Transvaginal mesh patch is a medical device that is implanted across the vaginal wall in order to provide support to the surrounding tissue and organs. The medical device is most commonly used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Transvaginal mesh has been manufactured by Boston Scientific, C.R. Bard, Johnson & Johnson, and other manufacturers. As of October 20, 2008, the Food and Drug Administration (FDA) has received over 1,000 reports that transvaginal mesh has caused unfavorable side effects.
These side effects include urinary complications, perforation, infection, and recurrence of POP or SUI. Additionally, three deaths have been linked to the medical device. Widespread and serious complications from the device have caused the FDA to issue 522 orders regarding the product. Specifically, the FDA has called for manufacturers of transvaginal mesh to conduct further medical studies. Johnson & Johnson has stopped marketing the device and has voluntarily recalled it. Drug and medical device manufacturers have a duty to provide reasonable warnings and instructions for their products. Here, transvaginal mesh manufacturers were unable to provide these reasonable warnings because the device was inadequately tested. The device was approved by the FDA under its 510(k) process, which only requires manufacturers to show the product is substantially similar to a previously approved product.
Transvaginal Mesh Patch Lawsuits
In California, the first jury verdict for a patient who received the transvaginal mesh patch was returned. The jury awarded Christine Scott $5 million and her husband $500,000 for injuries caused by Avaulta Mesh manufactured by C.R. Bard. In Texas, a woman filed a lawsuit after receiving the Johnson & Johnson Gynecare Prolift. The transvaginal mesh caused the woman to suffer from incontinence, bleeding, dyspareunia, extrusion and significant mental and physical pain and suffering. It has been reported that thousands transvaginal mesh lawsuits have been filed. Boston Scientific has been named in about 2,500 transvaginal mesh lawsuits for its Pinnacle Posterior Pelvic Floor Repair Kit and other similar transvaginal mesh products.
Do You Have A Transvaginal Mesh Patch Claim?
If you believe that you or one of your loved ones have been injured by transvaginal mesh patch, you may want to speak with a personal injury lawyer regarding a medical device claim. A transvaginal mesh lawyer familiar with new developments in the investigation of the transvaginal mesh medical device may be able to help you make important personal and legal decisions. d’Oliveira & Associates is working with some of the leading medical device lawyers and defective device lawyers in the country who are handling these cases.
Please contact the law offices of d’Oliveira & Associates at 1-800-992-6878 or fill out a contact form for a free legal consultation.