Safety Concern for Using Power Morcellators. Power morcellators have sparked safety concerns in the past few years when it was discovered that the devices presented a risk of spreading cancer in women undergoing gynecologic procedures, including a hysterectomy and myomectomy.
A hysterectomy is a procedure that surgically removes the uterus. A myomectomy removes uterine fibroids, benign growths in the uterus.
Power morcellators are used during minimally invasive, or laparoscopic, hysterectomies and myomectomies. Morcellators dice up tissue into smaller bits, making it easier for surgeons to remove through small incisions. The safety concerns stem from the fact that in some women, a presumed uterine fibroid is actually an undetected sarcoma, a type of cancer.
Using a power morcellator on this cancerous tissue can spread the malignancy to the pelvis, abdomen and other parts of the body. It can greatly advance the cancer. Furthermore, this type of cancer is not reliably detected before surgery.
The cancer-spreading risk of power morcellators was brought into the public sphere by Dr. Amy Reed, an anesthesiologist, and her husband, also a physician. Dr. Reed, who shared her personal story in 2013, underwent uterine fibroid removal due to complications such as bleeding and pain.
She says she asked for an open surgery, being aware of the risks due to her own knowledge as a physician. However, the surgeons she consulted with all recommended a laparoscopic procedure. She says she was never informed about the use of a morcellator.
Raise Awareness for Power Morcellators
About a week after the procedure, Amy’s doctor told her that her lab report tested positive for leimyosarcoma. She learned that the surgeon morcellated the cancerous tissue. At the time, it was believed that the chances of her having leiomyosarcoma were extremely rare, one in 10,000. However, after the couple conducted extensive research, it was discovered that the chances are significantly greater.
The FDA warned in 2014 that the chances of a uterine sarcoma, which could lead to leiomyosarcoma, in women undergoing hysterectomy or myomectomy for uterine fibroid removal were 1 in 350. The couple has made it their mission to have morcellators banned and raise awareness about how morcellators can “upstage” an undetected sarcoma.
In order to treat her aggressive cancer, Amy chose the Sugarbaker Procedure, an unusual seven-hour operation where 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. Surgeons also removed her gallbladder, appendix, ovaries and some supporting membranes.
The slow realization about the cancer-spreading risks of power morcellators has prompted lawmakers to take action. 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 Reed’s story, the sponsors say that it should not have fallen on patients to identify this problem.
Need Legal Help Regarding Power Morcellators?
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