Last year, approximately 75,000 women underwent procedures in which vaginal mesh was implanted into their bodies. The FDA has received at least 2,874 complaints of vaginal mesh complications between January 2008 and December 2010. Several manufacturers of transvaginal mesh have been dealt with lawsuits due to their product’s adverse effects.
The side effects of many transvaginal mesh products include 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.
Manufacturers That Have Been Sued
-Boston Scientific for its Scimmed’s Pinnacle pelvic mesh
-C.R. Bard
-Avaulta
-Ethicon (Johnson & Johnson) for Gynecare
-American Medical Systems’ for AMS Apogee, AMS BioArc, AMS Elvate, In-Fast Unltra, MiniArc, Monarc, AMS Perigee, SPARC, and Straight-In mesh.
-Covidien
-Sofradim
-Caldera
-Mentor Corporation.
To put into perspective, as of May 2012, there have been 313 cases filed against Boston Scientific, 457 against Johnson & Johnson’s Ethicon division, 529 against AMS, and 740 cases filed C.R. Bard.
Will mesh be reclassified?
Within the span of a few months, the FDA has stepped forward and taken action to communicate the danger of transvaginal mesh. In July 2011, the agency issued a warning that proclaimed “complications associated with surgical mesh patches are not rare.” In additional, they declared that surgical mesh treatment is no more effective than traditional non-mesh repair. In December 2011, the Committee of Gynecologic Practice instructed doctors to limit the use of transvaginal mesh patches when repairing pelvic organ prolapse. In January 2012 the FDA mandated further testing and began the discussion of reclassifying transvaginal mesh as Class III device. This classification requires thorough pre-market testing before receiving approval to sell the devices
For a free legal consultation with a transvaginal mesh injury lawyer serving Waco, call 800-863-5312
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.”
Regardless of the FDA’s decision, the facts speak for themselves. Transvaginal mesh is a dangerous device that has caused a great deal of harm and pain to women.
If you have suffered from the dangerous side effects of transvaginal mesh, contact the experienced personal injury lawyers at Zinda Law Group. We may be able to help you move forward with your life and fight for the damages that you deserve.
Call or text 800-863-5312 or complete a Free Case Evaluation form
