FDA’s Propose Tracking System Could Reduce Vaginal Mesh Complications

The FDA has proposed a new regulation that would require all new medical devices to carry a unique device identifier (UDI). The UDI would be a code of letters and numbers. Such a code would make it much easier to track devices, which in turn would make it much easier to report complications with a particular model or to find out about such problems.

According to the FDA, “A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety.”

For example, if such a tracking system were in place, a doctor who had a patient with stress urinary incontinence (SUI) or pelvic organ prolapse (POP) and wanted to implant a vaginal mesh device could look up the different models by the UDI and immediately see what transvaginal mesh complications, if any, had been reported with each specific model. Likewise, in the event of a recall, a UDI would make the process much more efficient: the company or the FDA would simply announce that the model carrying a particular UDI number was being recalled.

The FDA’s proposal was a response to legislation passed by Congress in 2007 that directed the FDA to develop regulations establishing a unique device identification system for medical devices.

Many women have suffered transvaginal mesh complications

Such a system might enable future patients to avoid problems resulting from transvaginal mesh. Many women have suffered such complications, including pain, infections, mesh erosion, protrusion, vaginal scarring, dyspareunia, and perforation of the bowels, bladder, or blood vessels. Many of these devices were approved under the FDA’s controversial 510(k) approval process, which allows products to be approved without first undergoing clinical trials to prove they are safe.

If the physicians treating these women had been able to easily look up the type of vaginal mesh device they were considering implanting, and immediately see reports of problems associated with the device, they would have been able to weight the risks and make an informed decision about whether to implant that particular device.

Vaginal mesh MDL consolidated lawsuits

Many women who have suffered complications have filed vaginal mesh lawsuits in order to get compensation for their pain, suffering, and reduced quality of life. Most of these lawsuits charge that the manufacturers of these devices did not test them for safety before putting the on the market and failed to warn the public of the devices’ risks. A number of federal lawsuits have been consolidated in a vaginal mesh MDL in West Virginia.

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