The U.S. Food and Drug Administration (FDA) has taken significant action to protect women from a rare breast implant-associated cancer, anaplastic large cell lymphoma (BIA-ALCL). Requesting that manufacture, Allergan, recall specific models of its Biocell textured breast implants.
The move comes after a total of 573 cases globally of BIA-ALCL, related to breast implants, have been reported to the FDA. There have also been 33 patient deaths, as outlined in the agency's press release.
According to FDA principal deputy commissioner, Amy Abernethy, M.D., Ph.D, the agency has been diligently monitoring this issue since it first identified the possible association between breast implants and BIA-ALCL in 2011.
“At that time, [the FDA] communicated to patients and providers that there is a risk for women with breast implants, more frequently occurring in women with textured implants, for developing this disease,” said Abernethy. “Since that time, we have worked to increase awareness and encourage reporting of all cases to the FDA so that we could continue to monitor this potential safety signal.”
However, based on currently available information, including newly submitted data, the FDA's analysis demonstrated that the risk of BIA-ALCL with Allergan Biocell textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S., the team concluded that action is necessary to protect the public health.
“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,” said Abernethy.
The FDA has also issued a safety communication for patients with breast implants, patients considering breast implants and their health care professionals, outlining the known risks and what steps patients should consider when monitoring for symptoms of BIA-ALCL, including swelling and pain in their breasts.
Though the request was to remove these implants from the U.S. market, Allergan has notified the FDA that it is moving forward with a worldwide recall of its Biocell textured breast implant products.