J & J–Led Vaginal Mesh Group Says FDA Should Require More Studies, Bloomberg, Sept 8, 2011
This article in Business Week (here) reports that medical device makers attending a September 8 & 9 panel of experts convened by the Food and Drug Administration (FDA) over the use of synthetic mesh in women with pelvic and incontinence problems agreed on the need for more safety studies, however they proposed new versions of mesh require clinical trials, not those currently on the market.
Studies Not Required
At the present time, the FDA does not require any science that assures safety and efficacy before a manufacturer can market the medical device. The move is an industry concession following last month’s recommendation from FDA staff that mesh be reclassified as high risk (Class III) and face even more regulatory controls. Manufacturers don’t want reclassification because of the cost burden, plant inspections and a longer time to bring a product to market, but reclassification would give the FDA greater control over clinical trials to determine whether the benefit outweighs the risk.
Mesh could also continue to be sold with some additional safety studies required or changing the label.
Mesh Injured Patients Testify
Most of the mesh injured women and men who testified at the hearing did not know what kind of mesh they had implanted and some only found out after their surgery that they had mesh at all, violating the principle of informed consent.
While an Ethicon director said adverse events are very low, the exact number is not known because the FDA adverse event database is largely unknown, difficult to maneuver, and thought to represent just a fraction of the injuries out there.
Bloomberg report a more than 75,000 women received vaginally-implanted petroleum based mesh last year to repair weak pelvic muscles. At least an equal number receive the same mesh material for urinary incontinence.
At the present time, patients who claim they were injured by synthetic mesh have filed almost 500 lawsuits against J & J and C. R. Bard.