Allergan Breast Implant Lawsuits
Rare Cancer BIA-ALCL Linked to Popular Allergan Implants
Breast implants manufactured by the Irish pharmaceutical company Allergan have been significantly linked to a rare type of non-Hodgkin’s lymphoma called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Specifically, patients that have been implanted with Allergan’s textured products called Natrelle Biocell have been proven at an extremely higher risk of developing BIA-ALCL.
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is not a breast cancer, but a lymphatic cancer that attacks the immune system is found in the scar tissue and fluid around the implant, with risk of spreading throughout the body. Although this cancer is rare, it is found in patients implanted with Natrelle Biocell textured implants at alarmingly high rates. Look for the following signs and symptoms associated with BIA-ALCL:
- Breast asymmetry or changes in appearance
- Breast enlargement
- Hardening of the breast
- Lumps in the breast or armpit
- Skin rash
- Weight loss
Recall of Allergan Biocell Breast Implant Products
On July 24, 2019, the U.S. Food and Drug Administration announced Allergan’s voluntary worldwide recall of a number of models of breast implants as per the FDA’s request, for what was called “the uncommon incidence” of cancer in patients with these implants. All of the models recalled were Biocell textured breast implant products, including the following:
- Natrelle Saline-Filled breast implants
- Natrelle Silicone-Filled breast implants
- Natrelle Inspira Silicone-Filled breast implants
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
The Cancer Risks Associated With Allergan Implants
These implants are linked to the rare non-Hodgkin’s lymphoma BIA-ALCL (breast implant-associated anaplastic large-cell lymphoma). This is not a breast cancer, but a cancer of the immune system. The cancer is believed to be linked to the implants’ textured surface, and in most cases develops in the scar tissue and fluid surrounding the implant. According to Dr. Daniel Maman, a board-certified plastic surgeon with 740 Park Plastic Surgery in New York City, “these rare cases are showing that the texture of the shell surrounding the implant can cause this lymphoma response in capsule tissue that surrounds the breast implant.”
At the time of the recall, of the 573 unique cases of BIA-ALCL reported globally, 481 (84%) are attributed to Allergan implants. Of 33 patient deaths, 13 patients could confirm the manufacturer of their breast implants; 12 (92% of) known implants were made by Allergan. As of August 2020, of the 733 total unique cases of BIA-ALCL reported to FDA, 620 (85% of) cases were reported for Allergan implants, and 47 cases involved implants with an unknown manufacturer. Of the 36 total patient deaths reported to FDA, 15 (94%) of the 16 patients for which the manufacturer of the implant is known are reported to have had an Allergan breast implant at the time of their BIA-ALCL diagnosis.
Most cases of BIA-ALCL are undiagnosed until years after implantation. While Allergan has ceased distribution of the FDA-recalled implants, many women throughout the country have been previously implanted with models.
Have Allergan Breast Implants Negatively Effected Your Health?
Although the FDA issued a recall of these products, Allergan will still be held responsible for putting patients using their product at such great risk—this cancer may not appear until years after the initial procedure. In the state of New Jersey, Allergan Biocell is facing hundreds of claims. If you currently have an Allergan Natrelle Biocell textured breast implant, have had your Allergan implants removed (explanted) by your doctor’s recommendation, or if you already have a diagnosis of BIA-ALCL, you may be entitled to significant compensation. Contact the skilled attorneys at Keefe Law Firm at 732-224-9400 for a free and confidential consultation.