Vaginal Mesh, Cases and Lawsuit The flawed approval system for medical devices is to blame for the harm caused by vaginal mesh implants, according to a new study. It maintains that if clinical trials had been conducted prior to the marketing of such devices, the serious risks would have been discovered and disclosed much more quickly. The publication of the study comes on the heels of a recent Guardian report that a vaginal mesh implant made by Johnson & Johnson was launched without a clinical trial. It was then marketed for five years after the company had learned that it had a higher failure rate than its two earlier devices. VAGINAL MESH RISKS Vaginal mesh devices were cleared for use in treating incontinence in 1996 and for pelvic organ prolapse in 2002. Since then, the U.S. Food and Drug Administration (FDA) has concluded that vaginal mesh implants do little to improve pelvic organ prolapse (POP), a condition where a woman’s uterus, bladder, or rectum can slip...
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