A study has found that vaginal bulge surgery, which treats pelvic organ prolapse (POP), fails in one out of every four cases.
Described as the most robust procedure to treat POP, vaginal bulge surgery only provides a temporary form of relief for most women, the study found, according to Bloomberg News. In POP, the uterus or vaginal walls bulge into the vagina.
They study provides the longest view into how women, some 225,000 each year, who undergo the surgery respond in the future. In one of four cases, according to Bloomberg News, a new bulge or symptoms returned within seven years. The study results appear in the Journal of the American Medical Association.
“The surgery that is considered to be the most durable and effective for pelvic organ prolapse fails to restore normal anatomy in one out of four women,” Ingrid Nygaard, a professor of obstetrics and gynecology at the University of Utah School of Medicine in Salt Lake City told Bloomberg News in a telephone interview. “We were interested in not only how women felt, but if surgery was doing what it was designed to do, which is hold the vagina up.”
Of the women studied, the surgery failed in nearly half the women—48 percent, after seven years; incontinence developed in those women who did not undergo another, preventative procedure in 81 percent of the cases and in 75 percent who did, according to Bloomberg News. The study did not include a review of transvaginal mesh surgery.
Thousands of women were recipients of vaginal mesh devices that were implanted transvaginally. The devices have come under increased scrutiny in the last two years, especially since many recipients of these devices began experiencing complications related to their defects. According to the U.S. Food and Drug Administration (FDA), the most common complications associated with transvaginal mesh devices potentially include:
- Mesh erosion through the vagina—exposure, extrusion, or protrusion
- Pain during sexual intercourse (dyspareunia)
- Organ perforation
- Urinary problems
The FDA has also stated that complications linked to transvaginal mesh implants are “not rare” and has warned that use of these devices may actually be more harmful when compared to alternative methods for treating POP. The FDA asked 33 manufacturers of vaginal mesh device products to conduct post-market safety studies so that the effect of vaginal mesh on organ damage and other health concerns may be better understood.
Recently, the first transvaginal mesh lawsuit to go to trial led to an $11.1 million verdict in favor of the plaintiff and was the first of 4,000 Gynecare Prolift cases expected to go to trial. Johnson & Johnson was ordered to pay $3.35 million in compensatory damages and $7.76 million in punitive damages, according to a prior Bloomberg News report.
We’ve long written that transvaginal mesh allegedly has a risk of erosion, in which it travels through the body’s tissues. In some cases, the device can become embedded in inappropriate areas and multiple surgeries are required to remove it. Sadly, in many cases, erosion is so significant and widespread that the mesh cannot ever be completely removed. Lawsuits allege that vaginal mesh device makers knew this, yet failed to warn consumers.