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The Staggering Statistics of Bladder Sling Injury Reports

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​In 2010 alone, there were approximately 560,000 surgical processes for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) throughout the United States, according to relevant data gathered by the Food and Drug Administration (FDA). Among these surgical operations, 300,000 were intended for the treatment of POP, with about 33 percent using bladder sling devices.

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Majority of the procedures were done transvaginally. About 260,000 operations were intended for the treatment of SUI and 80 percent were performed transvaginally with a mesh device or a bladder sling. 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.

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​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.


Indeed, fatalities were reported as the most serious complications coming in as a result from the use of bladder slings. Others required surgical procedures with a few needing multiple operations without guarantees for success. For the majority among them, they have to live with the constant pain and frustrations brought about by the side effects of the implantation of bladder sling devices.

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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 commonly reported adverse events included the tendency of the mesh device to erode, needing one or more repeat surgeries. 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, a complication that may lead to severe pelvic pain and painful sexual intercourse, was also reported as one of the potential adverse events associated with the use of a bladder sling.


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. The numbers do not even represent the entirety of women who went through surgical operations for POP and SUI in 2010 alone. And based on the findings revealed by the US FDA, it may be less difficult to perceive the staggering rate of complaints constantly taking an upsurge.


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

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