Bladder Sling Recall Site


















          Even with the least number of potential complications, the statistics may still be seen with a considerable increase. This may prove as an impending threat to women whose only intention was to minimize their symptoms of POP and SUI, and hopefully get a better quality of life. Now they have to endure another round of frustrations and agony which may be more fatal than the original disorder.

          Indeed, fatalities were reported as the most serious complications coming in as a result from the use of bladder slings. There were also reports of some patients having to go through more than one repeat operations, despite the uncertainty of a resolution. Majority of these women is faced with varying degrees of pain and symptoms of discomfort arising from the alleged side effects of 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. Prominently mentioned as a serious adverse event is vaginal mesh erosion, a complication that may need repeated surgeries. Other reported complications included pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring, and emotional problems. 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.

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Bladder Sling Recall Video
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    ​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


The FDA Warns of the Safety involving Bladder Sling Implants
About 560,000 surgical procedures involving pelvic organ prolapse (POP) and stress urinary incontinence (SUI) treatments have been reportedly performed in 2010 alone, according to government statistics reports. Of this figure, 300,000 were performed for the treatment of POP, with 33 percent using mesh devices, also known as bladder sling.
      Most of the surgeries were executed transvaginally, nearly reaching up to 75 percent. The other 260,000 would be for SUI repairs, with about 80 percent completed transvaginally using mesh or bladder sling devices. This statistics shows that 74,250 and 448,000 women have undergone surgery involving the use of bladder sling devices as treatment to POP and SUI, respectively.
Staggering Rates of Bladder Sling Injury Reports May Continue to Rise

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