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The FDA issued a public health notification yesterday to warn about a number of serious problems that have been associated with transvaginal placement of surgical mesh that is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
According to reports received by the FDA from nine different manufacturers, over 1,000 people have suffered severe complications from the surgical mesh, including reports of infection, pain, urinary problems and bowel, bladder or blood-vessel perforations. Women have also reported recurrences of the prolapse or incontinence, and the need for additional surgeries to remove mesh that had eroded into the vagina.
A pelvic organ prolapse occurs when organs such as the bladder, uterus, bowel or rectum drop and push against the wall of the vagina. This happens when the muscles holding the pelvic organ in place become weak or stretched, often due to childbirth or surgery. The surgical mesh is used to support the muscle.
Female stress urinary incontinence is a condition where urine is involuntarily released during moments of physical stress due to weakened of the muscles that support the bladder and urethra. In repair procedures, the surgical mesh is designed to act like a hammock to reinforce the muscle.
The FDA recommended that physicians obtain specialized training for various placement techniques and that they closely monitor patients for problems with the surgical mesh. They have also indicated that patients should be informed of the surgical mesh risks, so that they understand that complications could seriously impact their quality of life.
No specific groups of patients were identified as being at an increased risk of thee surgical mesh complications. In addition, the notification does not single out any particular manufacturers or types of mesh.
In 2006, a type of surgical mesh used for stress urinary incontinence, known as the ObTape Vaginal Sling, was removed from the market by Mentor Corporation just three years after it was introduced when a large number of women experienced severe problems.
The Mentor ObTape surgical mesh differed from most other mesh devices, since it contained a “non-woven” design. This blocked oxygen and nutrients, substantially increasing the risk of surgical mesh problems, and some estimates suggested that the complication rate could be as high as 17% to 18%.
There are currently 22 ObTape surgical mesh lawsuits pending throughout the United States, which have been filed by women who suffered severe infections, extrusions and urinary tract erosions.