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Panel Advises Not to Reclassify Transvaginal Mesh for SUI Repairs

Panel Advises Not to Reclassify Transvaginal Mesh for SUI Repairs

September 9, 2011, MedPage Today — While the public advisory committee recommended yesterday to reclassify transvaginal mesh used in pelvic organ prolapse repair, today the panel ruled not to reclassify transvaginal mesh products used in stress urinary incontinence repair. Yet, the panel is encouraging the need for additional clinical research on newer generations of the devices, including the most recent models of “mini-slings.”

Just one day after the committee recommended to reclassify transvaginal mesh devices used in pelvic organ prolapse (POP) repair from Class II to Class III products, the panel of non-FDA experts concluded today that transvaginal mesh used in stress urinary incontinence (SUI) repair should remain a Class II product, regulated under the 510(k) approval process. Under Class II 510(k) approval, most SUI transvaginal mesh products would not need to undergo premarket clinical trials before being released on the market.

On the other hand, panelists say they would like to see additional clinical research on any new mesh products — in particular, they would like to see additional information on “mini-sling” configurations of transvaginal mesh, which are a relatively new generation of surgical mesh. The panelists believe this additional data would be useful.

Panelists did not feel there needed to be any further data collected from other forms of transvaginal mesh for SUI repair because they believe there is already a sufficient amount.

The panelists arrived at their decision after hearing from FDA officials that a reclassification was not necessary. The FDA came to this conclusion after acknowledging that there was about 15-years worth of safety and effectiveness data available on mesh used for SUI repair. The data includes over 1,371 adverse event reports and 260 studies, which the FDA reviewed before reporting its findings.

However, mini-slings are a different story.

Since they are the newest device on the market, the panel believes the FDA does not have adequate data to fully understand the safety and effectiveness of mini-slings. Instead, the panel is pushing for premarket clinical study on new mini-slings that may be introduced in the future. Additionally, the panel would like postmarket review of mini-slings already on the market.

Of the evidence reviewed by the FDA, there were adverse event reports of 1,131 injuries, 236 malfunctions and three deaths. Two of the deaths were associated with bowel perforation directly related to mesh placement procedures, but unrelated to the mesh itself. The third was a complication from a mesh removal procedure.

In the adverse events, pain was the most reported complication, followed by erosion, infection, urinary problems and organ perforation. Other complications included recurrence, bleeding, dyspareunia and vaginal scarring.

After reviewing over 260 studies, the FDA found reports of similar complications. Additionally, they found between 9% and 17% of women who had surgical mesh repairs of SUI reported urinary problems between 6 and 60 months after surgery. This rate varied, depending on the type of procedure involved.

Nonetheless, the FDA did not believe these cases were serious enough to warrant transvaginal mesh reclassification from Class II to Class III for SUI repairs. Based upon the FDA’s review of the data, the panel is likewise not recommending a reclassification.

Like yesterday, the panel did not take a formal vote about the reclassification of SUI repair transvaginal mesh, but the majority of the panelists said they supported a continuation of a Class II label.

In total, the FDA has approved 78 mesh devices for SUI repair since the 1990s, under the 510(k) process. Only seven of these were mini-slings.

Friday’s discussion ended the two day debate regarding the safety and effectiveness of transvaginally-placed mesh as a form of POP and SUI repair.

While the FDA does not have to follow the recommendation of the panel, it usually does.

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