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The Prevalence of Bladder Sling Injuries in Patients Continue to Rise



More and More Patients are Complaining of Injuries from Bladder Slings

About 560,000 surgical treatments involving pelvic organ prolapse (POP) and stress urinary incontinence (SUI) treatments have been reportedly performed in 2010 alone, according to national statistics reports. Among these surgical operations, 300,000 were reportedly executed for the treatment of POP, with about 33 percent using bladder sling devices. Majority of the procedures were done transvaginally. An estimated 260,000 operations were for SUI treatment, with more than 80 percent completed through transvaginal placement with a surgical mesh or bladder sling. These numbers show that 74,250 and 448,000 women have been implanted with mesh devices or bladder slings for POP and SUI treatments, 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 find themselves facing a string of health problems that may be as potentially detrimental, if not more damaging than the disorder that had them go through the surgical repair.

Indeed, mortality was reportedly associated with POP repairs using a mesh or bladder sling implant. Some patients have been reported to go through multiple corrective surgical procedures, despite the risk of an unfavorable outcome. 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.

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. Other reported complications included pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. The report further mentioned of recurrent prolapse, neuro-muscular problems, vaginal scarring, and emotional problems. 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.

For the period January 1, 2008 to December 31, 2010, there were 2,874 reports of injury, death, and malfunction associated with the bladder sling devices, of which 1,503 was for POP repairs and the remaining 1,371 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 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