At FDA’s request, Allergan recalls breast implants linked to rare lymphoma
In response to a request from FDA, Allergan recalled specific models of its textured breast implants due to a potential risk for breast implant-associated anaplastic large cell lymphoma.
Allergan notified the FDA that it will proceed with a worldwide recall of its Biocell textured breast implant products. These include 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.
An FDA analysis showed the risk for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) with Allergan Biocell textured implants is about six times greater than the risk with textured implants from other manufacturers marketing their products in the United States.
“Patient safety is a priority for Allergan. Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns,” the company said in a statement posted on its website.
Allergan also will recall tissue expanders used by patients prior to breast reconstruction or augmentation, including the Natrelle 133 tissue expander with suture tabs and the Natrelle 133 Plus tissue expander.
The FDA issued a safety communication directed toward patients and health care providers to explain the established risks. The safety communication also offers advice for patients who are monitoring for symptoms of BIA-ALCL, which include breast pain and swelling.
“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, MD, PhD, said in an agency-issued press release.
The FDA became aware of the potential association between breast implants and ALCL in 2011. Since then, the agency has monitored trends and communicated with patients and clinicians about risk for women with breast implants, particularly those with textured implants.
Textured implants are less commonly used in the United States than other countries, and macro-textured implants — the type manufactured by Allergan — account for less than 5% of all breast implants sold in the United States.
FDA has encouraged reporting of all BIA-ALCL cases, and it has monitored reports in scientific literature and databases, including external patient registries.
“Based on new data, our team concluded that action is necessary at this time to protect the public health,” Abernethy said. “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. If action is needed in the future, we will not hesitate to do what is necessary to protect patients.”
As of today, the FDA reports 573 unique cases of BIA-ALCL and 33 patient deaths worldwide. This reflects an increase of 116 new cases and 24 deaths since the agency’s previous update earlier this year.
The majority (83%; n = 481) of identified BIA-ALCL cases have been attributed to Allergan implants, according to the FDA press release.
The manufacturer of the implant in place at the time of BIA-ALCL diagnosis has been identified for 13 of the 33 patients who have died. In 12 of those 13 cases, patients were confirmed to have had an Allergan breast implant, according to FDA.
“We understand that today’s news may be alarming to some patients with breast implants,” Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, said in the release. “In the safety communication issued today, we’re providing actionable information for individuals with specific breast implants and their health care professionals. 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 FDA will continue to assess whether the risk for BIA-ALCL is limited to certain models of textured breast implants, Shuren said.
“We will continually evaluate any new information and may — as a result — take action regarding other breast implants if warranted,” he said.