Mesh Attorneys

Transvaginal Mesh
Transvaginal mesh, also called surgical mesh and urogynecologic mesh, is a medical device that is inserted into the abdomen or pelvis in an effort to take pressure off damaged or weakened tissue. This allows time for the tissue to repair itself. Transvaginal mesh is fabricated from both biologic and synthetic materials. Some types of the porous material from which the mesh is made is supposed to be absorbable by the body. Other types are permanent.

Transvaginal Mesh Uses
Surgical mesh was originally used to treat abdominal hernias. Doctors later discovered that surgical mesh could be permanently implanted to reinforce a woman’s vaginal wall as a step in repairing tissue damaged from a pelvic organ prolapse (POP). It was also found to be useful in supporting the urethra in cases of stress urinary incontinence (SUI).

Pelvic Organ Prolapse
POP is the result of the tissue keeping the pelvic organs in place becoming weakened or stretched. Anywhere from 30 percent to 50 percent of women develop POP in their lifetime. During a case of POP, the pelvic organs may bulge into the walls of the vagina, sometimes causing the vagina to prolapse. A transvaginal mesh can hold the organs in place and keep them away from the vaginal wall.

Stress Urinary Incontinence
SUI occurs when urine leaks from the urethra during physical activity or sudden musculature contraction, such as during a sneeze or cough. A transvaginal mesh may relieve pressure from the urethra in order to prevent the problem.

FDA Public Health Notification
In October 2008, the U.S. Food and Drug Administration (FDA) issued an official health notification to the public regarding complications that can occur as a result of a transvaginal mesh implant. The FDA based the notification on a combination of patient reports and scientific data. However, this original notification stated that serious complications are rare.

In July 2011, the FDA updated their original notification to state that serious complications from transvaginal mesh implants are not rare. The FDA also noted that no evidence exists that shows treatment of POP using transvaginal mesh is no more effective than other, more traditional, treatments. The FDA has yet to issue a statement concerning transvaginal mesh for the treatment of SUI.

Transvaginal Mesh Complications
The most serious complication concerning the use of transvaginal mesh is mesh erosion. It has been found that the mesh can erode the tissue of the vaginal wall where it is implanted. Most cases of mesh erosion require multiple surgeries to correct.

Another complication of transvaginal mesh is mesh shrinkage. Some forms of transvaginal mesh may contract after implantation. This may cause a painful shortening and tightening of the vagina.

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 repair improves clinical outcomes any more than traditional POP repair that does not use mesh, and it may expose patients to greater risk.

In particular, these products are associated with serious adverse events, including vaginal mesh erosion (also called exposure, extrusion or protrusion), a complication which can require multiple surgeries to repair and may result in continued sequelae (e.g., pain) even after mesh removal. Compounding the concerns regarding adverse events are performance data that fail to demonstrate improved clinical benefit over traditional non-mesh repair, particularly for transvaginal apical and posterior repair. While the literature suggests an anatomic benefit to anterior repair with mesh augmentation, this anatomic benefit may not result in superior clinical outcomes, and the associated risk of adverse events should be considered.