By Victoria Ipri, Staff Writer
Pelvic organ prolapse (POP) occurs when pelvic floor muscles and tissue become weakened, torn or stretched. In POP, unsupported pelvic organs – the uterus, bladder and bowel – drop from their normal positions, prolapsing (bulging) into the vagina. POP is not life-threatening; however, for women experiencing the symptoms, ranging from low back pain and painful intercourse to issues with elimination, the recommended solution is often a minimally invasive transvaginal technique using surgical mesh to reinforce weakened muscles.
History of Surgical Mesh Use
The use of surgical mesh is not new. In the 1950s, surgeons used it to repair abdominal hernias. In the 1970s, gynecologists adopted surgical mesh for abdominal repair of POP, advancing to transvaginal repair by the 90s. In 2002, the first mesh device was cleared for use a class II moderate-risk device in transvaginal repair of POP. Five manufacturers currently market this product.
Since this time, the Food and Drug Administration (FDA) has experienced a marked increase in the number of reported adverse events. This led to the creation of an advisory panel in 2011 to establish the safety of the device, followed by several FDA actions aimed at warning physicians and patients about the use of surgical mesh for transvaginal POP repair.
The Philadelphia-area personal injury law firm of Kline Specter, P.C. recently won a $13.5 million award – including $10 million in punitive damages — on behalf of a local woman who suffered severe pain following surgical implantation of the mesh in 2005. Attorney Shanin Specter argued that the Johnson & Johnson subsidiary Ethicon was aware of the hazards of the vaginal mesh product but failed to alert patients or physicians, placing profits over patient safety. Previously, Specter won a similar case against the pharmaceutical giant with a $12.5 million award in the case of an Indiana woman who suffered permanent damage following implantation of the mesh product.
The Future of Surgical Mesh for POP Repair
Most recently, in January 2016, the FDA issued two final orders to manufacturers and the public to strengthen the data requirements for this procedure. The first order reclassifies these medical devices from a class II to class III device, indicating higher risk; the second order requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
These orders compel manufacturers to address safety concerns and demonstrate safety and effectiveness via a stringent PMA pathway.
It should be noted that the orders do not apply to the use of surgical mesh for indications other than transvaginal repair of POP, such as abdominal repair or stress urinary incontinence