Morcellation, a surgical technique that fragments tissue to facilitate removal through a small incision, has been done routinely by gynecologic surgeons since the US Food and Drug Administration (FDA) approved the first power morcellators in the 1990s. The procedure came under scrutiny in October 2013 when Boston-based cardiothoracic surgeon Hooman Noorchashm, MD, PhD, launched a campaign calling for a ban on morcellation after his wife had an unsuspected uterine leiomyosarcoma morcellated during what was supposed to be a routine hysterectomy. The procedure caused the leiomyosarcoma to progress to stage IV uterine cancer.
Since then, several hospitals have issued guidelines regarding the use of power morcellators. Some institutions, for example, only allow that they be used inside an isolation bag.
The FDA has responded to the controversy by announcing in April that laparoscopic power morcellators should no longer be used for hysterectomy or myomectomy in most women with uterine fibroids. This was followed by a meeting in July during which an FDA advisory panel called for greater restrictions on the use of morcellators because of the risk of spreading unsuspected cancerous tissue.
Most recently, Johnson & Johnson announced that it is voluntarily withdrawing its power morcellators from the market.
Medscape asked 4 physicians to discuss how gynecologists should move forward given these recent events. They include:
• The aforementioned Hooman Noorchashm, MD, PhD, a lecturer on surgery at Harvard Medical School and a cardiothoracic surgeon at Brigham and Women's Hospital in Boston, who has led a campaign calling for a ban on morcellation;
• Larry R. Kaiser, MD, a thoracic surgeon and Dean and Professor of Surgery at Temple University School of Medicine in Philadelphia, and President and CEO of Temple University Health System. In February, the Department of Obstetrics and Gynecology at Temple placed several restrictions on the use of morcellation, including directing surgeons to do so only within an isolation bag.
• Antonio R. Pizarro, MD, a gynecologic surgeon based in Shreveport, Louisiana; and
• Joseph Ramieri, MD, associate professor of obstetrics & gynecology and reproductive science at Icahn School of Medicine at Mount Sinai in New York City and chairman of OB/GYN at Morristown Medical Center in Morristown, New Jersey.
Medscape: Is there a way to make morcellation safer?
Dr. Noorchashm: No. When there is a possibility of an occult or missed malignancy being present, morcellation is never safe because once cancer is disrupted within a body cavity, it can -- and in most cases, does -- spread. A fundamental principle of surgery, especially when there is any possibility of a cancer being present, is en bloc resection of the diseased tissue with good margins.
Dr. Kaiser: As it currently stands, there is no way to make morcellation safer because a diagnosis of occult sarcoma in a fibroid tumor cannot be made prior to excision. The far bigger point is that morcellation violates a basic surgical principle of not "spilling" anything that may be tumor. As surgeons, we strive to remove a mass intact, not in pieces. It is far safer and certainly makes oncologic sense. Some have argued and advocated the use of a containment bag to allow for morcellation to be carried out, but these bags were never intended for that purpose and are subject to breakage. Similar to universal precautions, the safest approach is no morcellation within a body cavity.
Dr. Ramieri: One of the questions that come to mind is myomectomy, either for infertility or for symptomatic fibroids in a patient who desires future childbearing. Myomectomy could easily spread intraperitoneal disease as could morcellation.
Dr. Noorchashm: Uterine-sparing operations where there is any possibility of cancer spreading (ie, myomectomy) must be preceded by biopsy to make a best attempt at ruling out cancer, either pre-op image-guided biopsy or intra-op biopsy. This is what many general and thoracic surgeons do when confronted with masses of unknown significance. Gynecologic surgeons must adopt a similar policy for uterine-sparing operations. Fundamentally, universal precautions must be taken in operating on any tissues with malignant potential. Always assume the worst when there is a possibility of cancer being present, to protect every one of your patients.
Dr. Pizarro: The issue with myomectomy is that if we accept the FDA's oncologic premise, it cannot be performed in women who want to conceive in the future. The FDA reminds us in its Safety Communication of the unassailable, uncontroversial reality that "there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma."
Adherence to FDA's oncologic premise mandates that in the absence of irrefutably reliable pretreatment exclusion of hidden sarcoma, immediate hysterectomy without morcellation would be the only logical treatment for a woman with bleeding, growing, or painful fibroids. Otherwise, a hidden, aggressive sarcoma will go untreated and kill that woman.
Dr. Noorchashm: I would argue that developing new protocols combining preoperative imaging with preoperative or intraoperative biopsy will permit uterine-sparing operations to be performed with a reasonable degree of certainty. In either case, the argument posed by Dr. Pizarro does not justify continuing the practice of morcellation, and it certainly does not render morcellation safe. The incontrovertible reality that the gynecology specialty must face with courage is that for nearly 2 decades, it was almost entirely downplaying the fact that symptomatic fibroids carry malignant potential. The hazard of morcellation to a minority subset of women with occult or missed uterine cancers is simply too high for any reasonable physician to accept the practice and devices designed to support it.
Dr. Pizarro: Presurgical testing is fantasy. If reliable, validated testing becomes available one day, and hidden sarcoma can be excluded, then any treatment would be acceptable. On the other hand, if pretreatment evaluation is unable to exclude sarcoma to an acceptable degree, then no treatment that allows for a hidden sarcoma to remain inside the patient is safe. Hysterectomy on presentation would be the only acceptable treatment, lest a hidden sarcoma go untreated.
This is not about morcellation; it's about sarcoma. The same number of hidden sarcomas will be here tomorrow if we eliminate all morcellation today. What do we do for those women? Fertility-sparing myomectomy is not acceptable for a woman with hidden, lethal sarcoma.
Dr. Ramieri: Most cases of symptomatic fibroids have multiple myomata, and doing needle biopsies of each myoma pre-op is untenable. If fibroids are viewed as potentially malignant, we may be obliged to do total hysterectomies whenever we find them. This is not about morcellation only; it is about our approach to the diagnosis. As I see it, we are facing a conundrum.
Dr. Noorchashm: But you must explain why, if general and thoracic surgeons are able to perform pre-op and intra-op biopsies to diagnose cancers effectively, gynecologic surgeons are unable to do so.
Dr. Pizarro: We do so all the time for those diseases in which a validated test is feasible, safe, and effective. In endometrial, cervical, vaginal, and vulvar cancer we perform directed testing that is validated, proven, and accurate. This has simply not been developed for uterine sarcoma despite decades of effort by researchers around the world. Neither can ovarian cancer be presurgically tested despite the efforts of many. Suggestions that a simple biopsy be performed as if we hadn't thought of it, or as if we're not industrious enough to consider it, are needlessly tendentious and reveal a stunningly superficial understanding of the very nature of this aggressive and elusive disease that behaves exactly as fibroids until it is too often too late.
Morcellation is not safe for a woman with sarcoma. Neither are a myriad other mainstream, accepted treatments for fibroids: myomectomy, uterine artery embolization, ultrasound treatments, medical therapy. None of these can be made safe for a woman with sarcoma. They are all oncologically equivalent. I have yet to hear a call for a ban on these treatments. Informed analysis of FDA's oncologic premise mandates such a ban.
The FDA also asserts that "there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma." Taking Dr. Noorchashm's advice to also reject that diagnostic assertion by the FDA would then leave very little substantive text on the FDA Safety Communication on which the care of women could be based.
Medscape: What effect would a morcellation ban have on women seeking treatment for fibroids?
Dr. Noorchashm: The FDA statement is specifically focused on the oncologic hazard of morcellation. The risks of any other procedures will need to be independently assessed. But I do agree with your fundamental premise that in the absence of an oncologic diagnosis, any procedure that leaves tissue behind is potentially dangerous. Our purpose here, however, must be to focus on the issue at hand: Is morcellation oncologically safe? And is it ethical and correct for the gynecology community to continue performing it as a practice?
Dr. Pizarro: Your assessment that "any procedure that leaves tissue behind is potentially dangerous" supports the reality that FDA's oncologic premise leaves only one treatment for women with painful, bleeding fibroids: hysterectomy upon presentation, lest a hidden sarcoma go untreated.
Dr. Ramieri: I believe that Dr. Noorchashm's efforts have been extraordinarily effective in curtailing the use of the morcellator for the treatment of fibroids, and I know of no institutions that are currently permitting its use for this purpose. I think the real question at hand is, what modalities are now available to us for treating symptomatic fibroids, other than total hysterectomy?' We also must address the issue of asymptomatic fibroids, which, for all we know, may be harboring an early sarcoma.
Dr. Pizarro: I entirely agree. However, I would suggest also that it is the FDA, not Dr. Noorchashm, that has unthinkingly created confusion and blocked the path for the care of women with fibroids. Hundreds of thousands of women are hospitalized annually for fibroids. How do we help those women, now that the FDA has labeled fibroids as cancerous? There has been very little critical analysis of the overwhelming implications of FDA's oncologic premise.
And what about the millions upon millions more who have fibroids without symptoms? Sarcoma can be silent until it's too late. Forty percent of women have fibroids, and as many as 60% of African American women have fibroids by age 35. If we accept FDA's oncologic premise, how can we allow those women to go with untreated hidden sarcoma? Sarcoma is highly lethal and aggressive. What do we do now?
The only reasonable conclusion of that premise is that a high risk for sarcoma disallows any treatment that is not safe for sarcoma. Myomectomy is not safe for sarcoma. Uterine artery embolization is not safe for sarcoma. Medical (leuprolide, oral contraceptives) therapy is not safe for sarcoma. Ultrasound ablation is not safe for sarcoma. Endometrial ablation is not safe for sarcoma. In fact, FDA regulates many of these. Now what?
Dr. Noorchashm: Biopsy.
Dr. Pizarro: Perhaps one day - perhaps decades from now -- there will be a way to detect uterine sarcoma without surgery. But now, it is irresponsible and entirely without merit to suggest that we can detect sarcoma with biopsy or imaging. FDA makes this very clear in its Safety Communication. What do we do now for women who wish to preserve fertility? Uterine sarcoma is not prostate cancer or breast cancer. The uterus and other organs are neither similar nor analogous. Until sarcoma can be detected, the overwhelming logical conclusion of FDA's assessment is that all of the countless millions of women with fibroids carry a high risk for undetectable sarcoma.
Medscape: During a previous Medscape interview, Dr. Noorchashm mentioned that he'd like to change the way gynecologic surgeons are trained. Could you respond to his comments?
Dr. Pizarro: All specialties can benefit from ongoing improvements in training. However, the sweeping, ad hominem premise of this defamatory assertion is not intended to elicit a constructive answer. This misbegotten commentary is instead an illegitimate attempt to label obstetrics/gynecology as a failed specialty. I don't remember seeing any silos during my training. We focused on the care of women.
Nonetheless, I propose an exercise for anyone who questions the degree to which the science of women's reproductive care has benefitted its patients. I invite them to ask the opinion of any of the countless millions of women worldwide across generations who have been helped by those who practice OB/GYN and its subspecialties. Ask any of these women how their lives have been improved and very often saved -- with or without surgery. Then form your conclusions.
Dr. Ramieri: I agree with Dr. Pizarro's comments and find Dr. Noorchashm's characterizations of gynecologic surgeons to be patronizing and offensive. I have worked with many gynecologic surgeons who were/are far superior to their general surgeon colleagues.
Dr. Noorchashm: I will respond to your, perhaps understandable, indignation with a query. Please explain how and why gynecologic surgeons have adopted a practice that is a violation of every sound principle of general and oncologic surgery. My answer is undereducation in the principles of general surgery.
Dr. Pizarro: Morcellation does not cause sarcoma; it spreads a sarcoma that is already growing. Stopping all morcellation today will not decrease the number of women with fibroids who carry hidden, lethal uterine sarcomas. The FDA has not previously considered fibroids to pose a high risk for sarcoma. Because of this, over many years FDA has approved "treatment options" for fibroids to help women avoid hysterectomy. None of FDA's "treatment options" are safe or effective care for women with hidden, highly lethal sarcoma.
FDA's Communication against power morcellators must be amended to unambiguously specify that its clinical justification is inarguably peculiar to power morcellators, logically exclusive of all treatments that do not use power morcellators. Otherwise, the FDA must likewise warn against its own "alternative treatment options" and call for system-wide hysterectomy guidelines to this effect, and advocates for the Safety Communication in its current form must do the same.
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Cite this: Debate: Should Morcellation for Hysterectomy and Myomectomy Be Banned? - Medscape - Aug 01, 2014.