FDA May Reclassify Transvaginal Mesh as “High Risk”

January 6, 2012 — The Food and Drug Administration (FDA) may reclassify transvaginal mesh as “high-risk” and is now requiring manufacturers of the products conduct safety reviews. The agency will be considering elevating the risk from Class II to Class III, which would require ongoing safety studies. Do you have a transvaginal mesh lawsuit in Texas? A lawyer at The Clark Firm, LLP can help you get the compensation you deserve for your injuries.

Elevating a medical device from Class II to Class III would force the manufactures of the product to conduct pre-market and continuous post-market safety studies. Currently, transvaginal mesh and new surgical mesh products do not need to be studied before they reach the U.S. market, in an 501(k) exemption program that provides a loophole to the FDA-approval process. Surgical mesh has been used since the 1950s to repair hernias. The medical technology has evolved to treat female incontinence.

Unfortunately, using surgical mesh to treat female incontinence comes with more complications than hernia treatment. Many women who have suffered complications are now filing a transvaginal mesh lawsuit in Texas, seeking compensation for their injuries.

Complications include erosion of flesh around the mesh, life-threatening infection, chronic pain during intercourse, vaginal pain, incontinence, damage to internal organs, and protrusion of the mesh into the bowels or bladder.

Since the FDA has received so many injury reports, it has decided to order the manufacturers to conduct new safety studies. The agency issued 33 surgical mesh manufacturers to conduct 88 post-market safety studies. They also required that 7 manufacturers of single-incision mini-slings conduct 11 post-market studies.

When these studies are completed, the FDA will decide whether to change the classification of transvaginal mesh from Class II to Class III. If the medical products are reclassified, manufacturers would be required to continually monitor the safety, complications, and effectiveness of their products.

In the meantime, the FDA continues to ask consumers to report their injuries so they can gather and review as much information as possible.

Transvaginal mesh is a type of surgical mesh that is used to treat incontinence in women caused by weakened abdominal muscles. In a condition known as “pelvic organ prolapse,” the muscles in the lower abdomen weaken, and internal organs protrude into the vagina. During transvaginal mesh surgery, a surgeon uses the device to reinforce the vaginal wall. Some types of female incontinence can also be treated by implanting a “sling” made out of synthetic or biological materials.

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