The end of a breast implant product linked to a rare type of cancer is seemingly finally here. On Wednesday, the Food and Administration said it had pushed for a recall of Biocell textured breast implants, sold by the pharmaceutical company Allergan. Allergan announced the same day that it would pull all remaining implants from the global market.
The saga dates back to 2011, when the FDAfirst warnedthe public of a possible link between breast implants and women coming down with a very rare kind of cancer, called anaplastic large cell lymphoma (ALCL). These cancers, though found in the breast, actually affected the lymph system, a key aspect of the immune system. More specifically, they were often found in the pocket of scar tissue that formed near the implant.
Eventually, these cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) were largely traced to textured implants, as opposed to implants with a smooth surface. And in a recent analysis conducted by the FDA of all worldwide reports of BIA-ALCL, over 80 percent were linked to Allergan’s Biocell implants. Of the 573 cases documented by the FDA, 33 resulted in the patient’s death.
In a safety communication released Wednesday, the agencywarnedthat the continued distribution of Allergan’s Biocell “textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.”
For women with textured implants who might be understandably worried, it’s worth noting that the absolute chances of developing BIA-ALCL are still very low (one in every 500,000 people are thought to be diagnosed with ALCL annually, and the risk of BIA-ALCL is even lower). And despite the deaths reported, it’s usually very treatable; if the cancer hasn’t spread elsewhere, the typical treatment involves removing the implant and any scar tissue. Women with textured implants but no symptoms, such as persistent swelling or pain near the implant, aren’t advised to get them preemptively removed, the FDA said. But anyone who is experiencing those symptoms should see their doctor for an examination.
Despite the high rate of BIA-ALCL cases linked to Allergan implants, the agency isn’t ruling out the possibility of further action against other implant manufacturers.
“[W]e are continuing our assessment to determine whether the risk of developing BIA-ALCL is limited to specific models of textured, or all textured breast implants,” the agency said. “Therefore, at the present time, we believe all individuals who are considering a breast implant of any type be informed of the risk of developing BIA-ALCL.”
A full list of implants affected by the recall can be found here.