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Last month, the Food and Drug Administration (FDA) ordered manufacturers of surgical mesh to conduct new studies of the mesh products used to treat two conditions affecting millions of women in the United States.
Surgical mesh is a woven fabric used in a variety of medical procedures. The new studies recently ordered by the FDA focus on the use of surgical mesh when used to treat two conditions: stress urinary incontinence and pelvic organ prolapse.
Stress urinary incontinence, the most common type of urinary incontinence in women, is the unintentional loss of urine during physical activity, such as coughing, sneezing, laughing, or exercise. It can be the result of weakened pelvic muscles that support the bladder and urethra. When surgery is deemed an appropriate treatment, mesh slings can be surgically implanted to provide lift and support.
Pelvic organ prolapse occurs when the muscles and ligaments supporting a woman’s pelvic organs weaken to the point that pelvic organs can prolapse, or slip, out of place. Pelvic organs include the vagina, cervix, uterus, and bladder, with the bladder being the most common organ involved in pelvic organ prolapse. Symptoms of the condition may include pelvic discomfort or pain, pressure, leakage of urine, and sexual problems. If surgery is recommended for treatment, surgical mesh can be used to provide support to the affected organ(s).
The FDA has received reports of complications that can have serious consequences as a result of mesh placement. The most frequent complications reported include erosion through the vagina, infection, pain, urinary problems, and recurrence of the prolapse and/or the incontinence. Some patients required additional surgery to address the complications.
In July of 2011, based on an updated analysis of adverse events, the FDA issued a Safety Communication to inform the medical community and patients that:
In early January, the FDA ordered 33 manufacturers of urogynecologic surgical mesh for pelvic organ prolapse and 7 manufacturers of single-incision mini-slings for stress urinary incontinence to conduct new studies of their mesh products. The FDA is requiring the manufacturers to submit plans for studies that will follow women for at least three years to determine side effects and to address specific safety and effectiveness concerns related to the mesh products. The current regulatory status for mesh products for stress urinary incontinence does not require pre-market approval testing.
If your surgeon recommends surgery for stress urinary incontinence or pelvic organ prolapse, the FDA recommends you ask your surgeon the following questions:
If you or a loved one have been injured as a result of a defective medical device such as surgical mesh, you are urged to contact the Indianapolis Defective Medical Device Attorneys of Wilson Kehoe Winingham. The lawyers at WKW can help you get the compensation you deserve. Call 317.920.6400 or fill out an online contact form for a free, no-obligation case evaluation.
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