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Morcellation Media Monitoring 2/26/2015
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A “profile in courage”: Congressman Mike G. Fitzpatrick (R-PA)?
Feb 23, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm MD, PhD and Amy J. Reed MD, PhD.
Based on our recent personal experience with a deadly medical hazard known as “morcellation”, we’ve been highlighting and fighting to eliminate a very grave public health hazard in the United States. Amazingly, we discovered that the vast majority of medical devices cleared for marketing by the United States Food and Drug Administration (FDA) are neither safety tested, nor subjected to post-market surveillance of adverse outcomes. The “power morcellator”, cleared for marketing by our FDA and used by a large number of gynecologists in the United States and abroad, is one such medical device. It is responsible for, likely, thousands of avoidable, premature or unnecessary deaths of women across the world. -
FDA guidance highlights inappropriate use of power morcellation, but concern about interpretation lingers
Feb 25, 2015 | Healio
By Anthony SanFilippo
An FDA warning about the use of laparoscopic power morcellators to treat uterine fibroids has polarized the gynecologic oncology community. The agency’s “immediately in effect” guidance warns against the use of morcellators in hysterectomies or myomectomies in the majority of women due to the potential that they can spread undetected uterine sarcomas. -
Cancer Risk From Controversial Fibroid Device is Low, Study Says
Feb 25, 2015 | Yibada
By Marie de Vera
A small power tool which is sometimes utilized to remove fibroids in one's uterus may end up spreading bits of the hidden cancerous tumors in the entire abdomen, yet Health News reported that there is a new study suggesting the likelihood is low. -
Are Morcellation Fears Overblown?
Feb 24, 2015 | Outpatient Surgery
By Daniel Cook
The spread of unrecognized cancer during minimally invasive gynecological surgery has occurred in very few women, according to a pair of new studies, which may allay at least some fears about power morcellation's potential risks to patient health.
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Morcellation
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A “profile in courage”: Congressman Mike G. Fitzpatrick (R-PA)?
Feb 23, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm MD, PhD and Amy J. Reed MD, PhD.
We live in a complex world. That means that the truth is not always immediately visible. There’s so much complexity in our world today that a lot of people have given up on the concept that there is such a thing as truth. Everything seems to be relative these days. Everything is about compromise and consensus – about being polite.
But, there remain fundamental truths and injustices in this world worth fighting for. The trouble is that in our relativistic world of “consensus and compromise” very few leaders are willing to really fight for the truth – even when truths and justice are being clearly violated.
Courage seems lacking in American leadership in almost all quarters today – and this may be a systemic problem. We are pretty sure American leadership has become too comfortable and too blunted – punch drunk on our society’s financial success and meaningless cliches.
That’s why when you come across a leader who seems to see the truth and stands up to defend it, you’ve got to take notice and see if they’re for real.
Based on our recent personal experience with a deadly medical hazard known as “morcellation”, we’ve been highlighting and fighting to eliminate a very grave public health hazard in the United States. Amazingly, we discovered that the vast majority of medical devices cleared for marketing by the United States Food and Drug Administration (FDA) are neither safety tested, nor subjected to post-market surveillance of adverse outcomes. The “power morcellator”, cleared for marketing by our FDA and used by a large number of gynecologists in the United States and abroad, is one such medical device. It is responsible for, likely, thousands of avoidable, premature or unnecessary deaths of women across the world.
We vocally reported this unacceptable patient safety hazard to the FDA and several prominent United States senators after our own family was hit by it - including senators Lamar Alexander, Bob Casey, Elizabeth Warren, Jeanne Shaheen, Marco Rubio, Chuck Schumer, and Kristen Gillibrand among others. They all heard the problem and expressed their regret. A few wrote letters to the FDA commissioner. Senator Warren even sent a letter of query to the FDA commissioner. That was all good and we are grateful. But in the face of what history will certainly judge to have been a massive public health hazard and catastrophe, caused by a specific industry and the federal agency regulating it, their responses have been like squirting a water-pistol at a five-alarm fire. It’s just not enough – because many American lives are in deadly harm’s way and many have been irreversibly damaged and lost.
But recently we came across a Pennsylvania congressman who seemed to listen just a little bit more intently. On an icy Saturday morning in his Bucks County office, he listened very carefully for about 2 hours and seemed to see what we were telling him. The few words that he did say included, “that’s not right” and “I’m going to write a letter to the FDA commissioner and I’m going to talk to my colleague on the House Energy and Commerce committee – this may need a hearing” – and then, he wrote a letter!
In this letter to the FDA commissioner, who seems to be retiring, and her interim replacement, he writes: “Since its creation, the 510(k) process has come to dominate the path to market for virtually all Class I, Class II, and some Class III medical devices despite the fact that consumer protection is severely lacking.”
He also writes: “The FDA’s primary focus should be to ensure patient safety.”
He then asks: “Does the CDRH consider the medical device industry as equal stake-holder to patients and consumers in the United States?”
He goes on to write, “The reporting of adverse outcomes associated with the use of medical devices is a requirement set forth in the Code of Federal Regulation, Title 21, Section 803. This requirement was not followed by the manufacturers, practitioners, hospitals, or specialty organizations.“
But, perhaps most remarkably, he concludes his letter by asking the FDA’s commissioner: “Is there any role for the FDA, the HHS Office of Inspector General or the United States Congress to inquire and hold FDA, the device manufacturers or the gynecological specialty organizations accountable for the loss of life in the United States?”
Mike Fitzpatrick’s congressional letter to the FDA commissioner is no water pistol on a 5-alarm fire – it’s a cannon. It's a pointed and specific letter from a legislator that has risen to protect the lives of real people across the United States from his seat in our congress.
We wonder if Mike is alone in the House of Representatives – and we very sincerely hope not.
After having fought for a year to move our federal government and congress to pay attention to a severe public health hazard in the medical device industry, we were about to conclude that our congress lacks courage – some very powerful senators have certainly been equivocal or silent, almost as if our alarm is a theoretical one. Then we came across Fitzpatrick.
You see, it’s very easy for senators and congressmen, to speak of protecting the rights and lives of minority subsets of citizens in harm’s way by corporate and government failure – especially when their target of criticism doesn’t get them elected. It’s very easy to write polite, watered-down letters to protect political “tails” from future criticism for not having spoken out. Its quite another thing to roll up your sleeves, take off your gloves and start slugging when you see the truth violated. And we think Mike may just be aiming to give a few supposed "public servants and healthcare providers" a bloody nose or two. That's the way this question sounds like to us anyway: “Is there any role for the FDA, the HHS Office of Inspector General or the United States Congress to inquire and hold FDA, the device manufacturers or the gynecological specialty organizations accountable for the loss of life in the United States?” Mike has asked, and we think he means it – we think his gloves are off.
You see, it would be very easy for a pro-business republican congressman from Bucks County, PA to just fall in line with industry advocates and kiss up. PA does have a pretty sizable medical device lobby. Some of his colleagues probably think he should. Instead, Fitzpatrick has looked with care and sees his over-arching responsibility as a federal representative to protect the very lives of the American people across our nation. And we think he is poised to remind and convince his colleagues on both sides of the aisle in congress of this basic truth.
Don’t get us wrong, Fitzpatrick is a pro-business republican for sure - but he seems to clearly recognize that the medical device industry in our country has a massive problem and has caused unforgivable harm to subsets of unsuspecting Americans from all walks of life. Ultimately, this systemic hazard not only harms people, it harms our health insurance infrastructure, and it will ultimately damage the device industry itself.
These days, it takes courage to stand before the establishment, money and corporate lobby power to protect individual lives. John F. Kennedy described a few “Profiles in Courage” in his book. We will soon see if Mike is a “Profile in Courage” in the United States House of Representatives – we think he just may be. -
Feb 25, 2015 | Healio
By Anthony SanFilippo
An FDA warning about the use of laparoscopic power morcellators to treat uterine fibroids has polarized the gynecologic oncology community.
The agency’s “immediately in effect” guidance warns against the use of morcellators in hysterectomies or myomectomies in the majority of women due to the potential that they can spread undetected uterine sarcomas.
Soon after the announcement, several large institutions — including Cleveland Clinic and Brigham and Women’s Hospital — stopped performing laparoscopic power morcellation. One leading manufacturer of the devices, Johnson & Johnson, pulled its products off the market.
Yet, intense debate rages among surgeons and clinicians about whether FDA intended for power morcellation to be abandoned entirely, or if the agency intentionally left its guidance vague enough to allow surgeons to perform the procedures in patients who provide informed consent.
“The box warning was expected, but there’s sort of a mixed interpretation,”R. Wendel Naumann, MD, director of minimally invasive surgery in gynecologic oncology at Levine Cancer Institute at Carolinas HealthCare System, told HemOnc Today. “On one hand, there are many patients who either weren’t appropriate or weren’t the best candidates for morcellation, and this guidance highlights that. But, there is some concern with the way it was interpreted by hospitals — and some physicians — who made it even more restrictive than the FDA intended for it to be. That’s how it has been interpreted, but I’m not sure that’s how it was necessarily meant to be interpreted.”
HemOnc Today spoke with several surgeons and clinicians about whether the risks of the minimally invasive surgery outweigh the benefits, as well as the potential that power morcellation or the devices used during the procedure can be improved to reduce patients’ risks. Experts also offered their opinions about the quality of the data on which the FDA warning was based, and whether the agency’s guidance extends too far — or fails to go far enough — to protect women’s health.Data discrepancies
Power morcellation entails the insertion of a tiny instrument with a rapidly rotating blade that grinds up uterine fibroids and allows for their removal via a laparoscope. It allows for a smaller incision, quicker recovery period, fewer side effects and lower rate of morbidity than open surgery.
However, the FDA guidance — issued on Nov. 24, 2014 — recommends manufacturers of laparoscopic power morcellators include a boxed warning to acknowledge the risk that undetected leiomyosarcomas or other malignancies within uterine tissue can be disseminated throughout a woman’s pelvic and abdominal cavities during morcellation, increasing risks for morbidity and mortality.
The guidance also recommends to contraindications be included on product labeling.
One recommendation is to contraindicate laparoscopic power morcellators for women who are peri- or postmenopausal, as well as those who are candidates for en bloc tissue removal through the vagina or mini-laparotomy incision. A majority of the estimated 50,000 to 100,000 women who undergo laparoscopic procedures for hysterectomy annually in the United States meet these criteria.
The guidance also recommends contraindication of the devices during gynecologic surgery in which the tissue to be morcellated is either suspected or known to be cancerous.
Based on quantitative analysis of available data, the FDA estimated that approximately 1 in 352 women who undergo hysterectomy or myomectomy for presumed benign fibroids has an unsuspected uterine cancer, and that 1 in 498 has an unsuspected leiomyosarcoma.
Jason D. Wright
Jason D. Wright, MD, chief of the division of gynecologic oncology and associate professor of obstetrics and gynecology at Columbia University Medical Center, and colleagues conducted a separate study and reached a similar conclusion.
“We looked at more than 36,000 women,” Wright told HemOnc Today. “We found the risk of an occult malignancy as 1 in 368, and that aligns pretty closely with the FDA estimates.”
Other retrospective analyses — including one performed by Elizabeth A. Pritts, MD, an obstetrician–gynecologist at and medical director of Wisconsin Fertility Clinic in Middleton, Wisc., and colleagues — reached a far different conclusion.
“Their initial research identified 41 papers, of which they found nine that were evaluable. Our initial search identified 4,864 papers, and we identified 133 with data that were evaluable,” Pritts said in an interview. “I think the way they ran their meta-analysis was incomplete.”
The FDA data suggests an occult leiomyosarcoma would be found in 2.01 of every 1,000 surgeries, whereas results of the study by Pritts and colleagues — which she presented in November at the American Association of Gynecologic Laparoscopists Global Congress on Minimally Invasive Gynecology — suggested an occult leiomyosarcoma would be found 0.12 in every 1,000 surgeries.
Elizabeth A. Pritts
“Because I was so intimately involved in our statistics, because we had a professional statistician and because we had so many people involved in the analysis of our data, I think our data are closer,” Pritts said. “They may not be perfect, but I think they are the best evidence we have right now, and they are certainly better than theirs because ours are more inclusive. We found more information than they found.”
Naumann made a similar presentation, results of which indicated mortality from laparoscopic hysterectomy with power morcellation — taking possible dissemination of undiagnosed leiomyosarcomas into account — was 0.077%, compared with 0.085% with abdominal hysterectomy.A ‘silly’ debate
The Society of Gynecologic Oncology — which has more than 1,800 members, primarily gynecologic oncologists — issued a statement in July 2014 to the FDA’s Obstetrics and Gynecology Medical Devices Advisory Committee suggesting the FDA based its recommendation in studies included in a retrospective case series with “low-quality evidence.”
“The FDA would not approve a device using such low-quality retrospective data,” the statement read. “It is concerning that the FDA would now consider banning a device with a similar low level of evidence.”
Critics of the FDA guidance say better research could have been performed and allowed for clinicians to interpret subsequent guidance differently.
Jubilee Brown
“I am very concerned that, although we all recognize that some recognition and statement needed to be made by the FDA, this statement in many ways falls short and fails to evaluate some of the more current data that are being produced, all of which is remarkably consistent,”Jubilee Brown, MD, associate professor in the department of gynecologic oncology and reproductive medicine at The University of Texas MD Anderson Cancer Center, told HemOnc Today. “As we saw at the AAGL meeting, multiple different investigators — even from different countries — are showing the same thing: The prevalence rate is very likely less than that quoted by the FDA. Even when we use the data the FDA has, we still are able to model and predict that minimally invasive surgery — even with the risk of morcellation — is safer for the patient in general when appropriately worked up and counseled than open surgery.”
Not everyone shares that opinion.
David Mutch, MD, professor of obstetrics and gynecology and division chief of gynecologic oncology at Washington University School of Medicine in St. Louis, called the debate over the numbers “silly.”
“We have gotten into this mentality that if it’s minimally invasive, it has to be better,” Mutch told HemOnc Today. “That’s not so.”
Patients who undergo open hysterectomy typically spend a day or two more in the hospital — and have a couple extra weeks of recovery — compared with those who undergo the laparoscopic procedure.
David Mutch
“I get that, but if I do that on a thousand 38-year-olds and they stay in the hospital an extra couple days and have a decreased risk for metastatic disease, and then I have just one patient who I morcellate and I contribute to her death at age 38, I have to do a lot of those procedures to make up for that in the teeter-totter of life,” Mutch said.
The FDA guidance — and the multiple interpretations of the data on which the provisions are based — re-energized the risk-vs.-reward debate about power morcellation.
“There’s always a risk,” Naumann said. “The problem is, we always want to make things zero-risk, and we just can’t do that. Every time we get on an airplane, we know there’s a risk of a crash. We do everything we can to prevent it, but it’s going to occur. The question becomes: Is that risk worth the benefit of flying? What are the alternatives? Well, the fact is, driving is not as safe as flying. We have an unrealistic fear of airplane crashes, which is why people are afraid to fly.”
The same is true with cancer, Naumann said.
“When you look at the average mortality from morcellation in the model we created, it’s just over 1 in 10,000 cases, which is lower than the mortality of the hysterectomy itself, and it’s lower than the difference between abdominal hysterectomy and vaginal hysterectomy,” Naumann said.
Still, some surgeons do try to eliminate risk, regardless of how low the likelihood for complications might be.
Mark Wakabayashi, MD, chief of gynecologic oncology surgery at City of Hope does not use power morcellators. When necessary, he morcellates manually to reduce risk.
Yet, a potentially bigger problem is being overshadowed, Wakabayashi said.
“I used to counsel patients [about morcellation] before this all came out,” Wakabayashi said. “If you look at the numbers, we have ovarian cancers where people are offering cystectomies and are spilling the contents, and nobody counsels them. The incidence is even higher than [with morcellation]. It’s interesting how we’re focusing on [morcellation] but [cystectomies] are an even bigger problem.”
Even when morcellation is not used, cancerous uterine fibroids can pose threats. If a fibroid is removed intact and it turns out to be malignant, the chance of recurrence — even for stage I disease — is about 50%.
Mark Wakabayashi, MD, chief of gynecologic oncology surgery at City of Hope, does not use power morcellators. When morcellation is necessary, he does so manually to reduce risk.
Source: Photo courtesy of City of Hope
“[Cases in which] somebody who had a morcellation and had the tumor spread throughout the abdominal cavity are very rare,” Wakabayashi said. “So, I think what the FDA came out with is very reasonable, because they didn’t say, ‘Don’t use it on anybody.”
That is an important distinction, as many surgeons suggest power morcellators still could be viable in certain instances.
“We need to be really careful that the pendulum doesn’t swing too far to one side,” Wright said. “Certainly, there’s a risk with morcellation. That risk is now being recognized and we are better defining that risk. But the corollary to all this … is that morcellation probably does allow some women to undergo a minimally invasive procedure who would otherwise require a laparotomy. That is undoubtedly beneficial.”Menopausal status
About half of the leiomyosarcomas occur in post-menopausal women, and most other uterine cancers occur in post-menopausal women, Brown said.
“If we are able to eliminate morcellation as an option for post-menopausal women, that [alone] will substantially decrease the risk of an undetected malignancy,” she said.
When Pritts read the literature, she was “pretty shocked” how prevalent power morcellation was among postmenopausal women prior to the FDA’s guidance.
“That reflects poorly on the gynecologists,” Pritts said. “We shouldn’t be doing this.”
It is primarily for that reason that Mutch has taken such a strong stance against power morcellation. Surgeons often use it out of convenience rather than practicality, he said.
“They want to do it minimally invasively and that’s their little shtick,” Mutch said. “Sadly, I think perhaps they don’t want to look at the data — or they can’t look at it in an objective way. I don’t know why. The data seems pretty clear. Though rare, the dissemination of sarcoma must be part of informed consent.”
Most clinicians agree postmenopausal women should not undergo power morcellation, and they also agree that premenopausal women are at significantly lower risk, but considerable questions remain with regard to perimenopausal women, who comprise the majority of the population eligible for power morcellation.
The FDA didn’t clearly define “perimenopausal,” instead leaving that part of its guidance open to interpretation.
Some clinicians suggest “perimenopausal” status can begin at age 40 years; others contend it is closer to 45 years. Yet, no conclusive data exist to establish an optimal cut-off between premenopausal and perimenopausal.
“The need for a national registry is huge,” Brown said. “We need to do better in the United States for our patients. It is amazing that, in this country, we only have single-institution retrospective studies or big database studies that are very non-specific and don’t capture a full population. We have no way to know specific outcomes of every person who undergoes this procedure.”Risk-reduction strategies
The debate about power morcellation also has prompted conversations about whether steps could be taken to make the procedure safer, ensuring it remains accessible to patients who understand their potential risks and provide informed consent.
Some of those steps can be taken pre-operatively, yet development of a gold standard for diagnosing something as rare as leiomyosarcoma in uterine fibroids is still a ways off.
Some clinicians favor imaging, whereas others prefer biopsy. Published data suggests the rate of detection of leiomyosarcoma by endometrial biopsy is 38% to 86% (median, 62%).
“That’s really substantial,” Brown said. “No, it’s not a perfect test, and no, it’s not going to pick up every single leiomyosarcoma. But if every person is appropriately screened for menopausal status and with pre-operative biopsy, that will substantially decrease the rate of undetected leiomyosarcoma in patients undergoing morcellation.”
Pritts agreed, but also said MRI can be useful, too. Her retrospective analysis identified 60 reports of leiomyosarcomas. Of those, 56 were diagnosed preoperatively.
Another strategy that had been considered to improve safety was the addition of a containment bag to the end of the morcellator. In that scenario, fibroids would be morcellated inside the bag in the abdominal region to prevent the potential spread of the tissue.
A study of containment bags began last summer at Brigham and Women’s Hospital, but there was controversy because it was initiated without an Investigational Device Exemption, an FDA license that allows for clinical trials with high-risk devices.
Once the FDA issued its guidance, the study was halted.
“If someone develops a morcellator that allows you to put the specimen in the bag and a device that can morcellate it without injuring the bag and can pull it out without any spill, that would be perfect,” Wakabayashi said. “But it has to be something that anybody who does it can reproduce.”
Most clinicians who spoke with HemOnc Today said they would like to see continued study of morcellation with containment bags. Still, some emphasized the greatest concern isn’t necessarily with morcellators themselves, but rather with those who are using them.
“In the six studies we identified, there were 81 leiomyosarcomas that were removed and only three were removed in a power fashion,” Pritts said. “It’s not the power morcellator. … I trained before the morcellator was available, so I have many tricks to remove these fibroids, but some of the newer surgeons only know how to use the morcellator to remove fibroids or large specimens. Basically, this is going to turn all of these cases into either vaginal cases or abdominal cases.”
There are other ways to spread a leiomyosarcoma without a power morcellator, but the FDA only has an authority over the device itself. That is why it is in the spotlight, Pritts said.
“The problem is still with us, though,” she said. “If we do an abdominal case and we use a single-tooth tenaculum and we puncture the leiomyosarcoma during the removal of the uterus, that may indeed spread the cancer cells. [The FDA] only addresses the power morcellation instrument and they don’t address anything else. They don’t address hand morcellation, and they can’t because they are only in charge of the equipment that we utilize.”More data needed
The FDA guidance has created a line in the sand, of sorts, with some surgeons and clinicians lining up on each side.
Some, like Naumann, say they will continue to use the device.
“As an oncologist, I often have to take out the uterus intact because I can’t chop it up or I’m worried about the condition that I am treating,” Naumann said. “I am used to getting rather large uteri out through the vagina, and that can certainly be done. … If you can get the uterus out through a very small incision or through the vagina, you should. It’s very reasonable.”
Others, like Wright, said it would be prudent to pause before considering power morcellation. There still is not enough information to make a decision about the appropriate approach, even if available criteria suggest some patients’ risk is far lower than others.
“I think it’s still an open question,” Wright said. “The big problem with morcellation is this procedure diffused into practice with really minimal data. Now, you are seeing a lot of backlash against the entire technique. I think we need more data to study this to find those groups of women who benefit from this technology.”
Despite her concerns about the FDA guidance, Pritts said some positives could emerge from the recent attention — and criticism — power morcellation has received.
“This may push the medical community — in particular our colleagues in radiology — to really work on finding a pre-operative, diagnostic modality so that we are never taking these patients with leiomyosarcomas to surgery,” Pritts said.
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Cancer Risk From Controversial Fibroid Device is Low, Study Says
Feb 25, 2015 | Yibada
By Marie de Vera
A small power tool which is sometimes utilized to remove fibroids in one's uterus may end up spreading bits of the hidden cancerous tumors in the entire abdomen, yet Health News reported that there is a new study suggesting the likelihood is low.
The researchers refer to the findings as reassuring. However, the fibroid device, which is also known as a power morcellator, remained to be under restricted use.
Until recently, the doctors typically used power morcellators during invasive surgery to get rid of uterine fibroids, the non-cancerous growths found in the uterus wall.
Fibroids are common, yet several women eventually require a surgery to put an end to the symptoms like heavy menstrual bleeding and pelvic pain. Doctors may either perform a hysterectomy for uterus removal or remove the fibroids.
The power morcellator comes with a rotating blade, which breaks apart the growth of fibroids or during the hysterectomy, which is the uterus itself. Then, the tissue will be removed through the tiny incisions.
However, last November, the FDA has issued a strong warning on such devices saying that if women have an undetected cancerous uterine tumor, the power morcellator might spread and could worsen the cancer.
FDA also said that for majority of women with fibroids, the device must not be utilized including those who are going through or already gone through menopause since older age may increase the uterine cancer risk. Yet, the FDA stated that several younger women could still be candidates for having the fibroids removed using the device.
According to US News Health, Dr. Jason Wright, the lead researcher and chief of the gynecologic oncology in Columbia University situated in New York City, said that the recent study was made to know how many women who have remove fibroids could have hidden cancer. His team has looked at the records for almost 42,000 American women who had their fibroids removed from 2006 to 2012. The power morcellator was utilized in over 3,200 cases.
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Are Morcellation Fears Overblown?
Feb 24, 2015 | Outpatient Surgery
By Daniel Cook
The spread of unrecognized cancer during minimally invasive gynecological surgery has occurred in very few women, according to a pair of new studies, which may allay at least some fears about power morcellation's potential risks to patient health.
In November 2014, the FDA issued a warning about the use of power morcellators during fibroid surgery, stating that the devices may spread unsuspected cancer and decrease patients' long-term survival rates.
But a study published in Obstetrics and Gynecology showed a very low incidence of uterine sarcoma among hysterectomy patients. University of Michigan researchers had reviewed 7,499 cases — mostly undertaken for benign reasons — to find that the 2.7% of unexpected gynecologic cancers included only 0.22% were uterine sarcoma. Women with sarcoma were more likely to have a history of venous thromboembolism and pre-op blood transfusions, notes the study.
"We found that there is a risk of unexpected cancer discovery at the time of a hysterectomy for what was presumed to be for a benign or non-cancerous indication, however, the risk is fairly small," says senior author Sawsan As-Sanie, MD, MPH, an assistant professor of obstetrics and gynecology at Michigan.
Dr. As-Sanie says caution is still warranted when planning hysterectomies, but a minimally invasive approach can't be automatically avoided for many women. "Physicians need to balance optimizing technologies that have well-known patient-centered benefits while still being cognizant of the rare but true risk of undiagnosed cancer," she adds.
Another study, published in JAMA Oncology, showed uterine cancer appeared in 0.19% of nearly 40,0000 women who underwent myomectomy without power morecellation and in 0.09% of the approximately 3,000 women who had the procedure performed with power morecellation. Notably, incidence of pathologic abnormalities increased with age.
"Given that older women are at the greatest risk for pathologic abnormalities, electric power morcellation should be approached with caution in patients older than 50 years undergoing myomectomy," the authors write.
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