A few years ago, the use of power morcellators in minimally invasive gynecologic surgeries did not arouse much concern. The tool, which cuts up large masses of tissue into smaller pieces, make it easier for surgeons to remove through small incisions. Laparoscopic procedures with power morcellators were also sometimes preferred due to a faster a recovery time, in addition to being less invasive. This all changed when it became public knowledge that power morcellators, when used in women who have an unsuspected uterine cancer, can greatly worsen or “upstage” the cancer. Furthermore, the chances of these cancers occurring are much higher than previously believed.
During a minimally invasive hysterectomy or myomectomy (removal of uterine fibroids), power morcellators are used to mince up tissue for easy removal. However, in some women these fibroids are actually uterine sarcomas, which can lead to an aggressive cancer known as leimyosarcoma. In the past, it was generally thought that the chances of a woman having this tumor were very low; 1 in 10,000. Dicing up the cancerous tissue can cause it to easily spread to other parts of the body. Furthermore, this type of cancer is not reliably detected before surgery.
In recent years, however, a review of research has shown that the chances are greater. In 2014, the U.S. Food and Drug Administration (FDA) warned that 1 in 350 women undergoing hysterectomy or myomectomy for uterine fibroid removal had an undetected uterine sarcoma. The agency issued its alert and updated the device’s black box warning after the crusade of Dr. Amy Reed and her husband, Dr. Hooman Noorchashm. The married physicians made it their mission to have power morcellators banned and raise public awareness after Amy’s own cancer was greatly advanced following a procedure using a power morcellator.
Being a physician and fully aware of the risks, Amy says she wanted an open surgery to remove her fibroids but surgeons all advised a laparoscopic procedure. She says she was never informed about the use of a power morcellator. She and her husband later discovered through their own research that the chances of a uterine sarcoma in women undergoing such procedures are higher than believed.
Amy chose the Sugarbaker Procedure to treat her aggressive cancer. During the unusual seven-hour operation, doctors removed any sign of cancerous tissue, poured a heated chemotherapy mixture into her abdomen, and sewed her shut. The mixture was allowed to slosh around for an hour and a half before it was drained away. Amy’s gallbladder, appendix, ovaries and some supporting membranes were also removed.
The couple’s efforts have led to real change and widespread awareness. In light of the delayed awareness over power morcellators, U.S. Reps. Mike Fitzpatrick (R., Pa.) and Louise Slaughter (D.,N.Y.) proposed a new bill called the “Medical Device Guardian’s Act”, which would require physicians to report deaths and injuries related to medical devices. Currently, only manufacturers and hospitals are required to report this. Sponsors of the bill also say it would prevent these reports from being used against doctors in civil lawsuits. In reference to Amy’s story, the sponsors say that it should not have fallen on patients to identify this problem.