Boston Hospitals Enforce New Restrictions For Surgeons Using Power MorcellatorsFollowing the FDA safety warning regarding power morcellators, two Boston hospitals have implemented new rules for surgeons using the device. Brigham and Women’s Hospital and Massachusetts General have both announced that they have decided to enforce new regulations on how and when a power morcellator may be used during surgery.
The Changes In ProcedureBoth hospitals have decided to completely ban the use of a morcellator when a patient is being treated for a uterine mass. The surgical tool may be used to treat uterine fibroids, however, the hospitals have insisted that doctors must use a tissue bag.
This tissue bag is placed around the fibroids being cut and is then inflated with carbon dioxide. The hope is that any cells which may have been potentially disseminated throughout the abdomen will instead be contained within the bag.
Both hospital’s chief of obstetrics and gynecology have indicated that surgeons will be required to discuss with patients the potential risk of morcellation prior to surgery.
Response From Dr. Hooman NoorchashmDr. Hooman Noorchashm has been fighting for the ban of power morcellators since 2013 when his wife Dr. Amy Reed was diagnosed with leiomyosarcoma following a laparoscopic hysterectomy. Both he and his wife believe that her cancer was spread to other organs by the morcellator used during her surgery.
While Dr. Noorchashm is happy that hospitals are taking the dangers of using morcellation during hysterectomies and myomectomies seriously, he still believes it would be better to stop using the device completely. His biggest concern is that the tissue bags won’t be effective or will break open during surgery.
The Risks of MorcellationThe U.S. Food and Drug Administration approved the morcellator for use in laparoscopic surgeries over two decades ago. Surgeons around the country were thrilled because it allowed minimally invasive procedures to be performed.
But in 2014, the FDA announced that they no longer thought the device was safe to use during gynecological procedures. The safety warning they published indicated that if a morcellator is used on a woman who has undetected uterine cancer, the tool may spread the cancer cells throughout the abdominal cavity.
Women around the country have begun to file lawsuits against various morcellator manufacturers including Johnson & Johnson, Gyrus ACMI, Karl Storz GmbH, and Richard Wolf GmbH. Each complaint alleges that the plaintiff suffered from upstaged uterine cancer after undergoing a hysterectomy or myomectomy in which where a morcellator was used.
At this time, there are more than 30 power morcellator lawsuits filed. Trial dates will be scheduled after the Judicial Panel on Multidistrict Litigation announces their decision regarding the possible consolidation of all morcellator lawsuits into one court, under one judge.