Storm Gifford, New York Daily News: May 2, 2019.
A type of breast implant that has been linked to a rare cancer form will not get pulled from the American market.
That was the Food and Drug Administration’s decision on Thursday, which claimed its risks didn’t warrant a countrywide prohibition.
But the agency was mulling issuing a strong warning for the implants and requiring manufacturers to strictly report any potential problems.
Recently, regulators have contended with the recently confirmed link to a rare cancer and the thousands of unconfirmed complaints of other health woes attributed to the implants.There have been more than 600 documented cases of the cancer worldwide, among an estimated 10 million women with implants.
The announcement is the latest in a decades-long effort to manage implant risks and complications that can include scarring, pain, swelling and rupture, reported The Associated Press.
Although the FDA says it doesn’t have concrete proof that implants are harmful, women considering getting them “should be aware of these risks.”
French officials recently issued a ban of breast implants associated with a form of lymphoma, including those sold by Allergan. But the FDA’s director for medical devices said he won’t take that step yet.
“At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard,” said Dr. Jeffrey Shuren.
President of the National Center for Health Research Diana Zuckerman, who has studied breast implant safety, said a ban may not be needed to phase out textured ones.