The FDA announced on January 3, 2016 that trans-vaginal mesh products used to correct pelvic organ prolapse will now carry a class III warning which means that the products carry a high risk for adverse events. Previously the mesh products carried a class II or moderate warning. In addition manufacturers of the devices will also be required to submit to a premarket approval application to support the safety and efficacy of surgical mesh for the trans-vaginal repair of pelvic organ prolapse.
The move follows years of reports of pain, bleeding and infection among women receiving the implants. Thousands of lawsuits are pending against the manufacturers of trans-vaginal mesh. Showard Law Firm has been representing women effected by trans-vaginal mesh since 2011 and has recovered significant settlements for many women. There are strict time limits for filing claims so if you or a loved one has been injured by a vaginal mesh call today for a free consultation.