May 7, 2019 — The FDA is refusing to ban textured breast implants that are linked to cancer, despite at least 17 deaths worldwide and 38 countries that have pulled the implants off the market due to safety concerns.
In a statement, the FDA said it does not believe that textured breast implants “meet the banning standard.”
The agency explained that textured breast implants are not as popular in the U.S. as they are in Europe and other countries where they have been banned. Furthermore, a few cases of ALCL have occurred in women who had smooth-surfaced breast implants.
The vast majority of ALCL cases are linked to implants with a textured surface, which experts believe can harbor bacteria that contributes to low-level inflammation. Over time, this may boost the risk of cancer.
In recent months, at least 38 countries — including France and Canada — have banned the Allergan’s most popular textured breast implants due to safety concerns. Even so, the FDA believes they do not have enough evidence to ban the textured implants in the U.S.
The FDA has identified 457 reports of women who developed ALCL after receiving breast implants. Worldwide, at least 17 women have died of ALCL, including 9 women in the U.S.
Instead of banning textured breast implants, the FDA said it will update warning labels and require manufacturers to submit individual adverse event reports rather than “bulk” summary complaints.
Before the FDA recently ended its summary reporting system, it appeared as if breast implants were only linked to around 200 complaints in 2018. In reality, there were over 12,000 complaints. Around 350,000 injuries have been linked to breast implants over the last decade, the FDA recently admitted.
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