Transvaginal Mesh Patch
The Food and Drug Administration warned in July 2011 that women who undergo surgery to repair weakened or damaged tissue with the transvaginal mesh patch are at risk of serious complications from the device. The agency said that problems with surgical mesh can cause severe pain or other side effects which may require surgery.
The transvaginal mesh patch is a permanent synthetic implant designed to treat pelvic organ prolapse or stress urinary incontinence. Versions of the surgical mesh patch are manufactured by American Medical Systems, Boston Scientific, C.R. Bard, Johnson & Johnson and other companies.
According to the FDA’s warning, thousands of women have experienced complications after placement of the transvaginal mesh patch. The agency said that the most common side effect from the surgical mesh patch was erosion of the mesh through the vagina. Women have also reported other complications, including pain, infection, bleeding, mesh contraction, pain during sexual intercourse, organ perforation and urinary problems.
Scientific data reviewed by the FDA has found that the transvaginal mesh patch is no more effective than traditional surgery at correcting pelvic organ prolapse or stress urinary incontinence, and creates risks not found in non-mesh surgery. The FDA is planning to convene a panel in September 2011 to review the patch’s safety and potentially issue a recall of surgical mesh patches.
If you or a loved one underwent surgery involving the transvaginal mesh patch and have experienced problems with the device, you may be eligible to file a lawsuit and receive a settlement for your injuries. For a free legal consultation, contact the lawyers at Hissey Kientz, LLP by calling toll-free at 1-866-275-4454, or by filling out the free case evaluation form located on this page.