Problems With the Mesh Sling for Incontinence
For many women, incontinence is the embarrassing result of changes in hormones, damage during surgical procedure or pregnancy. The muscles in the pelvic floor, which keep your organs in place as well as help stop the flow of urine when you're not actively eliminating, begin to sag, causing leakage when sneezing, coughing or jogging or laughing. Initially, a device to place a mesh sling at the urethra, providing something for the pelvic muscles to clamp onto, was hailed as many women's health savior. Unfortunately, significant health problems have been reported with the use of this device.
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Significance
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Patients have reported issues involving pain, recurrence of incontinence as well as infection. However, these reports do not rule out the use of this device. Surgeons note that it's a relatively simple procedure, possible for women of advanced years. The majority of patients (about 85 percent, according to delawareurologic.com) have not experienced any issues.
Types
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"The New York Times" Health Briefing notes that the types of problems identified include scarring, pain, bloody discharge, infection, problems with urination and pain during intercourse. The nine companies that manufacture the sling have reported more than 1,000 women suffering complications in the past three years. In "Urology," the formal journal for the field, the study of the use of the device was terminated due to "unacceptably high vaginal extrusion rate."
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Effects
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The FDA's process to approve this device is under tremendous focus, according to "The New York Times." The FDA has processes that require stringent protocols for researching and approving new drugs. But the mesh sling falls under a different protocol, where the FDA merely clears the device for use. In fact, issues exist with why the sling was cleared at all in spite of problems with earlier devices (NY Times; "Women Sue Over Device to Stop Urine Leaks," May 4, 2009).
Function
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The key issue for the sling appears to be its density (NY Times; "Women Sue Over Device to Stop Urine Leaks," May 4, 2009). The sling is too dense and the body works to expel it rather than incorporating into the body and allowing tissues to grow through the mesh itself.
Benefits
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While the benefits of the device seem obvious, the potential downside is significant. Talk with your doctor about the potential for side effects and balance these against the level of incontinence you are experiencing. Given the problems, many doctors still favor the device. European manufacturers have also suggested that additional training in placement may be warranted for American doctors (NY Times; "Women Sue Over Device to Stop Urine Leaks," May 4, 2009).
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