was trained in AGGA’s use. But within months after the appliance, which looks like a retainer, was fitted in her mouth, Kragulj began noticing significant gaps between her teeth; then, her teeth began to flare dramatically forward. Her dentist applied braces, claiming they were part of the treatment, but Kragulj’s teeth had become loose and painful. The orthodontist she consulted for a second opinion was horrified by what he saw. Kragulj has now had to remove her four front teeth due to bone loss, and she will likely lose several more.

Kragulj, who currently wears false teeth and estimates it will cost $150,000 to repair the damage caused by the AGGA device fully, has filed a lawsuit In the United States District Court Southern District Of New York, alleging both dental malpractice and product liability.

But hers is not the only case against AGGA. A joint investigation by CBS and KHN found at least 20 active suits against Dr. Galella (who advises on AGGA treatment plans) and other dentists over disastrous results with the device.

Independent experts consulted by CBS, including board-certified dentists and surgeons, say it is physiologically impossible for the AGGA to do what Dr. Galella claims it does. Court documents show that Dr. Galella admitted he knows of no clinical trials or peer-reviewed studies that support the use of AGGA in adults. Furthermore, AGGA is not FDA-approved. CBS/KHN investigators found no record of the device being registered in the FDA’s database.

Yet you can still find AGGA, now called the Osseo-Restoration Appliance, advertised across the Internet.

What consumers and patients need to know.

While AGGA may be an extreme example, consumers and patients must be aware that there are health products and devices on the market that do not have FDA approval. Although most medications and medical devices undergo the FDA’s thorough review and testing, other widely available health-related items have not been held to the same standard.

What is a medical device?

Band-Aid. Bedpan. Thermometer. Home pregnancy test. Wheelchair. Blood pressure monitor. Pacemaker. MRI machine…

Despite these items’ clear and vast differences, they’re all considered medical devices. The FDA classifies medical devices into regulatory categories, I (lowest) – III (highest), based on intended use, indications for use, and risk level.

However, many health-related products we depend on for information, tracking, guidance, inspiration, and more are not classified by the FDA as medical devices and therefore do not need to be FDA-approved (though there are regulations and safety standards). These products include general exercise equipment, smartwatch fitness trackers, and software such as weight loss and nutrition apps, calorie counters, meal planners, sleep trackers for infants and adults, social gaming apps that incentivize healthy lifestyle changes, and so forth. Neither cosmetics nor dietary supplements need to be FDA-approved. But that does not mean they are risk-free.

In some cases, FDA-approved products are used for off-label or experimental purposes. Further, as Yale News reported early this year, “Manufacturers, through a loophole in the law, can use unsafe medical devices as a basis for bringing new, related products to market.”

It’s vital for consumers, patients, and healthcare providers to weigh the benefits and risks of using any medical device or health product, to know whether it is FDA-approved for the intended purpose, and to exercise great care when using a non-FDA-approved product or using it off-label. Never be afraid to ask questions about a medical appliance or procedure or seek a second opinion—know what products are being used in your treatment and whether they are regulated and proven.

At Aitken * Aitken * Cohn, our attorneys have extensive experience representing individuals in personal injury cases, including those that involve products liability issues.

Most recently our firm reached a $4.25 million settlement on behalf of a woman who suffered permanent blindness after her physician injected her with a non-FDA-approved facial filler.