On April 29, 2014 a press release was issued by the FDA. The FDA issued two proposed orders regarding the health risks associated with surgical mesh used for Transvaginal repair of pelvic organ prolapse (POP). If orders are finalized, this would reclassify the surgical mesh for Transvaginal POP, from class II (a moderate-risk device) to a class III (a high-risk device) and require manufacturer’s to submit a premarket approval application for the agency to evaluate safety and effectiveness of device.
POP is when pelvic organs like the bladder or uterus and bowel become weak and stretch or break and prolapse into the vagina. While this is not life-threatening, women with POP may experience pelvic discomfort, painful sexual intercourse, infections which in the end, reduces the quality of their life drastically.
If you or a loved one has been affected by the vaginal mesh product, you may be entitled to compensation. Call our MDL Attorneys at Gallon, Takacs, Boissoneault & Schaffer as they are available for a free initial consultation, as we want to protect your rights and explain your legal rights.