Lawsuit Filed Over Breast Implant Removal After Defective Design Recalled Due to Cancer Risk

A Tennessee woman indicates she was forced to pay out-of-pocket for her breast implant removal, even after the manufacturer recalled the products due to the risk the design may increase the risk of women developing a rare type of cancer which forms in the tissue surrounding the implant, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Pat Burress filed a product liability complaint (PDF) in the federal court system on August 11, indicating Allergan should be forced to pay for costs associated with removal of recalled breast implants that feature the company’s macrotextured Biocell design.

Allergan was forced to issue a worldwide breast implant recall last year for products featuring Biocell surface, which was a successor to the McGhan breast implant design. The action was taken after the FDA determined last year that the products were linked to nearly all reported cases of BIA-ALCL, which is a form of non-Hodgkins lymphoma.

Although Allergan allegedly knew about the breast implant lymphoma risk for years, the lawsuit notes that the only reason the implants are off the market is because the FDA forced the issue.

According to the lawsuit, Burress was implanted with Natrelle 410 MF 420cc implants in both breasts. However, in August 2019, Burress indicates she became aware of the recall when her doctor sent her a letter advising her the implants had been linked to cases of BIA-ALCL and were withdrawn from the market.

She underwent a breast implant removal surgery a short time later, at her own cost and expense, the lawsuit notes.

“At no time did Allergan provide surgical fee assistance for individuals, including Plaintiff, to have breast implant revision and removal of the implants,” Burress states in the lawsuit. “Plaintiff expended her own funds, out of pocket, to have the implants removed after being notified by her physician of the recall.”

The FDA indicates there are at least 573 known cases of BIA-ALCL diagnosed worldwide, including 33 deaths. Of those, 481 have been linked to Biocell breast implant designs. Allergan implants were also linked to 12 of the 13 deaths where the manufacturer of the breast implant was known.

The FDA is not recommending women have the breast implants removed if they are showing no symptoms. Instead, the regulators recommend recipients of these implants become familiar with the symptoms of BIA-ALCL, including persistent swelling or pain near the implant, and talk to their health care provider for further information. Those with BIA-ALCL should undergo breast implant removal and removal of the surrounding scar capsule.

The agency also recommends those who receive breast implants keep a record of the device manufacturer, unique device identifier and implant model name, which may have been provided on a patient device card from the surgeon.

The case joins dozens of similar individual and class action lawsuits filed in recent months,brought both by women diagnosed with the breast implant lymphoma and who were not diagnosed, but had them removed for safety issues, which have been centralized as part of a multidistrict litigation (MDL) in the federal court system.