After the U.S. Food and Drug Administration (FDA) requested that Allergan remove certain models of its textured breast implants from the U.S. market, the company initiated a worldwide recall of its BIOCELL textured breast implants and tissue expanders. Earlier this year, the FDA said the evidence did not warrant banning the implants, but after reviewing new data, the agency changed its tune. According to the FDA, 573 cases of implant-associated anaplastic large cell lymphoma (BIA-ALCL), including 33 deaths, have been reported worldwide.
24 Deaths Since February
Allergan removed its BIOCELL products from the European market last year and Canada banned the products in May of 2019. The FDA says it changed its position and requested the recall after seeing a significant increase in BIA-ALCL and finding that the risk associated with Allergan BIOCELL textured implants was six times the risk of developing the cancer with textured implants available in the U.S. from other manufacturers.
The FDA says there have been 116 new cases of BIA-ALCL and 24 deaths since its report in February, for a total of 573 and 33 deaths since it started tracking the problem in 2011. 481 cases are linked to Allergan products. The manufacturer was only identified in 13 of the 33 deaths. 12 of the 13 were Allergan.
If you have developed anaplastic large cell lymphoma after receiving breast implants, please talk to an experienced defective medical device attorney right away to learn more about your rights and potential compensation.