FDA: Serious Complications Associated With Surgical Mesh for Transvaginal Repair of POP are Not Rare

The U.S. Food and Drug Administration has issued an update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse (POP), indicating these complications are not rare, according to a report from the FDA and AORN.

 

In addition, the update states it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP, and it actually may expose patients to greater risk.

 

This is a change from what the FDA previously indicated in Oct. 2008.

 

The FDA also indicated it is evaluating the effects of using surgical mesh to repair stress urinary incontinence.

 

Medical specialties impacted by this update include gynecology, urogynecology, urology, general surgery, internal medicine, family practice and emergency medicine.

 

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Read the AORN report about this update and read the FDA report to learn updated recommendations for providers regarding surgical mesh for the transvaginal repair of POP.

 

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