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Reclassifies Vaginal Mesh Products as “High-Risk” Device

The United States Food & Drug Administration (FDA) recently announced an order that reclassifies surgical mesh for transvaginal repair of pelvic organ prolapse (POP) as a high-risk device. In doing so, the FDA provided manufacturers of the product 30 months to demonstrate that their products are safe and effective.

Previously, the FDA had issued warnings about the risk of severe pelvic pain, infection, urinary problems, and pain during intercourse associated with the use of the mesh. Recently, manufacturers have confronted a rash of litigation surrounding these products as more and more individuals are injured. Surgical mesh has been used by surgeons for decades, but only relatively recently for the purpose of transvaginal repair of pelvic organ prolapse. Despite efforts of the federal government to warn both patients and surgeons about the risks associated with the use of surgical mesh for transvaginal POP repair, individuals still remain unaware of the high danger they pose.

According to the FDA’s press release, “POP occurs when the muscles and tissue of the pelvic floor become stretched, torn or weakened and can no longer support pelvic organs such as the bladder, bowel or uterus; as a result, the organs drop from their normal position and bulge (prolapse) into the vagina.” In performing surgery to repair this condition, surgeons may permanently implant surgical mesh to reinforce the pelvic floor muscles. Unfortunately, thousands of instances of complications and injury have been reported as a result of this procedure. These injuries include: infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There have also been reports of bladder and bowel perforation during the surgical procedure. Those affected by the mesh often report a high and constant level of pain that causes a profoundly negative impact in the quality of their everyday life. At last, the federal government has recognized the high and unreasonable risk that these devices pose to patients.

The attorneys at Swartz & Lynch have decades of experience in litigating cases concerning unreasonably dangerous products that harm individuals. If you have been injured because of a defective product or because of the negligence of another, do not hesitate to contact us. You may be entitled to compensation for your injuries.

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