A medical device advisory panel for the U.S. Food and Drug Administration will take a closer look at the safety of metal-containing implants and dental amalgams.
The FDA's Immunology Device Panel will hold a two-day meeting Nov. 13-14 and focus on the risks that the medical devices pose to patients and the safety of the specific materials used in the devices, according to a Sept. 30 statement from the FDA.
Also, the panel will seek information to help improve the review and approval processes for the devices and identify gaps in scientific knowledge about the devices that future studies could focus on.
"We are continuing our efforts to determine how to better identify patients who might be at increased risk of experiencing a hypersensitivity response before they receive a metal-containing implant, so that they, along with their health care providers can better consider those risks along with the device's benefits," Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.
Shuren also said that the majority of patients rely on the devices and are not harmed by them, adding that the agency "continues to believe that the benefits of metal or metal alloys in medical device implants outweigh the risks for most patients."
Two scientific reviews were released along with the Sept. 30 statement: one on the risks of metal implants and the other on dental amalgams, which the agency is looking at to explore the health risks of mercury exposure associated with the devices.
In March, the FDA issued a notice saying it would be examining how materials like metal, silicon and animal materials that are used in medical devices impact patients. The specific devices highlighted in the March notice include metal-on-metal total hip replacement devices and Bayer AG's permanent birth control device Essure, both of which have been linked to patient injuries and lead to criticisms of the FDA's medical device approval process.
There are currently no metal-on-metal total hip replacement devices on the market, but there are still patients who have the devices implanted in them that could be at risk, according to the FDA's March notice.
Bayer has stood by the safety of Essure, but the company has pulled the device off the market, citing a lack of sales.
Metal-containing implants are not the only devices to face additional scrutiny from the FDA. The agency has also recently reclassified surgical staplers as higher-risk devices, and it released a warning about the cancer risks associated with certain breast implant devices in July, which led to Allergan PLC voluntarily issuing a worldwide recall of its Biocell breast implants.
