Transvaginal Mesh Injury Lawyers in Denton, Texas
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In spite of the many medical risks associated with the procedure, approximately 75,000 women had vaginal mesh implanted last year. Of the more than 300,000 pelvic organ prolapse surgeries that are performed each year, one third of them involve mesh implants. As of last July, the FDA reported that it received 2,874 reports of vaginal mesh complications between January 2008 and December 2010. Furthermore, many manufacturers of transvaginal mesh have been sued on account of the product’s adverse effects.
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.”
Lawsuits against Transvaginal Mesh Manufacturers
Among the manufacturers who have been sued are:
- Boston Scientific for its Scimmed’s Pinnacle pelvic mesh®
- C.R. Bard for Avaulta®
- Ethicon (Johnson & Johnson) Gynecare®
- American Medical Systems for AMS Apogee®, AMS BioArc®, AMS Elvate®, In-Fast Ultra®, MiniArc®, Monarc®, AMS Perigee®, SPARC® and Straight-In mesh®.
- Covidien
- Sofradim
- Caldera
- Mentor Corporation
The magnitude of lawsuits speaks for itself with the following figures. As of May 2012, there were 313 cases filed against Boston Scientific, 457 against Johnson & Johnson’s Ethicon division, 529 cases against AMS, and 740 cases against C.R. Bard.
Some of the proven side effects of transvaginal mesh products are erosion of the vaginal tissue, pain, infection, bleeding, urinary problems, pain during sexual intercourse, organ perforation, recurrence of prolapse or incontinence, neuromuscular issues, vaginal scarring and vaginal wall shrinking.
Transvaginal Mesh Recalls
To date there have been several instances of transvaginal mesh product recalls. In 1999, Boston Scientific recalled 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.
In July 2011, the FDA issued a warning in which it stated that “complications associated with surgical mesh patches are not rare.” The agency also declared that surgical mesh treatment was 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.
In January 2012 the FDA demanded further testing and also began discussions of whether or not to reclassify mesh. The agency has chosen not to recommend a recall, but it is considering the reclassification of transvaginal mesh as a Class III device. Manufacturers must go through rigorous pre-market testing before being approved to sell Class III devices.
If you or a loved one has been a victim of the dangerous side effects of transvaginal mesh, contact Zinda Law Group to learn more about your rights. We may be able to help you move forward with your life by fighting for the settlement that you deserve. Call today for a free consultation.
