The FDA says that vaginal mesh, such as the Gynecare repair system for the pelvic floor, poses greater risks to patients than other treatment methods. According to the FDA, there were well more than 1500 reports of adverse reactions to vaginal mesh since 2007.
What is the Gynecare repair system?
The Gynecare repair system is one of several brands of vaginal mesh used to treat stress incontinence in women. When women suffer from stress incontinence, they experience urine leakage during sudden movements, such as coughing or laughing. To treat this disruptive problem, a surgeon may use a vaginal mesh tape, such as that found in the Gynecare repair system, to provide support to the prolapsed urethra that the weakened pelvic muscle can no longer provide.
What are the dangers of Gynecare repair system?
The American College of Obstetricians & Gynecologists says it shares the FDA’s concern about the health risks of surgical mesh products, such as the Gynecare repair system.
These health risks include infection and urinary problems. A common problem among patients reporting adverse effects of a vaginal mesh procedure was pain during sexual intercourse. Some patients have suffered when the mesh becomes exposed through the vaginal tissue. Other incidents include organs perforated during the surgical procedure.
Despite these health risks, more than 75,000 transvaginal procedures were performed during 2010 to insert vaginal mesh tapes, such as in Gynecare repair surgeries. Yet, an FDA study found that mesh surgeries were no more beneficial than other procedures despite their increased health risk. Furthermore, removal of the vaginal mesh did not always resolve the adverse reactions reported.
The FDA goes on to say that “there are clear risks associated with the transvaginal placement of mesh to treat pelvic organ prolapse.” The FDA is urging health-care providers to treat stress incontinence and other types of pelvic organ prolapse without the use of vaginal mesh, like the kind found in the Gynecare repair system.
Hiring a Gynecare repair surgery lawyer
If you or a loved one has suffered an injury that may be related to the use of the Gynecare vaginal mesh repair system, you should contact one of Chaffin Luhana LLP’s Gynecare lawyers, who are knowledgeable about Gynecare complications. Call 1-888-480-1123 immediately for a free and confidential case review.
You may be entitled to compensation from a Gynecare lawsuit, and the experienced lawyers at Chaffin Luhana can help.
