Last summer, the FDA issued a warning about the risks of problems when vaginal mesh products are used, especially for repair of pelvic organ prolapse. The federal health regulatory agency indicated that it could find no benefit in using transvaginal mesh to treat POP when compared to older, safer alternatives. Vaginal mesh complications have occurred while the systems were marketed by a number of different medical device manufacturers have caused thousands of women throughout the United States to suffer severe injuries, leading to multiple vaginal mesh lawsuits. Arminta Bell of Minnesota has alleged that a hernia patch manufactured by C.R. Bard, Inc., resulted in a need for additional surgery, causing severe pain.
Due to the risk of vaginal mesh complications, the FDA warned in July 2011 that doctors should recognize that in most cases, pelvic organ prolapse can be treated successfully without a bladder sling or pelvic mesh. Thousands of women had a bladder sling or vaginal mesh implanted in recent years, and compensation may be available for serious injuries caused by the defective and dangerous design of the pelvic support systems. A vaginal mesh lawyer will also argue that his or her client was unaware of the risks associated with using a transvaginal mesh. In Arminta Bell’s case, she received the implant to repair a hernia, completely unaware of the complications that had been linked to the product manufactured by C.R. Bard, Inc.
The vaginal mesh products have been approved through the FDA’s controversial 510(k) fast-track approval process, which only requires that they be substantially equivalent to a device that has already been approved for sale. That means that there were no requirements for clinical studies or tests of safety or effectiveness before the medical devices were implanted in American women. An estimated 300,000 synthetic transvaginal meshes were implanted in women in the U.S. in 2010. As a result of the medical device manufacturers’ failure to adequately research the potential vaginal mesh problems or warn consumers and the medical community about the risk of complications, financial compensation may be available through a vaginal mesh lawsuit or class action claim.
Due to the risk of vaginal mesh complications, the FDA warned in July 2011 that doctors should recognize that in most cases, pelvic organ prolapse can be treated successfully without a bladder sling or pelvic mesh. Thousands of women had a bladder sling or vaginal mesh implanted in recent years, and compensation may be available for serious injuries caused by the defective and dangerous design of the pelvic support systems. A vaginal mesh lawyer will also argue that his or her client was unaware of the risks associated with using a transvaginal mesh. In Arminta Bell’s case, she received the implant to repair a hernia, completely unaware of the complications that had been linked to the product manufactured by C.R. Bard, Inc.
The vaginal mesh products have been approved through the FDA’s controversial 510(k) fast-track approval process, which only requires that they be substantially equivalent to a device that has already been approved for sale. That means that there were no requirements for clinical studies or tests of safety or effectiveness before the medical devices were implanted in American women. An estimated 300,000 synthetic transvaginal meshes were implanted in women in the U.S. in 2010. As a result of the medical device manufacturers’ failure to adequately research the potential vaginal mesh problems or warn consumers and the medical community about the risk of complications, financial compensation may be available through a vaginal mesh lawsuit or class action claim.
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