The Food and Drug Administration recently urged Allergan to recall its BIOCELL textured breast implants and tissue expanders from the global market due to concerns over a rare form of cancer. Here, the product liability attorneys at Sullivan Papain Block McGrath Coffinas & Cannavo, P.C. provide details about the recall.
Evidence Shows an Increase in the Number of Breast Implant-Associated Anaplastic Large Cell Lymphoma Cases
The FDA has found a link between breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and women who have textured breast implants. Textured breast implants are commonly used in the European and Asian markets, but also account for approximately 10% of the breast implants used in the United States. According to the FDA, 573 cases of BIA-ALCL were recorded worldwide as of July 6th, 2019. A total of 481 of the patients had Allergan implants at the time of their diagnosis, and 33 women have died due to complications of the cancer.
Risk of Cancer Development Found to Be Greater with Allergan Implants Specifically
According to the FDA, “our analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S.” Allergan has already discontinued the sale of the BIOCELL textured implants in Europe and Canada. No correlations between smooth implants and BIA-ALCL have been found at this time, and the recall does not impact Allergan’s smooth breast implants.
The FDA Has Reported on Complications and Concerns Related to Breast Implants Since Their Approval
The FDA provided an update on the safety and potential health concerns of breast implants in 2011, five years after the FDA first approved two silicone gel-filled breast implants. In this report, the FDA studied whether the use of breast implants correlated with a variety of negative health outcomes, including several types of cancer. The FDA has recommended that women with silicone breast implants of all types have routine MRIs or ultrasounds to determine whether a “silent rupture” has occurred within their implants. Silent ruptures can cause negative health outcomes, such as pain, lumps and a condition known as Breast Implant Illness.
Speak to a Product Liability Attorney at Sullivan Papain Block McGrath Coffinas & Cannavo, P.C. Today
The FDA continues to assess whether all brands of textured breast implants are connected to an increased risk of BIA-ALCL or just the brands that are currently under recall, including Allergan. The risks that textured breast implants may pose to women are serious, and anyone experiencing pain, swelling, skin irritation or lumps in or around the breast area should speak to a physician immediately. Women who have developed BIA-ALCL due to textured breast implants may also be entitled to compensation. To learn more about your legal options, we encourage you to contact the dedicated product liability attorneys at Sullivan Papain Block McGrath Coffinas & Cannavo, P.C. today.