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FDA Proposes to Reclassify Surgical Mesh for Pelvic Organ Prolapse as High-Risk Device — Physician’s First Watch

Medical News |
April 30, 2014

FDA Proposes to Reclassify Surgical Mesh for Pelvic Organ Prolapse as High-Risk Device

By the Editors

Surgical mesh used for the transvaginal repair of pelvic organ prolapse should be reclassified from a moderate-risk device to a high-risk one, according to a proposal released Tuesday by the FDA.

The most commonly reported complications associated with the mesh include mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems.

The FDA also proposed that manufacturers of mesh devices be required to submit a premarket approval application for the agency to evaluate safety and effectiveness.

Reader Comments (1)

Pino González Maria del Carmen Physician, Infectious Disease, Hospital UniversitarioClínicoQuirúrgicoMauel Fajardo

Is very important to know about pelvic organ prolapse ,what we can do ?Surgical condition?

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