FDA has finally drawn a line in the sand on an issue that has plagued the breast implant industry for years.
On Wednesday the U.S. regulatory agency called on Allergan to take specific models of its textured breast implants off the market due to the risk of a rare type of cancer.
"To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) associated with Allergan Biocell textured breast implants, [FDA] requested that Allergan recall its Biocell textured breast implants and tissue expanders," the agency said in a safety communication. "Allergan agreed and is removing these products from the global market."
Allergan said it is recalling the devices as a precaution following notification of recently updated global safety information concerning the "uncommon incidence" of BIA-ALCL. Neither FDA nor Allergan recommended removal or replacement of these implants in patients who have not shown any adverse symptoms.
"Patient safety is a priority for Allergan," the Dublin, Ireland-based company said. "Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns."
In March the agency said it was taking a harder look at materials used in medical devices and potential adverse biological response resulting from contact of certain materials with the body over extended periods of time. Silicone breast implants were one of the specific types of medical device materials mentioned in that statement.
Breast implants on the market today have a silicone outer shell, with either a textured or non-textured surface, and are filled with silicone gel or saline. Over the years there have been reports of risks associated with breast implants, such as capsular contracture, implant rupture, and BIA-ALCL. More confirmed cases of BIA-ALCL have been reported in patients with textured surface implants than in patients with smooth-surface implants, the agency said in March.
BIA-ALCL is not to be confused with breast cancer. BIA-ALCL is a type of non-Hodgkin’s lymphoma (cancer of the immune system), FDA noted.
The recall does not affect Allergan's Natrelle smooth or Microcell breast implants and tissue expanders.
The United States is not the first country to take action against these devices. In April, France banned several types of textured breast implants due to the BIA-ALCL risk, followed by Canada and the Netherlands.
In a table updated Wednesday on the agency’s BIA-ALCL webpage, FDA reported a new worldwide total of 573 unique cases of BIA-ALCL and 33 patient deaths. Most of the cases of BIA-ALCL (481) were attributed to Allergan implants.
FDA said that based on the currently available information, including the newly submitted data, the risk of BIA-ALCL with Allergan Biocell textured implants is about six times the risk of BIA-ALCL with textured implants from other manufacturers on the U.S. market.
Continued distribution of Allergan's Biocell textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL, FDA said.