More Trouble to Transvaginal Mesh Makers: Safety Studies Ordered
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
The sad story of defective transvaginal mesh continued in January as the FDA demanded over thirty manufacturers of transvaginal mesh to immediately implement safety studies. The mesh is commonly used to treat pelvic organ prolapse and stress urinary incontinence . Major manufacturers are Johnson & Johnson and C.R. Bard Inc. Our firm is currently litigating these cases before the Honorable Carol Higbee in the "In Re: Pelvic Mesh Litigation" Case No. 292", Atlantic County Superior Court. One of our clients had three repair surgeries mesh from three different doctors and is still suffering on a daily basis from the "Prolift" product which still is partially implanted. Part of the design defect is that the mesh adheres to internal organs and can never be fully removed.
Over 2,800 new reports of complications associated with transvaginal surgical mesh procedures from January 2008 through December 2010. The most common problems are erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. Pushes have been made to classify use of pelvic mesh as high risk surgery, thus requiring pre-market approval by the FDA. Presently, no such approval has been required.