Risk alert – Textured breast implants recalled

July 25, 2019 Gracie Awalt

Allergan’s Biocell textured breast implants and tissue expanders are six times more likely to cause breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) compared to other similar devices marketed in the U.S., according to the Food and Drug Administration. Allergan has notified the FDA that they are recalling these devices from the global market.

The FDA recommends that patients with these breast implants should only remove them if there are symptoms, and to consult their physician about the risk for developing BIA-ALCL.

Along with removing Allergan Biocell breast implants from existing inventory, physicians should provide educational materials to patients explaining the benefits and risks of the different types of implants.

BIA-ALCL is a cancer of the immune system found near the scar tissue and fluid near the implant, but it can spread throughout the body. The likelihood of developing BIA-ALCL is low, but a diagnosis can lead to death if not found early or treated promptly. Symptoms include persistent swelling or pain near the implant.

According to the FDA recall notice, 573 unique BIA-ALCL cases were found worldwide during an FDA analysis, with 481 of those cases reported to have Allergan breast implants at the time of diagnosis. Of the 13 patient deaths where the implant manufacturer was known, 12 had an Allergan breast implant.

The recalled products have the same Biocell macro-textured surface unique to Allergan; however, the FDA is still determining whether the risk of developing BIA-ALCL expands to all textured breast implants.

Physicians should report all cases of BIA-ALCL in individuals with breast implants to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

Previous Article
Good documentation never goes out of style
Good documentation never goes out of style

Times change, but the advice stays the same

Next Article
Risk alert: Transvaginal mesh products
Risk alert: Transvaginal mesh products

More on the FDA's announcement to halt sales of transvaginal mesh products