Animals’ Urinary Success Led to Bladder Sling Implant Failures
By John Curran
When the FDA first started receiving warnings about transvaginal mesh implant failures, it slowly processed them the same way it does with all medical devices. However, by 2011, the FDA issued warnings about erosion in these devices, a scant 15 years after they first approved the device. One of the major problems with the process by the federal agency is the sped-up approval process for demonstrably similar devices.
It is unclear whether or not vaginal mesh implant failures were a result of missed opportunities. However, the FDA has often allowed companies to run clinical tests on animals rather than with humans and not submit many other forms. This was the case with metal on metal hip implants, where newer products were approved based on earlier devices that should have been recalled. What’s worse for many women who face the risk of bladder sling implant failures is that the FDA does not even recommend them.
More than a year ago, the deputy FDA director for medical devices noted that using mesh-based devices offered no greater rate of success than those of other surgical options, and revision surgeries to completely remove the mesh is impossible. So it is unclear why the FDA continued to allow the product on the market when there were nearly 3,000 adverse event reports of transvaginal mesh implant failures, or roughly four percent of all patients.
Even if the rate is low enough for the FDA to not care, women need to be aware that the number of reports are growing. In fact, the number of revision surgeries to repair the damage from bladder sling implant failures has doubled, from two to four procedures. As mentioned, that does not even guarantee that the problem will be completely fixed.
Have you or has someone you know dealt with these conditions? Legal help may be able to offset the medical bills of frequent surgeries as well as treatment for ongoing pain and sexual difficulties. Get in touch with an experienced vaginal mesh implant failure lawsuit lawyer now. It’s as easy as filling out the short form at the Transvaginal Mesh, Vaginal Sling, Vaginal Mesh and Bladder Sling Class Action Lawsuit Investigation for a free legal consultation. Regardless of the manufacturer, most of these devices have the same faults, but having medical records available is important. So, too, is contacting one of our partner vaginal mesh implant failure lawsuit lawyers today.
Updated November 26th, 2012
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