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Allergan Inc. last week voluntarily recalled several models of textured breast implants after concerns that they could be linked to a rare form of cancer, breast implant-associated anaplastic large cell lymphoma, came to light, according to a press release. The Food and Drug Administration had urged the company to pull some of its implants and tissue expanders from the market after new information revealed a disproportionate number of BIA-ALCL cases in people with the products.
BIA-ALCL, a type of non-Hodgkin’s lymphoma, has been strongly linked to textured implants, which make up less than 5 percent of the implants sold in the U.S., according to the FDA. Most implants sold in the States have smooth surfaces, but Allergan’s Biocell implants feature a macro-textured surface that’s unique to the company.
“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., said in a statement. She added that the FDA has been monitoring the association between breast implants and BIA-ALCL since 2011.
The FDA requested the recall after an updated analysis found that out of 573 people with BIA-ALCL worldwide, 481 reportedly had Allergan breast implants. Considering the new data, the FDA’s analysis says that the risk of BIA-ALCL in those with Allergan Biocell implants is six times higher than in those with textured implants from other manufacturers. BIA-ALCL is usually found in the scar tissue and fluid near an implant.
The news may be disconcerting for anyone who already has the now-recalled implants, but the FDA isn’t calling for their removal in symptomless patients. The announcement regarding the recall is simply meant to make patients and doctors aware of the connection.
“We will continually evaluate any new information and may, as a result, take action regarding other breast implants, if warranted,”Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said. “In addition, we are continuing our assessment to determine whether the risk of developing BIA-ALCL is limited to specific models of textured, or all textured breast implants. We continue to advise women and health care professionals that the use of breast implants is associated with a risk of developing BIA-ALCL and that the risk is greater with textured implants.”
Again, the FDA isn’t advising those with no symptoms to have the recalled implants removed, but it does provide a bulleted list of important information and recommendations for those with them. Get the full list at the end of the press release at fda.gov, and tell your medical provider if you have concerns about implants.