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SALT LAKE CITY — Adverse effects with a material used to correct the sagging of various vaginal organs in women are occurring at a more frequent rate than previously anticipated.
The U.S. Food and Drug Administration issued a new warning Wednesday regarding the commonly used synthetic vaginal mesh, saying more than 2,800 women have been affected since the first warning was issued on the matter in 2008. That is in addition to the "more than 1,000" reports of complications associated with the mesh devices in the three years prior to the FDA's warning, according to the FDA.
"Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remain high," the new warning states.
Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remain high.
–FDA Warning
The most commonly reported complications include vaginal erosion, pain, infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems. There have also been reports of neuro-muscular problems, vaginal scarring/shrinkage and emotional problems, according to the FDA.
A systematic review of the mesh is under way, however, officials at the University of Utah Health Care's Pelvic Floor Center said such widespread use of the product, as well as less than adequate education on the matter, are making things worse.
While the U. does not use mesh for vaginal prolapse repairs, its physicians have helped many patients suffering from complications of vaginal mesh use in previous surgeries, according to Dr. Peggy Norton, professor and chief of the U.'s urogynecology division.
"Mesh has improved surgery for hernia, but the same can't be said for mesh used for vaginal prolapse," she said, adding that the multiple FDA warnings should be considered when patients are making a decision on potential surgical methods.
The U. also posted a video of Norton speaking about the FDA warning and the procedure online Wednesday.
Pelvic floor disorders, such as pelvic organ prolapse or slipping of organs, are common and result in surgery for an estimated one in nine women in the United States. The problem occurs when the muscles and ligaments holding the pelvic organs, such as the bladder and uterus, weaken, resulting in uterus and vaginal walls slipping through or beyond the vaginal opening.
During the past 10 years, doctors have used the mesh material to repair the tissues to hold the affected organs in place, despite little evidence of its safety and efficacy.
Unlike drug approvals that require extensive clinical trials to prove their safety and efficacy, the FDA sometimes clears the use of a product if there is a similar product already approved. Synthetic mesh products have responded well in hernial surgical repairs.
Now, the FDA is urging professionals to obtain specialized training for each mesh placement technique, and be aware of the risks involved. The agency is also saying the problems of organ prolapse can be treated with other methods, thus avoiding problems altogether.
Email:wleonard@ksl.com
