Lawsuit Claims Sientra Textured Breast Implants Caused Breast Lymphoma
A lawsuit filed in federal court in Tennessee on September 23 claims that Sientra textured breast implants made in Brazil caused a woman to develop breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
BIA-ALCL is a cancer of the immune system which numerous lawsuits say is caused by breast implants. Most lawsuits so far have involved Allergan’s Biocell textured implants, which have been recalled.
The complaint states that the plaintiff “chose to undergo double mastectomies in order to avoid the risk of developing cancer,” on or about November 13, 2013, utilizing Sientra textured oval shaped silicone gel implants for reconstruction. The complaint claims that the plaintiff and her surgeon were never warned that there was a BIA-ALCL risk associated with the textured breast implants.
The complaint states the plaintiff returned to her surgeon on September 26, 2019, complaining of swelling in her right breast. The plaintiff was diagnosed with BIA-ALCL on October 1, 2019 and underwent surgery to remove the implants on or about November 11, 2019.
Lawsuit Alleges Poor Manufacturing Practices
The complaint says that Sientra’s implants were made by Silimed in Brazil. The complaint says that Sientra said in a 2014 annual report, “our reliance on Silimed involves a number of other risks, including… our products may not be manufactured in accordance with agreed upon specifications or in compliance with regulatory requirements, or its manufacturing facilities may not be able to maintain compliance with regulatory requirements, which could negatively affect the safety or efficacy of our products.”
The complaint notes that Sientra’s first quarter of 2015 report acknowledged that their manufacturer failed to follow good manufacturing practices.
“Sientra knew of, or recklessly disregarded information about, [good manufacturing practices] non-compliant conditions at the Silimed manufacturing plant,” the complaint states.
The complaint implies that these conditions led to negligently manufactured implants.
“When an implant is negligently manufactured, overly textured, rough implant shells are produced with foreign and adulterated silicone particles, fragments, implant materials and residues on the implant surface that are recognized as a foreign body that triggers T-cell lymphoma and over time, BIA-ALCL,” the complaint states.
The complaint states that the plaintiff has endured pain and suffering as well as permanent physical impairment and disfigurement, seeking to recover damages based on negligence, strict liability – manufacturing defects, strict liability – failure to warn, and breach of express and implied warranties, as well as punitive damages.