Cowper Law LLP Named to the Plaintiff Steering Committee in Allergan Biocell Textured Breast Implant Product Liability Litigation (MDL 2921) Before Judge Martinotti

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1. In March 2015, an analysis identified 173 cases of ALCL. That same month, the French National Cancer Institute announced, “There is a clearly established link between the occurrence of this disease and the presence of a breast implant.”
2. On May 19, 2016, the World Health Organization (“WHO”) gave the disease an official designation as “BIA-ALCL” and classified it as a distinct clinical entity, separate from other categories of ALCL.
3. It was a few months after the National Comprehensive Cancer Network (“NCCN”) released the first worldwide oncology standard for the disease.
4. In November 2016, Australia’s Therapeutic Goods Administration (“TGA”) convened an expert advisory panel to discuss the association between breast implants and ALCL and provide ongoing advice.
5. On March 21, 2017, the FDA released a safety communication updating the current

In its July 24, 2019 announcement recalling the product, the FDA stated that there are 573 cases of BIA-ALCL worldwide and that 33 people have died, a “significant increase” since the FDA’s last update earlier in 2019—reflecting 116 new cases and 24 more deaths.  The FDA stated that the risk of developing BIA-ALCL with Allergan BIOCELL textured implants is about six times that of becoming ill with textured implants from other manufacturers available in the U.S.  The FDA noted that of the 573 cases of BIA-ALCL, 481, or more than 80%, were attributed to Allergan implants, and of the 33 deaths caused by BIA-ALCL, 12 of the 13 patients for whom the implant manufacturer was known had an Allergan implant when they were diagnosed.

Dr. Amy Abernethy, principal FDA deputy commissioner, stated: “Based on new data, our team concluded that action is necessary at this time to protect the public health.”  She further stated: “Once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action.”  If you were implanted with Allergan textured breast implants, please call us at 877.529.3707 for a free consultation and case review.