There is a great need to return to scientific reason when evaluating minimally invasive morcellation and to move away from the reactionary climate that has surrounded the issue, according to a report published in the March 10 issue of the New England Journal of Medicine.
That climate has now begun to impinge on women's choice of treatment for fibroids because power morcellation is now more difficult to obtain, writes Lisa Rosenbaum, MD, a cardiologist at Brigham and Women's Hospital in Boston and a national correspondent for the journal.
Thus, a woman's autonomy in making her own medical decisions on the basis of a balanced review of risks and benefits of the available treatment options is now a causality of the controversy, she states.
Dr Rosenbaum also argues that the cancer risk associated with power morcellation during minimally invasive surgery for the removal of uterine fibroids has been inflated.
She cites a meta-analysis that found one case of leiomyosarcoma in 8300 surgeries (Gynecol Surg. 2015;12:165-177).
In contrast, the US Food and Drug Administration (FDA) estimated, in a safety communication issued in April 2014, that one in 352 women undergoing surgery for uterine fibroids developed uterine sarcoma and one in 498 developed leiomyosarcoma.
Dr Rosenbaum contends that the FDA used flawed or low-quality evidence in its decision to issue a black-box warning about the procedure.
And another expert agrees.
"The FDA's analysis only captured studies that included cancer cases and did not consider the full spectrum of minimally invasive literature, or morcellation literature," Amanda Nickles Fader, MD, director of the Kelly Gynecologic Oncology Service at Johns Hopkins University in Baltimore, told Medscape Medical News.
Part of the problem is that the type of uterine cancer in question — uterine leiomyosarcoma — is incredibly rare, so studying it can be very challenging. However, Dr Nickles Fader pointed to the meta-analyses conducted after the FDA action, which have shown that the risk for occult sarcoma in women who undergo surgery for presumed fibroids is lower than the FDA estimate.
The controversy erupted in 2013, when Amy Reed, a 40-year-old anesthesiologist and mother of six, underwent laparoscopic hysterectomy with power morcellation at Brigham and Women's Hospital, with the tragic consequence of spreading occult leiomyosarcoma. The tragedy made headlines, and Reed's husband, Hooman Noorchashm, MD, then a cardiac surgery fellow, launched a campaign to ban power morcellators.
The campaign was effective, Dr Rosenbaum writes.
Though several professional societies have issued statements saying that morcellation still has a role in patient care, some medical centers have banned the procedure outright. Johnson & Johnson, the largest maker of power morcellators, pulled its product from the market. Some insurers stopped covering the procedure, and others now require preapproval.
"What has been lost is the opportunity for patient autonomy to weigh risks and benefits," Dr Rosenbaum told Medscape Medical News. "Autonomy is about being able to refuse something you don't want, which I think has been the focus of this controversy. It's also about the ability to say, 'I'm going into this with eyes wide open, recognizing there is a risk, but the benefit for me outweighs the risk'."
Benefits of minimally invasive surgery using power morcellation include less blood loss, less pain, faster wound healing, fewer complications, less scarring, faster return to work, and less lost income.
Level I randomized controlled data show "time and time again" that minimally invasive surgery is "far superior" to open surgical techniques in terms of patient outcomes and mortality, according to Dr Nickles Fader.
"It is very important to stress that all medical procedures have potential risks, and the patient's understanding of risk is really the foundation of medical decision making," she said. "All women making these kinds of decisions about whether to undergo surgery and how to undergo it have the right to self-determination."
"I truly think that women should be able to make their own decisions regarding what's best for their bodies and what surgical approach is going to lead to a better outcome for that individual patient," she stressed.
Already, research is showing evidence of the impact of the FDA black-box warning.
A recent study using the Michigan surgical registry showed that in the 8 months after the FDA decision, open hysterectomy and open gynecologic surgery in general increased significantly. This was accompanied by increases in surgical complications, readmissions, and substandard care, according to Dr Nickles Fader.
Dr Rosenbaum brings up the idea of "information asymmetry," or presentation of only part of the data, which can create an information gap for patients and physicians faced with making medical decisions.
The FDA has a history of creating such "information asymmetry," she writes, with a disproportionate focus on harms caused by using a treatment rather than harms that result from abandoning it. One example is the banning of silicon-based implants in 1992 over concerns about autoimmune disease, even though the research wasn't all in. Data collected in the subsequent 14 years failed to support this claim.
"We know that we should not consider using the morcellation technology when there is a suspicion of cancer, or in postmenopausal women where we know that the risk of cancer increases with age," Dr Nickles Fader said. "This is really about being very nuanced and individualizing decisions based on the patient."
Premenopausal women have an "exceedingly low" risk of developing a uterine sarcoma and are most likely benefit from a minimally invasive procedure, she added.
Another example concerns tamoxifen and breast cancer. Using tamoxifen to treat hormone-positive breast cancer decreases recurrence rates and improves survival. At the same time, it stimulates the lining of the uterus and increases the risk for uterine cancer two- to fourfold, even though the absolute numbers are small, according to Dr Nickles Fader.
"The risk of uterine cancer with tamoxifen is much higher than the risk of uterine cancer from a morcellation," she said, "but we don't use tamoxifen in every woman. We use tamoxifen in women who we know will most benefit from it."
One of the problems is that morcellation has been portrayed as a moral issue, which has thrown scientific reasoning to the wind, said Dr Rosenbaum.
Tragic stories are powerful, she writes. Though the suffering of women affected by uterine cancer should not be discounted, the public's reaction may have trumped evidence-based reasoning, she suggests. The result has been to place the focus on immediate damage, rather than long-term harms caused by reactionary policies influenced by emotion.
In the controversy, Drs Rosenbaum and Nickles Fader both see reflections of a paternalistic impulse to protect "vulnerable" women from a "crime against women" (i.e., morcellation).
The image of the morcellator as an instrument that grinds up tissue is very visual and could understandably be aversive to some people, Dr Rosenbaum pointed out.
"My perspective is that you could just as easily argue that the controversy has taken away women's choice," she said. "This isn't about brutalizing women; that's not the moral problem. It's actually that we've taken away their right to choose how they would want to undergo this procedure."
Dr Rosenbaum and Dr Nickles Fader have disclosed no relevant financial relationships.
N Engl J Med. 2016; 374:986-990. Abstract
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Cite this: Morcellation, Cancer, and Loss of Women's Choice - Medscape - Mar 09, 2016.