Rising Reports of Injuries Prompts FDA Warnings

bladder mesh lawsuits

Women suffering from severe pelvic organ prolapse (POP) and stress urinary incontinence(SUI) often undergo a surgical operation for vaginal or bladder mesh implantation, medical experts say. POP occurs when their reproductive or pelvic organs fall into or go through the vaginal opening; SUI is a medical condition marked by the involuntary leakage of urine from a woman’s urethra during moments of physical stress. However, the use of these medical devices have been reported to result to a rising number of inadvertent effects which have been reportedly behind the safety warnings released by the United States Food and Drug Administration 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.

Finding no signs of decrease, the FDA continued to receive more complaints, reaching a number of 2,874 reports of complications blaming surgical bladder mesh devices for the injuries incurred by recipients who have been treated for 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 staggering statistics, the safety notification, directed to medical practitioners, indicated that these adverse events albeit serious, may only happen rarely.

In July 2011, the agency issued another safety communication that applies to the transvaginal implantation of mesh devices for POP repair alone. 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. Most of these problems have also been reportedly the subject of bladder mesh product cases brought into court by recipients who claim of experiencing these inadvertent effects.

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.

Based on the findings of an extensive retrospective review of more than a decade’s worth of studies, the FDA revealed that mesh devices placed transvaginally for POP repair neither yielded therapeutic benefits, nor improvement to quality of life among recipients, compared to non-mesh traditional treatment options.

Sources:

  • ucurology.org/areas-of-specialization/female-pelvic-organ-prolapse
  • ucurology.org/areas-of-specialization/female-incontinence
  • fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm
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