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FDA Fails When It Comes To Banning Textured Breast Implants

June 5, 2019 By Law Offices of Thomas J. Lamb, P.A.

The U.S. will not be following in the footsteps of Canada and France as regards banning textured breast implants, at least as of May 2019.

The New York Times provided us with an article on May 2, 2019, “F.D.A. Won’t Ban Sales of Textured Breast Implants Linked to Cancer” which informs us that while most BIA-ALCL cases have occurred in relation to textured implants, the risk and data is still too low to prompt a ban. Smooth implants cannot be disregarded as a potential cause for the rare lymphoma.

Additionally, on May 3, 2019, The Washington Post published an article, “FDA won’t ban breast implants linked to cancer at this time” which shared information similar to the article from The New York Times, but gives some additional insight:

The FDA does not believe the product — a kind of textured implant — meets the legal standard for being banned at this time, based on available data and information, according to a statement issued Thursday by Amy Abernethy, FDA principal deputy commissioner, and Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health.

Even without an FDA ban, it seems like women may steer away from textured implants altogether now because of the associated risks. Rest assured that we will continue to monitor the situation of textured breast implants and report any new information as regards the FDA’s plan considering there will be no ban.

[Read article in full at original source]

 

Written by: Laura Beasley, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.

 


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Filed Under: Unsafe Medical Devices Tagged With: breast implant-associated anaplastic large cell lymphoma, breast implants, textured breast implants

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