Transvaginal Mesh for Pelvic Organ Prolapse Should Be Limited: Medical Grps
Two associations representing American gynecologists and obstetricians are calling for doctors to limit the use of transvaginal mesh products for repair of pelvic organ prolapse, due to a high number of painful complications experienced by women throughout the United States.
Earlier this month, a transvaginal mesh warning was put out by the Committee on Gynecologic Practice, which includes members from the American College of Obstetricians and Gynecologists and the American Urogynecologic Society.
The committee opinion warns doctors only to use vaginal mesh or bladder slings in cases where women are at high risk from pelvic organ prolapse, which could justify exposure to potential transvaginal mesh complications.
The committee said that currently it is hard to determine who would benefit from a transvaginal mesh as a mainline defense or treatment for pelvic organ prolapse (POP), and called for continued review of outcomes and post-marketing and surveillance data. The committee urged surgeons placing vaginal mesh to undergo specific training for each device and to have experience with reconstructive surgical procedures and a “thorough understanding of pelvic anatomy.”
According to the committee report, some studies have indicated that the complication rate for transvaginal mesh procedures could be as high as 20%. The problems are most obvious in studies with longer follow-up, but some studies showed almost immediate complications, including an ultrasound study that found severe mesh shrinkage of 50% or more after just three months in nearly 10% of transvaginal mesh recipients.
The committee opinion follows an FDA warning issued this summer about the risks of problems with vaginal mesh products for pelvic organ prolapse (POP).
Between 2008 and 2010, the FDA received more than 1,500 reports of problems with transvaginal mesh after pelvic organ prolapse repair surgery, including erosion of the mesh into the vagina, contraction or shrinkage of the mesh, infections, pelvic pain, urinary problems, vaginal scarring and other complications.
FDA investigators could find no benefit for women to undergo the risk of transvaginal mesh complications when there were other surgical options for dealing with pelvic organ prolapse, which occurs when the pelvic floor holding organs in place is weakened or damaged, often after childbirth.
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