The American College of Obstetricians and Gynecologists and the American Urogynecologic Society recently issued a joint statement expressing the organizations’ concerns about the safety and effectiveness of transvaginal mesh implants to treat the condition pelvic organ prolapse.
In the statement, the groups say there’s an “urgent need” for a national registry to track outcomes for all current and future patients who get the procedure.
Pelvic organ prolapse occurs when there’s stretching or tearing of the pelvic floor muscles and connective tissue holding the uterus, bladder, urethra, small intestine, rectum, and top of the vagina in place. Childbirth is a major cause, but other causes include menopause, aging, intense physical activity, being overweight or obese, prior pelvic surgery and genetic factors.
Symptoms include lower back pain, urinary incontinence, sexual difficulties, or problems having a bowel movement.
The statement mentions that the FDA has identified the use of surgical mesh to treat the condition as an issue of “continuing serious concern.” It also notes that a “significant group” of patients “experience permanent and life-altering problems, including pelvic pain and painful sexual intercourse because the mesh erodes through the vaginal wall.”
The two groups make a number of recommendations, including:
- Adopting new mesh products and devices only after clinical long-term data has demonstrated that they’re equal or better than existing products and devices.
- Surgeon training for vaginal mesh placement specific to each device.
- Rigorous comparative effectiveness trials of synthetic mesh and long-term follow-up.
- Counseling to inform patients that there are treatment alternatives and that synthetic mesh is permanent, as well as discussion of the risks, benefits, and alternatives to the procedure.
- Limiting use of vaginal mesh repair to high-risk women.
See the statement here.
If you’ve had a mesh implant and suffered health problems, contact Lopez McHugh to discuss your options for pursuing compensation or have your questions answered by a qualified attorney with no obligation.
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