New York, New York

HomeNew YorkNew York

Email Eric T. Chaffin Eric T. Chaffin on Twitter Eric T. Chaffin on Facebook Eric T. Chaffin on Avvo
Eric T. Chaffin
Eric T. Chaffin
Attorney • (888) 480-1123

New Study Reports That Benefits of Vaginal Slings May Outweigh Risks of Complications

Comments Off

For those women who elect to go through surgery to treat pelvic organ prolapse (POP), implantation with a vaginal sling may help them avoid urinary incontinence, which is a common complication of POP surgeries. A recent study in the New England Journal of Medicine on June 21, 2012 noted that those women implanted with vaginal slings are at a higher risk for complications like infections, excessive bleeding, and bladder perforations, than are women who are not implanted with slings. The study also followed the women for only a year after surgery, so it's still unclear what the longer-term results would be.

Complications of Pelvic Organ Prolapse Repair

Pelvic organ prolapse is a condition in which a woman's pelvic muscles become weak or overly stretched from multiple childbirths, hysterectomies, or other causes. As a result, these muscles may then drop or fall into the vaginal wall, creating symptoms like pressure, pain, and a bulge into the vaginal opening.

According to previous research, about 25 percent of women who elect to go through surgical repair for POP will experience urinary incontinence afterwards. Researchers at the University of Michigan decided to study whether or not the implantation of a vaginal mesh sling would help reduce that occurrence.

What the Study Shows

John T. Wei and colleagues studied over 300 women who went through vaginal surgery for POP. These women did not have symptoms of urinary incontinence prior to the operation. The women were separated into two groups. One group received implantations of the Gynecare TVT midurethral sling, while the other group received sham incisions mimicking those that would be made when inserting the sling.

The Gynecare TVT is a section of mesh material that is placed underneath the mid portion of the urethra, the tube that carries urine from the bladder out of the body. The mesh-like material remains as a permanent sling, and actually creates a kink in the urethra when a woman coughs, sneezes, or lifts something, preventing urine leakage.

According to the study results, the sling reduced by half a woman's risk of suffering urinary incontinence after the surgery. After three months, 23.6 women with the sling and 49.4 without had urinary incontinence, while after 12 months, 27.3 percent of those with slings and 43 percent of those without suffered from it.

Those implanted with the sling, however, had a higher risk of complications. Nearly 7 percent of the sling group, but none in the non-sling group, suffered bladder perforation. In addition, 31 percent in the sling group experienced urinary tract infections, compared to 18.3 percent in the non-sling group. Finally, bleeding complications and incomplete bladder emptying occurred in 3.1 and 3.7 percent of the sling group, respectively, but not at all in the non-sling group.

The Take-Away for Women

While this study may seem to counter reports of problems with transvaginal mesh, upon further investigation, we see that vaginal mesh slings are somewhat different from other types of vaginal mesh used for the repair of POP. Vaginal slings, for instance, are small and shaped like straps, about 1 cm wide and 10 cm wide, while transvaginal mesh sheets can span up to 10 cm wide and 20 cm long.

In their July 13, 2011 safety communication, the FDA warned consumers and physicians that complications with transvaginal mesh surgery were not rare. Since that time, more women have hired a transvaginal mesh lawyer to hold mesh device companies liable for a transvaginal mesh injury like erosion, infections, bleeding, mesh shrinkage or contraction, and more.

The FDA also noted that though transvaginal repair to correct weakened tissue between the bladder and vagina—such as what a vaginal sling accomplishes—may provide an "anatomic" benefit, such as reducing the risk of urinary leakage, it may not result in better symptomatic results. Since we do not have long-term results from the study mentioned here, we still don't know how women will fare three, five, or ten years after vaginal sling implantation.

The FDA has required that Johnson & Johnson, C.R. Bard, and other companies study the rates of organ damage and complications linked to vaginal mesh implants. We may eventually have more information on the risks of the various procedures. On behalf of our clients, we advocate that the manufacturers should have had those results before the products went out on the market in the first place.