Surgical mesh was used as long ago as the 1950s, when it was applied in the repair of abdominal hernias. The mesh is a metallic or polymer screen meant to be implanted to reinforce soft tissue or bone in weakened areas of the body.
Gynecologists started using surgical mesh products to repair pelvic organ prolapse (POP) in the 1970s. POP means the protrusion of the pelvic organs from the place where they normally are in the lower abdomen into the area of the vagina, pushing against the vaginal wall. Prolapse of these organs often is caused by strain during childbirth. The organs most frequently involved in POP are:
- Top of the vagina
In the 1990s, gynecologists started using surgical mesh for abdominal repair of POP. Surgeons would cut the mesh into the proper shape to fit the area needing reinforcement. Eventually, manufacturers began to make surgical mesh designed for POP. In 2002, the U.S. Food and Drug Administration (FDA) cleared the first surgical mesh product specifically to be used in repairing POP.
Surgical mesh products are currently regulated as Class II devices and reviewed under the 510(k) Premarket Notification Program. This approval focused primarily on how well the mesh performed mechanically and how safe the material was. These qualifications were approved in animal tests. But, according to the FDA "clinical performance data [i.e., studies in humans] typically has not been used to support clearance for POP or SUI [stress urinary incontinence] urogynecologic mesh products."
This essentially means gynecological mesh products for use in POP and SUI were not cleared in human tests. Four general types of surgical mesh products are used:
- Non-absorbable synthetic
- Absorbable synthetic
- A combination of any of the above three
Uses of Vaginal Mesh
Transvaginal mesh is used in POP in the vaginal wall to support the organs that are pressing against the vagina.
In doing a search of complications from medical devices among urogynecologic surgical mesh products, the FDA between Jan. 1, 2005, and Dec. 31, 2010, received 3,979 reports of injury, death and malfunction. Of these, 2,874 were received in the last three years. This included:
- 1,503 reports associated with POP repairs
- 1,371 reports associated with SUI repairs
The number of reports associated with POP repairs increased by more than five-fold in the last three years compared to the three years before that. Although increased awareness or new products on the market may account for some of the increase, the FDA said, "The overall increase in the number of serious adverse event reports is cause for concern."
From 2008 to 2010, the most frequent reports of complications the FDA received from the use of surgical mesh devices for POP were:
- Vaginal mesh erosion (also called exposure, extrusion, or protrusion)
- Pain (including painful intercourse)
- Urinary problems
- Organ perforation
Other adverse event reports involved:
- Recurrent prolapse
- Neuro-muscular problems
- Vaginal scarring/shrinkage
- Emotional problems
The FDA recommended that women considering surgery for POP be aware of the risks of transvaginal POP repair and realize that having a mesh surgery may increase the need for additional surgery due to mesh-related complications. The FDA also recommends that patients ask their surgeons about all POP treatment options, including surgical repair with or without mesh, and non-surgical options.
Have You Experienced Problems with Transvaginal Mesh?
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