Group Urges Women to Avoid Surgery with Transvaginal Mesh

The consumer advocacy group Public Citizen is warning women not to allow doctors to use <"">transvaginal mesh should they need to undergo pelvic organ prolapse (POP) surgery. The advice is proffered in the groups’ latest issue of Worst Pills, Best Pills News, which usually doesn’t cover medical devices. However, Public Citizen was apparently so concerned about the serious complications associated with transvaginal mesh that it chose to make an exception.

The Public Citizen caution comes less than two weeks after the U.S. Food & Drug Administration warned that transvaginal mesh products have been associated with serious and painful complications, especially when used in POP repair. According to the agency, it has received more than 2,800 complaints about transvaginal mesh complications since it last issued a warning in 2008. In three of those cases, women died.

In its latest alert, the FDA emphasized that complications from this procedure are NOT rare – a change from the position it took in 2008. The agency also it was not clear that POP repair involving transvaginal mesh was better than traditional non-mesh procedures, and may actually expose patients to greater risk of complications.

The FDA also received more than 1,300 more reports of complications when the mesh was used in stress urinary incontinence (SUI) surgery, which did not represent as sharp of an increase as what was seen in POP repair. The FDA is still studying that issue, and will make recommendations about the use of transvaginal mesh in SUI surgery at a later date.

In Worst Pills, Best Pills News, Public Citizen issued the following warning

“Do not undergo surgery for POP if it involves transvaginal placement of surgical mesh because it commonly results in many serious and potentially life-threatening complications. If you have had surgery with implantation of surgical mesh for POP or SUI, you should monitor yourself for symptoms of these serious complications, as discussed below.”

According to the group, the most common transvaginal mesh complications include erosion of the mesh through the vaginal wall (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during intercourse (dyspareunia), organ perforation and urinary problems. Other reported complications include recurrent prolapse, neuromuscular injury, vaginal scarring/shrinkage, emotional problems and death. Treatment of these problems can require multiple surgeries and may result in permanent debilitating pain and other symptoms, even after the mesh is removed, Public Citizen said.

The group advises that women suffering from POP choose to undergo surgery without mesh or consider nonsurgical options, such as pelvic-floor muscle exercises or vaginal inserts, called pessaries, to support the prolapsing tissue. Those who have already been implanted with transvaginal mesh should continue with medical care and follow-up. This includes alerting their healthcare providers of any symptoms that could point to a transvaginal mesh complication, such as persistent vaginal bleeding or discharge, pelvic or groin pain or pain during sex. Women in this situation must also make sure they inform their healthcare provider that they received the implant before undergoing any other surgical procedures.

Transvaginal mesh products are marketed by several companies, including <"">American Medical Systems (AMS), C.R. Bard and Mentor. Over the past several years, AMS, C.R. Bard and Mentor have all been named in lawsuits filed by women who claim to have been injured as a result of transvaginal mesh complications.

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