Allergan has begun a worldwide recall of its textured breast implants following a request by the FDA over new reports of cases and deaths linked to a specific type of rare cancer.
The move represents a new, high-profile démarche as scrutiny of the devices’ safety has expanded over the first half of this year.
In February, the FDA acknowledged that it recently spotted a spike in the number of reported cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)—a form of non-Hodgkin lymphoma that develops in the scar tissue surrounding an implant the agency has been tracking since 2011.
A month later, the FDA sent warning letters to breast implant manufacturers for failing to complete postmarket studies of their products and launched a broader scientific review of how different materials can affect long-term implant biocompatibility.
The recall—which aims to ensure that any unused products are removed from suppliers and doctors’ offices—affects the company’s Biocell line of products, including its Natrelle saline- and silicone-filled breast implants and tissue expanders. It does not include Allergan’s smooth breast implants nor its Microcell implants and tissue expanders.
For patients with breast implants or those considering them in the future, the FDA issued a new safety communication outlining the risks of BIA-ALCL as well as potential signs such as swelling and breast pain.
“The FDA does not recommend removal for patients without symptoms due to potential risks, but we provide helpful information for patients and providers to consider when discussing next steps,” the agency’s device center director, Jeff Shuren, M.D., said in a statement.
Since the last update of the FDA’s statistics earlier this year, there has been a sharp increase in reports of the disease. The recent addition of 116 unique cases and 24 deaths brings the global total to 573 cases and 33 deaths.
Of the 573, 481 cases were attributed to Allergan implants, the agency said. Twelve of the 33 patients who died were confirmed to have a breast implant from the company during their cancer diagnosis.
The FDA is assessing whether the risks of developing BIA-ALCL can be traced solely to specific models or if they are linked to all types of 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,” Shuren said.
According to analysts at Wells Fargo, Allergan’s full range of breast implants accounted for about $263 million of its total U.S. sales in 2018, with textured implants making up about $26 million of that.
Overall, textured implants are less common in the U.S. compared to other countries, the FDA said, and the type of macro-textured implant made by Allergan represents less than 5% of all breast implants sold in the country. The Big Pharma previously pulled the same Biocell product line from markets in Canada, Europe and the U.K. in April.
The agency is also considering changes to the labeling of breast implants, including a potential boxed warning and a patient decision checklist. In addition, the FDA has requested that all breast implant manufacturers submit quarterly trending analyses of adverse events, including BIA-ALCL, and has required the reporting of individual events in its safety database for devices.