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FDA: Women at Risk of Serious Vaginal Mesh Complications

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Seattle, WAWomen who had Avaulta mesh or other vaginal meshes implanted to treat Pelvic Organ Prolapse or Stress Urinary Incontinence may have been put at risk of serious vaginal mesh side effects. Reported Avaulta side effects, similar to other vaginal mesh side effects, reportedly include a risk of erosion of the mesh, infection and urinary problems. Lawsuits have been filed against the makers of various vaginal mesh products, alleging patients were not adequately warned about the risks associated with use of the products.

Concerns about the use of vaginal mesh, including the use of Avaulta mesh, were recently raised when a doctor, Anne Weber, wrote to the American Journal of Obstetrics & Gynecology (11/29/10) with her criticisms of the mesh.

Weber writes, "Sufficient data do not yet exist regarding the use of vaginal mesh in procedures for pelvic organ prolapse. In the absence of these data, obtaining truly informed consent itself is impossible. Therefore, the use of vaginal mesh for prolapse should be treated as experimental, and patients should provide consent on that basis."

By classifying the use of vaginal mesh as experimental, Weber is essentially arguing that there is not enough published medical evidence regarding the risks, benefits and safety of vaginal mesh to consider its use "established medical practice." She goes on to argue that although surgeons and some patients may be aware of the general risks associated with mesh placement, it is not yet known what the true consequences of complications associated with vaginal mesh are, making it impossible to balance the risks against the benefits.

"In conclusion, obtaining informed consent from patients for vaginal mesh placement during prolapse surgery cannot be achieved in light of the current dearth of data regarding risks and benefits," Weber writes.

In October 2008, the US Food and Drug Administration (FDA) issued a warning about the use of vaginal mesh to treat Pelvic Organ Prolapse and Stress Urinary Incontinence. According to the warning, between 2005 and 2008, the FDA received more than 1,000 reports of complications involving nine surgical mesh manufacturers. Complications included erosion through the vaginal epithelium, infection, pain, recurrence of prolapse and urinary problems. "In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia," the FDA wrote.

As a result of these complications, lawsuits have been filed against the makers of various vaginal mesh products, alleging patients were not adequately warned about the risks associated with the use of those products.

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