Transvaginal Mesh Injuries

Some patients that have received transvaginal mesh have reported injuries, including mesh contraction, which causes vaginal shortening, tightening and severe pain; surgical mesh erosion; bowel and bladder perforations; and hemorrhage.

If you've been injured by transvaginal surgical mesh, we may be able to help you seek compensation for your injuries. To learn more, please contact us to schedule a free review of your case.

Transvaginal Mesh to Repair POP

The use of transvaginal surgical mesh to repair pelvic organ prolapse (POP) in women has come under increasing scrutiny by the U.S. Food and Drug Administration (FDA). The agency has questions about both the safety and the effectiveness of the devices.

The FDA concluded a July 2011 report by saying, "Based on evaluation of adverse event reports and assessment of the scientific literature, the FDA has NOT seen conclusive evidence that using transvaginally placed mesh in POP repairs improves clinical outcomes any more than traditional POP repair that does not use mesh, and it may expose patients to greater risk."

Pelvic organ prolapse occurs when the floor of the pelvis in women becomes weakened or stretched, allowing the organs to prolapse or bulge into the vagina. The organs that can prolapse include the:

• Bladder
• Uterus
• Rectum
• Bowel
• Top of the vagina

POP usually occurs after childbirth. It also can occur after surgery to remove the uterus, or a hysterectomy. Gynecologists began to use surgical mesh products to repair POP by operating abdominally in the 1970s.

Surgical mesh is a screen-like device made of metal or polymer. It is implanted to reinforce soft tissue or bone in places that are weak. Gynecologic surgeons cut the mesh to the desired shape and put it in place through an incision in the abdomen. The type of mesh used for most gynecological procedures is a non-absorbable synthetic polypropylene.

510(k) Clearance

Device manufacturers saw an opportunity to make surgical mesh products specifically for POP, and in 2002 the FDA cleared the first surgical mesh products for this use. The devices are reviewed under the 510(k) Premarket Notification Program, meaning the review focuses primarily on the adequacy of the mechanical performance and safety of the material.

Animal studies have confirmed that the engineering specifications are met and that the mesh is biocompatible. But, the products in general have not been cleared by testing in humans.

Adverse Event Reports

The FDA conducted a MAUDE (Manufacturer and User Device Experience) search of adverse events reported between Jan. 1, 2005, and Dec. 31, 2010 regarding all urogynecologic (the mesh also has been used to correct incontinence) surgical mesh products. The search found 3,979 reports of injury, death and malfunction, including:

• Mesh contraction, which causes vaginal shortening, tightening and severe pain
• Surgical mesh erosion
• Bowel and bladder perforations
• Hemorrhage

Of the 3,979 reports, 2,874 were received in the last three years (1,503 were associated with POP repairs; 1,371 were associated with stress urinary incontinence repairs). Also, the number of reported adverse incidents increased by more than five-fold compared to the number of adverse incidents reported in the previous three years.

FDA Warnings Involving Transvaginal Mesh

Regarding safety, the FDA identified numerous concerns about transvaginally (operating through the vagina, as opposed to through the abdomen) placed surgical mesh for POP repair. These included:

• Patients undergoing the mesh repair surgery faced mesh-related complications not faced by those undergoing traditional surgery without mesh.
• The adverse events associated with transvaginally placed mesh can alter women's lives, despite removal of the mesh. This often involves continued pain.
• Mesh-associated complications are not rare: 10 percent of 11,785 women experienced mesh erosion within a year of surgery.
• More than half of those experiencing erosion from non-absorbable synthetic mesh needed to have the mesh removed surgically, sometimes requiring as many as two to three additional operations.
• Mesh contraction (which causes vaginal shortening, tightening and/or vaginal pain) is being increasingly reported in the literature.
• Abdominal POP surgery using mesh seems to result in lower rates of mesh complications compared to transvaginal surgery with mesh.

When judging efficacy, the FDA said transvaginal POP repair with mesh often restores anatomy, but it has not been shown to benefit patients more than traditional, non-mesh repair.

Have You Been Injured by Vaginal Mesh?

If you have suffered from the complications of a transvaginal mesh repair, you should seek the advice of a transvaginal mesh injury attorney. You might be eligible for financial compensation. Contact us today to schedule a free review of your case.