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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.

Because of these complications from using the Bard Avaulta System, on October 20, 2008, the FDA issued a Public Health Notification which warned of problems by women who had these defective medical devices implanted. The warning was intended for women considering the surgery, to let them know about potential problems if they chose this method of treatment. However, this did little to help those women who had already experienced complications from the Bard Avaulta System, and even with the warnings, some surgeons chose to continue to use these transvaginal mesh implants, reasoning that the benefits outweighed the risks.

While the FDA has not ordered an official recall of these products, it is clear that there are problems with the system, and recall movements have gained momentum over the years since the FDA issued its warning. In the meantime, there are several large class-action suits pending, as well as several individual suits, against the Bard Company for damages incurred by women who have suffered from the complications which can be caused by their transvaginal mesh implants.

If you have been the victim of injuries caused by a transvaginal mesh implant designed to relieve the symptoms of pelvic organ prolapsed, you are not alone. Many women do not even realize that their complications are not normal; those who do may not be aware of the warnings which were issued by the FDA about these products. Contact an expert Bard Avaulta recall attorney immediately to explore the possibility of collecting damages for your injuries.

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