The U.S. Food and Drug Administration (FDA) has reclassified the surgical mesh device utilized for transvaginal repair of pelvic organ prolapse (“POP”) and other conditions in women as a high-risk (class III) product. Previously, the agency classified the product as moderate-risk (class II). [Read more…]
Thousands of injured women nationwide have filed lawsuits in state and federal courts against manufacturers of surgical pelvic mesh implants, claiming that the design of the product was defective and led to serious side effects and permanent injuries. These serious health complications include vaginal mesh erosion, vaginal scarring, contraction or shrinking of the mesh, infection, bleeding, neuro-muscular problems, onset or resurgence of urinary problems, and severe pelvic discomfort and pain.