UNITED STATES – According to an online news article published by www.nytimes.com, Allergan has issued a worldwide recall of its textured breast implants that have been linked to rare cancer.
Allergan, at the request of the United States Food and Drug Administration (FDA), has recalled its textured breast implants and tissue expanders in the United States amid concerns that the implants are linked to cancer. The recall follows other recalls in Europe that pulled the textured breast implants from the market in late 2018.
The FDA was faced with the decision to remove the textured breast implants from the market in May of 2019 but chose not to do so, stating that the risk of the rare form of cancer was low and that insufficient data was available demonstrating a link between the implants and cancer. Because of recent reports of rare cancer, the FDA finally decided to instruct Allergan to recall the textured breast implants.
According to the FDA, the BIOCELL textured implants and tissue expanders manufactured and sold by Allergan have been linked to anaplastic large-cell lymphoma, a rare cancer of the immune system. Symptoms of this rare cancer include, but may not be limited to, swelling, pain, and fluid accumulation around the breast implant.
So far, there are a total of 573 reported cases of the rare form of cancer in women with BIOCELL textured breast implants worldwide. Of the 573 cases, a total of 33 women died. In 13 reported deaths, the implant type was known, and the manufacturer of the breast implants in 12 of these cases of deaths was Allergan.
Data suggests that women with Allegan’s BIOCELL textured breast implants and tissue expanders are 6 times more likely to develop anaplastic large-cell lymphoma than with textured breast implants manufactured by other companies. While the risk is higher, the FDA states that women with BIOCELL textured breast implants that have no symptoms do not need to have the implants removed. Because of the worldwide recall, no doctors or hospitals will be using the BIOCELL textured breast implants going forward, and all implants in a hospital or doctor’s inventory should be returned to Allergan.
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