Transvaginal Mesh

Thousands of women have suffered serious and painful injuries following surgery with transvaginal mesh to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI).  Surgical mesh is used transvaginally to treat two conditions: pelvic organ prolapse (POP) or stress urinary incontinence (SUI). POP involves a weakening or stretching of internal structures that support organs such as the bladder, bowel and uterus which causes the organs to drop to below their normal position and bulge into the vagina. SUI is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise.

If you or a family member or friend has suffered injury as a result of transvaginal mesh complications, contact Foley & Small. Our attorneys and staff have represented clients in a variety of defective medical implant cases, including defective mesh and patch claims. We will work to provide you with a recovery for your injuries and losses caused by these defective mesh implants. We invite you to continue reading to learn more about these transvaginal mesh products.

Transvaginal Mesh Complications

Recipients of transvaginal mesh/ sling products have suffered from complications, including:

• erosion of vaginal tissue
• infection
• vaginal mesh erosion
• pain
• perforations of the bowel, bladder or blood vessels
• recurrence of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI)
• urinary problems
• vaginal scarring

In at least three instances, women are known to have died as a result of transvaginal mesh complications. Transvaginal mesh complications can lead to permanent injury and pain. 

Transvaginal Mesh Manufacturers and Distributors

If you or a loved one suffered complications as a result of POP or SUI surgery that involved transvaginal mesh, you may be able to receive compensation from the manufacturer of the device used in your procedure. Transvaginal mesh is marketed by several manufacturers, including:

• American Medical Systems
• Boston Scientific
• Caldera
• C.R. Bard, Inc.
• Ethicon
• Gynecare
• Johnson & Johnson
• Mentor
• Sofradim
• Tyco

Transvaginal Mesh History of Complications and FDA Action

Since 2008, the FDA has issued two safety alerts regarding transvaginal mesh complications. On Oct. 20, 2008, the FDA warned that between 2005 and 2007, more than 1,000 people had reported experiencing problems with mesh made by at least nine different manufacturers. The most frequent complications included erosion, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, the FDA said.

On July 13, 2011, the FDA said in a Safety Communication that it had received 2,874 new reports of complications associated with transvaginal surgical mesh procedures from January 2008 through December 2010. Of these, 1,503 reports were associated with POP repairs and 1,371 associated with SUI repairs. Studies reviewed by the agency indicated that about 10 percent of women who have the mesh placed transvaginally experience mesh erosion within 12 months of surgery and that more than half of them require additional surgeries to remove the mesh. In some cases, even multiple surgeries will not resolve the complication.

The 1,503 adverse event reports associated with POP procedures was five times as many as the FDA received from 2005 to 2007. The reports involving POP complications also included three fatalities. The FDA also noted that a previously unidentified complication associated with transvaginal POP repair - mesh contraction or shrinkage - has been reported in the published scientific literature and in adverse event reports to the FDA since its 2008 alert.

The FDA emphasized that transvaginal mesh complications associated with POP repair are NOT rare, a change from the position it took in 2008. Finally, the agency said it was not clear that POP repair involving transvaginal mesh was better than traditional non-mesh procedures, and may actually expose patients to greater risk of complications.

Transvaginal Mesh Complications – Contact Foley & Small

We’ve handled various cases involving defective medical implants. We are experienced in handling such defective medical product claims both in federal and in state courts. We are dedicated to helping women who are dealing with symptoms and loses and heart ache that comes with dealing defect transvaginal meshes. If you or a family member or friend is suffering from complications from a transvaginal mesh implant, contact Foley & Small.

You can call Foley & Small on our toll free number 800-276-2525, you can email us or you can complete new client contact form located to the upper right column of this page. A member of our office will contact you and we can begin steps to evaluate your case and provide needed help.