If you’ve been considering breast augmentation with Dr. Yates, you’ve likely been doing some research, and you’ve probably come across news about a recall of textured breast implants. Here’s what’s going on.
This issue first came to light in the public on March 21, 2017. That was when 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).
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 halt the manufacture of all Biocell textured implants.
Dr. Yates wants his augmentation patients to have all the information they need to make truly informed decisions. To that end, here’s the latest news on this recall.
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 the 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.
This is only a single type of implant made by a single manufacturer. This is not in any way a wide recall of numerous implant types.
There is no recommendation for women to remove 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. Many women with Allergan textured implants simply choose to change implant types for peace of mind.
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 make a difference. It is the implant texture of this specific brand and model.
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.