In 1995, the Food and Drug Administration approved the laparoscopic power morcellator, a tool for OB/GYN surgeons to use in the removal of uterine fibroids. After Dr. Amy Reed of Philadelphia underwent a hysterectomy in 2013, she developed a uterine sarcoma. She and her husband, Dr. Hooman Noorchashm, discovered fabricated studies and increased cancer risks with use of the device. From then until she passed away in 2017, Dr. Reed became a staunch opponent of the power morcellator.
After Dr. Reed and Dr. Noorchashm exposed the flaws in the device, which led to FDA approval, Johnson & Johnson removed its defective medical devices from the market. Shortly after, an FDA panel determined that a warning should be issued. The warning stated that because of the risk and availability of alternative surgical options for women, the FDA is warning against the use of laparoscopic power morcellators. This applies to the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids. Initial statements by manufacturers of power morcellators in laparoscopic uterine surgery suggested that serious complications would only affect one out of every 10,000 patients.
If there is an unknown leiomyosarcoma within the walls of the uterus when the hysterectomy is performed, the power morcellator spreads the cancer cells throughout. This causes the cancer to become far more aggressive. Because the surgery is performed to remove benign fibroids, the risks far outweigh the benefits. The conclusion is that in most cases of fibroids, it is best to simply leave them be unless they are causing serious discomfort. When fibroids are causing problems for a patient, it would be better for them to have a traditional hysterectomy and deal with the longer recovery period rather than risk the uterine sarcoma. In cases where the sarcoma is present and later shows itself, it may be successfully treated.
Dr. Noorchashm is continuing to fight against the use of power morcellators, still manufactured by Olympus. Olympus has just received FDA approval for studies related to its next-gen device. His argument is that the company is misleading study participants and not properly addressing the intent of the studies, placing more women at risk without fully informed consent. Olympus recently settled civil and criminal lawsuits with the government related to its illegal and aggressive product promotions to hospitals and physicians.
If you or someone you love has developed uterine sarcoma after a hysterectomy involving a power morcellator, you may be entitled to compensation. The Philadelphia defective medical device lawyers at Brookman, Rosenberg, Brown & Sandler would like to help. If you live in Pennsylvania or New Jersey, including Delaware County, Chester County, and Philadelphia County, contact us online or call 215-569-4000 for a consultation.