Allergan, one of the leading pharmaceutical companies known for their leading brands and best in class products, has had one of their products recalled by the Food and Drug Administration (FDA). They created textured breast implants that have been linked to an unusual cancer. The FDA recalled all of the products in the United States. The FDA’s decision has come one full year after Europe banned these products last year.
Last Wednesday, Allergan announced that they are recalling the products globally. The particular rare cancer is an anaplastic large cell lymphoma of the immune system. The cancer caused is not breast cancer, but cancer around the tissue of the implant. There have been 573 cases reported worldwide of the disease with 481 of the cases linked to Allergan Biocell Implants. Of those 481 cases, 33 deaths have been reported. The FDA first recognized the link in 2011.
Breast implant surgery, whether for enlargement or after a mastectomy, is the sought after plastic surgery. Given how many women receive this procedure, the lymphoma is very rare. However, the specific textured biocell has a six times higher rate of getting cancer than other textured implants.
Symptoms of the lymphoma include swelling and fluid accumulation around the implant. If this occurs, they advise you to have the fluid removed and tested for cancer. They also advise for patients with this implant, but no symptoms to not remove them. The recall is meant for doctors to no longer use these products in surgery and to give Allergan the products back if they are on the shelf.
The specific products that are recalled are: Biocell Natrelle saline-filled breast implants, Biocell Natrelle silicone-filled breast implants, Biocell Natrelle Inspira silicone-filled breast implants, Natrelle 410 highly cohesive anatomically shaped silicone-filled breast implants, Natrelle 133 Plus tissue expander, and Natrelle 133 tissue expander with suture tabs.
The issue is not what is inside the implants (silicone or saline), but the textured surface has been highlighted as the cause. The reason why the textured surface causes the lymphoma is still unsure to doctors. The recall will lessen the risk, but will not eliminate it. Have an honest conversation with your doctor about the risks and benefits of breast implants.