What You Should Know About A New FDA Mesh Warning

What You Should Know About A New FDA Mesh Warning

Jul 15, 2011 4:19 PM

The U.S. Food and Drug Administration (FDA) has issued a second warning regarding a material that is commonly used in surgery to correct pelvic organ prolapse in women. The material is marketed under a few different names, but is commonly referred to as synthetic vaginal mesh. This warning could have important implications given that it is so commonly used, and many care providers and patients are undereducated on the risks of using mesh. Simply put, this is an important consumer health and patient safety issue.

Pelvic floor disorders such as pelvic organ prolapse are common and result in surgery for an estimated one in nine women. 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 prolapsing through or beyond the vaginal opening. To treat this, many physicians traditionally repaired tissues that hold these pelvic organs in place. Other conditions of tissue weakness, such as hernia, have responded well to the use of synthetic mesh in surgical repairs. Over the last decade, some surgeons began using these meshes in vaginal surgery for prolapse, despite little evidence for their safety and efficacy. The FDA sometimes clears the use of devices such as mesh if there is a similar product already approved. This is unlike drug approval, where the FDA requires large clinical trials proving safety and efficacy. Some 40% of vaginal prolapse surgery now involves the use of mesh.

In recent years, however, health officials have grown more concerned over the number of women coming forward with complications after a pelvic organ prolapse surgery. These women reported problems associated with the permanent mesh in the vagina that became taut or eroded into nearby tissues, causing pelvic pain, groin pain, infection, and ongoing pain with sex. In 2008 the FDA issued the first warning about the use of mesh in surgeries for incontinence and prolapse in women.

As the Intermountain West’s leaders in medical research and expert specialized care, physicians at University of Utah Health Care’s Pelvic Floor Center have corrected complications resulting from pelvic organ prolapse surgery. While the U of U does not use mesh for vaginal prolapse repairs, its physicians have helped many patients suffering complications of vaginal mesh use in previous surgeries, says Peggy Norton, M.D., professor and chief of the Division of Urogynecology at the U of U School of Medicine and vice chair of the Gynecology Practice Committee of the American College of Obstetrics andGynecology.

“Mesh has improved surgery for hernia, but the same can't be said for mesh used for vaginal prolapse,” Norton says. “A small but important number of women undergoing these surgeries experience complications that may not improve after multiple surgeries to remove the mesh from the vagina. For the second time, the FDA has issued a warning to gynecologic and urologic surgeons about the use of vaginal mesh, specifically targeting mesh for prolapsed repair. These warnings are directed also toward women considering the use of these products for their surgery.”

Dr. Norton stresses the importance of being a well-informed, empowered patient when considering any corrective procedure, and this FDA warning reaffirms her position. You can view a video of Dr. Norton explaining the warning and what women and care providers should know.

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Media Contacts

Ryann Rasmussen
U of U Health Care Public Affairs
Phone: (801) 581-7387
Email: ryann.rasmussen@hsc.utah.edu

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