FDA: Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence

The FDA has issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). McSweeney / Langevin is now providing legal advice to women and families affected by transvaginal mesh systems.

(PRWEB) November 30, 2012

The FDA issued a Public Health Notification and Additional Patient Safety Communication on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI.

Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.

In particular, the literature reviewed by the FDA revealed:

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 to the penis 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.

Women who suffered complications following implantation of transvaginal mesh systems may be entitled to compensation for medical bills, pain and suffering, and other injuries. McSweeney / Langevin is offering free claim evaluations to any women and families injured by a transvaginal mesh system. A McSweeney / Langevin attorney can be reached at 1-800-888-4425.


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