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Thu, Dec 6th - 11:35AM

Staggering Rates of Bladder Sling Injury Reports May Continue to Rise

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About 560,000 surgical procedures involving pelvic organ prolapse (POP) and stress urinary incontinence (SUI) treatments have been reportedly conducted in 2010 alone, according to national statistics reports. Among these surgeries, 300,000 were intended for the treatment of POP, with about 33 percent using bladder sling devices. Up to 75 percent of them were done transvaginally. The remaining 260,000 would be for SUI repairs, with about 80 percent completed transvaginally using mesh or bladder sling devices. These numbers would translate to 74,250 and 448,000 women inserted with surgical mesh or bladder sling implants for POP and SUI repairs, respectively.

Even with the least possibility of a complication, these numbers may still be irrefutably staggering. This would be a great tragedy for a lot of women whose only wish was to have a better quality of life, and the chance to function normally without the burden of going through the pains of POP and SUI. Now, they may be faced with a different, albeit similar distress which may just be as equally detrimental, if not more damaging, than the condition itself.

Yes, deaths have been reported due to complications resulting from the use of bladder sling implants. Others required surgical procedures with a few needing multiple operations without guarantees for success. Most of the patients have to endure the wide-ranging discomfort and varying pain stemming from the adverse events linked to bladder sling implants.

After conducting an evaluation, the FDA affirmed that it has not seen conclusive evidence that using bladder sling devices for POP repair has improved clinical outcomes compared to the traditional method of repair and that it may expose patients to greater risk. One of the most prominent adverse effects associated with mesh devices was the ability of a bladder sling to erode through the vaginal wall, necessitating multiple repeat surgical procedures. Along with bladder sling erosion, other complications cited were infection, pain, urinary problems, bleeding and organ perforation. Recurrent prolapse, neuro-muscular problems, vaginal scarring, and emotional problems were also reported in some cases. Mesh contraction, which causes vaginal shortening, tightening, and vaginal pain, was included as among the possible adverse events resulting from the use of bladder sling devices.

Between January 2008 and December 2010, more than 2,800 cases of injury, malfunction, and even deaths have been reportedly associated with the use of bladder slings, of which more than 1,500 were for POP repairs and beyond 1,300 were associated with SUI repairs. This figure of 2,874 is a far cry from the number of women who underwent surgical procedures for POP and SUI for the year 2010 alone. And based on the findings of the FDA, it will not be surprising to see their office swamped with a multitude of complaints.

References:
fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm
fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf Online Marketing
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