FDA panel wants info on metal implant reactions (TMGPulse)
An FDA panel will meet this week to discuss immunological responses to medical device implants made of metal, including artificial hips and the Essure permanent birth control device.
The Immunology Devices Panel of the agency’s Center for Devices and Radiological Health is seeking scientific information on how metal implants or inserts elicit a prolonged and/or heightened immunological inflammatory response.
Corrosion of the metals used in artificial hips, for example, have been linked to metallosis, or metal poisoning. Symptoms include bone and tissue death, implant failure and severe pain. Implant makers have reached billions of dollars in legal settlements and researchers continue to study and test alternatives.
Bayer’s (ETR:BAYN) Essure inserts are metal coils made of polyester fibers, nickel, titanium, platinum, silver-tin and stainless steel. Designed for implant in the fallopian tubes, Essure was pulled from the U.S. market in 2018 after women reported suffering a variety of ailments after implant, including pain, bleeding and autoimmune disorders.
The discussion on Wednesday and Thursday will include patie...
