A surgical procedure that may involve the placement 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 muscles and tissues supporting the pelvic organs weaken, causing the organs to shift from their position or descend to the vagina – and stress urinary incontinence (SUI), a urinary difficulty that results to uncontrollable urine leakages because of sudden pressure to the bladder, medical researchers say. However, these medical products have been reportedly linked to high incidence of complications in women, reportedly urging the United States Food and Drug Administration (FDA) to accordingly issue public health warnings in 2008 and 2011.
The agency first issued a Public Health Notification to address more than 1,000 reports of adverse events it has received between 2005 and 2007.
With no signs of reduction, more reports of adverse events remained at the FDA’s doorstep, reaching up to 2,874 cases of injuries in women, purportedly stemming from faulty pelvic mesh implants used to address POP and SUI. Among 2,874 reports, 1,503 and 1,371 cases were consequently connected to the use of surgical mesh implants for POP and SUI repair.
Despite the constantly increasing rate of complaints, the safety advisory highlighted how these adverse events, albeit rarely-occurring, may lead to serious medical consequences. The latest safety communication, which was issued July of last year, only covers mesh devices inserted transvaginally in surgical procedures for POP repair. Within a two-year duration (2008-2010), a growing number of complaints have been reportedly received by the FDA, describing the tendency of surgical meshes to erode into vaginal tissues, resulting to increased discomfort, severe pelvic pain, pain during sexual contact, and even inability to sexual intercourse. Women are also held susceptible to injuries associated with a newfound complication referred to as mesh contraction or shrinkage.
Other injuries reported to the agency include organ perforations, bleeding, infection, and urinary problems. The use of bladder mesh devices may also hold patients vulnerable to another prolapse, neuro-muscular problems, and vaginal scarring which may only be addressed through further surgical procedures. Major mesh device makers are reportedly facing legal challenges at hand with thousands of bladder mesh injury cases pending in courts across the US due to most of the aforementioned adverse effects.
Results from a previously conducted retrospective review by the FDA also reveal insufficient evidence that may support the effectiveness of mesh devices placed transvaginally for POP repair over conventional non-mesh treatments.