Written by: Laura Beasley, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
In our most recent article on breast implants and their link to Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), “Textured Breast Implants Bans on the Rise” we left off wondering whether or not the U.S. was going to follow in the footsteps of Canada and France as regards banning textured implants.
No Ban in the U.S.- Why?
As of early May, we can now confirm that the U.S. will not be part of the ban at the current time.
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.
This may have you questioning whether or not a ban on textured implants should occur, since the potential risks have been made well-known and other countries have already banned them. This May 2019 New York Times article educates us that, “Only about 10 percent of the implants used in the United States are textured, but in other countries the figure can be as high as 80 percent”
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.
Measures to be Taken Rather than a Ban
An NBC news article from May 3, 2019, “FDA will not ban textured breast implants at this time” tells us that the FDA plans to make label changes and requirements for reporting incidents:
The agency says it plans to work with patient groups and manufacturers to make changes to the labels of textured implants that could include a black box warning - the FDA’s strictest caution. Manufacturers will also be required to submit adverse event reports instead of the current practice of quarterly summary reports, and details of these will now be made available to the public.
The May 2019 Washington Post article reiterates the possibility of the black-box warning to come and adds that the FDA “may require doctors and patients to sign risk checklists to make sure patients have the necessary information to make an informed decision.”
In furtherance, the FDA is going to require individual medical device reports to be filed by the manufacturing companies if any problems occur with the breast implants. This will ensure that the presence of these breast implant problems is made more available to the public.
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. You can visit our Breast Implants Lymphoma Cancer page on our website for more information on the topic.