Vaginal mesh devices have recently been used to vaginal wall prolapse and incontinence in women, but unfortunately they have been proven to be problematic in a number of ways. Legal issues have been arising as treatment involving the surgical use of vaginal mesh kits have led to complications related to both abnormal injury and inadequate informed consent. Recent clinical focus has been concerned with understanding why vaginal mesh devices lead to medical complications and how to make changes to improve their safety and efficacy.
A recent study conducted by Patrick Nosti and Cheryl Iglesia in Clinical Obstetrics summarizes the current legal issues and why they have followed from the surgical use of transvaginal mesh. In their article, titled, “Medicolegal Issues Surrounding Devices and Mesh for Surgical Treatment of Prolapse and Incontinence,” their research suggests that there has only been a limited amount of research done to verify that mesh kits are both safe and effective. They report, “Although vaginal mesh devices are currently cleared through the 510(k) process, new development at the U.S. Food and Drug Administration requiring additional postmarket studies (522 studies) for transvaginal mesh for prolapse and mini suburethral synthetic slings has been issue to ensure product safety and effectiveness.”
This research suggests that there is a lack in conformational data to suggest the long term effects and potential complications involving the use of transvaginal mesh. If you or any loved ones have suffered from the adverse effects of synthetic mesh devices for the treatment of pelvic organ prolapse or incontinence, then it may be the result of the lack of postoperative research conducted to ensure the safety and effectiveness of the vaginal mesh devices used. You may be entitled to compensation for your suffering. Please contact our law offices for a free consultation to determine if you are eligible for a vaginal mesh lawsuit.