Many women have breast implants with no serious complications, but there have been cases where women suffer pain and fatigue, among other health problems.
Now, the US Food and Drug Administration is holding a meeting to take a closer look at such cases and put breast implant safety under a microscope. The meeting involves hearing from from patients, physicians and industry representatives.
The FDA Medical Devices Advisory Committee’s General and Plastic Surgery Devices Panel convenes Monday and Tuesday to discuss and make recommendations relating to the risks and benefits of breast implants.
The meeting, which is open to the public, comes just days after the FDA issued warning letters to two breast implant manufacturers for failing to comply with the agency’s requirements to conduct long-term studies assessing the safety and risks of their silicone gel-filled implants.
The committee plans to discuss reports of breast implants being linked to a rare cancer called anaplastic large cell lymphoma; the use of registries for maintaining breast implant surveillance; and best practices for informed consent discussions between patients and clinicians, among other topics.
“We’ve also heard from patients who are concerned that their implants may be connected to other health conditions that could be associated with their immune system’s response to these devices, resulting in symptoms like chronic fatigue, cognitive issues and muscle pain,” FDA commissioner Dr. Scott Gottlieb and Dr. Jeff Shuren, director of the Center for Devices and Radiological Health, said in a FDA statement earlier this month.