Transvaginal Mesh Statistics
Women having problems called Pelvic Organ Prolapse (POP) and Stress Urinary incontinence (SUI) often use transvaginal mesh medical devices to correct the problem. This device is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. Transvaginal mesh is permanently implanted through urogynecologic procedures to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.
POP affects 30 to 35 percent of women in their lifetime with two percent developing symptoms. When POP happens, the organs bulge (prolapse) into the vagina and sometimes prolapse past the vaginal opening. More than one pelvic organ can prolapse at the same time. Organs that can be involved in POP include the bladder, the uterus, the rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel.
SUI on the other hand, is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise.
These two problems can cause uncomfortable situations for affected women for which the transvaginal mesh patch seeks to correct or solve. However, the use of transvaginal mesh patch was reported to have some painful medical complications.
Here are the statistics from the FDA on the reported complications:
- The number of adverse events associated with the use of surgical mesh devices from 2005-2007 was over 1000. This number was reflected in FDA’s Public Health Notification issued October 20, 2008.
- From January 1, 2008 to December 30, 2010, the FDA received additional 2,874 reported cases of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI.
- From 2008 – 2010, 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, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. The FDA stated that many of these complications require additional intervention, including medical or surgical treatment and hospitalization.
These reports prompted the FDA to conduct systematic review of the published scientific literature from 1996 – 2011 to evaluate its safety and effectiveness in order to better understand the use of device for POP and SUI. The review indicated that transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair.
Moreover, the FDA issued the following findings as a result of the literature review:
- Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
- Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
- There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
- While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.
- The FDA’s literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.
- Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA since the Oct. 20, 2008 FDA Public Health Notification. Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.
- Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain during sexual intercourse when the mesh is exposed in mesh erosion.
- The complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh.
The FDA stated that they will continue to evaluate the literature for SUI surgeries using surgical mesh and will report about that usage at a later date.
PubMed conducted a retrospective audit of 133 vaginal mesh reconstructive operations at Hinchingbrooke Hospital, Cambridgeshire, UK. A total of 14 (10.53%) cases of mesh erosion into the vagina were reported. PubMed concluded that an increased rate of mesh erosion was associated with concurrent vaginal hysterectomy and previous vaginal reconstructive surgery.
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