The recall and subsequent ban
On March 21, 2017, the U.S. FDA made a safety announcement about a link between textured breast implants and a very rare form of cancer: anaplastic large-cell lymphoma. In the announcement, the FDA called the cancer “breast implant-associated anaplastic large-cell lymphoma” (BIA-ALCL).
Since then, the ante has been upped. On May 28, 2019, Health Canada suspended the sale of Allergan Biocell breast implants. In July, the U.S. FDA followed suit with a ban, requesting Allergan to recall all Biocell textured implants.
At CRS, we haven’t been placing Biocell textured implants, but we’ve had patients inquiring about what’s going on. Here’s more information on the recall and ban and BIA-ALCL.
What the FDA said
The FDA requested that Allergan recall all Biocell textured breast implants and tissue expanders marketed in the U.S. due to risk of breast implant-associated anaplastic large cell lymphoma, a cancer of the immune system. Based on the currently available information, the FDA’s analysis demonstrated 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 in the U.S. That’s why the FDA instructed Allergan to stop distribution.
The suspension means that Allergan is no longer allowed to sell its Biocell macro-textured implants in the U.S., and all unused implants are to be sent back to the manufacturer.
There is no recommendation for women to remove these specific textured implants, as the number of cases is exceedingly low. Still, women who have received Allergan Biocell macro-textured implants should be on the lookout for any signs such as swelling, lumps, and pain in the breast.
What is ALCL?
ALCL is an uncommon cancer that can develop in any part of the body, most commonly the lymph nodes and skin. Research suggests that BIA-ALCL is usually found near the breast implant within the surrounding scar tissue, not in the breast itself. The lifetime risk for developing BIA-ALCL from a textured implant is estimated to be from one in 4,000 to one in 30,000. At this point, the type of implant (silicone or saline) doesn’t seem to make a difference. It is the implant texture.
How is BIA-ALCL treated?
This is still a very rare risk. Plus, when BIA-ALCL is caught early it is usually curable. Treatment involved surgical removal of the implants and the scar tissue capsule, as the lymphoma appears almost always to be only in the scar tissue capsule.
Do you have questions about breast implants or about BIA-ALCL? Please call us at our Fort Lauderdale office, (954) 533-8029.
