A product used to treat a common problem afflicting women primarily of child-bearing age should be pulled from the market and recalled, Public Citizen told the FDA in a petition today.
WARNING: I’ll go into some graphic descriptions in this blog post. Have a weak stomach? Proceed at your own risk.
The condition is called pelvic organ prolapse (POP), and approximately 300,000 women in the U.S. were treated for it last year. In this condition, one or more of a woman’s pelvic organs (think bladder, rectum or uterus) bulges or descends into her vaginal cavity, sometimes past the opening of the vagina, because of weakness in the connective tissue and muscles that surround and support the pelvic organs.
Most women with POP have no symptoms. For symptomatic patients, treatment can involve surgical or non-surgical interventions; in surgical procedures, non-absorbable mesh often is implanted transvaginally (through incisions and punctures made through the wall of the vagina) with the intent of reinforcing the tissues around the pelvic organ that prolapsed and increasing the longevity of the repairs. Public Citizen estimates that approximately 67,500 of these procedures last year used non-absorbable mesh.
But the mesh should be recalled because it offers no significant benefits but exposes patients to serious risks and the potential for permanent life-altering harm, Public Citizen said in the petition. The most frequent complications reported to FDA and described in scientific journals included vaginal mesh erosion (in which tissue between the implanted non-absorbable mesh and the lining of the vagina breaks down and the mesh becomes exposed on the surface of the vagina), infection, pain and urinary problems such as incontinence. There were also reports of injuries to the bowel, bladder and blood vessel during transvaginal insertion of the mesh for POP repair. In some cases, vaginal scarring, mesh erosion, and contraction or shrinkage of the mesh led to a significant decrease in patient quality of life due to severe pelvic discomfort and pain, including pain during sex. Many of the complications seen with transvaginal surgery for POP repair with non-absorbable mesh do not occur following POP surgery without mesh.
Worst of all, women whose transvaginal POP surgery involved non-absorbable surgical mesh did not experience better outcomes in terms of symptom relief and quality of life – the clinically significant indicators for measuring treatment success for this condition – than women who underwent transvaginal POP repair surgery without mesh.
The FDA admitted last month that complications with mesh are higher than previously estimated, with many women experiencing pain, bleeding and infection, the Associated Press reported.
Even the FDA seriously questions the safety and effectiveness of these mesh products, so they should be removed from the market immediately,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group.
If I haven’t totally killed your appetite for the day, check out the petition sent to the FDA, as well as statements from two OB/GYN physicians about why they think this product has got to go.