On June 24th, 2019, the U.S. Food and Drug Administration (FDA) issued a recall of breast implants manufactured by Allergan, a pharmaceutical company, after research revealed that there is an increased risk of cancer in patients with the implants. The textured implants were designed to prevent unnatural movement of the implant in the breast. Unlike smooth implants, the sandpaper-like outer texture increases stability by developing a better connection to surrounding soft tissue. The FDA discovered that people with Allergan Biocell textured breast implants had an increased risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
The FDA based this finding on “newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices.” The recalled devices also include tissue-expanders.
Following the study, the FDA found that of the 573 unique BIA-ALCL cases reported:
- 481 are reported to have Allergen breast implants
- 33 have died from BIA-ALCL
- At least 12 of the deceased patients had Allergen breast implants
The risk of BIA-ALCL is six times higher in people with the Allergen textured-implants compared with textured-implants from other manufacturers. All of the products recalled have the signature Biocell textured surface. The FDA said that the “continued distribution of Allergan’s […] Biocell textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.”
BIA-ALCL is a form of non-Hodgkin’s lymphoma—cancer of the immune system. Unlike breast cancer, BIA-ALCL is found in the scar tissue surrounding the implant and can be treated by removing the implant and the tissue capsule. However, some patients may need to be treated with chemotherapy and radiation therapy.
Women who have been diagnosed with BIA-ALCL have reported symptoms of pain and swelling near the breast implant. Others have reported symptoms including “chronic fatigue, hair loss, intestinal issues, and unexplained rashes and itching.” The FDA has not advised patients to remove their textured-implants unless they have any of the symptoms above. The US is the last of a string of countries to ban the Allergen textured-implants following Canada, Australia, and France.
If you have experienced these symptoms and have Allergen textured-implants, seek out your healthcare provider for a BIA-ALCL exam. You can also click on the link below to have our attorneys start working on your case.