The U.S. Food and Drug Administration (FDA) recently issued a warning regarding vaginal surgeries that use mesh to repair pelvic organ prolapse. According to the warning, the procedures are no more effective than other options and complications are common.
A growing number of reports involving surgical mesh-associated complications in women have spurred the FDA to issue its second warning about the device in under three years. Many patients were never told that mesh used in their pelvic surgery could break through or scar their body.
As many as 75,000 such surgeries are performed yearly.
Background on Vaginal Mesh
Mesh products were first introduced in the 1950s for hernia repairs. Though the agency didn’t approve the material for use in prolapsed surgeries until 2002, doctors began using it “off label” for abdominal procedures in the 1980s and for vaginal procedures in the 1990s.
Surgical mesh is typically used in pelvic floor surgery to treat prolapse and incontinence. In an attempt to simplify and standardize the technique of vaginal mesh replacement, “Vaginal mesh kits” were introduced about seven years ago.
The FDA considers surgical mesh to be a "Class II" medical device, posing an intermediate risk of harm to patients.
Vaginal Mesh Injuries
After the mesh is implanted, it can move around the body and often lead to serious injury including puncturing nearby organs, cutting through tissues and more – caused by frayed edges of the mesh material. Some women have become septic, suffering from infection. And, if not treated promptly, these infections can lead to death.
Other injuries commonly associated with vaginal mesh can include: erosion into the vagina, painful intercourse, scarring, prolapsed recurrence, infection, urinary problems and more.
An estimated half of all women will experience some type of pelvic prolapse – a condition in which the bladder or other organs begin to slip out of place – after childbirth, a hysterectomy, during menopause or with age. While symptoms are typically mild, in some cases it can cause significant pain and/or discomfort. Yet, few scientific studies exist about prolapse treatments and which are most effective.
Erosions occur in about 10 percent of women undergoing vaginal prolapsed repairs that use mesh. The piece of material can easily be removed in some cases, but in others, tissue may have grown in and around the mesh requiring multiple medical interventions, notes the FDA.
In 2010, the agency says, doctors performed at least 100,000 prolapse repairs using surgical mesh, and about three-quarters of them were transvaginal.
Vaginal Mesh Alternatives
Alternatives include vaginal repairs that don’t involve mesh and repairing through an abdominal inclusion with and without mesh. The FDA warning does not apply to these alternatives.
Also, refer to our article series “Suffering In Silence From A Medical Device – Surgical Mesh” (Parts 1 -4)
A partner with Childers, Schlueter & Smith, LLC,, Brandon Smith has devoted his practice to pharmaceutical litigation, mass torts, products liability and serious personal injury. A frequent guest speaker at legal seminars all over the country—Brandon is focused on helping injured victims nationwide, however possible. Named a SuperLawyer again in 2019, he has also been called out as one of 10 Best Attorneys For Georgia by the American Institute Of Personal Injury Attorneys and a Top 100 Lawyer in Georgia by the National Trial Lawyers in 2019.