October 2019

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 of this year, Health Canada suspended the sale of Allergan Biocell breast implants. In July, the U.S. FDA followed suit with a ban.

Dr. Frank does not use textured implants, but wants his patients to know about this move from Health Canada.

What Health Canada said

Health Canada issued its May suspension citing research that, compared to other implants, found patients with textured implants had a higher risk of breast implant-associated large cell lymphoma (BIA-ALCL), a rare cancer that affects the immune system.

Health Canada had previously issued an announcement of textured implants and BIA-ALCL, but not a ban. The group then received reports of new cases of BIA-ALCL. When a safety review was conducted in 2017, Health Canada knew of only five confirmed Canadian cases. Since that time, that number of confirmed cases has risen to 26.

The suspension means that Allergan is no longer allowed to sell its Biocell macro-textured implants in Canada, and all unused implants are to be sent back to the manufacturer.

There is no recommendation 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.

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.

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 your implants? Please call Dr. Frank at (403) 245-1228 for more information.