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Medical News & Perspectives |

Critics of Fibroid Removal Procedure Question Risks It May Pose for Women With Undetected Uterine Cancer FREE

Tracy Hampton, PhD
JAMA. 2014;311(9):891-893. doi:10.1001/jama.2014.27.
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Published online

Use of a surgical technique that involves cutting fibroid or uterine tissue into small pieces for extraction during minimally invasive surgery has come under scrutiny recently—scrutiny prompted by concerns that the process may disperse fragments of undetected malignant tumors throughout the abdominal cavity and upstage otherwise contained cancers.

Because it’s not possible to reliably detect the presence of uterine sarcomas before surgery, some experts say that use of the technique—known as intracorporeal uterine morcellation, which can be performed with an electric morcellator or by hand with a knife—may be too risky under any circumstance. Others say more research on risks associated with the procedure is needed before banning it outright. In the meantime, some professional groups and medical institutions are stressing the importance of counseling patients about both the potential risks and benefits of morcellation of a fibroid or uterus.

An estimated 600 000 hysterectomies are performed annually in the United States, with uterine fibroids being the most frequent indication for the surgery, according to the US Centers for Disease Control and Prevention (http://1.usa.gov/Lt2d3q). Studies suggest that for every 6 hysterectomies among women aged 15 to 44 years, 1 of them is for the purpose of removing fibroids (Mauskopf J et al. J Womens Health [Larchmt]. 2005;14[8]:692-703).

Place holder to copy figure label and caption

Graphic Jump LocationImage not available.

Using a power morcellator to slice up fibroids—such as the fibroid visible here (upper center) on the uterus—for removal during minimally invasive surgery may increase the risk of dispersing cells from an undiagnosed cancerous tumor.

CNRI/http://www.sciencesource.com

Morcellation can be performed with any type of hysterectomy—abdominal, vaginal, laparoscopic, or robotic-assisted—explained Kimberly Kho, MD, MPH, director of gynecology at the UT Southwestern Center for Minimally Invasive Surgery in Dallas. Electric (power) morcellation is generally used only with laparoscopic or robotic cases, but not with all of them, she said.

Women undergoing any type of surgery for fibroids are typically advised that their risk of having an underlying malignancy is 1 in 10 000, a figure that is based on the rate of uterine malignancies in the general female population. What the rate may be in women who elect to undergo surgery for a symptomatic uterine mass presumed preoperatively to be a benign condition is under debate.

“The problem is that, in most cases, we don’t have a perfectly reliable way to identify patients with uterine sarcoma in the preoperative setting,” said Suzanne George, MD, clinical director of the Dana-Farber Cancer Institute’s Center for Sarcoma and Bone Oncology. She noted that the symptoms and imaging findings associated with uterine sarcoma or benign fibroids are often identical. In addition, the limited data regarding the use of endometrial sampling for uterine sarcoma point to a sensitivity of only 38% to 62% (Leibsohn S et al. Am J Obstet Gynecol. 1990;162[4]:968-974; Bansal N et al. Gynecol Oncol. 2008;110[1]:43-48).

If unsuspected malignancy is present, the procedure carries the risk of disseminating and upstaging a rare but deadly tumor and reducing survival. A study by George and colleagues investigated adverse outcomes associated with morcellation in women with preexisting malignancies that were unsuspected and undiagnosed before they underwent surgery. The team’s analyses found that 2 of 7 patients with presumed stage I uterine leiomyosarcoma (which begins in smooth muscle cells of the uterine wall) and 1 of 4 patients with presumed stage I smooth muscle tumors had disseminated intraperitoneal disease after morcellation; they also found evidence that the disseminated disease “originated from engrafted pieces of viable tissue chips as opposed to natural development or progression” (Oduyebo T et al. Gynecol Oncol.doi:10.1016/j.ygyno.2013.11.024 [published online December 1, 2013]).

In a larger study by another group that included more than 1000 instances of uterine morcellation at 1 institution, 9 of 14 patients, or 64.3%, with benign and malignant uterine tumors experienced dissemination (Seidman MA et al. PLoS One. 2012;7[11]:e50058).

Other studies that have assessed uterine sarcoma (mostly leiomyosarcoma) diagnosed postoperatively after morcellation for presumed benign fibroids support the hypothesis that the procedure may negatively affect patients’ outcomes (Leung F and Terzibachian JJ. Gynecol Oncol. 2012;124[1]:172-173; Hagemann IS et al. Int J Gynecol Pathol. 2011;30[5]:476-483; Park JY et al. Gynecol Oncol. 2011;122[2]:255-259; Einstein MH et al. Int J Gynecol Cancer. 2008;18[5]:1065-1070).

The potential for causing additional harm to patients is especially sobering when considering the already poor prognoses associated with leiomyosarcoma: the estimated 5-year survival is 60% for patients with stage I disease, compared with 22% for those with stage III and 15% for those with stage IV (http://bit.ly/1a5B7Wq).

“The upstaging or worsening of cancer caused by morcellation is a clear harm to patients,” said Michael Paasche-Orlow, MD, MPH, an associate professor of medicine at the Boston University School of Medicine. Paasche-Orlow, George, and colleagues recently drafted a literature review on the topic to help call attention to this risk.

The American Congress of Obstetricians and Gynecologists (ACOG) acknowledged in a statement that if an unanticipated uterine cancer is present and morcellation is used during surgery, there is a risk that cancer cells may spread and further worsen the patient’s outcome. “Though the precise risk of this happening is not known in the case of leiomyosarcoma, it is extremely rare,” it stated.

Electric (power) morcellation may carry additional risks in the form of significant accidental injuries to organs, according to Camran Nezhat, MD, the director of the Center for Special Minimally Invasive and Robotic Surgery in Palo Alto and a member of the obstetrics/gynecology departments at Stanford University Medical Center and the University of California, San Francisco. “Some surgeons may think that morcellation requires less time and training than other alternatives, but actually doing it safely requires considerable skill,” he said.

However, Kho noted, there are patient benefits to opting for minimally invasive procedures for removal of fibroids or the uterus, including quicker recovery, less pain, and shorter hospital stays, as well as known risks to open surgeries, including wound complications and surgical site infections. Clinical use of electric morcellation needs to be clarified and alternatives should be offered, but it seems premature to ban the procedure entirely, she said.

“It is clear that we need to do more work to find out the incidence of cancer upstaging, as well as other morcellator-related complications, like the frequency of spreading of nonmalignant tissue and other injuries. We need data to drive action,” she said. “A prospective registry of procedures and obligatory adverse events reporting would serve to help quantify these unknowns, particularly when they are rare.”

Much of the latest attention to uterine morcellation has come after a Boston physician and her husband began sounding an alarm in November about the risks associated with the procedure. Amy J. Reed, MD, PhD, an anesthesiologist at Beth Israel Deaconess Medical Center and a mother of 6, was diagnosed with stage IV leiomyosarcoma after undergoing uterine morcellation to remove fibroids. After magnetic resonance imaging and biopsy screening, she was cleared for the surgery and says she was not told of the risks that it might upstage any undetected cancer that may be present.

Her husband, Hooman Noorchashm, MD, PhD, a cardiothoracic surgeon at Brigham and Women’s Hospital, where the procedure was done, is reaching out to physicians, hospitals, medical societies, regulators, and others, with the goal of persuading the medical community to halt the use of intracorporeal uterine morcellation. Among other things, he has started an online petition that includes a video of uterine morcellation, directed to ACOG and the American Board of Obstetrics and Gynecology (http://chn.ge/1a0j2Jq).

Some hospitals and relevant medical societies have recently issued statements stressing the importance of counseling patients about the procedure. For example, in early December, Brigham and Women’s Obstetrics and Gynecology Chairman Robert Barbieri, MD, sent a memo to staff that urged physicians to talk with patients about the risk of spreading cancer through the procedure. “The risk of power morcellating an occult cancer in women with a presumed benign uterine condition is not precisely known,” he wrote. “This complication may occur as frequently as 1 in 400 cases or as infrequently as less than 1 in 1000 cases.”

Issues that merit discussion with the patient “are the possibility that morcellation can cause the dissemination of cancer cells and that morcellation can make it more difficult for the pathologist to evaluate the surgical specimen,” Barbieri said in the memo.

The Cleveland Clinic also plans to reinforce the importance of counseling patients about the risks and benefits of morcellation of a fibroid or uterus. In addition, Massachusetts General Hospital’s physicians have been instructed to be aware of the possibility that patients may have undetected tumors and to offer patients recommendations on other surgical options. Gynecologists there also must provide informed consent to patients on the risks of morcellation if they plan to perform the procedure, said Isaac Schiff, MD, the hospital’s chief of obstetrics and gynecology.

In addition, the Society of Gynecologic Oncology issued a statement in December about the potential risks of uterine morcellation and the concern that there are no reliable methods to differentiate benign growths from malignant cancers before they are removed (http://bit.ly/1bKS6wS).

Although Noorchashm and other critics of uterine morcellation say the society’s statement is a step in the right direction, they say it has several flaws, such as underestimating the risk it poses for women undergoing surgery for uterine fibroids who have an underlying malignancy, as well as its focus on informed consent rather than whether the risk associated with the procedure is acceptable.

“Morcellation of a woman’s uterus is playing Russian roulette with a deadly outcome,” Noorchashm said. “It is done for ease, speed, and to reduce length of hospital stay—and that end simply does not justify the deadly flawed means.”

While the debate continues on the fate of uterine morcellation, some say there may be a middle ground.

Nezhat notes that there are ways to perform uterine morcellation without risking cancer dissemination, such as by grasping fibroids through a minilaparotomy incision or the vagina and then shelling the fibroids inside a bag before morcellating them (Nezhat C et al. Int J Fertil Menopausal Stud. 1994;39[1]:39-44; Kho KA et al. J Minim Invasive Gynecol. 2009;16[5]:616-617). “In our experience, these methods could eliminate the spread of benign or malignant tissue and also decrease or eliminate traumatic injuries related to intracorporeal morcellation,” he said.

Kho noted that these techniques are very promising. The existing studies, although few in number, are “quite compelling and have demonstrated the feasibility and safety of [such modifications] to electric morcellation,” she said.

George agreed that these and other alternatives deserve a closer look. “It’s clear that when a sarcoma is disrupted inside a body cavity, it leads to worse outcomes,” she said. “We need to think about what can be done to avoid these worsened outcomes for patients with unsuspected sarcomas while maintaining the benefits that minimally invasive surgery has for many women.”

Published Online: February 6, 2014. doi:10.1001/jama.2014.27.

Figures

Place holder to copy figure label and caption

Graphic Jump LocationImage not available.

Using a power morcellator to slice up fibroids—such as the fibroid visible here (upper center) on the uterus—for removal during minimally invasive surgery may increase the risk of dispersing cells from an undiagnosed cancerous tumor.

CNRI/http://www.sciencesource.com

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