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

A federal judge rejected a request by manufacturers to dismiss a Mentor MemoryShape lawsuit brought by a woman diagnosed with breast implant ALCL

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.

Learn More About

Breast Implant Lawsuits

Women may face a risk of Anaplastic Large Cell Lymphoma (ALCL) from certain breast implants.


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However, an unpublished opinion (PDF) by U.S. District Judge Zahid Quraishi on January 18 determined that D’Addario’s lawsuit can proceed, denying the motion to dismiss.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


  • AngelaMarch 7, 2024 at 2:58 pm

    I have read the same they will replace but not remove. I have not been diagnosed yet with any cancers however I have bilateral breast implant illness and autoimmune. I want an explant with capsulectomy and avoid the next illness of the rare cancer associated from my 2015 silicone implants.

  • LauraJune 20, 2023 at 10:41 pm

    I called Mentor about implant removal surgery asking what they cover due to the recalls and complications. I was told that their warranty covers up to 10 years if rupture is confirmed by an MRI. Since it’s over 10 years, they would replace the ruptured implants but not the surgery. Thay did not even acknowledge the association & being a direct cause of BI-ALCL.

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Leadership Development Committee for Suboxone Dental Injury Lawyers Established in Federal MDL
Leadership Development Committee for Suboxone Dental Injury Lawyers Established in Federal MDL (Posted yesterday)

The U.S. District Judge presiding over all Suboxone lawsuits has created a mentorship program to use the litigation to provide some attorneys an opportunity to gain experience in handling complex federal multidistrict litigations.

Gilead Settlement Resolves 2,625 HIV Drug Lawsuits Pending in Federal Courts for $40M
Gilead Settlement Resolves 2,625 HIV Drug Lawsuits Pending in Federal Courts for $40M (Posted 3 days ago)

Gilead says it will pay $40 million to resolve HIV drug lawsuits over Truvada, Atripla, Viread, Stribild and Complera pending in the federal court system, involving claims that the the company sat on safer formulations of the drugs for years to increase profits.