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Ethicon's Role in Hernia Mesh Litigation
Ethicon Inc., headquartered in Raritan, New Jersey, is a wholly-owned subsidiary of Johnson and Johnson and one of the world's largest manufacturers of surgical products. Ethicon entered the hernia mesh market with products including Prolene Soft, Proceed, and ultimately Physiomesh Flexible Composite. Ethicon marketed these devices heavily to general surgeons performing laparoscopic hernia repairs, promoting them as superior options based on their composite construction and reduced adhesion profiles.
Physiomesh — Withdrawal and Its Aftermath
Physiomesh Flexible Composite was a laparoscopic ventral hernia mesh featuring a polypropylene core sandwiched between two layers of absorbable polydioxanone film. Ethicon launched Physiomesh in 2010 and marketed it aggressively as reducing adhesions and improving tissue integration. In May 2016, following an urgent safety communication from the European Hernia Society and Americas Hernia Society citing two independent hernia registries documenting recurrence and reoperation rates significantly higher than comparable devices, Ethicon voluntarily withdrew Physiomesh from global markets. The withdrawal itself generated thousands of lawsuits from patients who had already been implanted.
Internal Ethicon documents produced in litigation reveal that the company had access to registry complication data before the 2016 withdrawal and received adverse event reports of mesh failure significantly earlier. Plaintiffs allege that Ethicon chose commercial considerations over patient safety in delaying the withdrawal and continued marketing the product to surgeons in the period before withdrawal without adequate warnings.
Proceed and Prolene Soft Mesh Claims
In addition to Physiomesh, Ethicon's Proceed Surgical Mesh — an oxidized cellulose-covered polypropylene mesh for intraperitoneal use — and Prolene Soft Mesh face litigation alleging adhesion formation, chronic pain, and hernia recurrence. Proceed's cellulose coating, like the absorbable layers in Physiomesh, was alleged to degrade inconsistently, leaving patients with unprotected polypropylene against bowel. Prolene Soft, a lightweight polypropylene mesh, faces allegations of excessive shrinkage causing mesh contracture and chronic pain.
Where Ethicon Cases Are Filed
Federal Ethicon hernia mesh cases are consolidated in MDL 2753, In re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation, in the District of New Jersey. New Jersey state court cases are coordinated in MCL 616 before Judge Christine Farrington in Bergen County Superior Court. Claims involving Ethicon mesh products that were filed in other federal districts are transferred to MDL 2753. Plaintiffs with Ethicon mesh complications should ensure their attorney files in the appropriate MDL or state coordination depending on the specific product and case facts.
Key data
Data & Statistics
2016
Ethicon/EHS-AHS Safety Communication
$35M
Court records, Bergen County Superior Court
2-3x
European Hernia Society / Americas Hernia Society joint communication (2016)
FAQ
Frequently Asked Questions
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Related Guides
- Davol and C.R. Bard Hernia Mesh ProductsDavol Inc. and its parent C.R. Bard (now Becton Dickinson) manufactured the largest portfolio of recalled and litigation-linked hernia mesh products in the United States. Products including 3DMax, Ventralex ST, and the recalled Composix Kugel are at the center of MDL 2846 — one of the largest active medical device MDLs in federal court.
- Hernia Mesh Infection ClaimsHernia mesh infection is a devastating complication because bacteria colonize the mesh material in treatment-resistant biofilms, usually requiring complete surgical removal. Mesh design characteristics — including pore size, material composition, and surface coatings — directly affect infection susceptibility, creating strong product liability theories.
- Hernia Mesh Settlements — What to ExpectHernia mesh mass tort settlements are structured as tiered grids based on injury severity, number of revision surgeries, and individual case factors. Understanding how settlement grids work and what factors increase your tier placement helps you evaluate your claim and avoid accepting inadequate offers.
- Hernia Mesh Evidence — Building Your ClaimA strong hernia mesh claim rests on three evidentiary pillars: confirmed product identification (which specific mesh was implanted), documented complications in medical records, and expert opinions causally linking the mesh to the injuries. Gathering and preserving this evidence from the moment complications are identified is the single most important step a potential claimant can take.
- Hernia Mesh Complications — What Can Go WrongDefective hernia mesh can cause a spectrum of complications from painful but treatable infections to catastrophic bowel perforation and sepsis. Understanding which complications are associated with mesh defects — versus routine surgical risks — is essential for evaluating whether a legal claim exists.
- Hernia Mesh Revision Surgery — What It InvolvesHernia mesh revision surgery — including adhesiolysis, partial mesh removal, and complete explantation — is a significantly more complex and dangerous operation than the original hernia repair. The risks, costs, and recovery demands of revision surgery are core elements of damages in hernia mesh litigation.
- Hernia Mesh Recall History — What the FDA FoundThe FDA has issued safety communications, ordered 522 post-market surveillance studies, and presided over multiple hernia mesh recalls. The regulatory history establishes that manufacturers had notice of mesh complications well before many patients were implanted — a critical element of failure-to-warn and design defect claims.
- Inguinal Hernia Mesh ClaimsInguinal hernia mesh repairs are the most common hernia surgery in the United States, accounting for approximately 800,000 procedures annually. The inguinal region's proximity to critical nerves and spermatic cord structures makes mesh complications in this location particularly likely to cause chronic, debilitating pain.
- Ventral Hernia Mesh ClaimsVentral hernias — including incisional hernias following prior abdominal surgeries — are typically repaired with large sheets of synthetic mesh placed intra-abdominally or in the retromuscular space. The large surface area of ventral mesh in contact with bowel creates significant risk of adhesion, migration, and bowel obstruction.
- Hernia Mesh MDL 2846 — What You Need to KnowMDL 2846 in the Southern District of Ohio is the federal coordination for all Davol/C.R. Bard hernia mesh cases. With over 20,000 cases and ongoing bellwether trials, understanding how the MDL works is essential for any potential claimant navigating this litigation.
- Hernia Mesh Chronic Pain — Inguinodynia ClaimsChronic groin pain (inguinodynia) following hernia mesh repair affects an estimated 10 to 30 percent of patients in some surgical registry studies and is the most common basis for hernia mesh legal claims. Nerve entrapment by mesh fixation devices and mesh contracture are the primary mechanisms. Chronic pain claims are legally cognizable even without revision surgery.
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