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FDA Won’t Ban Textured Breast Implants Linked to Cancer

FDA Won’t Ban Textured Breast Implants Linked to Cancer

May 7, 2019 — The FDA has decided not to ban textured breast implants that are linked to a rare cancer called Anaplastic Large Cell Lymphoma (ALCL) that has killed at least 17 women.

In a statement, the FDA said it does not believe that textured breast implants “meet the banning standard.”

Most cases of breast implant-associated ALCL are linked to a type of textured breast implant that is manufactured by Allergan.

In recent months, at least 38 countries have pulled Allergan’s textured implants off the market due to safety concerns, including France and Canada. But the FDA said there isn’t enough evidence to justify banning the implants in the U.S.

In the U.S., the FDA has identified 457 women who have been diagnosed with ALCL from their breast implants. Worldwide, 17 women have died of the disease.

Instead of banning textured breast implants, the FDA says it plans to update the warning labels. Manufacturers will also be required to submit individual adverse event reports instead of “summary” reports.

Until the FDA recently ended its summary reporting system, it seemed like there were only about 200 complaints about breast implants because the FDA allowed manufacturers to report injuries in bulk. In reality, over 12,000 complaints were filed in 2018 alone. The FDA recently admitted receiving around 350,000 complaints about breast implants over the last decade.

Do I have a Breast Implant Cancer Lawsuit?

The Schmidt Firm, PLLC is currently accepting breast implant induced injury cases in all 50 states. If you or somebody you know has been diagnosed with Anaplastic Large Cell Lymphoma (ALCL), you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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