FDA May Reclassify Transvaginal Mesh as “High Risk” Class III Medical Device
January 6, 2012 — The U.S. Food and Drug Administration announced that it would be considering a recommendation to reclassify transvaginal mesh and surgical mesh as a “high-risk” medical device, elevating it from Class II to Class III. The FDA has also ordered manufacturers to complete postmarket studies. If you have suffered a serious complication caused by this product, you may have a transvaginal mesh lawsuit. Contact a lawyer at The Schmidt Firm, LLP — we can help you get the compensation you deserve.
A Class III device is considered “high-risk,” and the manufacturers must get approval from the FDA before they can reach the market. In addition, the manufacturers must provide the FDA with ongoing information about the safety and effectiveness of the product.
Currently, surgical mesh is exempt from pre-market and post-market safety studies under the FDA’s 501(k) program, which gives exceptions for products already on the market. Surgical mesh has been around since the 1950s to repair hernias, but has recently been adapted to treat urinary incontinence. This exemption has been criticized since the surgical mesh implants have resulted in so many injury reports. The manufacturers are facing an onslaught of transvaginal mesh lawsuits from injured women who are now seeking compensation for their injuries.
The FDA is concerned because of a growing number of adverse events, which include organ damage. They have ordered 88 post-market study orders to 33 manufacturers of surgical mesh. They have also ordered 11 post-market study orders to seven manufacturers of single-incision mini-slings.
Serious side effects include: Serious erosion of the mesh into the body, infection, chronic pain, incontinence, damage to nearby organs, and perforation of the bowel and bladder.
The FDA will base their decision on whether to reclassify the surgical mesh as Class III, high-risk medical device based on the following information:
- Adverse events reported to the FDA. If you have suffered an injury caused by transvaginal mesh or surgical mesh, the FDA asks that you report your problem so they can gather and review as much information as possible.
- Collaborate with professional societies to better understand the safety and effectiveness of these devices.
- Evaluating the post-market safety data that the manufacturers will conduct and provide to the FDA
Transvaginal mesh and surgical mesh are medical devices that are implanted in women to treat female incontinence. When a woman has “pelvic organ prolapse” (POP) the muscles in the lower abdomen weaken. 30-50% of women experience POP, with about 2% reporting symptoms. When the muscles in the vaginal wall weaken, internal organs may protrude. Surgical mesh treats this condition by permanently implanting a “sling” that may be synthetic or biologic, which reinforces the weakened muscles.
How do I contact a Lawyer for a Transvaginal Mesh Lawsuit?
The Schmidt Firm, LLP is currently accepting transvaginal mesh induced injury cases in all 50 states. If you or somebody you know has experienced a side effect after receiving a surgical mesh implant, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Transvaginal Mesh Lawsuit Group or call toll free 24 hours a day at (866) 920-0753.
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