Transvaginal Mesh - Consumer Drug Report
Transvaginal mesh lawsuits expected to grow

Last month, all transvaginal mesh lawsuits filed against certain manufacturers of transvaginal mesh were centralized and consolidated in the Southern District of West Virginia for pretrial proceedings before Chief Judge Joseph R. Goodwin. The number of lawsuits is expected to grow as more women suffer complications from the device.

Transvaginal mesh, often referred to as “surgical mesh,” is a permanent implant designed to reinforce weakened or damaged tissue in women with stress urinary incontinence and pelvic organ prolapse. Both conditions cause complications that may lower a woman’s quality of life.

Stress urinary incontinence is a condition in which leakage occurs during normal physical activity, and pelvic organ prolapse occurs when the internal structures supporting the uterus and bowel become so weak that the organs drop from their regular position and prolapse into the vagina.

Manufacturers being sued due to transvaginal mesh complications include Johnson & Johnson, Ethicon, American Medical Systems, and Gynecare. According to plaintiffs’ complaints, the surgical mesh causes pelvic floor damage, inflammation, erosion, and other painful injuries.

In addition to personal injury claims, plaintiffs allege that transvaginal mesh manufacturers marketed the device as being safe and effective and implanted via minimally invasive surgery. Women who have been injured by surgical mesh often have to undergo multiple painful surgeries to locate and remove the mesh.

In 2010, at least 100,000 pelvic organ prolapse repairs used surgical mesh, 75,000 of these were transvaginal procedures. Between 2008 and 2010, the Food and Drug Administration received about 2,874 adverse event reports associated with transvaginal mesh. Of these, 1,503 were associated with pelvic organ prolapse repairs, and 1,371 were associated with stress urinary incontinence.

The FDA issued a public safety warning in July 2011 stating that no additional benefits of transvaginal mesh surgery for pelvic organ prolapse and stress urinary incontinence treatment were discovered over traditional treatment.

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