Bard Avaulta Recall Overview
For many years, women suffering from pelvic organ prolapse, or POP, could do little to alleviate the problems associated with this condition. Pelvic organ prolapse occurs when pelvic organs, such as the bladder, drop from their normal position into the lower part of the pelvis, creating pressure against the vagina and other organs. This change in position can result in a variety of health issues, such as stress incontinence, bowel problems, and difficulty with sex. Pelvic organ prolapsed is most common after childbirth, although women of any age can suffer from this condition.
When transvaginal surgical mesh products were first introduced, it seemed the answer to POP problems had been found. These devices, which were surgically placed in the vagina to correct the prolapsed organs’ position, provided surgeons with a useful tool to combat the condition. Over 200,000 women each year benefitted from the use of these products, and the Bard Avaulta System, manufactured by C. R. Bard, was one of the most popular.
However, the elation over this new surgical system was short-lived. Instead of correcting the problems associated with POP, many women found that they experienced health problems after their surgery, which were directly attributable to the Bard Avaulta System. These side effects included difficulty or pain during sex, undiagnosed vaginal pain, urinary problems such as incontinence and infection, pelvic pain and inflammation, general infections, erosion or hardening of the vaginal mesh, and damage to other organs. In some cases, the effects of the Bard Avaulta System were actually worse than the symptoms of the POP the device was designed to treat.
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