Recent months have witnessed the eruption of a controversy over the safety of laparoscopic power morcellation, a surgical technique that mechanically fragments tissue to facilitate removal. Now 3 groups – the American College of Obstetricians and Gynecologists (ACOG), the European Society of Gynecologic Endoscopy (ESGE), and AAGL (formerly known as the American Association of Gynecologic Laparoscopists) – have weighed in. These groups have issued statements, all within a week of each other, saying morcellation still has a place in gynecologic surgery, but with stipulations.
The ACOG, ESGE, and AAGL statements come in response to a US Food and Drug Administration (FDA) safety notice issued April 17 discouraging the use of laparoscopic power morcellation in hysterectomy or myomectomy. The FDA based its decision on an analysis of data linking laparoscopic power morcellation to an increased risk of disseminating occult malignancy into the abdominal and peritoneal cavities.
Laparoscopic power morcellation “poses a risk of spreading undetected cancerous tissue, notably uterine sarcomas, beyond the uterus,” the notice states. Because of this, “the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
In its safety communication, the FDA instructed manufacturers of power morcellators used for gynecologic procedures to review their product labeling for accurate risk information and issued several recommendations for women and healthcare professionals. On April 30, Johnson & Johnson pulled its laparoscopic power morcellator from the worldwide market.
Morcellation as a surgical technique has been around for decades, with the first power morcellator for gynecologic use receiving FDA approval in 1995. About 600,000 hysterectomies are performed annually in the United States, according to the Centers for Disease Control and Prevention, and of that group, the FDA estimates that the number of power morcellations ranges from 50,000 to 150,000 each year.
In 2012, a study published in PLOS ONE may have sparked the current controversy. The study suggested that the rate of undetected leiomyosarcomas among women undergoing power morcellation for fibroids was 9-fold higher than commonly believed, suggesting a higher risk of spreading undetected cancer than previously suspected.
In 2013, the issue became highly publicized when the Wall Street Journal published a story about Amy Reed, MD, an anesthesiologist at Beth Israel Hospital in Boston and mother of 6. Dr. Reed was found to have occult leiomyosarcoma while undergoing minimally invasive hysterectomy using morcellation for fibroids, a procedure that may have worsened her prognosis. Since then, Dr. Reed’s husband, cardiothoracic surgeon Hooman Noorchashm, MD, has become a vocal advocate for banning morcellation.
After that, the controversy gained momentum. Later in the year, the Society of Gynecologic Oncology published a statement saying that women with premalignant conditions should not undergo morcellation and that physicians need to thoroughly inform patients of the risks involved.
In January 2014, the AAGL established a task force both to collect information from practitioners regarding their use of tissue extraction techniques and to review literature on the risks and benefits of these procedures. Since then, hospitals in at least 2 academic medical centers – Temple University in Philadelphia, Pennsylvania, and Brigham and Women’s Hospital in Boston, Massachusetts – have required the use of surgical bags during procedures using power morcellation.
Expert opinion has also drawn attention to this issue, including a February editorial published in the Lancet Oncology quoting a 1 in 400 risk of morcellating an undetected tumor and calling this risk “unacceptable.”
Rarity of Uterine Cancers
One of the issues is the rarity of these types of cancers. The American Cancer Society estimates that more than 52,000 cases of uterine cancer are newly diagnosed each year, although only about 1600 of these turn out to be uterine sarcomas. In its report, however, the FDA estimated that 1 in 350 women undergoing surgery for fibroids have undetected uterine sarcoma.
A central concern, then, is balancing the risks of disseminating a rare, occult malignancy against restricting women’s access to a technique from which they could benefit. Laparoscopic hysterectomy or myomectomy minimizes operative risks of open surgery, which include infection, bleeding, deep vein thrombosis, nerve injury, genitourinary or gastrointestinal injury, and overall longer postoperative recovery time. Women who undergo abdominal hysterectomy have 3 times the mortality rate of those who undergo laparoscopic hysterectomy, according to an article published in the May 2013 issue of Gynecological Surgery.
In contrast, samples obtained via morcellation may be more difficult to evaluate, complicating diagnosis and staging. Moreover, morcellation carries the risk of spreading ectopic tissue, such as endometriosis and ovarian tissue, into the abdominal cavity, requiring further treatment. More seriously, occult malignancies disseminated via morcellation carry the risk of upstaging undiagnosed cancer and worsening patient prognosis.
For example, the 5-year survival rate for stage I leiomyosarcoma hovers around 60%, whereas more advanced disease carries about a 15% 5-year survival rate. To complicate matters, physicians possess woefully inadequate means to differentiate between benign and malignant uterine masses preoperatively.
“Although the risk of a presumed fibroid being a sarcoma is considered very small, morcellation may upstage a uterine sarcoma confined to the uterus by spreading the sarcoma cells in the abdominal cavity,” the ESGE said in its May 3 statement.
“As abandoning power morcellation of fibroids can seriously affect the [minimally] invasive approach in surgery for women, the literature on this subject must be [conscientiously] reviewed to estimate the extent of the risks,” the ESGE concludes. The statement emphasized that physicians should inform patients about the rarity of these types of cancer while also discussing the potential risks involved with morcellation.
A special committee of the ESGE will gather to review literature on the topic, propose recommendations, and define future research directions. The ESGE plans to present its findings at scientific meetings, as well as to publish the final review paper on its Web site and in Gynecological Surgery.
On May 8, the AAGL went a step beyond the FDA and ACOG by issuing new guidelines on morcellation during uterine tissue extraction. On the basis of a critical review of the literature, the AAGL guidelines discuss types of tissue extraction other than power morcellation, including morcellation with a scalpel or using a bag, mini-laparotomy, laparotomy, and vaginal extraction.
The guidelines point out that the risk for undetected malignancy seems to be “extremely low,” especially in reproductive-aged women. Because the majority of diagnoses for uterine cancer occur among postmenopausal women, the guidelines recommend that physicians consider alternatives to power morcellation in such women.
Other points include a focus on uterine leiomyosarcoma, the incidence of which among women undergoing uterine surgery remains little known, and a discussion of the technical drawbacks and limited research surrounding morcellation bags. The AAGL reinforced recommendations of other groups about the importance both of informed consent and of thorough discussion of the risks and benefits in women for whom morcellation remains an option.
“It is the opinion of the AAGL that all existing methods of tissue extraction have benefits and risks, which must be balanced,” the statement says. “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.”
Key points of the AAGL guidelines include:
- Do not perform morcellation in risk-reducing surgery or in women with known malignant or premalignant conditions.
- Use morcellation only after appropriate and reassuring evaluation of the myometrium, cervix, and endometrium.
- Use alternatives to morcellation in women with suspected malignancy.
- Consider alternatives to morcellation in postmenopausal women, who have an increased risk for uterine malignancy.
- Obtain informed consent, including a thorough discussion of risks and benefits, from women considering electromechanical morcellation.
- Use of bags during morcellation requires “significant skill and experience,” and the safety and outcomes regarding their use require further study.
The ACOG statement, issued May 9 in conjunction with its special report, “Power Morcellation and Occult Malignancy in Gynecologic Surgery,” presented a recent review and analysis of the scientific evidence regarding power morcellation and undetected malignancy in gynecologic surgery.
A risk analysis included in the report highlights the challenges of determining the risk of spreading occult uterine sarcoma, given studies limited by small sample size, age variability, and lack of age stratification. Preoperative evaluation, the report pointed out, should include cervical cytology. Depending on patient presentation, evaluation could also include pelvic imaging and endometrial assessment, although the report also noted that no preoperative diagnostic imaging tests can reliably diagnose uterine sarcoma.
In addition, physicians should consider risk factors, such as patient age, menopausal status, uterine size, and presence of rapid uterine growth, as well as a history of treatments such as tamoxifen or pelvic radiation and hereditary conditions such as Lynch syndrome or hereditary leiomyomatosis and renal cell cancer. Careful preoperative evaluation, however, does not completely rule out occult malignancy, the report warns.
According to the ACOG report, physicians need to thoroughly discuss risks and benefits, as well as alternatives to power morcellation, with their patients. Alternatives include removal of intact tissue through mini-laparotomy, laparotomy, and colpotomy incisions, as well as total abdominal hysterectomy, vaginal hysterectomy, and laparoscopic vaginal hysterectomy.
Other treatments, such as catheter-based artery embolization and high-intensity focused ultrasound, lack sufficient evidence to support their benefits, the report said, and could delay proper diagnosis. Likewise, insufficient evidence supports the use of a bag during morcellation procedures. Bags carry limitations, the report mentioned, such as being the wrong size, being prone to tearing, and decreasing visualization, which increases the risk for injury to surrounding tissue.
“The potential risk of morcellating an undiagnosed uterine, endometrial, or cervical malignancy is currently very difficult to calculate,” the report states. “Minimally invasive surgery, including with power morcellation, continues to be an option for some patients when performing hysterectomy or myomectomy. At the same time, it is critical to minimize the risks for patients undergoing these surgeries who may have an occult gynecologic cancer.”
Key points from the ACOG report include that:
- Minimally invasive surgery, including the use of power morcellation, should still be an option for some women undergoing hysterectomy or myomectomy.
- Women with known uterine cancer, or for whom there is a high suspicion of it, should not receive power morcellation.
- Women for whom power morcellation is an option should have careful preoperative evaluation for occult malignancy.
- Patients require counseling about the risks, benefits, and alternatives to treatment with morcellation. Informed consent should be obtained.
In the report, ACOG called for:
- more research to develop better and more reliable preoperative diagnostic tests for uterine malignancies;
- the development of more effective and safer techniques for reducing the risk of spreading tissue during morcellation;
- continued emphasis on training, including techniques for morcellation, pathological evaluation, and diagnosis of tissue fragments extracted via morcellation, as well as better ways to evaluate clinical indications for morcellation; and
- a request to the FDA to establish a national registry on gynecologic power morcellation to fill the gap in data on preoperatively undiagnosed uterine sarcoma.
The FDA plans to convene an advisory committee meeting on power morcellation, which representatives of ACOG plan to attend. Issues for discussion may include adding a boxed warning about the risk of spreading cancer to the product labeling for laparoscopic power morcellators, the efficacy of morcellation bags, and the use of power morcellation in treating uterine fibroids.