On September 20, 2019, class claims were filed in U.S. District Court for the Central District of Illinois against breast implant manufacturer Allergan alleging that the defendant’s BIOCELL textured saline- and silicone-filled breast implants cause an increased risk of developing breast implant-associated anaplastic large cell lymphoma (“BIA-ALCL”).
In the complaint, named plaintiff Lana Tauben alleges that in July 2017, just a year after she received her first set of BIOCELL textured implants, she had them removed due to significant problems with pain and swelling around the implants. Plaintiff explains that she then had a second set of BIOCELL implants implanted, only to find out the FDA issued a Class 1 recall of the implants in July 2019.
A Class 1 recall, the complaint explains, is the most serious type of FDA recall and indicates the affected product may cause serious injury or death. According to the FDA, BIOCELL textured implants have been linked to BIA-ALCL. The FDA further reported that the risk of developing BIA-ALCL in women with BIOCELL textured implants ranges from 1:3,817 to 1:30,000.
BIA-ALCL is a type of non-Hodgkin’s lymphoma and is not breast cancer. In most cases, it affects scar tissue and fluid near the breast implant. Symptoms of the cancer include persistent swelling or enlargement of the patient’s breast or surrounding tissue, which can develop a year or more after the implants are implanted. Plaintiff points out that BIA-ALCL is a very serious cancer and can be fatal. Thus far, the FDA has reported 573 cases and 33 deaths due to BIA-ALCL worldwide.
According to court documents, Allergan has announced a BIOCELL replacement warranty for all customers that currently have BIOCELL textured implants. The warranty will only provide replacement smooth implants, but will not provide any surgical fee assistance or reimbursement for the surgery to remove the BIOCELL textured implants. The warranty will be available for 24 months (until July 24, 2021) and will apply only to revision surgeries on or after the date of the FDA recall dated July 24, 2019.
The suit seeks to represent a class comprised of all individuals in Illinois with implanted BIOCELL saline- or silicone-filled breast implants or tissue expanders that have been recalled by the FDA. The case brings causes of action for strict liability-failure to warn, negligence, negligent recall, breach of the implied warranty of merchantability and violations of Illinois Consumer Fraud and Deceptive Business Practices Act.
The case is: Tauben v. Allergan USA, Inc. et al., Case No.: 2:19-cv-02257 in the U.S. District Court for the Central District of Illinois.