FDA to require stronger safety warnings for breast implants
The Food and Drug Administration on Wednesday issued stricter safety requirements for breast implants, mandating that patients receive detailed information about potential complications.
Why it matters: The new regulations come as the agency experiences increased pressure from the public over the sometimes severe complications that thousands of women who received breast implants have endured for years, Axios' Marisa Fernandez reports.
- Women who received implants have reported severe muscle and joint pain, weakness, cognitive difficulties and fatigue, according to the New York Times.
Details: The FDA's order restricts the sale and distribution of breast implants to only health care providers and facilities that provide people with a "Patient Decision Checklist," per the release.
- The agency also issued a requirement for manufacturers to post new warning labels on several types of breast implants.
What they're saying: "Protecting patients’ health when they are treated with a medical device is our most important priority," said Binita Ashar, director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health.
- "[T]he FDA is working to close information gaps for anyone who may be considering breast implant surgery," she added.