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Entries in prolopse (1)

Friday
Sep092011

Vaginal Mesh Product Under Scrutiny 

Jupiterimages/Thinkstock(WASHINGTON) - Surgical mesh treatments were developed over the past decade in part to avoid having to perform a hysterectomy on women with pelvic organ prolapse.

While surgical mesh has been used safely to treat hernias or urinary incontinence, the use of a mesh device, such as Prolift, which has several "arms" that spread out and attach at several places in the pelvis, is only a few years old.

However,  between 2008 and 2010, the FDA received 1,503 reports of injury, malfunction or death associated with the surgery. These reports represented a five-fold increase compared to a few years -- a spike that led the agency to issue warnings about these products last July.

In a review issued by FDA staff reviewers, they found that erosion occurred in 35 percent of all adverse events associated with mesh used in treating pelvic organ prolapse. Pain was reported 31 percent of the time; infection, 16 percent; and bleeding, 8 percent.

Now the FDA is considering pulling the product from the market, pending further safety data, and convened a two-day meeting of the Obstetrics and Gynecology Devices Panel Thursday to review the safety of using transvaginal mesh to treat pelvic organ prolapse.

But while erosion is a commonly reported problem, the high rate of adverse effects seen with the Prolift and similar products may have to do with the "arms" of the device, not the mesh itself, Dr. Emanuel Trabuco, a Mayo Clinic surgeon told ABC. He said that other complications may also be attributed to the several incisions that are necessary to insert the mesh and its arms.

The preliminary review presented at the hearing this week urged that surgical mesh devices for pelvic organ prolapse be reclassified and put through the standard safety regulations, but Trabuco said an all-out ban on these products should be avoided.

Echoing the comments made by the American Urogynecological Society, he said that more stringent use of the products and more safety data is necessary, but not an all-out ban.

Copyright 2011 ABC News Radio







ABC News Radio