The agency is requiring that Allergan, the company that manufacturers the textured breast implants in question, recall specific models that may be associated with BIA-ALCL. Allergan responded by saying that they will issue a worldwide recall of their BIOCELL textured implants, which includes the following models:
- Natrelle Saline-Filled breast implants
- Natrelle Silicone-Filled breast implants
- Natrelle Inspira Silicone-Filled breast implants
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
The following tissue expanders will also be recalled: Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.
“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, M.D., Ph.D.
The FDA’s action is coming after months of debate, and a hearing in March 2019 where patients and providers shared their stories, and the FDA stated that they wanted more information.
Updated numbers from the FDA state that there have been 573 unique cases of BIA-ALCL, a rare type of non-Hodgkin lymphoma, reported globally. It is reported that 481 of these are related to Allergan’s implants. Additionally, there have been 33 patient deaths from the disease, according to the FDA.
“Based on the currently available information, including the newly submitted data, our analysis demonstrates 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 FDA reported in a statement.
“We understand that today’s news may be alarming to some patients with breast implants. 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,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, in the statement.
Shuren also emphasized that the FDA will continue to provide clear communication and vital information regarding BIA-ALCL to the public. This includes ensuring that women who are considering getting breast implants have the important facts that would aid in their decision.
“Moving forward, we are committed to continuing to share updates with patients about this issue. We will continually evaluate any new information and may, as a result, take action regarding other breast implants, if warranted. In addition, we are continuing our assessment to determine whether the risk of developing BIA-ALCL is limited to specific models of textured, or all 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,” Shurenn said.