FDA Re-Evaluating Transvaginal Mesh Implants
Women who have undergone transvaginal mesh implant surgeries are reporting even more complications, prompting additional warnings from the Food and Drug Administration (FDA).
Women who have undergone transvaginal mesh implant surgeries are reporting even more complications, prompting additional warnings from the Food and Drug Administration (FDA). Frenkel & Frenkel, a Dallas law firm, explains the new information from the FDA and what it means to women who have undergone surgical mesh surgery.
Use of Transvaginal Mesh
Transvaginal mesh has been used for many years to treat pelvic organ prolapse and urinary incontinence in women related to stress. Pelvic organ prolapse occurs when pelvic organs, such as the bladder, uterus or small bowel drops from its normal location and protrudes into the vagina, normally after childbirth or surgery. Urinary incontinence, or the loss of bladder control, ranges in severity from occasional leakage when coughing or sneezing to a strong urination urge so sudden that it is often difficult to get to a toilet in time. A doctor implants the surgical mesh through an incision in either the vagina or the abdomen, creating a type of sling or hammock designed to support the pelvic organs.
Problems with Transvaginal Mesh
According to the initial FDA warning, more than 1500 reports regarding complications related to transvaginal mesh have been received by the agency over the past few years. The most frequent complications reported relate to surgical mesh erosion through the vagina, infection, pain, urinary problems, and a recurrence of prolapse or incontinence according to the FDA. Bowel, bladder, and blood vessel perforation, as well as scarring and significant discomfort, were the more serious side effects reported. Some women required additional surgical procedures, while others needed IV therapy, blood transfusions and drainage of serious abscesses related to the surgical mesh.
The most important thing about the new warnings regarding transvaginal mesh is that the procedure is associated with more risks than other surgical options. In addition, the warnings suggest that surgeons recommend other treatment options for treatment of the disorders. For women with mild cases of pelvic organ prolapse, Kegel exercises, which strengthen the pelvic floor, may be the only treatment necessary. A vaginal pessary, which is a small device similar to a diaphragm or cervical cap may also be recommended for women with more advanced cases of the disorder who are not surgical candidates or who plan to have more children. For those with debilitating symptoms, however, pelvic reconstruction surgery may be required. New techniques allow the surgery to be performed through laparoscopic surgery where the prolapsed organ or organs are repositioned and secured with stitches.