This statement comes from the American Urogynecologic Society (AUGS) about the use of a midurethral sling to treat stress urinary incontinence (SUI).
SUI is a condition that up to one-third of women will experience sometime in their life. It is a condition where the woman will experience a leakage of urine during coughing, exerting or laughing. An SUI mesh implant, usually made of polypropylene, is used to hold up a sagging urethra and prevent the leakage of urine.
While the FDA in a statement issued July 2011 said complications with pelvic organ prolapse (POP) mesh repairs, using the same type of mesh were NOT rare, it left open the door to the SUI mesh implants basically saying the jury was still out. Now the jury is in, at least from the medical professionals who use mesh implants as a tool in the treatment of POP and SUI.
Along with the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU), the group of doctors issued a disappointing conclusion:
“The procedure is safe, effective, and has improved the quality of life for millions of women.”
That will come as a surprise to the tens of thousands of women who have filed defective product lawsuits over SUI mesh in federal and state courts. These are women experiencing pain, mesh erosion and migration, infection, perforation of organs, nerve damage and a return of incontinence, among other symptoms. Polypropylene has been found not to be inert in the body, sometimes causing infections, erosion and shrinkage. In many cases, an explanted mesh sling will be found to have hardened like a piece of plastic.
Since the July 2011 FDA warning, law firms including ours have decided to represent clients to prove their claims that the polypropylene mesh products are defective in their manufacture and design and should never have been put on the market. The professional societies conclude that these efforts have hurt SUI slings as a treatment option!
“We are concerned that the multimedia attention has resulted in confusion, fear, and an unbalanced negative perception regarding the midurethral slings a treatment for SUI.”
Blame the media and lawyers.
In fact, this AUGS statement says “An overwhelming majority of women.. have been satisfied with the MUS (midurethral slings).”
What a huge disconnect? They must not be listening to the stories from thousands of women who say their lives have been forever ruined as a result of the pain they are experiencing. Couple that with the relative scarcity of doctors who are fully trained to be able to remove this permanent mesh implant.
Safe and effective? Not really. In January 2012, the Food and Drug Administration ordered the makers of mesh slings for incontinence to conduct three-year post-approval monitoring of patients to see if the mesh really is safe and effective. This is something that should have been done before the medical device was put on the market, but it was not.
There is so much cross-mingling between industries which have the money for funding studies and clinicians and academics who need funding, that it’s difficult to fully understand what role those potential conflicts of interest may ultimately play.
How unfortunate to ignore the very patients they were trained to treat when the women need them most.