The U.S. Food and Drug Administration (“FDA”), in attempts to protect women from the risk of developing breast implant-associated anaplastic large cell lymphoma (“BIA-ALCL”), requested that Allergan, Inc. recall some models of its textured breast implants from the U.S. market. According to the FDA, following their request, Allergan voluntarily moved forward with a worldwide recall of its Biocell textured breast implants and tissue expanders. This recall included Natrelle:
- Saline-Filled breast implants;
- Silicone-Filled breast implants;
- Inspira Silicone-Filled breast implants;
- 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants;
- 133 Plus Tissue Expander; and
- 133 Tissue Expander with Suture Tabs.
Unique to Allergan, each of the above referenced recalled products have the same BIOCELL textured surface.
A newly submitted Medical Device Report, analyzed a total of 573 unique BIA-ALCL cases, including 33 patient deaths. As of July 6, 2019, of the 573 cases of BIA-ALCL, 481 are reported to have Allergan breast implants at the time of diagnosis. Additionally, 12 of 13 deaths occurring in patients with BIA-ALCL occurred in patients with an Allergan breast implant. A nationwide class action lawsuit has been filed against the medical device manufacturer Allergan.
On July 24, 2019, the FDA’s addressed 13 questions regarding BIA-ALCL. The FDA stated that while BIA-ALCL is a rare cancer, it is not breast cancer - it is a type of non-Hodgkin's lymphoma (cancer of the immune system). The FDA explained that in most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. The main symptoms associated with BIA-ALCL are persistent swelling or pain in the area of the breast implant.
At this time, the overall incidence of developing BIA-ALCL is considered to be low. Though, a BIA-ALCL diagnosis is serious and can lead to death, especially if not diagnosed early or promptly treated. In most patients, BIA-ALCL is treated successfully with surgery to remove the implant and the scar tissue surrounding the implant; however, some patients may require chemotherapy and/or radiation therapy.
The FDA is continuing to gather available evidence to help inform future regulatory actions and assure that women and health care professionals are informed of the risk of BIA-ALCL as they consider breast implants. The FDA further issued important recommendations if you currently have the Allergan BIOCELL breast implants.
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