Transvaginal mesh implants used to treat pelvic organ prolapse and stress urinary incontinence have caused devastating injuries to thousands of women, resulting in one of the largest mass tort litigations in U.S. history. Manufacturers including Johnson & Johnson, Boston Scientific, and C.R. Bard have paid billions in settlements to women injured by these devices.

Understanding Transvaginal Mesh

Surgical mesh was adapted for transvaginal implantation to treat two conditions: pelvic organ prolapse (POP), where pelvic organs descend into the vaginal canal, and stress urinary incontinence (SUI), characterized by urine leakage during physical activity. The mesh was intended to provide permanent support by reinforcing weakened tissue.

Unlike mesh used in other surgeries, transvaginal mesh is implanted through the vaginal wall and positioned to support the bladder, uterus, or other pelvic organs. This placement created unique risks that manufacturers allegedly failed to adequately study or disclose.

Transvaginal Mesh Complications

Women implanted with transvaginal mesh have experienced severe and often permanent complications:

Mesh erosion occurs when the mesh wears through vaginal tissue, becoming exposed inside the vaginal canal. Erosion causes pain, infection, bleeding, and can make sexual intercourse impossible. Eroded mesh often requires multiple surgeries to remove.

Mesh contraction happens when scar tissue causes the mesh to shrink and harden, pulling on surrounding tissue and causing chronic pain, organ damage, and restricted movement.

Chronic pelvic pain affects many mesh recipients, caused by nerve damage, inflammation, infection, or mesh complications. This pain may persist even after mesh removal and can be permanently disabling.

Painful intercourse (dyspareunia) results from mesh erosion, contraction, or positioning that makes sexual activity extremely painful or impossible, profoundly affecting quality of life and relationships.

Recurrent infections develop when bacteria colonize the mesh, causing infections that antibiotics cannot fully resolve. Complete mesh removal may be required to eliminate chronic infection.

Organ perforation can occur when mesh erodes into the bladder, bowel, or other organs, potentially requiring emergency surgery and causing permanent damage.

Regulatory History and Recalls

The FDA initially cleared transvaginal mesh products through the 510(k) pathway, which required manufacturers only to show substantial equivalence to previously marketed devices rather than proving safety through clinical trials. This pathway allowed mesh designed for hernia repair to be adapted for transvaginal use without adequate testing.

Following thousands of adverse event reports, the FDA issued safety communications in 2008 and 2011, reclassified transvaginal POP mesh to require premarket approval in 2016, and ultimately ordered manufacturers to stop selling transvaginal POP mesh in 2019 after they failed to submit required safety data.

Legal Claims and Settlements

Transvaginal mesh litigation has resulted in massive settlements:

Johnson & Johnson/Ethicon agreed to pay over $8 billion to settle mesh claims.

Boston Scientific has paid billions in settlements and verdicts.

C.R. Bard and Coloplast have also resolved thousands of claims through settlements.

Individual settlement amounts vary based on injury severity, with women requiring multiple revision surgeries, experiencing permanent complications, or suffering complete mesh removal receiving higher compensation.

Pursuing a Transvaginal Mesh Claim

Women who received transvaginal mesh and experienced complications should gather surgical records identifying the specific mesh product, document all complications and treatments, and consult with an attorney experienced in mesh litigation. While major settlement programs have resolved many claims, some litigation continues, and statutes of limitations for unfiled claims continue to run.