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New warning issued on pelvic mesh from the FDA

January 6, 2016

As medical science continues to advance, manufacturers of medical devices are always developing new products and releasing them out on the market to patients in Pikeville. Before a device can be sold, it must go through a series of clinical trials which are intended to show their effectiveness as well as any potential harm that can arise. However, despite such requirements, thousands of people have claimed that they have caused injury.

One such device, referred to as vaginal mesh, is the subject of thousands of lawsuits. Plaintiffs claim that the mesh has caused problems such as infection, bleeding and pain. These problems often require additional surgery to take the mesh out or reposition it. As a result, the US Food and Drug Administration has received dozens of complaints over the past several years.

Now, the device, which was under a class II warning and was classified as a moderate-risk device by the FDA, has been upgraded recently to a high-risk device. With the new classification comes new and more stringent requirements that manufacturers must meet to prove that their product is safe to use and works correctly. Mesh can be used on patients with urinary incontinence, hernias or pelvic organ prolapse. The new warning however, only applies to mesh for the latter purpose, and also comes with the recommendation that people should discuss all treatment options with a surgeon before deciding to have the mesh inserted.

While medical devices are intended to improve the quality of a patient’s life, in some cases, the opposite occurs. This can leave people facing ongoing pain, additional surgeries, emotional trauma and permanent damage. In such matters, it may be beneficial for them to seek the advice of an experienced injury attorney.

Source: ABC News, “FDA labels pelvic mesh as “high-risk” medical device,” Jan. 4, 2016