The FDA's regulatory history with transvaginal mesh is a powerful tool for mesh plaintiffs. The 2011 Safety Communication — in which the FDA explicitly stated that 'serious complications associated with surgical mesh for transvaginal repair of POP are not rare' — directly contradicted years of manufacturer marketing portraying mesh as a routine, low-risk procedure. This document is entered into evidence in virtually every mesh trial as proof of manufacturer failure to heed regulatory warnings.
The April 2019 market withdrawal order was unprecedented in scope. The FDA ordered Ethicon and Boston Scientific — the two remaining POP mesh manufacturers — to immediately cease sales and distribution, stating that neither company had demonstrated their products were safe and effective. This order effectively confirmed, at the highest regulatory level, that transvaginal POP mesh should never have been marketed as a standard treatment option.
Frequently Asked Questions
Related Pages
C.R. Bard, now part of Becton Dickinson, settled over 3,000 mesh cases for more than $184 million. Its Avaulta, Align, and Ajust mesh products were subjects of MDL 2187, the first major mesh MDL consolidated in West Virginia. Bard's per-case average was approximately $61,333.
Learn moreBoston Scientific settled more than 3,000 transvaginal mesh cases for over $188 million, with an average payout of approximately $62,667 — among the highest per-case averages in the mesh litigation. The company's Advantage, Obtryx, Uphold, Pinnacle, and Solyx mesh products are the primary subjects of these claims.
Learn moreThere is no single filing deadline — each state has its own statute of limitations, typically 2–3 years. But the discovery rule means the clock starts when you knew or should have known mesh caused your injuries — not when you were implanted. Women implanted a decade ago may still have active claims.
Learn moreJohnson & Johnson's Ethicon division paid over $775 million to resolve pelvic mesh claims involving its Gynecare TVT, Prolift, and Prosima devices. Ethicon cases command among the highest individual settlement values in the litigation. SUI mesh cases (TVT/Obtryx) remain active in MDL 2327.
Learn moreThe most critical piece of evidence in a mesh lawsuit is the device identification label — a sticker placed in your surgical chart at implantation identifying the manufacturer, device name, and lot number. Combined with records of your complications and treatment, this evidence forms the foundation of your case.
Learn moreMesh used to repair pelvic organ prolapse (POP) transvaginally was ordered off the market by the FDA in April 2019 — the clearest possible regulatory confirmation that these devices were unsafe. Women implanted with POP mesh who experienced erosion, pelvic pain, revision surgery, or sexual dysfunction may qualify for significant compensation.
Learn moreYou may qualify for a transvaginal mesh lawsuit if you had mesh implanted for pelvic organ prolapse or stress urinary incontinence and experienced complications including erosion, chronic pain, revision surgery, sexual dysfunction, or organ damage. You do not need to have had a diagnosis of 'mesh erosion' — any documented complication may be sufficient.
Learn moreFull transvaginal mesh removal is rarely achievable — the mesh integrates with surrounding tissue, and attempts at complete removal risk damage to the bladder, bowel, and nerves. Most women require multiple partial removal procedures over years, each with its own risks and costs. Every mesh removal surgery is fully compensable as part of a transvaginal mesh lawsuit.
Learn moreHaving one or more revision surgeries to address mesh complications significantly increases the value of a transvaginal mesh lawsuit. Each revision surgery represents documented proof of injury severity, additional medical costs, and ongoing harm. The need for revision surgery also often satisfies statute of limitations concerns through the discovery rule.
Learn moreGlobal MDL settlements averaged $38,750 to $62,667 per claimant depending on the defendant. Individual cases based on injury severity have settled from $50,000 to over $80 million at verdict. Factors including number of revision surgeries, permanent dysfunction, and defendant significantly affect individual case value.
Learn moreTransvaginal mesh complications include erosion through vaginal tissue, chronic pelvic pain, dyspareunia (painful intercourse), mesh contraction, urinary problems, and organ perforation. Many women do not connect their ongoing symptoms to their mesh implant until years later — and may still be eligible to file a lawsuit.
Learn moreTransvaginal Mesh Lawsuit
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.
View full case overview