Metal Implant Risks, Safety to be Topic of FDA Advisory Committee Hearing

As federal regulators continue to evaluate the safety and side effects of metal medical devices, a panel of experts will be convened in November to make recommendations about any steps that should be taken to protect consumers in the U.S.

The FDA announced a meeting of its Immunology Devices Panel in a press release issued on September 30, indicating that the panel will the use of various different materials in medical devices during meetings planned for November 13-14, 2019, specifically focusing on concerns about metal implant risks and dental amalgams.

This is the first public advisory committee meeting to convene experts and the public on medical devices containing metal, such as birth control implants, as well as metal-on-metal hip implants and other devices which have been linked to complications in recent years. While recommendations made by the advisory panel are not binding, they usually have a significant influence on the FDA’s policy and regulatory decisions.

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The panel will review new scientific evidence on the effects of metals used in implants, including how it affects the tissue, muscle, and blood supply.

A small number of patients who receive implants have biological responses to some materials used in those devices, including inflammatory reactions, allergic reactions, and tissue changes that cause pain and fatigue.

The meeting comes amid what appears to be growing concerns about nitinol problems in certain medical devices, particularly implants. Nitinol is used in many medical devices; including wires, stents, surgical instruments, orthopedic fracture fixation devices, and transcatheter heart valves. Many of those devices have been linked to adverse tissue responses which health experts had difficulties explaining or confirming.

The FDA notes that it was also used in the Essure birth control implant, which was removed from the market in December following years of reports of adverse events including fracturing and migration, but also of mysterious ailments and claims that women’s bodies had what appeared to be allergic reactions to the device.

In April, the FDA issued a draft guidance calling for manufacturers of metal implants to test for corrosion, biocompatibility, and performance under conditions of stress, strain and temperature variations. It also explained how label warnings should be handled regarding potential allergic reactions to metals in implants.

Now, the agency is focusing on efforts to identify patients at risk of side effects before they receive a metal-containing implant.The meeting will focus on how to evaluate which patients may experience side effects, as well as testing a device before implantation, modifying a device, and other solutions to avoid reactions.

The announcement was accompanied by two reviews. The first summarizes current scientific knowledge about the aspects of metal impacts and how it may affect the body’s tissues, muscles, and blood supply.

The second review is an assessment of the latest literature and data on the risks linked to dental amalgams.

“The FDA continues to believe that the benefits of metal or metal alloys in medical device implants outweigh the risks for most patients,” Dr. Jeffrey E. Shuren, Director of the FDA’s Center for Devices and Radiological Health, wrote in the press release. “However, we recognize that it is critical to closely monitor and evaluate new data as science is always evolving. We continue to explore ways to modernize the FDA’s review of medical device materials in an effort to support safety and innovation in medical devices that can significantly improve patient health and quality of life while working to minimize the potential for patient risk.”

Essure Problems

Although Essure was recalled from the market in most countries in 2017, Bayer continued to sell the device in the United States until the end of last year. Amid mounting pressure and publicity about the injuries women were experiencing from Essure, the company announced in July 2018 that it was removing Essure from the US. market on December 31, 2018.

Approximately 750,000 women worldwide have been implanted with the device, and Bayer has previously estimated that 70% of those have been implanted in women in the U.S.

Bayer currently faces more than 18,000 product liability lawsuits filed nationwide, each involving similar allegations that side effects of Essure coils caused women to experience painful and debilitating complications after receiving the birth control device.

The manufacturer has reportedly spent about $413 million defending the litigation over the last year, and may face substantially greater liability at trial if Essure settlements or another resolution for the cases is not reached.


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