Bladder Sling Recall Weblog

Jan 18, 2013 at 14:34 o\clock

Reports of Injuries from Bladder Slings Continue to Increase

 In 2010 alone, as many as 560,000 surgical procedures have been reportedly performed in women who needed treatment to conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI), according to market data gathered by the United States 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. Up to 75 percent of them were done transvaginally. About 260,000 surgeries were intended for the treatment of SUI and 80 percent were performed transvaginally with a mesh device or a bladder sling. This demography demonstrates that 74,250 and 448,000 women have undergone surgery involving the use of bladder sling implants as treatment to POP and SUI, respectively.

Even using the most conservative probability of suffering complications, the number would still be very staggering. This may be a looming threat to women who only wished to improve their symptoms of POP and SUI, and in turn, their quality of life. Now they have to endure another round of frustrations and agony which may be more fatal than the original disorder.

Indeed, mortality was reportedly associated with POP repairs using a mesh or bladder sling implant. 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, 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. The figures are not even half of the number that represents women who have gone through 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

 

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