Serious Health Concerns Associated With Vaginal Mesh
Over a lifetime, up to half of all women will develop some degree of pelvic organ prolapse, or POP, due to weakened vaginal muscles. The condition, which can allow pelvic organs to sag, is usually mild; only about one in 50 women will experience troublesome symptoms.
In more serious cases of POP, doctors may recommend surgical treatment. More than 75,000 women a year receive a vaginal mesh implant during surgery. But complications from vaginal mesh include pain, infections and bleeding, which have proven to be much more frequent than expected.
FDA Investigation
In 2008, after receiving more than 1,000 reports of adverse effects in three years, the U.S. Food and Drug Administration (FDA) issued a statement that serious complications could result from vaginal mesh, including bacterial infection leading to significant vaginal pain. After 2,900 additional reports of problems from 2008 through 2010, the FDA recently strengthened its statement to consumers and physicians.
Reviewing scientific reports, the FDA discovered that surgery using mesh did no better at relieving POP symptoms than traditional surgery without it.
The FDA review also found that the most common complications were shrinkage of the mesh and erosion through the vagina, causing severe symptoms and requiring extensive corrective surgery.
The corrective surgery, moreover, isn’t always effective at relieving the pain.
Medical Recommendations
The FDA now urges physicians to use vaginal mesh only after thoroughly considering the benefits and risks of all surgical and non-surgical treatments for POP. Physicians should also tell patients about its possible risks. If vaginal mesh is used, health care professionals must be especially vigilant to watch for adverse effects after surgery.
Options for Consumers
Women diagnosed with POP should question their physicians about possible complications and side effects of surgery and ask about alternative treatments.
If you’ve already had POP-related surgery, the FDA advises that you ask your doctor whether vaginal mesh was used, so that you can catch early signs of complications.
If you’ve suffered complications because of vaginal mesh, you may be entitled to compensation; in fact, manufacturers now face multiple lawsuits.
A case consolidating the claims of about 600 women will be heard in federal court in February 2013. Lawsuits are also pending in a number of state courts. Any woman who has been treated with vaginal mesh and has had complications will want to consult with an injury lawyer about her options for recovering compensation for her injuries.