FDA Orders Safety Studies on Transvaginal Mesh

Following years of reports of serious injuries resulting from the use of transvaginal mesh for treatment of female stress urinary incontinence (SUI), the Food and Drug Administration (FDA) has ordered the manufacturers to begin studying the associated health and safety risks. Those manufacturers include Boston Scientific, CR Bard, Ethicon and WL Gore & Associates.

Last year the FDA took a similar step in dealing with the issues surrounding all-metal artificial hip implants. Neither the surgical mesh products nor the hip implants are required to be tested in patients prior to going to market. Nor do these products require close post-implant monitoring.

However, in 2008 the FDA issued a warning regarding surgical mesh and associated complications. According to a report by The New York Times there has been a five-fold increase in the rate of adverse events reported to the agency since 2008, in women who have received the mesh implants for pelvic organ prolapse (POP). As many as 185,000 women have undergone mesh implant procedures in 2010 alone, and during that same year, reports surfaced that roughly 15 percent of women treated experienced complications.

Transvaginal mesh complications include the following:
mesh erosion into the vagina, bladder, intestines and uterus
infection,
pelvic pain,
urinary problems, including recurrence of prolapse and/or incontinence,
development of urinary retention
bowel, bladder, and blood vessel perforation during insertion,
vaginal scarring,
dyspareunia (pain with sexual relations),
fistulas and recurrence of prolapsed organs
neuropathic pain

FDA Orders Safety Studies on Transvaginal Mesh

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