The FDA has asked Allergan to recall certain models of its textured breast implants due to an increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Allergan agreed to the request, confirming a worldwide recall of its BIOCELL textured breast implants. Tissue expanders used before breast augmentation or reconstruction are also a part of the recall.
Overall, the FDA has recorded a total of 573 cases of BIA-ALCL around the world, including 33 patient deaths. Of those 573 cases, 481 were connected to implants produced by Allergan. In addition, the implant’s manufacturer is known for 13 of the 33 recorded patient deaths—produced by Allergan in 12 of those 13 instances.
“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,” Amy Abernethy, MD, PhD, FDA principle deputy commissioner, said in a prepared statement from the agency.
“The FDA has been diligently monitoring this issue since we first identified the possible association between breast implants and ALCL in 2011 and, at that time, communicated to patients and providers that there is a risk for women with breast implants, more frequently occurring in women with textured implants, for developing this disease. Since that time, we have worked to increase awareness and encourage reporting of all cases to the FDA so that we could continue to monitor this potential safety signal.”
The FDA also published a safety communication for patients with Allergan’s BIOCELL breast implants, noting that symptoms of BIA-ALCL include “persistent swelling or pain near the breast implant.”
“If you have no symptoms, we are not recommending the removal of these or other types of breast implants due to the low risk of developing BIA-ALCL,” according to the communication. “However, if you have any questions, talk to your health care provider.”
The same document also recommends that providers “immediately stop using” these products and “work with your facility to return existing inventory.”
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.