The most frequent complications reported to the FDA for surgical mesh devices for POP repair include:
- Mesh erosion through the vagina (also called exposure, extrusion, or protrusion)
- Pain
- Organ perforation
- Bleeding
- Infection
- Pain during sexual intercourse (dyspareunia)
- Urinary problems
Surgical meshes have been developed fairly recently and are used to treat women suffering from pelvic organ prolapse and stress urinary incontinence. Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched. The lack of pelvic floor support causes the pelvic organs and vaginal walls to protrude or bulge (prolapse) into the vagina and sometimes past the vaginal opening. Organs that can be involved in POP include the bladder, the uterus, the rectum, the top of the vagina after a hysterectomy, and the bowel. Stress urinary incontinence (SUI) is the involuntary leaking of urine that can occur during moments of physical activity, such as coughing, sneezing, laughing, or exercise due to insufficient strength of the pelvic floor muscles.
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Transvaginal Mesh Surgeries
For decades, non-mesh suture repair techniques have been the primary choice for treatment of POP and SUI. Recently, transvaginal meshes (where a mesh is placed through the vagina) have been used in an effort to strengthen the weakened vaginal walls. This technique was approved through the FDA’s expedited 510(k) approval process, and studies now show that serious complications associated with surgical mesh for transvaginal repair of POP and SUI are not rare.
Physicians in the United States perform about 75,000 surgeries each year with these mesh products. From 2008 to 2010, the FDA received more than 2,800 reports of complications associated with the surgical mesh. In July 2011, nearly 4000 complaints associated with surgeries performed between 2005 and 2010 were received.
An FDA review revealed that mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP and SUI repair. The review also found that there is no evidence that transvaginal repair to support the top of the vagina or the back wall of the vagina with mesh provides any added benefit compared to traditional surgery without mesh.
When problems with the vaginal mesh do develop, future surgical repairs become more challenging because the surgical mesh is considered a permanent implant. Removal of the mesh due to mesh complications may involve multiple surgeries and can significantly impair the patient’s quality of life. Complete removal of the mesh may not be possible and may not result in complete resolution of the complications, including any pain being experienced.
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