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In a new development in the ongoing controversy regarding the use of transvaginal mesh, the American Urogynecologic Society (AUGS) has released a position statement against bans of surgical options such as mesh.
"The American Urogynecologic Society strongly opposes any restrictions by state or local medical organizations, healthcare systems, or insurance companies which ban currently available surgical options performed by qualified and credentialed surgeons on appropriately informed patients with pelvic floor disorders," the statement reads.
In a letter to AUGS members regarding the position statement, AUGS President Anthony G. Visco, MD, explained that in recent months a state medical organization, a healthcare system, and a malpractice insurance company have considered restricting or have banned the use of transvaginal mesh for prolapse.
"A ban on mesh would have a chilling effect on research in this area and would severely limit the advancement of science and future innovations that could significantly help women,” Visco said in the letter. “We recommend preserving all surgical options, including transvaginal mesh for pelvic organ prolapse, adopting recently published credentialing guidelines, standardizing the informed consent process, and establishing a robust mechanism to track both surgeons and products being implanted to fully assess safety and efficacy."
AUGS provided several justifications for the position statement, including:
• A complete restriction on the use of surgical mesh was not the stated intent of the July 2011 US Food and Drug Administration (FDA) safety communication regarding mesh.
• The decision on surgical alternatives should be made by the patient and her surgeon.
• A ban on surgical mesh would prohibit the surgical studies mandated by the FDA and recommended by the National Institutes of Health, the American College of Obstetricians and Gynecologists, and AUGS.
• In some circumstances, transvaginal mesh for pelvic organ prolapse may be the most appropriate surgical option.
• Any restriction of mesh slings for the treatment of stress urinary incontinence is clearly not supported by any professional organization or the FDA.
• Any restriction of mesh placed abdominally for the treatment of prolapse is clearly not supported by any professional organization or the FDA.
• Instead of a ban on mesh, AUGS recommends the implementation of credentialing guidelines so that mesh procedures are performed by qualified surgeons.
"It is imperative that local hospitals and health systems establish and strictly enforce robust processes to both credential and audit surgeons with specific expertise, experience, training, and skill to perform these procedures," AUGS said in the position statement.
Visco AG. AUGS position statement on the restriction of surgical options for pelvic floor disorders. http://www.augs.org/p/bl/et/blogid=6&blogaid=160. Published March 26, 2013. Accessed April 9, 2013.