The Food and Drug Administration (FDA) met with medical device manufacturers, representatives of the medical community and health advocate groups today to discuss possible regulation regarding surgical mesh used to treat a pelvic organ prolapse. Surgical mesh is a medical device that has been linked with serious medical complications in some patients.
The recommendation of those at the meeting was to re-classify surgical mesh for pelvic organ prolapse surgery as a class III medical device. A class III device designation means that that the device needs premarket approval to evaluate the device’s safety. Premarket approval is a much stricter process than the premarket notification process known as 510(k).
Through the current 510(k) process, manufacturers of medical devices only need to show that their product is equivalent to a device already on the market.
The FDA has received at least 2,000 reports of complications suffered by patients who had surgical mesh implanted trans-vaginally since 2008. In recent months, there have been reportedly 500 product liability lawsuits filed against manufacturers.
Complications associated with the surgical mesh include pelvic pain, incontinence, painful intercourse and infection. Another complication is the fact that the surgical mesh erodes or wears away the tissues surrounding the implant. Some patients have required multiple surgeries.
The Farber Law Group, a product liability law firm located in the Seattle area, represents patients with serious personal injuries due to defective and dangerous medical devices. With our help, you may recover compensation for your damages.
FDA warns about the risk of using mesh in Pelvic Organ Prolapse surgery
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