Johnson & Johnson (JNJ)’s vaginal sling, used to support the urethra after surgery to treat weakened pelvic muscles, cuts in half a women’s risk of subsequently developing incontinence, a study found.
About 1 in 5 women need surgery to fix bulges and complications caused when the pelvic muscles weaken and allow organs such as the bladder and uterus to fall into the vagina. The procedure to add the sling, a smaller version of the J&J mesh used to support organs, lifts the bladder and relieves pressure to prevent incontinence that develops in one-quarter to half of women after the surgery, researchers said.
The study results, published in the New England Journal of Medicine, show that implanting a sling at the time of surgery cuts the risk of incontinence or the need for future surgery. The slings were linked to bleeding, infections and bladder perforations, though not the debilitating defects found with the larger vaginal mesh products, the researchers said.
“There have been two schools of thought: put in a sling as a preventive measure when we put the bladder back up, or wait until there is a problem and then fix it,” often with surgery, said lead researcher John Wei, a professor of urology at the University of Michigan in Ann Arbor. “What we found is that by putting in a sling, the risk of having leakage is halved.”
J&J declined less than 1 percent, to $66.39 at the close in New York.
The study involved 337 women who were slated for surgery to treat a pelvic organ prolapse. Half were treated with the Gynecare TVT sling, made by New Brunswick, New Jersey-based J&J’s Ethicon unit, and half were given “sham” incisions that mimicked those in the women treated with a sling. After three months, 23.6 percent of women with the sling and 49.4 percent of women in the sham group had urinary incontinence or were treated for the condition.
The benefits lasted for the full year the women were followed and they will outweigh the risks for most patients, Wei said in a telephone interview. There was no difference in serious or unexpected dangers between the two groups, though women getting the sling were more likely to experience common side effects seen with treatment for urinary leakage, he said.
Almost 7 percent of women getting a sling and none in the sham group experienced a bladder perforation, the study found. The perforation can result from a needle used to place the device puncturing the bladder, and it often clears up on its own, Wei said. Thirty-one percent of women in the sling group and 18.3 percent in the sham group had urinary tract infections.
The study was funded by the U.S. National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’ Health. J&J wasn’t involved in the study and didn’t provide funding or the devices used.
J&J’s Ethicon unit has been sued by more than 600 women claiming vaginal mesh devices used to support falling organs were defective and caused internal injuries. The company told a federal judge in West Virginia earlier this month that it intends to stop selling four vaginal mesh implants worldwide.
The U.S. Food and Drug Administration in January asked J&J and 30 other makers of vaginal mesh implants to study organ damage and other health complications blamed on the products.
The vaginal slings used in the current study and vaginal mesh are different products and don’t carry the same risks, wrote Cheryl Iglesia, from Georgetown University School of Medicine in Washington, D.C., in an editorial. An FDA advisory panel that Iglesia served on concluded the slings were safe and effective, while more study was needed on the vaginal mesh.
Women who show signs of incontinence before surgery will most likely benefit from a sling, Iglesia wrote. For others, the doctor and patient must weigh a much-less predictable ratio of benefits and risks, taking into account the goals of treatment and the surgeon’s ability, she wrote.
“The study found that inserting the bladder sling may lead to complications,” said Susan F. Meikle, program director of the NICHD-funded Pelvic Floor Disorders Network. “Although these complications can be treated, it may also make sense to wait for symptoms to appear before inserting the bladder sling,” she said in a statement.
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