Transvaginal Mesh Trials Underway in Courts Across U.S.Jan 31, 2013
Bellwether trials involving victims of defective transvaginal mesh products are now underway and the results should impact thousands of women this year.
The first trial involves the defective Gynecare Prolift System, manufactured by Ethicon, a division of pharmaceutical giant Johnson & Johnson. Proceedings got underway earlier in January in a state court where at least 1,800 other similar lawsuits have been filed.
Victims of this device believe that it is defective and not a suitable treatment for either pelvic organ prolapse or stress urinary incontinence, the two conditions it has been federally approved to treat. Not only are victims who’ve filed lawsuits out to prove that this device is defective but also that Ethicon knowingly hid evidence that its device was dangerous and likely to cause women serious and permanent injuries.
In early February, the first trial in a federal Multidistrict Litigation against the C.R. Bard Avaulta device will commence. Claims against the Avaulta device mirror those leveled against the Gynecare Prolift.
The results of these trials will likely impact the fate of the thousands more lawsuits already filed against manufacturers of transvaginal mesh devices and could spur more action against women who’ve been implanted with one of these devices.
Many who’ve suffered serious injuries because of a transvaginal mesh like the Gynecare Prolift device say they’ve been forced to endure numerous revision surgeries that attempt to either correct the device or remove it. Transvaginal mesh devices are prone to erosion through the vaginal tissue, extrusion of the mesh device, recurrent pelvic organ prolapse, urinary problems,vaginal bleeding and pain, and scarring. Some of these injuries can be life-altering, causing women to be unable to sit or stand in one place for any length of time due to severe pain. Some of these problems do not subside even after the device has been removed.
Transvaginal mesh devices were largely approved through the Food and Drug Administration’s flawed 510(k) “fast-track” approval system that grants clearance to the market based on the fact that a device mirrors the design of a previously approved device. This system requires much less or no pre-market safety testing.
Trials involving victims of these devices, including the Gynecare Prolift and Avaulta devices will aim to prove that not only are they defective but that their makers were aware of their faults but continued to market them as safe and effective.
These claims were finally stifled by the Food and Drug Administration, which recently determined and warned that injuries caused by transvaginal mesh devices were “not rare.” The agency also ordered more than 30 manufacturers of transvaginal mesh devices to conduct post-market safety testing on these devices to prove they’re safe and effective in the treatment of pelvic organ prolapse and stress urinary incontinence.
Since that order, some companies have removed their devices from the market, though they haven’t cited flaws or defects as the reason for doing so. This includes the Gynecare Prolift, which Ethicon stopped marketing last year.