The Current Controversy Regarding Power Morcellation in Gynecologic Surgery

“…in November of 2014, the FDA issued a boxed warning, which is its strongest citation. This boxed warning included a notification about the risk of dissemination of uterine malignancy when power morcellation is used.”

Synopsis

Over the course of the 2 years following power morcellation during laparoscopic hysterectomy in the presence of an occult cancer in a Boston area physician, the previously frequently used tool has been banned in the majority of hospitals following warnings from the US FDA.

An increasing number of hysterectomies and myomectomies performed annually in the USA are done using laparoscopic or robotic techniques. Power morcellation, which allows removal of surgical specimens through a narrow tube via a sharp circular rotating cutting knife has greatly facilitated this increase. First FDA approved for gynecologic surgery in 1995, laparoscopic power morcellation was used to allow removal of uterine tissue from the peritoneal cavity after myomectomy or hysterectomy via a 12 mm trocar port [1]. It is not known to what extent power morcellation is used in gynecologic procedures, however, it was a widely employed method across the country. Currently, there is controversy surrounding power morcellation use in gynecologic surgery due to the possible risk of dissemination of occult cancers.

The power morcellation controversy began in 2013 when Amy Reed, MD, PhD, an anesthesiologist, underwent a laparoscopic supra-cervical hysterectomy with removal of uterine tissue via the use of a power morcellator. Unfortunately, Dr Reed's pathology report showed an unsuspected diagnosis of leiomyosarcoma [1]. Concerns were raised that during the morcellation process small fragments of malignant tissue were seeded throughout her peritoneal cavity, potentially upstaging her cancer and worsening her prognosis. Due to this concern, Dr Reed's husband, Hooman Noorchashm, MD, PhD, initiated a media campaign to ban the use of power morcellation. The campaign has been spread via the website on Change [2], interviews with the news media and the issued warnings from the FDA.

Several hospitals in the Philadelphia area, where Dr Reed and Dr Noorchashm trained, banned the usage of power morcellation after this was initially done at Temple University Hospital (PA, USA).

Two Pennsylvania senators, Sen. Robert Casey Jr (D-PA) and Sen. Michael Fitzpatrick (R-PA) became involved in this controversy. The senators pointed out to the FDA that there may be a large gap in the process of medical device approval and evaluation. Power morcellators have been on the market since 1990s and the possible spread of cancer with its use has been dispersed throughout the literature since then, yet the FDA still did not issue a report on this adverse outcome until 2013, after Dr Reed's case was in the public eye [3].

The theoretic risk of inadvertently disseminating cancerous disease was known, prior to Dr Reed's campaign [4]. Recently, several publications have examined this issue. In 2012, Seidman published a review of 1091 women who underwent morcellation for uterine masses presumed to be benign fibroids at Brigham and Women's Hospital in Boston from 2005 to 2010. The results, published in PLoS ONE, reported the rate of unexpected leiomyoma variants or atypical and malignant smooth muscle tumors to be 0.09% [5]. Also, Wright in 2014 reported an incidence of cancer later found in morcellated specimens to be 1/370 (0.27%) [6].

Due to the wide publicity of Dr Reed's case, gynecologic medical societies have published several statements on the matter.

In December of 2013, the Society of Gynecologic Oncology (SGO) published a statement on power morcellation. “Uterine leiomyomas are a common indication for power morcellation. Fewer than 1 out of 1000 women who undergo hysterectomy for leiomyomas will have an underlying malignancy. The SGO recognizes that currently there is no reliable method to differentiate benign from malignant leiomyomas (leiomyosarcomas or endometrial stromal sarcomas) before they are removed. Furthermore, these diseases offer an extremely poor prognosis even when specimens are removed intact.” The SGO also noted that power morcellation has the potential to disseminate malignancies throughout the abdominal cavity and therefore is contraindicated in cases of suspected malignancy [7].

In April of 2014, the FDA issued a medical device safety communication cautioning both physicians and patients about the use of power morcellation. “The FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.” When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids.” The FDA quoted an incidence of one in 350 women will have a diagnosis of uterine sarcoma after hysterectomy or myomectomy for suspected fibroids [8].

In April of 2014 the American Association of Gynecologic Laparoscopy (AAGL) cited an “estimated that between 1 in 400 and 1 in 1000 women who undergo hysterectomy for presumed benign uterine myoma will be diagnosed with LMS.” The position of AAGL regarding power morcellation was summarized as “It is the opinion of the AAGL that all existing methods of tissue extraction have benefits and risks, which must be balanced. At this time, we do not believe there is a single method that can protect all patients; therefore, all current methods of tissue extraction should remain available.” It is important to note that the AAGL has received industry support from companies that manufacture power morcellators and that the majority of AAGL members were previously frequent users of power morcellation [9].

The American College of Obstetricians and Gynecologists (ACOG) stated that it recognized the risk of disseminating malignant disease and recommended against the use of power morcellation when malignant conditions were suspected. ACOG also recognized that “without power morcellation, some patients may be ineligible for minimally invasive gynecologic surgery” and its benefits [10]. ACOG recommended that gynecologists discuss the risk disseminating cancerous tissue with patients prior to use of power morcellation.

Then, in November of 2014, the FDA issued a boxed warning, which is its strongest citation. This boxed warning included a notification about the risk of dissemination of uterine malignancy when power morcellation is used. Contraindications for power morcellation usage were peri- or postmenopausal women or those who are candidates for en bloc removal of uterine tissue with fibroids through the vagina or mini laparotomy or if cancer is suspected [11].

Following the FDA warnings, manufacturers such as Ethicon and Johnson & Johnson, have taken their power morcellators off the market. Additionally, the vast majority of hospitals were power morcellation was frequently used in gynecologic surgery have banned its performance. This has rapidly occurred both out of concern for patient safety and to decrease potential legal risk. Some gynecologists and hospitals, however, have continued to use power morcellation with the reasoning that the benefits of laparoscopic or robotic myomectomy and hysterectomy for some patients may outweigh the rare occurrence of peritoneal seeding of an unsuspected malignancy. Of these hospitals allowing power morcellation, some are requiring patients to first undergo additional testing such as a pelvic MRI and D & C. Neither of these, however, has been shown to be good predictors of leiomyosarcoma.

Health insurance providers, such as Aetna, have placed obstacles in the way of power morcellation usage, requiring precertifications or other limitations for hysterectomies and myomectomies using the power morcellators.

Power morcellation within an intra-abdominally placed bag has been suggested by some minimally invasive surgeons to contain potentially cancerous tissue. Due to the potential safety risk of injury to internal organs due to lack of visualization, this technique is not currently endorsed by ACOG [12].

In May of 2015, the New York Times reported that the Federal Bureau of Investigation was investigating whether in failing to report the risks of power morcellation, the manufacturers, physicians and hospitals had broken the law [13].

In June of 2015, the Wall Street Journal reported that a lawsuit had been filed against Boston's Brigham and Women's Hospital regarding the death in 2013 from disseminated cancer of a woman who had undergone laparoscopic hysterectomy with power morcellation [14].

During the past 2 years, a campaign started by one affected family against the previously frequently occurring usage of power morcellation in gynecologic has led to a strong recommendation from the FDA not to use the technology for most patients, cessation of manufacturing and its banning in the majority of US hospitals. Unfortunately, it was recently reported that Dr Reed has developed a cancer re-occurrence.