Transvaginal mesh is a surgically implanted device designed to help with problems of organ prolapse (or “falling out”) and bladder incontinence. This mesh is a synthetic material which acts as a reinforcing sling around the intended organs. Such mesh has been used with some success in other surgeries, but has proven especially problematic in the female pelvic region due to the increased number of organs involved, the very small area, and possibility of erosion from movement. According to the American Association for Justice, in 2010, approximately 300,000 transvaginal mesh devices were implanted in American women.
Surgeries involving transvaginal mesh have proven the risk for disastrous consequences. Some side effects include organ perforation, extreme pain, infection, bleeding, urinary problems, mesh contraction and mesh erosion through the vagina. After such complications ensue, multiple surgeries are often required to remove the device and reconstruct any damage it caused. A patient may suffer for years after their original surgery from debilitating pain and discomfort.
If transvaginal mesh is such a problem, why is it on the market? The answer lies in the FDA’s 501(k) approval process. If a device is considered low to moderate risk or if it can prove it is sufficiently similar to another device that has already gained approval, then there are very few requirements necessary to begin marketing and selling a product. Most transvaginal mesh devices have been approved in this manner, meaning they did not have to prove rigorous clinical testing to the FDA before they began selling the devices. In fact, very few studies have even been conducted that aim to assess the safety of transvaginal mesh. However, those studies that have been conducted provide conclusive evidence that transvaginal mesh is neither safer nor more beneficial than traditional methods of surgery. Transvaginal mesh devices were approved because they are similar to the forms of mesh used in other surgeries without consideration of the fact that they are intended to be used in a totally different procedure. The FDA has since recognized the extreme risks involved and issued a statement recognizing that serious complications are not rare in these procedures.
Many lawsuits have already been filed against transvaginal mesh manufacturers. Most patients are horrified to find that the procedures they have undergone with the assumption that they are safe have, in fact, been approved without sufficient attention to safety. Widespread concern and litigation has prompted Johnson & Johnson to remove their transvaginal mesh device from the market. However, there are other manufacturers producing these devices. Every patient deserves assurance that their intended surgery is safe and effective. It should be the responsibility of the medical community and the FDA to ensure the safety of U.S. consumers of medical devices.
At Borchardt Law Firm, we wish for no family to ever experience incapacitating tragedies due to defective medical devices. Our firm has the experience and the drive necessary to continue to strive for the improved protection of future generations of Texans. If you or a loved one have ever suffered from a related misfortune and feel you were not properly warned about the potential risks, don’t hesitate to contact a lawyer to discuss any legal compensation you might be entitled to. Borchardt Law Firm represent clients over many areas in Texas; feel free to give us a call.
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