There Isn’t Enough Data To Justify Banning Breast Implants Linked To Rare Cancer, FDA Decides
But the FDA is considering bold warnings for a type of textured breast implant. The agency’s announcement followed a two-day public hearing in March, in which researchers and implant makers presented data, and women described a number of illnesses they developed after getting implants, including lymphoma.
The New York Times:
F.D.A. Won’t Ban Sales Of Textured Breast Implants Linked To Cancer
A type of breast implant linked to a rare cancer can still be sold in the United States, even though it has been banned in many other countries, the Food and Drug Administration said on Thursday. The implants, which have a textured or slightly roughened surface, as opposed to a smooth covering, have been associated with a cancer of the immune system called anaplastic large-cell lymphoma. The vast majority of the cases have occurred in women with textured implants, mainly those made by Allergan. But the F.D.A. said that the risk, though increased, was still low, and that there was not enough data to justify banning the implants. (Grady and Rabin, 5/2)
The Associated Press:
Breast Implants Tied To Rare Cancer To Remain On US Market
In recent years, the FDA and other regulators around the world have grappled with the recently confirmed link to a rare cancer and the thousands of unconfirmed complaints of other health problems that women attribute to the implants, including arthritis, fatigue and muscle pain. FDA regulators said in a statement that while they don't have definitive evidence that implants cause those chronic ailments, women considering implants "should be aware of these risks." To that end, the agency said it will consider adding a boxed warning — its most serious type — to breast implants and a checklist describing various potential harms for patients considering them. (Perrone, 5/2)
The Washington Post:
FDA Won’t Ban Breast Implants Linked To Cancer At This Time
As of last Sept. 30, the FDA had identified 457 cases of implant-related lymphoma and nine deaths worldwide. The American Society of Plastic Surgeons reported 16 disease-related deaths worldwide as of Jan. 1, 2019. The FDA officials also addressed “breast implant illness” a constellation of autoimmune problems that includes joint and muscle pain and allergies and fatigue — a topic that was repeatedly raised at the March hearing. The agency 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. (McGinley, 5/2)
The Wall Street Journal:
FDA Won’t Ban Certain Breast Implants Despite Cancer Concerns
The agency said Thursday it doesn’t have definitive evidence demonstrating implants caused such symptoms, but it said some problems may get better when implants are removed. “We believe women considering a breast implant should be aware of these risks.” (Maidenberg and Burton, 5/2)
