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Vaginal Mesh Lawsuits Lead To Proposed FDA Changes

There are currently an estimated 50,000 pending federal vaginal mesh-related product liability lawsuits and thousands of pending state lawsuits. These pending lawsuits are in addition to the thousands of lawsuits that have been resolved over the last few years. Due to the large and increasing number of reported complications and lawsuits, the Food and Drug Administration (FDA) recently proposed a reclassification of vaginal mesh devices.

Mesh-Related Claims

There were around 300,000 vaginal mesh devices implanted to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) in 2010 alone. While the majority of the women implanted with the devices do not suffer complications, some reports suggest that nearly 10% of women implanted to treat SUI have suffered various complications. Some of the complications claimed in vaginal mesh lawsuits include bleeding, pelvic pain, organ perforation, infection, painful intercourse, and device erosion.

In a number of cases, the complications required multiple corrective surgeries and removal of the implant. For instance, in Linda Gross’ mesh liability claim, she claimed she required 22 surgeries to correct complications and to remove the device and doctors were still unable to remove the device completely. Mesh-related lawsuits focus on compensation for the complications, but are based on the claim that the manufacturers made and sold products that were defective and unsafe and are liable for the injuries the devices caused.

FDA Actions

In 2008, after receiving over 1,000 incident reports in three years, the FDA issued a warning to healthcare providers about serious vaginal mesh-related complications. The warning also provided suggestions for reducing the risk of these complications. Yet despite the warning and suggestions, in 2011 the FDA found that complications related to mesh implants continued and were not rare. In 2012 the FDA ordered post-market safety studies from mesh device manufacturers. The mesh device manufacturers were also ordered to monitor the rate of reported implant-related complications. Now the FDA is in the process of reclassifying many of the mesh devices involved in the growing number of mesh-related liability lawsuits. The reclassification will make the mesh devices high risk class III devices.

Currently FDA regulations and the current mesh device classification only requires mesh device manufacturers to provide evidence that there is a similar device currently on the market before they introduce a new mesh product. This means mesh manufacturers do not have to provide proof of the safety and efficacy of their devices prior to putting them on the market for the public to use. The FDA’s proposed reclassification would require manufacturers to provide actual proof that the device is safe. This proof includes pre-release clinical trials, facility inspections, and additional post-market safety studies.

If you or someone you know has an implanted vaginal mesh device and believe you have suffered injuries related to the mesh device, you may be entitled to compensation. As a consumer you have the right to safe, effective devices. Contact your doctor about your symptoms and then contact our knowledgeable attorney to discuss your claim at no cost. Or complete our Free Vaginal Mesh Case Review form and our top-rated legal team will evaluate your claim. These lawsuits are time sensitive; it is important you contact us as soon as possible.  

Lawrence J. Buckfire
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