Johnson & Johnson Breast Implant Lawsuit: BIA-ALCL and Preemption

The Johnson and Johnson breast implant lawsuits are product liability claims brought against J&J’s subsidiary Mentor Worldwide LLC, which makes silicone and saline breast implants. Plaintiffs allege that Mentor implants cause a rare immune-system cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), connective tissue disorders, and a cluster of systemic symptoms known as breast implant illness. In the United States, the cases are moving individually through federal district courts with no multidistrict litigation consolidation.¹ In Canada, a class action covering Mentor MemoryGel silicone implants has been certified and is heading toward a common-issues trial.²

J&J acquired Mentor Corp. in December 2008, and Mentor now sits inside J&J’s MedTech segment as the company’s breast aesthetics and reconstruction business.³⁴ Its product lines named in litigation include MemoryGel silicone gel-filled implants, MemoryShape textured silicone implants with a Siltex surface, and saline-filled implants.

What Plaintiffs Are Alleging

The complaints fall into three broad groups.

BIA-ALCL From Textured Implants

BIA-ALCL is a cancer of the immune system, not of the breast tissue itself, and it appears overwhelmingly in patients with textured-surface implants. The FDA first flagged a possible link in 2011. By June 2024, the agency had received 1,380 unique reports; 73 percent involved textured implants and 3 percent involved smooth ones, with 75 reports naming Mentor as the manufacturer.⁵ Researchers have theorized that a rough implant surface triggers chronic inflammation or traps bacteria in a biofilm.⁶

Most global BIA-ALCL cases have been attributed to Allergan’s Biocell macro-textured implants rather than Mentor’s Siltex line. A 2019 study using Australian and New Zealand data found Allergan Biocell implants carried a BIA-ALCL risk roughly 16 times higher than Mentor Siltex textured implants.⁷ Mentor’s textured products have still drawn suits.

Breast Implant Illness and Autoimmune Symptoms

A separate group of plaintiffs alleges that leaking silicone implants cause pain, fatigue, skin rashes, nausea, and autoimmune responses. Two early individual suits against Mentor were filed in California, in San Francisco in September 2016 and Los Angeles in February 2017, by women attributing these symptoms to their implants.⁸ Some plaintiffs also allege that heavy metals used in manufacturing can enter the bloodstream.⁹

Manufacturing Defects and Failure to Report

Rather than challenging the FDA-approved design, several suits target how the implants were actually made. Plaintiffs have alleged that Mentor’s manufacturing process left residual polyurethane debris on the surface of Siltex implants in violation of federal regulations requiring removal of manufacturing material.¹⁰ A related line of allegations is that Mentor failed to report adverse events to the FDA in a timely way and failed to conduct the post-approval studies required as a condition of the 2008 return of silicone implants to the U.S. market.

How U.S. Cases Are Faring

There is no multidistrict litigation for Mentor breast implant claims. Each case proceeds on its own, and the outcomes have varied significantly based on how the complaint is pleaded.¹

The Preemption Hurdle

Because Mentor’s silicone implants went through the FDA’s premarket approval process, federal law generally blocks state-law claims that would impose requirements different from or in addition to what the FDA approved. To survive, plaintiffs have to identify a specific federal requirement the manufacturer violated and point to a state-law duty that runs parallel to it. Generalized “the implant was defective” allegations are not enough.

McGee v. Johnson & Johnson

Christine McGee sued J&J, Ethicon, and Mentor in the Western District of Pennsylvania, alleging she developed BIA-ALCL because polyurethane debris was left on her MemoryShape Siltex implants. Her complaint raised four Pennsylvania-law counts: manufacturing defect, breach of implied warranties, failure to warn, and negligence.¹⁰

On July 26, 2023, the court issued a mixed ruling on the motion to dismiss. It allowed the manufacturing defect claim to move forward, finding McGee had adequately alleged the process deviated from FDA-approved specifications and that 21 C.F.R. § 820.70(h) supplied a parallel federal requirement. The court also preserved a negligence sub-claim based on Mentor’s alleged failure to report adverse events. The failure-to-warn and implied-warranty claims were dismissed.¹⁰ The surviving claims remain active on the available record.

Avrin v. Mentor Worldwide

A federal judge in the Central District of California dismissed Avrin v. Mentor Worldwide LLC on March 15, 2024, in a ruling that turned on preemption.¹

Diodato v. Mentor Worldwide

Kelly Diodato sued Mentor in the District of Maryland. The court’s analysis reinforced that a plaintiff must allege specific deviations from the FDA-approved manufacturing process for the particular device at issue, not generalized defect allegations.¹¹

The Canadian Class Action Against Mentor

Bosco v. Mentor Worldwide, filed as B.C. Supreme Court Action No. VLC S-190084, is the largest formally consolidated proceeding against Mentor. It covers everyone implanted with Mentor MemoryGel silicone gel-filled breast implants in Canada between October 19, 2006, and October 21, 2024.²

The class action alleges that the implants cause connective tissue disorders such as rheumatoid arthritis, lupus, and Sjögren’s syndrome, along with breast implant illness, and that Mentor failed to adequately warn patients and surgeons or conduct proper post-market surveillance.¹² It was certified by court order on October 21, 2024, with Mentor consenting to 12 common issues proceeding to trial, including whether the implants can cause specific connective tissue disorders and breast implant illness, whether Mentor breached duties of post-market surveillance, and whether its conduct was negligent or violated consumer protection and competition legislation.²

On November 20, 2024, the same court denied certification of additional contested common issues about alleged “toxins” (heavy metals and volatile chemicals) in the implants. The court found no “basis in fact” that these substances diffuse from the implants in quantities sufficient to cause adverse health effects, and excluded the plaintiffs’ expert on platinum toxicity.¹² Mentor denies the allegations and intends to defend the action. The opt-out deadline for class members who do not wish to participate is August 11, 2025.²

FDA Actions Plaintiffs Rely On

On March 18, 2019, the FDA issued a warning letter to Mentor for failing to comply with post-approval study requirements for its MemoryShape implant, approved in 2013. The letter cited the company for enrolling only 102 subjects against its target, maintaining an effectiveness cohort of just 189 evaluable patients instead of roughly 500, and producing data with significant inconsistencies including poor patient accounting and missing demographic information. The FDA warned that continued noncompliance could result in withdrawal of the premarket approval.¹³¹⁴

Plaintiffs point to that warning letter as evidence Mentor failed to track long-term safety outcomes as the FDA required, leaving patients and regulators without data needed to identify risks in time.

Mentor has also had several Class 2 recalls, though narrow in scope. A 2016 recall of MemoryGel involved 35 units with incorrect labeling.¹⁵ Separate Class 2 recalls for Mentor saline-filled implants were posted in 2017 and 2021.¹⁶ None involved the BIA-ALCL cancer risk that drives most of the litigation.

What the Allergan Recall Did and Didn’t Cover

On July 24, 2019, the FDA requested that Allergan voluntarily recall its Biocell textured breast implants and tissue expanders after determining they carried a BIA-ALCL risk roughly six times higher than textured implants from other manufacturers. At the time, Allergan’s products accounted for 481 of the 573 known BIA-ALCL cases globally.¹⁷ Mentor was not part of that recall.¹⁸ Anyone assuming a Mentor recall exists because of the 2019 news should know it does not. The Allergan action did, however, raise public awareness of BIA-ALCL and produced Canadian precedent, particularly the 2022 Ontario ruling in Kibalian v. Allergan Inc., that plaintiffs have cited against Mentor.¹⁹

Where Things Stand Now

In the United States, individual cases continue in federal district courts. Whether a claim survives has depended heavily on whether the plaintiff can identify a specific manufacturing deviation and a parallel federal requirement, as McGee did and Avrin and Diodato did not. In Canada, the Bosco class action is moving toward a common-issues trial on 12 certified issues, with an opt-out deadline of August 11, 2025.² No public settlements or jury verdicts specifically against Mentor in breast implant cases have been reported in the available research. J&J’s 2024 annual report discloses billions in litigation-related adjustments across the company but does not break out figures for Mentor breast implant claims.⁴

1
Bloomberg Law. Mentor Worldwide Defeats Suit Alleging Defective Breast Implants
2
Yahoo Finance Canada. Press Release Regarding Bosco v. Mentor Worldwide
3
DrPancholi.com. Breast Implant Manufacturer Mentor Acquired by Johnson & Johnson
4
Johnson & Johnson. Johnson & Johnson 2024 Annual Report
5
FDA. Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma
6
Breastcancer.org. Breast Implant Illness
7
ICIJ. France Bans Breast Implants Linked to Heightened Cancer Risk
8
TruLaw. Breast Implants Lawsuits
9
WRSH Law. Mentor Breast Implant
10
FindLaw. McGee v. Johnson & Johnson
11
U.S. District Court, District of Maryland. Diodato v. Mentor Worldwide LLC
12
Bennett Jones. BC Supreme Court Denies Certification of Contested Common Issues in Mentor Breast Implant Litigation
13
FDA. Warning Letter – Mentor Worldwide LLC
14
FDA. FDA Issues Warning Letters to Two Breast Implant Manufacturers
15
FDA. Recall – Mentor MemoryGel Breast Implant
16
FDA. Recall Results – Mentor Saline Breast Implants
17
FDA. FDA Takes Action to Protect Patients From Risk of Certain Textured Breast Implants
18
AdventHealth. Major Manufacturer Voluntarily Recalls Textured Breast Implants
19
TR Law. Kibalian v. Allergan Inc., 2022 ONSC 7116