Injured Women Sue Johnson & Johnson Over Vaginal Mesh Product

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Transvaginal Mesh for POP – Safety Questionable?

In the past, pelvic organ prolapse was often treated by hysterectomy -- removing the uterus -- and putting in sutures to add support and prevent further prolapse.

Surgical mesh treatments were developed over the past decade in part to avoid having to perform a hysterectomy on women with pelvic organ prolapse. Some studies had also suggested that the suture procedure had a high failure rate.

While surgical mesh has been used safely to treat hernias or urinary incontinence for decades, 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.

According to the FDA, about 75,000 patients were treated for pelvic organ prolapse using transvaginal surgical mesh. The most common problem with the mesh is that it can begin to erode within months of being implanted and pieces of the mesh may dip down into the vaginal canal.

In a review issued by FDA staff reviewers before Thursday's meeting, reviewers 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.

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 who has removed a number of the devices from patients experiencing adverse effects, told ABCnews.com.

"The arms pass through several structures in the pelvis. They can be put in overly taut and pull on the groin muscles, causing pain," he says. Other complications may be attributed to the several incisions that are made in the vagina to insert the mesh and its several 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.

"Though the adverse reactions can be severe in some cases, we have no idea if these strong reactions represent one percent or just a fraction of a percent, or more than that, of all the users. We need more data," he said.

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