Transvaginal Mesh

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Transvaginal mesh and slings were created to help patients suffering from pelvic organ prolapse and stress urinary incontinence. Originally, surgeries for stress urinary incontinence or pelvic organ prolapse were performed abdominally by placing sutures above the bladder neck to prevent incontinence or sutures under the vaginal skin to prevent prolapse. These surgeries were widely successful in the 1970s and 1980s. However, given concerns regarding the invasive nature of the surgeries and recovery time for abdominal surgeries, manufacturers began to market the use of mesh and slings during vaginal surgery. For a more complete timeline of events, please visit the vaginal mesh timeline page.

Manufacturers including:

  • American Medical Systems (AMS);
  • C.R. Bard, Ethicon (Johnson & Johnson subsidiary);
  • Boston Scientific;
  • Coloplast; and
  • Mentor

began to market their mesh and sling products for vaginal surgery by hosting cadaver workshops. During these workshops, doctors would practice implanting the mesh and slings in cadavers. Generally, the workshops would take place over one day and gynecologist and urologist attendees would begin to implant the mesh and slings in patients over the next couple of months.

Patients began to experience terribly painful symptoms including pelvic pain, pain during intercourse (dyspareunia), urinary tract infections, vaginal bleeding and urinary retention. These symptoms were associated with mesh complications including mesh erosion, mesh exposure, mesh shrinkage/contraction and mesh migration. In many instances, patients have undergone removal surgeries to attempt to repair these conditions.

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FDA Has Issued Safety Communications Regarding Adverse Events Associated with Transvaginal Mesh and Sling

  • The Food and Drug Administration (FDA) reported approximately 2, 874 adverse events from January 1, 2008 until December 31, 2010. The most common adverse events for pelvic organ prolapse included erosion (35.1%), pain (31.4%), infection (16.8%), bleeding (8.2%) and dyspareunia (7.2%).
  • On October 20, 2008, the FDA issued a Public Health Notification warning of serious complications associated with transvaginal placement of surgical mesh of pelvic organ prolapse and stress urinary incontinence. Specifically, the FDA noted that they had received over 1,000 reports from nine mesh manufacturers of serious complications including erosion through vaginal epithelium, infection and pain. The notification encourages physicians to obtain specialized training for each mesh placement and to be aware of the potential adverse events, especially erosion and infection.
  • On July 13, 2011, the FDA issued a Safety Communication to physicians and patients stating that vaginal mesh had been associated with complications including erosion through the vaginal epithelium, infections, pain, urinary problems and bladder perforation. The FDA found that there was very little evidence to support the use of mesh in pelvic organ prolapse and an advisory panel recommended that the FDA reclassify the mesh as a “high-risk” product.
  • Disturbingly, it has been reported that approximately 300,000 women have received vaginal mesh implants in the United States in 2010.

The FDA has asked mesh manufacturers including Ethicon (J&J subsidiary), C.R. Bard and AMS to conduct three years of trials on the safety and effectiveness of their products.


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Frequently Asked Questions

What is Transvaginal mesh?

Transvaginal mesh is a type of woven surgical mesh, generally made of polypropylene, inserted through the vagina for treatment of stress urinary incontinence (“SUI”) or Pelvic Organ Prolapse (“POP”)

What conditions do Transvaginal mesh treat?

Transvaginal mesh is used to treat stress urinary incontinence (“SUI”) which is a condition involving weakened pelvic muscles that cause the urethra to involuntarily leak urine. Transvaginal mesh is also used to treat pelvic organ prolapse (“POP”) which is a condition in which the muscles stretch and weakened pelvic muscles cause the bladder and urethra to fall from their normal position pushing against the vaginal wall.

What are the most common complications associated with Transvaginal mesh?

The most frequent complications with Transvaginal mesh include erosion, organ perforation, infection, dyspareunia, pelvic pain and recurrent prolapse and incontinence.

What are the treatment options for these complications?

In some of the more severe cases, the treatments for complications such as erosion and organ perforation can include surgical removal of the mesh, trimming of the mesh and antibiotic treatment for the infections. If you have experienced pelvic pain, dyspareunia, infections or vaginal bleeding, it is important that you see your doctor and discuss treatment options. Your doctor might recommend a vaginal ultrasound or physical examination to determine the severity of your complication.