By the age of 40 in 2013, Amy Reed seemed to have obtained everything you could want in life. She grew up in Philadelphia, her father a computer programmer and her mother a health industry executive, and then went to Penn State University for her undergraduate degree before going on to the University of Pennsylvania for a PhD in immunology and her MD degree. By the time she was 40, she and her husband were on the faculty at Harvard Medical School as an anesthesiologist and an up-and-coming cardiothoracic surgeon, respectively, and they lived in the Boston suburbs with their six children.
In the fall of 2013, she was diagnosed with uterine fibroids or leiomyomata, a type of benign muscle tumor in the uterus. These are extremely common—70 to 80% of women will develop them at some point in their lives. If they become large enough or if they cause symptoms, such as uterine enlargement or heavy bleeding, removal will be recommended. In the past, this was the most common indication for abdominal hysterectomy. However, the advent of minimal surgery in the 1980s led gynecologists to adopt less invasive procedures, so that open hysterectomies were gradually replaced, and laparoscopic hysterectomies or myomectomies became the norm for treatment of fibroids. This involves only small cutaneous incisions with insertion of a laparoscope into the uterus and therefore significantly less hospital time and fewer complications. There are now 50,000-100,000 such procedures performed annually in the U.S. for fibroids.
And so, when in October of 2013 Dr. Reed received her diagnosis, it was routine that she underwent a laparoscopic hysterectomy at Brigham and Women’s Hospital, a major Harvard teaching hospital in Boston, but here is where things went wrong. She and her husband were unaware that as of the early 2000s it was standard practice in about 15% of laparoscopic hysterectomies to use a device known as a power morcellator during this procedure. This is a power tool with rotating blades that is used to slice up the tissue into smaller pieces so that they can be removed easily through the small incisions. How else would you get the uterus or a large fibroid out? This was a standard tool in laparoscopic procedures, and Reed and her husband later said they had not been informed that it would be used.
In Dr. Reed’s case, unfortunately, there was an undetected high-grade leiomyosarcoma in the fibroid, and the use of the morcellator spread this malignant tumor throughout her pelvis and abdominal cavity, making her tumor unresectable and stage 4. Subsequently, she went through various surgical, immunotherapy and chemotherapy treatments, but ultimately succumbed to the disease in 2017. In the interim, she and her husband became major activists against the use of morcellation and, therefore, this became a major controversy in gynecologic oncology. They did find other isolated cases similar to her own of undiagnosed sarcomas in fibroids that were similarly identified subsequent to morcellation. A few became disseminated in a similar fashion.
It is estimated that the prevalence of an undetected or unknown leiomyosarcoma in a fibroid is approximately one in 500, and of any sarcoma around one in 350-400. Based on these figures, the FDA issued a warning that the use of power morcellators be used only when other procedures could not be utilized. This was in response to the appeals of Dr. Reed and her husband. However, the FDA has never completely blocked the use of the device.
Surveys of gynecologists show that they still wish to use the device in many circumstances when fibroids are large or otherwise. The argument is made that it reduces hospital stays and complication rates, such as infections, in the treatment of fibroids and outweighs the negative impact of morcellation in causing dissemination of sarcoma. Several studies suggest that morcellation does indeed increase the mortality rate from malignancies, but whether this outweighs the benefits of morcellation is uncertain. As a result, the FDA at present still permits the use of morcellation at the discretion of the gynecologist.
The current recommendation of the American College of Obstetrics and Gynecology is that the patient be evaluated to rule out an increased risk for a uterine malignancy. If there is no increased risk, there should then be a discussion between the gynecologist and the patient and shared decision-making with regard to what procedures should be utilized. The most recent analysis by investigators led by Xiao Xu of Yale Cancer Center suggests that the changes in rates of the use of power morcellation (a decrease in its use) have resulted in a small increase in the rate of mortality from laparoscopic and abdominal hysterectomies, a definite increase in other complications of these procedures (infections, etc.), but a concomitant decline in the dissemination of uterine leiomyosarcoma and other uterine cancers. Clearly this requires careful discussion between the patient and her surgeon.
Alfred I. Neugut, MD, PhD, is a medical oncologist and cancer epidemiologist at Columbia University Irving Medical Center/New York Presbyterian and Mailman School of Public Health in New York.
This article is for educational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment, and does not constitute medical or other professional advice. Always seek the advice of your qualified health provider with any questions you may have regarding a medical condition or treatment.
