FDA Requests Recall of Textured Breast Implants and Tissue Expanders

Textured breast implants

UNITED STATES – As reported in an online news article published by www.nbcnews.com, Allergan has issued a recall of its BIOCELL textured implants upon request by the FDA.

The United States Food and Drug Administration (FDA) has requested that Allergan recall its BIOCELL textured breast implants and tissue expanders distributed within the United States amid numerous reports of a link between the implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a form of cancer that affects the immune system.

Before Allergan’s recall of the implants in the United States, the implants were already subject to recall in 38 other countries worldwide.  The FDA stated that Allergan has now issued a worldwide recall of the BIOCELL textured breast implants.

According to the FDA, the risk of BIA-ALCL is relatively low.  However, because there have been reports of BIA-ALCL in women with Allergan’s BIOCELL textured breast implants, with some of those women dying, the FDA felt compelled to request a recall of the product and remove them from the market.  While the overall risk of BIA-ALCL may be low, women who have Allergan’s BIOCELL textured breast implants and tissue expanders are 6 times more likely to be diagnosed with BIA-ALCL than women who have textured breast implants manufactured by another company.

The FDA reports that there is a total of 573 known cases of BIA-ALCL, and of this number, 481 cases are attributed to Allergan breast implants.  A total of 33 women have died from the cancer, and many of these women had Allergan implants.  Allergan states that it is issuing the voluntary worldwide recall as a precaution after receiving information from the FDA.  The FDA does not advise women to have the textured breast implants removed if they do not have any symptoms of BIA-ALCL, which include, but may not be limited to, swelling, pain, and skin irritation.