The FDA Chose Not to Ban Breast Implants Linked to Cancer and Autoimmune Problems

Illustration for article titled The FDA Chose Not to Ban Breast Implants Linked to Cancer and Autoimmune Problems
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One month after hearing from dozens of women who claimed they’d suffered from health problems linked to textured breast implants, including cancer and autoimmune issues, the FDA has decided not to ban the implants.


According to The Washington Post, a statement from the FDA says the organization, “does not believe that the product — a kind of textured implant — meets the legal standard for being banned at this time, based on available data and information.”

During a two-day panel hearing that took place in March, patients who’d had a rare lymphoma linked to implants, along with others who have suffered autoimmune or connective-tissue disease, testified that they hadn’t been adequately warned about risks before getting the implants. And though the FDA did not ban textured breast implants outright, they are considering much stronger warnings:

“Responding to such concerns, the agency said it is considering requiring implants to carry what’s called a boxed warning — the agency’s strongest safety warning. And it may require doctors and patients to sign checklists of risks to make sure women have the necessary information to make an informed decision.”

Worldwide, the FDA has identified 457 cases of breast implant-related lymphoma, as well as nine deaths. However, the organization noted that while textured implants account for as much as 80% of implants worldwide, they make up just 10% or less of breast implants in the U.S.

At the hearing, women also raised concerns of “breast implant illness” causing autoimmune issues such as pain, allergies, and fatigue. The FDA said it “‘doesn’t have definitive evidence demonstrating breast implants cause these symptoms,’” but added that evidence supports “that some women experience systemic symptoms that may resolve when their breast implants are removed” — and that women should be made aware of the risk before getting implants.”

The agency will also now require breast implant manufacturers to “file individual medical device reports for problems involving the products” rather than the previous system, which allowed them to file something called “alternative summary reporting” that made it less likely for reports of complications to become public.

The FDA has only banned two devices in its entire history: powdered surgeon’s gloves and prosthetic hair fibers.



I work in oncology clinical trials. You would be amazed at how little the FDA has to do with my job. One of the things I do is maintain and update FDA specific documents, namely the form 1572 which is used to attest that our physicians are qualified and that we will use properly accredited pathology laboratories. We never actually submit these forms to the FDA. We provide them to our drug company sponsors and to our own institutional review boards, but the only time the FDA will see them is if they audit the study.

As far as I can tell, the FDA rarely takes an in depth view at our trials. They seem to assume that our internal policies will ensure that we manage our own conflicts of interests, and also protect patients from unacceptable risks. Fortunately, my institution has a rigorous process for approving clinical trials and requires that we provide proof that we are doing everything we can to keep our patients safe (by definition, any trial that treats cancer is considered high risk) during the trial. I can’t help but feel though that the FDA really isn’t monitoring us as closely as it should.