Allergan Breast Implants Removed From Market By FDA Due To BIA-ALCL Fears
Following months of speculation and concern about the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), federal regulators are calling on Allergan to remove all microtextured breast implants from the market in the United States.
The FDA issued a safety communication on Wednesday, announcing that it has requested Allergan issue a breast implant recall for its Natrelle and Biocell lines of microtextured breast implants. The agency says Allergan has agreed, and will remove the line from the global market and not just the United States.
The announcement comes following similar recalls for Allergan breast implants in Canada, Australia and France. However, previously the FDA has suggested that there was not yet sufficient evidence linking the textured design to reports of rare lymphoma that has developed in the tissue surrounding the breast implants among certain women.
The agency now indicates that there is sufficient cause to recall Allergan breast implants due to the risk of BIA-ALCL.
“The FDA requested that Allergan recall all Biocell textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices,” the agency’s safety communication states. “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 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and continued distribution of Allergan’s Biocell textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.”
The FDA indicates that there are at least 573 known cases of BIA-ALCL worldwide, including 33 deaths. Of those, 481 have been linked to Allergan breast implants. Allergan implants were also linked to 12 of the 13 deaths where the manufacturer of the breast implant was known.
The recall affects Allergan Natrelle Saline-Filled Breast Implants, Allergan Natrelle Silicone-Filled Textured Breast Implants under the Biocell label, as well as Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants’ textured styles and some tissue expanders which have Biocell texturing. A complete list of affected products is included in the safety communication linked above.
Breast Implant Cancer Concerns
In June 2017, a study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants.
Another study, published in October 2017, warned that many breast implant cancer cases worldwide have likely not been reported, and noted that doctors and patients may not be aware of BIA-ALCL.
The FDA is not recommending women have the breast implants removed if they are showing no symptoms. Instead, the regulators recommend recipients of these implants become familiar with the symptoms of BIA-ALCL, including persistent swelling or pain near the implant, and talk to their health care provider for further information. Those with BIA-ALCL should undergo breast implant removal and removal of the surrounding scar capsule.
The agency also recommends those who receive breast implants keep a record of the device manufacturer, unique device identifier and implant model name, which may have been provided on a patient device card from the surgeon.
Those with questions regarding the safety communication can email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or by calling 800-638-2041 or 301-796-7100.
Cases of BIA-ALCL or other complications should be reported to the FDA MedWatch Adverse Event Reporting Program.
This latest action is likely to increase the number of breast implant cancer lawsuits filed against Allergan by women throughout the United States, including class action lawsuits for medical monitoring.