Mentor MemoryShape Lawsuit Over Breast Implant-Associated ALCL Risk Cleared To Move Forward

A federal judge has cleared a Mentor MemoryShape lawsuit to move forward, involving claims that the breast implant design caused a woman to develop a rare form of cancer in the tissue surrounding the device, known as breast implant-associated anaplastic large cell lymphoma (BI-ALCL).

ALCL is a serious type of non-Hodgkin lymphoma linked to breast implants, which is often aggressive and may spread quickly if not diagnosed promptly. Researchers found that women with breast implants were 40 times more likely to develop the cancer, compared to women without implants, and there is growing evidence that certain designs carry a particularly high risk.

After a growing number of breast implant ALCL cases were identified several years ago, the FDA began requiring manufacturers to provide black box warnings designed to alert patients about the risk, and a number of manufacturers have faced breast implant cancer lawsuits brought by women who allege they may have avoided a diagnosis if proper warnings had been provided to users and the medical community about the ALCL risk.

In July 2019, Lory D’Addario filed a complaint (PDF) in the U.S. District Court for the District of New Jersey, pursuing damages against Johnson & Johnson, Ethicon, Inc. and Mentor Worldwide, LLC, indicating she developed BIA-ALCL after being implanted with a Mentor MemoryShape breast implant in July 2015.

After her 2017 diagnosis, she underwent bilateral implant removal surgery and a total capsulectomy.

The lawsuit claims the defective design and manufacturing of the Mentor breast implant were responsible for the development of the cancer, claiming the company did not properly sterilize the implants before shipping them to hospitals.

Defendants sought to have the lawsuit dismissed, based on statements by D’Addario indicating there was a label warning on the implant, including BIA-ALCL, but says the label was never given to her doctor. They also sought to dismiss the claim on federal preemption grounds.

However, an unpublished opinion (PDF) by U.S. District Judge Zahid Quraishi on January 18 determined that D’Addario’s lawsuit can proceed, denying the motion to dismiss.

Judge Quraishi indicated her claims applied to state laws that were parallel to the FDA’s laws, thus causing no conflict between the two to allow for preemption claims. He noted plaintiff’s claims included allegations that the manufacturers had failed to remove debris from the silicon shells.

“This manufacturing defect caused an uncontrolled and unintended increase in the surface area of the implants and expanders and left residual manufacturing material on the Siltex surfaces, which led directly to Plaintiffs’ harm,” his opinion states. “Plaintiffs have therefore plausibly pled the product was defective and that the defect existed when the product left the manufacturer’s control.”

BioCell Breast Implant Associated ALCL Recall Lawsuits

While this lawsuit focuses on the Mentor MemoryShape breast implant, most breast implant ALCL lawsuits have focused on Allergan, Inc. and it’s macrotextured Biocell breast implant line.

In response to concerns about the ALCL risk associated with certain Allergan Biocell implants featuring a textured surface design, a massive breast implant recall was issued in 2019, after the FDA determined the design was linked to nearly all known cases of BIA-ALCL.

In mid-2020, the FDA reported it was aware of at least 733 breast implant-associated ALCL cases, leading to the rapid adoption of the term BIA-ALCL to describe the diagnosis. Since then, the number of diagnosed cases has risen rapidly.

There are currently more than 1,000 Allergan breast implant ALCL lawsuits pending in the federal court system, each raising similar allegations that the textured design was unreasonably dangerous and defective.