An important deposition was recently taken in the Allergan textured breast implant national litigation, reported Levin Papantonio Rafferty (LPR) Attorney Virginia Buchanan. The deposition provided meaningful insight into the inner workings of Allergan in its design, manufacture, and sale of BioCELL textured breast implant products.
According to the U.S. Food and Drug Administration (FDA), by January of 2020, the government agency had received 733 medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) diagnoses and treatments.
Three types of highly textured implants can no longer be supplied or imported to, or exported from, Australia. On October 29, the Therapeutic Goods Administration (TGA) had dropped the following three breast implant entries from the Australian Register of Therapeutic Goods (ARTG), effective October 27, 2020:
In September 2019, the U.S. Food & Drug Administration reported that at least 12 women had died from breast implant associated anaplastic large cell lymphoma (BIA-ALCL)—a rare cancer of the immune system—caused by textured breast implants and tissue expanders made by Allergan.
Floridian women in the West Palm Beach area, please take note: The Breast Institute in West Palm Beach is unauthorized to perform mammography.
The U.S. Food and Drug Administration (FDA) took corrective action against The Breast Institute, located in West Palm Beach, Florida, after declaring that the mammograms performed by the facility are a “serious risk to human health.”
A group of women is accusing breast implant manufacturer Allergan of intentionally keeping the public in the dark about the cancer risk their product poses. Six women filed lawsuits against the company for its understated label warnings regarding BIOCELL textured implants, and the plaintiffs explain other ways in which the company’s cloak-and-dagger reporting tactics put the women in harm’s way.
This week the U.S. Food and Drug Administration finally requested that manufacturer Allergen issue a “voluntary” recall for its textured Biocell breast implants. The request comes two months after the FDA announced that despite having received a number of reports linking textured breast implants with a rare form of cancer known as anaplastic large cell lymphoma (ALCL) it would not remove the products from the U.S. market.