A Pennsylvania state court jury awarded $2.16 million in damages to a woman with an Ethicon ProLift +M Pelvic Floor Repair System which eroded inside her body and cannot be removed. This is the fourth consecutive win for plaintiffs in the Philadelphia Court of Common Pleas, and the fourth multi-million dollar award against Johnson & Johnson and its subsidiary Ethicon. It is the first time punitive damages were not awarded.… Read More


The FDA has issued a final order reclassifying transvaginal mesh used to repair Pelvic Organ Prolapse (POP) from class II (moderate-risk) to class III (high-risk). The FDA will also require manufacturers of every surgical mesh used to treat POP to conduct a PreMarket Approval application demonstrating the safety and effectiveness of their mesh product for treating POP. Manufacturers have 30 months — two and one half years — to show that their products are safe and effective for POP. These new FDA orders do not apply to mesh sold for Stress Urinary Incontinence (SUI) or abdominal repair.… Read More