FDA Mesh Warning: Transvaginal Mesh Complications Not Rare
- Aug 10, 2011
- Consumer Alerts
On July 13, 2011, the Food and Drug Administration (FDA) released a safety communication update on the serious complications of transvaginal surgical mesh placement. These procedures have been used to treat pelvic organ prolapse (POP), a distressing and painful condition in which the inner pelvic organs, such as the uterus, bladder, and bowel, slide downward and forward to the point of bulging, or prolapsing, into the vagina. In some cases, the organ may protrude past the vaginal opening. POP is the result of weakened vaginal walls, sometimes due to childbirth. It can cause stress urinary incontinence (SUI) due to pressure on the bladder, as well as general pain and discomfort, interference with sexual intercourse, and mental distress.
Many transvaginal mesh injury victims have reportedly required multiple revision surgeries to attempt to correct the issues they have faced, sometimes without success.
Transvaginal surgical meshes have been used to support weakened vaginal walls by placement through an incision. However, this most recent FDA update was issued to inform healthcare providers and patients “that serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” These transvaginal mesh side effects reportedly include: chronic pain, pain during sex, an inability to engage in sexual intercourse, infection, bleeding, vaginal scarring, recurrence of prolapse, shortening or tightening of the vagina, perforation of organs, and painful urination. Many of these are caused by erosion of the mesh through the vaginal wall, and some by a contraction of the mesh.
The FDA recommends that other treatment options be considered by physicians before proceeding with these surgeries. Many transvaginal mesh injury victims have reportedly required multiple revision surgeries to attempt to correct the issues they have faced, sometimes without success. In light of this warning, it is important that women who have been injured by these procedures learn their legal rights. Transvaginal mesh lawsuits are currently being filed against numerous manufacturers. If you have been injured by a transvaginal mesh procedure or placement, contact us today for a free consultation and to find out if you can seek compensation for your vaginal mesh problems.