Fda Does Not Recommend The Use Of Vaginal Mesh Implants

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The United States Food and Drug Administration cautions that vaginal mesh surgery may do more harm than good even if it provides some relief for women who have experienced pelvic organ prolapse after surgery or childbirth.

Pelvic organ prolapse, or POP, occurs when the pelvic organs- most commonly the bladder, but also includes the uterus, vagina, small bowel or rectum- slip out of place and press against the vagina, causing pain and discomfort.

When the muscles and ligaments holding these organs in place are weakened or stretched, this occurs.. Most often this occurs during childbirth or after surgery like a hysterectomy.

As one form of organ prolapse treatment, a vaginal mesh allows physicians to repair those weakened tissues.. Implants are inserted to reinforce the vaginal wall. The implant is used to support the urethra to prevent urine leakage, also.. According to MedPage Today, a news service for physicians, approximately 100,000 mesh implants were implanted in the U.S. in the year 2010.

However, the FDA strongly discourages the use of vaginal mesh due to the high risk of complications. In a report released in early August, the agency says they have received more than 1,000 manufacturer complaints about the device.

In its report, the FDA says, "Serious complications associated with surgical mesh for transvaginal repair of POP are not rare. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients [...] and it may expose patients to greater risk."

The FDA reported that the most common complaint was "mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems."

According to several mesh manufacturers, approximately 100,000 have been treated for pelvic organ prolapse with vaginal mesh implants, and of those, 75,000 of those were implanted vaginally.

After the FDA saw an increase in manufacturer complaints between 2003 and 2007, they warned doctors about the potential risks of vaginal mesh.. The agency recommended that physicians receive specialized training on correct implantation techniques and suggested warning patients of potential complications the agency identified as serious but rare.

As long as manufacturers can show that a device is "substantially similar" to others like it on the market, medical devices can pass the formal clinical trial period that drugs must pass.. Vaginal mesh implants were approved in 1998 to treat incontinence and in 2002 to treat pelvic organ prolapse..

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To learn more about vaginal mesh and to find out more information about filing a potential vaginal mesh lawsuit, please visit LegalView, a leading online legal resource.



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