A surgical procedure that may involve the insertion of bladder or surgical mesh devices are often advised to women with severe cases of pelvic organ prolapse (POP), a condition that occurs when the pelvic floor weakens, causing the organs to move from their location or descend to the vagina – and stress urinary incontinence (SUI), a urinary difficulty that results to uncontrollable urine leakages because of an abrupt pressure to the bladder, medical researchers say. However, a growing rate of injuries in patients has been connected to these medical devices, reportedly evoking safety advisories from the United States Food and Drug Administration (FDA) in 2008 and 2011.
The first Public Health Notification issued by the agency addresses over 1,000 adverse events reports it has received over a span of two years, within 2005 and 2007.
As they continued to increase, more complaints have been reported to the FDA, accumulating to about 2,874 reports of complications associated with the use of bladder mesh implants used to treat POP and SUI. Of more than 2,000 cases of adverse events, more than 1,500 were connected to POP repair and nearly 1,400, with SUI treatment. Despite the staggering statistics, the safety notification, directed to medical practitioners, indicated that these adverse events albeit serious, may only happen rarely.
The most recent safety communication, which was released July 2011, solely applies to surgical procedures involving the transvaginal placement of mesh devices for POP repair. Over the course of two years (2008-2010), the FDA consistently received complaints pertaining to the tendency of bladder meshes to erode into vaginal tissues, causing more discomfort, severe pelvic pain, dyspareunia (pain during sexual contact), as well as inability to sexual activity. Alongside these complaints were a slew of bladder mesh product lawsuits filed against major mesh manufacturers by many women who purportedly have had a first-hand experience of some of these injuries, online media reports.
Reports of other injuries, including punctures to the nearby organs, internal bleeding, infection, and urination problems, have also been documented by the federal agency. In spite of a promising surgical operation, patients also face the risk of a recurrent prolapse, neuro-muscular problems, and vaginal scarring as from bladder mesh devices, all of which may necessitate multiple corrective surgeries.
Based on the results from a systematic review conducted by the FDA from 1996-2011, findings showed that transvaginal POP repair with mesh devices does not improve patient’s symptoms or even quality of life over conservative non-mesh repair.
Sources:
- ucurology.org/areas-of-specialization/female-pelvic-organ-prolapse
- ucurology.org/areas-of-specialization/female-incontinence
- fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm
