Medical devices expert witnesses testified in multi-district litigation over pelvic mesh products made by Ethicon. Transvaginal mesh is used to treat pelvic organ prolapse and stress urinary incontinence in women. Some of these products were a contributing factor in patients developing infection, erosion of the vaginal tissues and organ perforation.
American Medical Systems is also a major defendant in litigation over the controversial mesh products. The company accused doctors of performing unnecessary surgeries and subsequently settles over 130 cases as part of an MDL in West Virginia.
The FDA issued two proposed orders in 2014 to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse.
If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.
Medical device safety is critical to a patient’s health. Unfortunately, plaintiffs suffered injuries when pelvic mesh products degraded following implantation. Medical device litigation requires expert witnesses knowledgeable in specific medical products which may include defibrillators, infusion pumps, and surgical implants. In the Johnson & Johnson and American Medical Systems cases, medical devices expert witnesses are able to consult and testify on the material used in pelvic mesh products which is usually comprised of polypropylene.
J&J is the world’s sixth-largest consumer health company. The Medical Devices segment is comprised of the Global Medical Solutions, Global Orthopaedics and Global Surgery Groups.
In 2015, Boston Scientific Corporation purchased American Medical Systems’ Men’s Health and Prostate Health businesses, combining with the Boston Scientific Urology and Women’s Health businesses to form the Boston Scientific Urology and Pelvic Health business. The combined company employs 25,000 people in forty countries.