Lawsuits & Recalls
Last year, approximately 75,000 women had vaginal mesh implanted. More than 300,000 pelvic organ prolapse surgeries are performed each year, with one-third using mesh. In July, the FDA reported that at least 2,874 reports of vaginal mesh complications were received by the agency between January 2008 and December 2010. There are many manufacturers of transvaginal mesh that have been sued as a result of the mesh's adverse effects.
Manufacturers That Have Been Sued
Boston Scientific has been sued for its Scimmed's Pinnacle pelvic mesh, C.R. Bard has been sued for Avaulta, Ethicon (Johnson & Johnson) has been sued for Gynecare and American Medical Systems' have faced a host of lawsuits involving AMS Apogee, AMS BioArc, AMS Elvate, In-Fast Unltra, MiniArc, Monarc, AMS Perigee, SPARC and Straight-In mesh. Other manufacturers of surgical mesh products, that have reported complications, include Covidien, Sofradim, Caldera and Mentor Corporation. As of May 2012, there have been 313 cases filed against Boston Scientific, 457 cases filed against Johnson & Johnson's Ethicon division, 529 cases filed against AMS and 740 cases filed against C.R. Bard.
Many transvaginal mesh products have been proven to cause erosion of the vaginal tissue, pain, infection, bleeding, urinary problems, pain during sexual intercourse, organ perforation, recurrence of prolapse or incontinence, neuro-muscular issues, vaginal scarring and vaginal wall shrinking. From 2005 to 2010, the FDA has received nearly 4,000 reports of complications from transvaginal mesh products.
Transvaginal Mesh Recalls
As a result of these side effects, there have been three transvaginal mesh product recalls to date. In 1999, Boston Scientific pulled its ProteGen. In 2012, Johnson & Johnson's Ethicon recalled most of its brands- Gynecare Prolift Kit, Gynecare Prolift + M Kit, Gynecare TVT Secure, Gynecare Prosima Pelvic Floor Repair System Kit- after more than 1,000 lawsuits.
Will mesh be reclassified?
Within a period of just a few months, the FDA has taken serious steps to show just how dangerous transvaginal mesh can be. In July 2011, the FDA issued a warning that said "complications associated with surgical mesh patches are not rare." The agency also informed consumers that surgical mesh treatment was no more effective than traditional non-mesh repair. In December 2011, The Committee of Gynecologic Practice called for doctors to limit the use of transvaginal mesh patches when repairing pelvic organ prolapse. In January 2012 the FDA demanded further testing and also began discussions of whether or not to reclassify mesh.
According to a deputy director of Public Citizen's Health Research Group, "Given the absence of evidence for clinically significant benefit and the overwhelming evidence of very serious, common risks, use of synthetic surgical mesh products for transvaginal repair of POP is not ethically justifiable." While the FDA advisory committee has refused to recommend a recall, it is seriously considering reclassifying transvaginal mesh as a Class III device. If the devices become Class III classified, manufacturers will have to participate in rigorous pre-market testing before obtaining approval to sell the devices.
Regardless of what the FDA decides to do about transvaginal mesh, the facts speak loud and clear: transvaginal mesh is a dangerous device and has caused much harm and pain to women across the country. According to a study by the New England Journal of Medicine, a transvaginal mesh implant has a seven times greater risk of bladder perforation than colporrhaphy, twice the risk of urinary incontinence and 3.2% of women required follow-up surgery to correct exposure problems.
If you are one of the victims of the dangerous side effects of transvaginal mesh, contact Zinda Law Group to learn more about how you can move forward with your life and fight for the damages that you deserve. Don't allow a transvaginal mesh implant to render you a victim any longer!