Drugs & Medical Devices Law

Vaginal Mesh: Frequently Asked Questions

What is Vaginal Mesh?

Vaginal mesh, or surgical mesh, is a device made from synthetic or biological material that is used to reinforce the vaginal wall.

What is vaginal mesh used for?

Vaginal mesh is used to support the urethra to treat urinary incontinence or to reinforce the vaginal wall to repair pelvic organ prolapse.

What is pelvic organ prolapse?

Pelvic organ prolapse is when the tissues that hold the pelvic organs in place become weak or stretched. When pelvic organ prolapse occurs, pelvic organs, including the bladder, uterus, rectum, or the top of the vagina prolapse (bulge) into the vagina, sometimes the prolapse or bulge can extend past the opening of the vagina.

Is there an alternative to using vaginal mesh to treat pelvic organ prolapse?

Yes, surgery to repair pelvic organ prolapse can be perfomed through the vagina using stitches.

Is vaginal mesh permanent?

Yes, vaginal mesh is a permanent implant, and complete removal may not be possible.

What is stress urinary incontinence?

Stress urinary incontinence is urinary leakage during physical activity. The physical activity that causes stress urinary incontinence may be as simple as coughing, sneezing, laughing, or exercising.

Is vaginal mesh safe?

The FDA released a safety update on July 13, 2011, informing healthcare providers and patients that complications associated with transvaginal repair using surgical mesh are not rare. Additionally, the FDA reported that it is not clear if vaginal mesh is more effective than traditional non-mesh repair, and vaginal mesh may expose patients to a greater risk.

What are the complications associated with vaginal mesh?

The most common complication with vaginal mesh is erosion of the mesh through the vagina; the erosion can be debilitating for some women, and several surgeries may be necessary to correct the erosion. In addition to erosion, mesh shrinkage has been reported. Both erosion and shrinkage may lead to severe pelvic pain, pain with intercourse, or the inability to have intercourse. Moreover, some men may experience pain during intercourse when the penis is exposed to vaginal mesh that has eroded.

Is vaginal mesh more effective to treat urinary incontinence or pelvic organ prolapse?

No, the FDA conducted a systematic review of scientific literature regarding the use of vaginal mesh from 1996-2011, and the review showed transvaginal repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair.

Are complications with vaginal mesh common?

Yes, the FDA reported the number of adverse events associated with vaginal mesh between 2005 – 2007 was over 1,000, and the number of complications between 2008 – 2010 was 2,874. The FDA further reported that it is concerned that the number of adverse events is high.

Are the complications with vaginal mesh associated with a particular company?

No, the complications associated with the use of surgical mesh for pelvic organ prolapse repair have not been linked to a single brand of mesh.