Product News and Recalls

FDA Updates Language on Agency’s Breast Implant Site

FDA updates breast implant warning language on websiteAs global attention to the potential risks of breast implants of all types continues to increase, the U.S. Food and Drug Administration has updated the language on its own breast implant information site to include some of the most recent developments.

While the agency was incredibly slow to react to news of ailments like Breast Implant Illness – a moniker given to a collective group of systemic illnesses that are all tied to breast implants – as well as life-threatening illnesses like breast implant associated-anaplastic large cell lymphoma, it has now acknowledged and publicized those risks as well as more generalized symptoms like breast pain and the risk of breast implant ruptures. The agency goes on to describe the potential for additional surgeries to be required for implant repair and replacement as well as infection of the surgical site.

Long since thought of as a trivial cosmetic procedure with little risk, breast implants have been under fire recently as reports of cancers and other illnesses have come to light. While initially originating in European markets, reports of breast cancers tied to the use of textured breast implants quickly made their way across the Atlantic to U.S. doctors. As research into the condition intensified, it became apparent that while smooth-textured implants did not seem to trigger breast implant associated-anaplastic large cell lymphoma at the rate that rough textured implants appeared to, enough of a link existed that the agency would eventually have to act.

As is the case with so many of the FDA’s other failures, the agency moved with such titanic slowness that public dissatisfaction grew to the point of public admonishment from the established medical community. As evidence of potential risks for millions of women across the country started to stack up, organizations like the National Center for Health Research watched as the FDA launched “investigations” but otherwise took no decisive action.

With this latest change to the agency’s website, it appears that additional attention may be paid to this issue. But for far too many, the damage has already been done.