Today July 24, 2019, the FDA has formally recalled textured implants manufactured by Allergan. Allergan is abiding by the FDAs request by initiating a worldwide recall of their BIO CELL textured breast implants products including; 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 and certain tissue expanders. The official FDA release can be found here as well as the full list of products affected.
FDA Warning of Link Between Textured Breast Implants and Rare Form of Cancer:
Breast augmentation came in at the top for most performed cosmetic procedures in 2017, according to the American Society of Plastic Surgery. This was a 40% increase from 2000. With breast augmentation on the rise, last month, the FDA warned of reports linking cancer to textured breast implants. In December of 2018, Allergan textured breast implants where withdrawn from the European market after six women were diagnosed with anaplastic large cell lymphoma (ALCL), a rare form of cancer. Whether you undergo breast augmentation for cosmetic or reconstructive reasons, you deserve a safe product for a lifetime to come.
There have been 457 women diagnosed with breast implant-associated anaplastic large cell lymphoma BIA-ALCL. After analysis of several years of data, the FDA now reports they believe the link between this rare cancer and breast implantation is stronger in those who received textured implants as opposed to smooth. BIA-ALCL is a specific type of Non-Hodgkin's Lymphoma and is not a cancer of the breast tissue. More than 600 cases have been reported to date, but it is difficult to track the exact number of people BIA-ALCL has affected. This is because the diagnosis of ALCL does not have to be reported to the FDA or plastic surgeons if the patient also has breast implants. The FDA has proposed a regulation which would make it mandatory for the FDA to be notified every time someone with breast implants gets diagnosed with BIA-ALCL.
Hundreds of women are now considering legal action against the manufacturer of their breast implants on grounds that the manufacturers failed to warn them of the risk of ALCL. The link between textured breast implants and ALCL was not widely publicized until now. The signs are commonly unknown to patients and misdiagnosed by physicians. Diagnoses such as mastitis (an infection in the breast) and/or shingles share many of the same symptoms and are often diagnosed without thought of cancer.
Some of the warning signs for ALCL include:
- Swelling around lymph nodes in neck, armpit or groin
- Excessive swelling in the breasts, causing pain and redness
- Lumps in the breast or armpit
If you have been diagnosed with BIA-ALCL, you should contact a lawyer to explore your legal options. While it is still early to say what the manufactures of these breast implants knew about the risk of ALCL, it is likely that continued investigation and litigation will answer this question. If the manufacturers where aware of an increased risk of ALCL associated with textured breast implants and failed to disclose this risk to physicians and patients, they should be held accountable.
Our New York City personal injury lawyers will continue to follow these investigations, and we are open to hearing/reviewing potential cases. Contact us at Sullivan & Brill, LLP if you think you have a case: (212) 566-1000 or complete an online consultation form here.