Surgical mesh implanted transvaginally to treat pelvic organ prolapse and stress urinary incontinence caused widespread injuries including erosion, chronic pelvic pain, and the need for revision surgery. Six MDLs were consolidated before Judge Joseph Goodwin in the Southern District of West Virginia. Major manufacturers paid over $1.9 billion in global settlements. Individual cases remain active, especially for women who recently connected their symptoms to their mesh implant.
Litigation Timeline
FDA Issues First Public Health Notification on Mesh Complications
The FDA issued its first Public Health Notification warning of complications associated with surgical mesh used to repair pelvic organ prolapse and stress urinary incontinence. The agency reported over 1,000 adverse events in a 3-year period. Manufacturers were not required to pull products, and the warning was largely ignored by the medical community.
FDA Upgrades Warning: Mesh Complications 'Not Rare'
The FDA issued an updated Safety Communication on surgical mesh for POP, explicitly stating that serious complications were 'not rare' — directly contradicting manufacturers' marketing claims. The FDA issued 522 post-market surveillance orders requiring manufacturers to conduct clinical studies on their devices. This communication became a central exhibit in thousands of mesh lawsuits.
Six MDLs Consolidated Before Judge Joseph Goodwin in S.D. West Virginia
The Judicial Panel on Multidistrict Litigation transferred and consolidated six separate mesh MDLs to Judge Joseph R. Goodwin in the Southern District of West Virginia. The MDLs covered Ethicon (MDL 2327), C.R. Bard (MDL 2187), Boston Scientific (MDL 2326), AMS/Endo (MDL 2325), Coloplast (MDL 2387), and Neomedic (MDL 2440). At peak consolidation, over 100,000 cases were pending.
FDA Orders Market Withdrawal of All POP Mesh Products
The FDA ordered all manufacturers to immediately stop selling and distributing surgical mesh intended for transvaginal repair of pelvic organ prolapse, citing an inability to demonstrate reasonable assurance of safety and effectiveness. Affected products included Ethicon's Prolift and Gynecare systems, Boston Scientific's Uphold and Pinnacle, and others. This was the most decisive FDA action in the litigation and effectively confirmed plaintiffs' core legal argument.
$80M Verdict Against Ethicon in NJ — Hrymoc v. Ethicon
A New Jersey jury awarded plaintiff Patricia Hrymoc $80 million in damages against Ethicon in one of the largest individual transvaginal mesh verdicts in history. The jury found that Ethicon failed to warn of known risks and acted with actual malice. The verdict included substantial punitive damages and sent a powerful signal in ongoing bellwether litigation.
Ethicon and AMS Global Settlements Top $1.6 Billion Combined
Johnson & Johnson's Ethicon division settled over 20,000 pelvic mesh cases for more than $775 million, while Endo International's AMS division settled approximately 20,000 cases for approximately $830 million. Combined with Boston Scientific ($188M+) and C.R. Bard ($184M+) settlements, total industry payouts exceeded $1.9 billion across the major defendants.
Notable Verdicts & Settlements
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