Are women better off not having transvaginal mesh implanted to treat pelvic organ prolapse or urinary incontinence? A prominent urologist who conducted a review of the medical devices thinks so.
Pelvic organ prolapse and urinary continence are two common medical conditions for which women seek medical treatment. As they age their abdominal muscles weaken and organs in that area may sag, causing discomfort or pain that requires attention.
Transvaginal mesh has been a medical device implanted in tens of thousands of operations to treat these conditions but with mixed results.
The Food and Drug Administration has warned about side effects caused by repeated reports of failures with these devices and tens of thousands of women have turned to our court system to file transvaginal mesh lawsuits.
Over 40,000 such lawsuits, for instance, have been consolidated before a U.S. District Court judge. Named as defendants in these lawsuits are such companies as Ethicon, C.R. Bard, American Medical Systems Inc., Boston Scientific Corp. as well as other manufacturers.
A Mayo Clinic urologist conducted a review of mesh and posted a scathing review about the medical devices on PubMed.com, a valuable medical information site of the National Institutes of Health. His findings were not complimentary:
“Transvaginal synthetic mesh kits have minimal to no improved clinical success over nonmesh repairs,” the urologist concluded in his review. “Compounding this, mesh kits are clearly associated with multiple relatively common and unique complications without any significant proven benefit for symptomatic relief of pelvic organ prolapse and improvement of quality of life. Continued routine use will needlessly and potentially harm patients permanently without providing any significant benefit.”
Here are some interesting statistics that women who may be seeking treatment for pelvic organ prolapse or urinary incontinence should familiarize themselves with:
The Food and Drug Administration, in October, 2008, issued a Public Health Notification informing health care professionals and patients that as many as 10 percent of the women undergoing operations with transvaginal mesh could suffer complications.
The FDA later followed up on these concerns and found that between 2008 and 2010 there were 2,874 Medical Device Reports for urogynecologic surgical meshes, including reports of injury, death, and malfunctions. Among the 2,874 reports, 1,503 were associated with pelvic organ prolapse repairs, and 1,371 were associated with stress urinary incontinence repairs.
Among the reports received by the FDA were those of women complaining about extreme pain while urinating or attempting to have sex, vaginal scarring and punctures of body organs caused by a failed mesh device.
In its health alert the FDA said the most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.
Agency officials said that women who suffered these health problems were treated for their complications through additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.