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FDA calls for stricter safety guidelines, pre-market approval for transvaginal mesh for incontinence

Stricter safety requirements may be required for the manufacturing of transvaginal mesh under a Food and Drug Administration (FDA) proposal. The surgical mesh used to treat common pelvic floor disorders in women should be reclassified as “high risk,” the agency said in response to mounting reports of complications from the device. Transvaginal mesh, also known as vaginal mesh or a bladder sling, is used to treat pelvic organ prolapse and stress urinary incontinence. It is inserted through the vagina to hold up organs that have dropped causing symptoms such as discomfort and incontinence. The mesh was widely used in women ... Read More