Dr. Noorchashm and Dr. Reed have been at the forefront of the anti-morcellator movement.Two doctors from Boston have been campaigning against power morcellators since 2013. Their story has helped countless women learn of the risks associated with the tool. Dr. Hooman Noorchashm and Dr. Amy Reed have been fighting to ban the use of power morcellators during gynecological procedures for over two years.
The two doctors, a married couple with six children, live outside of Boston. Dr. Noorchashm works as a cardiothoracic surgeon at Brigham and Women’s Hospital and his wife, Dr. Reed, works as an anesthesiologist at Beth Israel Deaconess Medical Center. Neither one of them ever had any particular interest in gynecology until October of 2013.
Dr. Reed sought treatment at Brigham and Women’s Hospital for uterine fibroids. She had been experiencing pelvic pain for several months and, after consulting with her doctor, decided to undergo a hysterectomy. To avoid a large incision which would mean six to eight weeks of recovery time, her hysterectomy was performed laparoscopically. During the procedure, her surgeon used a power morcellator.
Following her surgery, she and her husband were shocked when they were informed that one of her fibroids also contained leiomyosarcoma. This uterine cancer is difficult to treat because it does not respond well to chemotherapy and radiation treatments. Both Dr. Reed and Dr. Noorchashm believe that the morcellator used during her surgery spread the leiomyosarcoma throughout her abdomen, worsening her prognosis.
Their CampaignDr. Noochashm began an aggressive campaign against morcellator manufacturers while sitting next to his wife’s hospital bed. He sent mass emails to every doctor in his hospital and started to publically speak out, insisting that hospitals change their procedures. He even went so far as to threaten leaving his job if his hospital did not stop using morcellators. When Dr. Reed was well enough, she too joined the campaign.
Their efforts have not been wasted. In 2014, the U.S. Food and Drug Administration (FDA) issued a safety warning which stated that if morcellators were used during hysterectomies and myomectomies, there was a risk that the surgical tool may spread undetected uterine cancer. They estimated that 1 in 350 women undergoing these procedures has uterine cancer. Unfortunately, uterine cancer encapsulated by a uterine fibroid is virtually undiagnosable until a biopsy of the fibroid is performed.
Both doctors have also reported that the Federal Bureau of Investigations has spoken with them twice. Additionally, they spearheaded a movement which lead to the U.S. Government Accountability Office announcing that they had agreed to investigate the manner in which the FDA had approved the morcellator.
The MorcellatorThe power morcellator was first approved by the FDA in 1991. Manufacturers like Ethicon, a subdivision of Johnson & Johnson, were able to bypass the usual required safety testing by using the 501(k) approval process. In order to proceed with a 501(k), the manufacturer just has to show that their product is “substantially equivalent” to a previously approved device.
Current LawsuitsFollowing the FDA’s safety warning, more than 30 women have filed lawsuits against various morcellator manufacturers including Ethicon, Karl Storz GmbH, Richard Wolf GmbH, and Gyrus ACMI. These lawsuits have been consolidated to form an MDL, which means that all cases will be seen in one court by one judge. The trial dates have not yet been set.
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