The U.S. Food and Drug Administration (FDA) has requested that Allergan recall its BIOCELL textured breast implants due to a risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), according to an announcement from the agency.
“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 FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD.
The FDA’s decision is based on an increasing number of cases and deaths from implant-associated cancer. Globally, there have been 573 cases and 33 cancer deaths, 481 of which are clearly linked to the Allergan BIOCELL implants, according to the FDA. The agency focused on the 33 deaths when requesting the recall. Of the 33 deaths, the manufacturer was known in 13 cases. In 12 of those cases, Allergan was the manufacturer.
BIA-ALCL is not a primary breast cancer, but a lymphoid malignancy that develops in tissue around the implant. Generally, removing the implants and the surrounding scar tissue treats the cancer. But if the condition is not identified early, it can spread and cause death. The FDA first identified the link between breast implants and cancer in 2011.
The recall also extends to other BIOCELL breast implants, including: Natrelle saline-filled breast implants, Natrelle silicone-filled breast implants, Natrelle Inspira silicone-filled breast implants, and Natrelle 410 highly cohesive anatomically shaped silicone-filled breast implants. The recall also includes tissue expanders used in breast augmentation procedures, including Natrelle 133 Plus tissue expander and Natrelle 133 tissue expander with suture tabs.
“We will continue to monitor the incidence of BIA-ALCL across other textured and smooth breast implants and tissue expanders as well as other devices intended for use in the breast,” Dr. Abernethy said. “If action is needed in the future, we will not hesitate to do what is necessary to protect patients.”