FDA issues a new plan for vaginal mesh

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The Food and Drug Administration has proposed stricter classifications on surgically implanted vaginal mesh devices. The new classification would place pelvic mesh devices in the “high risk” classification, moving it up from the “moderate risk” category. The more restrictive classification would require makers of the devices to submit clinical data to the FDA regarding the newly manufactured devices safety before approval is given.
Pelvic mesh devices have been widely used since the 1990s to treat to treat pelvic organ prolapse. Pelvic organ prolapse is a condition in which either the bladder or the reproductive organs slip and fall down into the vagina, sometime causing them to protrude outward. The devices have been under fire in recent years following a slew of personal injury lawsuits, with at least 22,000 filed against the leading manufacture, Johnson & Johnson.
The call for change of classification began when an analysis by the FDA found that 10 percent of women who had mesh implants experienced mesh erosion within the first 12 months. Mesh erosion occurs when the implanted mesh wears its way through the vaginal wall and into the surrounding tissue or organs. More than half of women who experienced mesh erosion required additional follow up surgeries.
The FDA’s leading device scientist stated: “The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products.” The new mesh classification will only apply to pelvic mesh used to treat pelvic organ prolapse, and not for hernias, urinary incontinence or other ailments.
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