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Morcellation Media Monitoring 2/20/2015
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Language of deception in gynecology: The devil at work
Feb 20, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm MD, PhD and Amy J. Reed MD, PhD
We have recently been immersed in a very big fight to protect women across the United States, and worldwide, from the spread of cancer by a common gynecological practice known as “morcellation”. It’s used to extract enlarged tumors of the uterus through small incisions by mincing them up inside the patient’s body. Unfortunately for about 2-3 out of every 100 of these women, an unsuspected cancer is present and can be spread and upstaged, with potentially deadly consequences. -
How Morcellators Received an Endorsement from a Medical Society
Feb 19, 2015 | Wall Street Journal - Pharmalot
By Ed Silverman
Last May, as controversy mounted over a surgical device called the power morcellator, a professional association for surgeons issued a report defending the tool. The report arrived just one month after the FDA warned the device could spread cancer in surgeries, such as hysterectomies. -
New estimates of uterine morcellation risks
Feb 19, 2015 | The Philadelphia Inquirer
By Marie McCullough
The dangers of a power tool used in gynecological surgery have been debated for more than a year, with experts offering varying estimates of the chance that an undetected uterine cancer would be spread - and likely worsened - by the tissue-slicing device. -
Cancer risk low in women with fibroids removed using morcellator
Feb 19, 2015 | Bloomberg
By Anna Edney
Women who had uterine fibroids removed with or without a medical device that chops up the growths had a low prevalence of cancer, a study found, adding new data to debate over risks from the technique. -
Low Cancer Risk With Device Used to Remove Fibroids, Study Finds
Feb 19, 2015 | U.S. & World Report News - Health
By Amy Norton
*Note: This article was also recirculated on Web MD and Philadelphia Inquirer A small power tool that is sometimes used to remove fibroids in the uterus can end up spreading bits of hidden cancerous tumors throughout the abdomen, but a new study suggests the likelihood is low. -
Morcellation: Uterine Cancer Risk Low, Increases With Age
Feb 20, 2015 | MedScape
By Veronica Hackethal, MD
Electric power morcellation is the fragmentation of tissue to facilitate removal during minimally invasive surgery. Surgeons use the technique in laparoscopic myomectomy and hysterectomy for benign fibroids. However, the technique has come under scrutiny because of the possibility of fragmenting occult malignancy, with the potential for spreading and upstaging disease. The controversy began after a patient who underwent uterine morcellation for presumed benign leiomyoma was later found to have leiomyosarcoma, and the morcellation procedure had spread her cancer. -
Uterine cancer low in myomectomy with power morcellation
Feb 19, 2015 | Family Practice News
By Jennifer Shepphird
Electric power morcellation facilitates the excision of uterine leiomyoma in minimally invasive surgery. Its use has received increased scrutiny after a patient underwent hysterectomy with electric power morcellation for presumed benign leiomyoma that was, in fact, a uterine sarcoma, which was disseminated. The case has prompted an evaluation of electric power morcellation safety in performance of hysterectomy and myomectomy. -
Know the Risks of Your Uterine Fibroid Surgery
Feb 19, 2015 | Daily Rx News
By Katie Chamberlain
*Note: Daily Rx News has a video embedded into the article that summarizes Dr. Jason Wright's work and reiterates that doctors should use morcellation on older women with caution. Not all patients face the same risks from the same surgeries. Such is likely the case with surgeries to remove benign uterine tumors. A recent study found that electromechanical morcellation (EMM) use during a myomectomy had little effect on adverse outcomes like cancer. Older patients undergoing this surgery may face a raised cancer risk, however.
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Language of deception in gynecology: The devil at work
Feb 20, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm MD, PhD and Amy J. Reed MD, PhD
The words we use matter. Our rhetorical characterizations and the language we use matter. Because they define our understanding of the reality we live and act in. Words are powerful.
We have recently been immersed in a very big fight to protect women across the United States, and worldwide, from the spread of cancer by a common gynecological practice known as “morcellation”. It’s used to extract enlarged tumors of the uterus through small incisions by mincing them up inside the patient’s body. Unfortunately for about 2-3 out of every 100 of these women, an unsuspected cancer is present and can be spread and upstaged, with potentially deadly consequences.
Sounds terrible. Right?
And, one would think it’s simple enough for any reasonable person, especially doctors, to stop doing this “morcellation” – after all it is totally avoidable and potentially deadly. But unfortunately, this is not the case. High ranking leaders of gynecological surgery and even the doctors who are now analyzing the data and admitting that the risk is far higher than previously thought are failing to abandon this practice. They are using language and words to deceive themselves and the public into believing that their comfortable practice is justified and correct.
So let’s analyze their words.
They are saying that the risk of occult or missed uterine cancer in women with symptomatic fibroids is “low”. But is “2.7 percent” or almost 3 out of 100 women at risk of having deadly cancers upstaged really a “low” number? Of course not! But when a professional in a nice white coat characterizes it like that for an unsuspecting patient, guess who accepts the risk as “low”? It’s the woman - whose cancer will be spread and upstaged, a human sacrifice to the altar of irresponsible language.
They are saying that this potentially deadly practice is a “woman’s choice”. Of course the words “women’s choice” are now sacred bastions of progress in our society. What woman would want her “choice” taken away in America? But what ethical doctor would ever offer a patient an avoidable but potentially deadly treatment under the guise of “women’s choice”? It’s reprehensible when sacred words, like “women’s choice”, get hijacked by an industry to sell a lucrative, but potentially deadly product to women – another human sacrifice to the altar of deceptive language.
They are saying that this potentially deadly practice “benefits the majority”. Of course these words are tightly linked to our society’s sanctification of majority rule – or “democracy”. And of course morcellation may have some benefit and comforts for “the majority” of women. But does that make it right? You see, slavery used to “benefit the majority” too, but it was a horrific lapse of human judgment and ethics. Professionals’ use of the “benefit of the majority” argument to justify an unacceptable and deadly cost to a minority subset of people is more than deceptive - it’s criminal. And this crime is masked and sugarcoated by the sweet democratic language of “majority benefit” – another sacrifice to the altar of deceptive language.
They are saying that morcellation is the same as “minimally invasive” surgery. It is not. And “minimally invasive” surgery is great because it leaves small scars behind, there’s less bleeding and fewer hospital days. Is mincing up and emulsifying tumors inside a patient’s body for the purpose of extracting the tissues from small incisions “minimally invasive”? We would suggest that to any reasonable person, morcellation is “maximally invasive” surgery through small skin incisions. Again language, used to paint a deceptive picture for unsuspecting patients.
Finally, and perhaps most importantly, the gynecologists use the word “hysterectomy” to describe resection of the uterus in women. This word finds its origin in the root “Hysteria”. And the suffix “-ectomy” means removal or resection. So in other words a “hysterectomy” is the removal of the source of hysteria – the uterus. Everyone seems to have accepted the unacceptable when it comes to the word “hysterectomy” – after all “morcellating” the seat of “Hysteria” might be just fine. Just like back in the day, people of African American origin, American-Indians and women were classified using derogatory and dehumanizing language to justify great wrongs. How dehumanizing! How atrocious! But the truth is that when our language is constructed and used in insensitive and dehumanizing ways it becomes very easy for society to act in an insensitive and dehumanizing way to suit. You see “hyster-ectomy” doesn’t sound like such a big deal, and it even subliminally suggests that it’s rooting out hysteria. But “uterine resection” is more precise, respectful and correct. Why aren’t gynecologists using the precise, respectful and correct language? We think it’s because of traditional societal prejudice against women – and of all fields of medicine it’s persisting in gynecology?! Isn’t it time gynecologists start using respectful terminology to refer to women whose uterus is in need of surgical management? It is the year 2015, after all.
So let’s rehash the rhetorical defense of morcellation: “The use of morcellation for ‘hysterectomy’ makes ‘minimally invasive gynecology’ possible. It is a good thing because it ‘benefits the majority’, and because it respects ‘women’s choice’”.
But, language is also powerful enough to expose the truth: “The use of morcellation during resection of the uterus using laparoscopic or robotic operations makes small incision surgery a routine in gynecology. However, morcellation will cause the spread and upstaging of unsuspected cancers in nearly 3 out of 100 women. It is an ethically unacceptable practice because it causes the avoidable, premature or unnecessary death of an unsuspecting minority subset of women by upstaging their cancers.”
You see language is a powerful device. It can expose the truth. Or it can create great deception. The devil himself used language to cause humanity’s fall from grace – and he hasn’t stopped since he started.
Read more at http://www.philly.com/philly/blogs/healthcare/Language-of-deception-in-gynecology-The-devil-at-work.html#LXrqXxL1bcmWf6Xt.99 -
How Morcellators Received an Endorsement from a Medical Society
Feb 19, 2015 | Wall Street Journal - Pharmalot
By Ed Silverman
Last May, as controversy mounted over a surgical device called the power morcellator, a professional association for surgeons issued a report defending the tool. The report arrived just one month after the FDA warned the device could spread cancer in surgeries, such as hysterectomies.
Yet the report from the AAGL – once known as the American Association of Gynecologic Laparoscopists – declared that morcellation “remains safe when performed by experienced, high-volume surgeons.” Those words were influential because doctors look to such reports for guidance on these devices, which cut and remove tissue through small incisions.
But doctors who read the report did not know that an AAGL executive officer who received consulting fees from a morcellator maker had sway over the publication, according to The Wall Street Journal. The officer, a surgeon named Arnold Advincula, joined the board’s final discussions about the report, raising concerns among some in the group’s leadership, according to documents reviewed by the paper.
His involvement violated conflict-of-interest policies, according to a May 7 e-mail sent by Ceana Nezhat, who was AAGL president at the time, to the AAGL executive director and medical director. “Given the importance of COI surrounding this topic,” he wrote, “and the potential press involvement in dissecting COIs of our board members in relation to morcellation, I am shocked the organization would allow their own policies to be ‘flexible.’ ”
When asked about this, an AAGL spokeswoman told the paper that “it is inevitable there is sometimes going to be conflicting and different points of view,” and added that AAGL ”should and does listen to all points of view before it reaches its formal position and guidance to our 7,500 members.” She declined to comment on internal documents, however.
As for Advincula, the AAGL spokeswoman said on his behalf that the board decisions were “the result of input from many board members.” Advincula, by the way, is chief of gynecological surgery at Columbia University Medical Center and has held several leadership roles at the organization since 2012 and has been president since December.
The episode is only the latest instance in which guidelines followed by the medical community were formulated or reviewed beforehand by experts with ties to manufacturers that have a stake in the final wording. In past years, the issue emerged with guidelines that were developed for prescribing drugs to control obesity and cholesterol, raising concerns about undue industry influence on medical practice.
The disclosure comes on the heel of controversy over the devices. Morcellators made headlines last year after a number of women reported their health worsened after undergoing procedures. Specialists argued that doctors and device makers, while playing up the benefits of the devices, overlooked the risks. And, the Journal wrote at the time, the U.S. medical system failed to disclose the risks to women.
The AAGL, meanwhile, had begun strengthening its conflict-of-interest provisions in 2013, when it adopted a policy forbidding executive-committee members from paid work for drug or device makers, the paper writes. But Advincula and other incumbents on the committee were exempted under a grandfather clause that Advincula lobbied for, according to the Journal.
For 2014, the Columbia University website, by the way, reports that Advinculareceived at least $50,000 for speaking and other services in the prior 12 months from Blue Endo, which sells morcellators. What else took place? You can read the rest of the story here.
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New estimates of uterine morcellation risks
Feb 19, 2015 | The Philadelphia Inquirer
By Marie McCullough
The dangers of a power tool used in gynecological surgery have been debated for more than a year, with experts offering varying estimates of the chance that an undetected uterine cancer would be spread - and likely worsened - by the tissue-slicing device.
Now, two new studies have waded into the controversy.
Using a nationwide insurance claims database, Columbia University researchers looked at women treated for uterine growths called fibroids. Uterine cancer was discovered in one out of every 1,073 who underwent power morcellation, and one out of 528 without morcellation.
In the second study, University of Michigan researchers used a statewide hospital group database and found that among women undergoing hyterectomy for presumed benign conditions, 1 in 454 actually had uterine cancer. The study could not tell whether electric morcellators were used.
Both studies characterized the risk of discovering unexpected cancer as small.
For Hooman Noorchashm, the physician who set off the debate after the worst-case scenario befell his wife, trying to quantify the harm of power morcellation misses the point.
The new studies are "adding to a collage of estimates that are trying to sugar-coat this practice" said Noorchashm, a cardiac surgeon at Thomas Jefferson University Hospital. "If you put your patients in harm's way for an avoidable hazard, that is unforgiveable."
Noorchashm and his wife, anesthesiologist Amy Reed, began pushing for a ban on power morcellators after her October 2013 diagnosis with stage-four leiomyosarcoma, a rare, aggressive uterine cancer. Brigham and Women's Hospital in Boston, where she had the hystectomy with morcellation, has acknowledged that the procedure likely worsened her prognosis.
The couple, who trained at the University of Pennsylvania, moved back to Philadelphia with their six children last summer.
Power morcellators were introduced in 1993 and have been defended by gynecological specialty groups because dissecting tissue with the motorized blades enables it to be removed through tiny abdominal incisions. Alternative surgical approaches that require large incisions increases pain, recovery time, and the risk of infection, bleeding and blood clots.
Many factors complicate this risk-benefit tradeoff. Pre-operative tests and scans can't reliably distinguish benign fibroids, which can cause bleeding and pain, from cancerous ones. No surgical methods - not even ones that remove tissue largely intact - are guaranteed to prevent the spread of an unsuspected cancer. Enclosing a power morcellator in a bag to prevent tissue from spewing in the body cavity also has limits and downsides.
Until Noorchashm raised the alarm, gynecologists downplayed the chance of power-morcellating a hidden uterine sarcoma, citing the risk as 1 in 10,000.
Recent studies have calculated that between 1 in 1,000 and 1 in 350 women who undergo power mocellation for presumed benign problems will have uterine cancer.
The worse estimate is from the U.S. Food and Drug Administration. In November, it stopped short of a ban, instead issuing tougher warning labels that say the devices "may spread cancer and decrease the long-term survival of patients." The agency also said the devices are rarely the most prudent surgical option.
Before the safety debate, about 600,000 hysterectomies were done each year, and 50,000 of them involved power morcellation, the FDA said.
Now, most hospitals, including Brigham and Women's, have stopped using power morcellators. Johnson & Johnson's Ethicon division withdrew its top-selling version from the market last July.
Sawsan As-Sanie, director of minimally invasive gynecological surgery at the University of Michigan Medical School and senior author of the new study in this month's Obstetrics and Gynecology, said she uses the device "in a very limited scenario."
"My primary goal is to help my patients relieve symptoms using the least invasive and least risky methods possible," she said. "The vast majority of patients [with bothersome fibroids] don't necessarily need surgery."
Both new studies looked at the prevalence of unexpected cancers other than just uterine sarcoma.
The Columbia study, published in this week's JAMA Oncology, found that among 41,777 women who had "myomectomy" - surgery to remove fibroids but leave the uterus - cancerous or precancerous abnormalities were diagnosed in 802 women, or 1.9 percent.
The Michigan study found an even higher rate. Among 6,360 women who had hysterectomies for benign indications, 2.7 percent were found to have malignancies including ovarian, fallopian tube, and cervical cancers.
"Comprehensive patient counseling should address the usual risks of surgery, the risk of unexpected malignancy, and the possibility of poor prognosis should an unidentified malignancy be morcellated," As-Sanie's team concluded.
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Cancer risk low in women with fibroids removed using morcellator
Feb 19, 2015 | Bloomberg
By Anna Edney
Women who had uterine fibroids removed with or without a medical device that chops up the growths had a low prevalence of cancer, a study found, adding new data to debate over risks from the technique.
Known as power morcellators, the devices have come under scrutiny from regulators as potentially raising the risk of cancer, since fragments of undetected tumors could be spread during the procedure. A study published Thursday in the journal JAMA Oncology analyzed data on 41,777 women who had fibroids removed, 7.7 percent of whom underwent morcellation.cCommentsGot something to say? Start the conversation and be the first to comment.ADD A COMMENT0
The study found that among women who had morcellation, 1 in 1,073 developed uterine cancer. In women who didn't have morcellation, 1 in 528 did.
Power morcellators are used to help surgeons remove a woman's uterus or the fibroids by cutting tissue into pieces that can be taken out through a small incision in the abdomen.
The Food and Drug Administration last year warned that most women shouldn't use the devices because of a risk they could spread undetected cancer cells in the uterine tissue. In November, HCA Holdings Inc., which operates 280 hospitals and surgery centers in the U.S. and England, said it would stop use of the devices. Johnson & Johnson, based in New Brunswick, New Jersey, suspended sales of its power morcellators last year after an FDA warning.
The study's conclusion that the surgical approach should be used with caution in women older than 50 is in line with the FDA's recommendation that a young woman who wants to keep her uterus intact may still be a candidate for the technique. The devices had been widely used despite a lack of conclusive data on cancer risk, according to the researchers.
"These events highlight the difficulty of evaluating, using and marketing surgical devices," said the researchers, led by Jason Wright, a gynecologic oncologist at Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital. "From a public health perspective, these findings highlight the need for more rigorous comparative effectiveness research and heightened regulatory oversight for new devices and procedures."
Risk also differed by age. Of women younger than 40 who had fibroids removed without morcellation, 0.05 percent had uterine cancer, compared to 3.4 percent in women 60 or older.
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Low Cancer Risk With Device Used to Remove Fibroids, Study Finds
Feb 19, 2015 | U.S. & World Report News - Health
By Amy Norton
A small power tool that is sometimes used to remove fibroids in the uterus can end up spreading bits of hidden cancerous tumors throughout the abdomen, but a new study suggests the likelihood is low.
Researchers called the findings, reported online Feb. 19 in JAMA Oncology, "reassuring." But the device, called a power morcellator, remains under restricted use.
Until recently, doctors commonly used power morcellators during minimally invasive surgery to remove uterine fibroids -- non-cancerous growths in the wall of the uterus.
Fibroids are very common, but some women eventually need surgery to put an end to symptoms like pelvic pain and heavy menstrual bleeding. Doctors can either remove the fibroids or perform a hysterectomy to remove the uterus.
The power morcellator has a rotating blade that breaks apart fibroid growths or, during a hysterectomy, the uterus itself. The tissue can then be removed through tiny incisions.
But last November, the U.S. Food and Drug Administration issued a strong "boxed" warning on the devices -- saying that if a woman has an undetected cancerous uterine tumor, the morcellator could spread and worsen the cancer.
The agency said that for most women with fibroids, the device should not be used -- including women who are going through or have gone through menopause, since older age increases the risk of uterine cancer.
But the FDA said some younger women might still be candidates for having fibroids removed with the device.
The new study was done to get a handle on how many women having fibroids removed -- but not the uterus -- might have hidden cancer, explained lead researcher Dr. Jason Wright, chief of gynecologic oncology at Columbia University, in New York City.
His team looked at records for almost 42,000 U.S. women who had fibroids surgically removed between 2006 and 2012. A power morcellator was used in just over 3,200 cases.
Of those women who were treated with a morcellator, three were later found to have uterine cancer -- a rate of one in slightly over 1,000 patients. (When fibroids are removed, they are typically sent for testing to confirm whether they are, in fact, benign.)
By comparison, the odds of uterine cancer were one in 528 among women who had fibroids removed without the device.
As expected, the likelihood of a hidden cancer increased with age: Of women younger than 40 who had power morcellation, none were found to have uterine cancer; the rate increased to almost 1 percent among women in their 50s.
"Overall, the risk is low, and I think that's reassuring," Wright said.
He noted that the results are also in line with the FDA's recommendations for older and younger women.
It's not clear how often power morcellation is still being used, according to Wright. After the FDA began investigating the devices, the leading manufacturer -- Johnson & Johnson -- pulled its products from the market in July. And some U.S. hospitals have reportedly banned their use.
The most important message for women is that they have other options for fibroid removal, said Dr. Ceana Nezhat, a surgeon at the Atlanta Center for Minimally Invasive Surgery and Reproductive Medicine.
"The restrictions on power morcellation do not mean that women should have more hysterectomies, or not have minimally invasive surgery," said Nezhat, who wrote an editorial published with the study.
Uterine fibroids can be removed through small incisions, even without morcellation, Nezhat noted.
However, Wright pointed out, that does depend on factors such as how many fibroids a woman has, and the size of the growths. So for some younger women, power morcellation might still be recommended.
"I think that women should ask questions, no matter what [procedure] the doctor recommends, and make sure they understand the potential risks and benefits," Wright said.
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Morcellation: Uterine Cancer Risk Low, Increases With Age
Feb 20, 2015 | MedScape
By Veronica Hackethal, MD
Uterine cancer and precancer in women undergoing myomectomy with or without power morcellation is rare, according to a study was published online February 19 in JAMA Oncology. However, the prevalence increases with age.
"The current data...suggest that 1 in 1073 women [who undergo myomectomy with electric power morcellation] will be diagnosed with a uterine cancer and 1 in 230 with some form of pathologic abnormality," write Jason Wright, MD, from the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, New York City, and colleagues.
"Age was one of the strongest risk factors for pathologic findings in our analysis. The role of myomectomy in perimenopausal and postmenopausal women remains controversial," the authors add. "These data...suggest that electric power morcellation should be approached with caution in older women."
Electric power morcellation is the fragmentation of tissue to facilitate removal during minimally invasive surgery. Surgeons use the technique in laparoscopic myomectomy and hysterectomy for benign fibroids. However, the technique has come under scrutiny because of the possibility of fragmenting occult malignancy, with the potential for spreading and upstaging disease. The controversy began after a patient who underwent uterine morcellation for presumed benign leiomyoma was later found to have leiomyosarcoma, and the morcellation procedure had spread her cancer.
In April 2014, the US Food and Drug Administration issued a black box warning about the procedure. Several gynecologic professional societies responded by issuing statements and new guidelines saying morcellation still has a place in gynecologic surgery, but cautioned against its use in older women.
However, a recent report in the Wall Street Journal suggests that one of the reviewers involved in crafting the statement from the AAGL (previously known as the American Association of Gynecologic Laparoscopists), which generally supported the continued use of morcellators, had received consulting fees from a morcellator manufacturer.
Age Is Critical Factor
A past study found older age to be a strong risk factor for uterine cancer. In contrast, myomectomy for fibroids is generally done in younger women who are thought to be at low risk for uterine cancer, the authors explain.
Dr Wright and colleagues used the Perspective database, a nationwide all-payer database, to identify women who had had myomectomies at 496 hospitals between January 2006 and December 2012. Then they looked at the use of power morcellation at the time of myomectomy and estimated prevalence of uterine cancer, uterine neoplasms of uncertain significance, and endometrial hyperplasia.
Of 41,777 women who underwent myomectomy, 7.7% (n=3220) had electric power morcellation.
Seventy-six women were found to have uterine cancer. One in 528 women (n=73) who had myomectomy without power morcellation had uterine cancer (0.19%; 95% confidence interval [CI], 0.15% - 0.23%). One in 1073 women (n=3) who underwent myomectomy with power morcellation had uterine cancer (0.09%; 95% CI, 0.02% - 0.27%).
The prevalence of pathologic findings generally increased with age. In those who underwent myomectomy without morcellation, uterine cancer was found in 0.05% (95% CI, 0.02% - 0.07%) of those younger than 40 years, 0.62% (95% CI, 0.30% - 0.94%) of those between 50 and 59 years old, and 3.40% (95% CI, 2.22% - 4.58%) of women aged 60 years and older. Similarly, among those who underwent myomectomy with power morcellation, the prevalence of uterine cancer was 0% (95% CI, 0% - 0.19%) in women younger than 40 years, 0.97% (95% CI, 0.12% - 3.45%) in those aged between 50 and 59 years, and 0% (95% CI, 0% - 7.25%) in women aged 60 years and older.
"The increased scrutiny surrounding electric power morcellation has led to a number of proposals to improve safety, including more rigorous preoperative evaluation and thorough informed consent guidelines," Dr Wright and colleagues conclude. "[G]iven the controversy surrounding electric power morcellation and the overall low prevalence of pathologic abnormalities, the development of national registries of patients who undergo the procedure would be of great utility."
In a linked commentary, Ceana Nezhat, MD, from the Atlanta Center for Minimally Invasive Surgery and Reproductive Medicine in Georgia, and past president of AAGL, pointed out that administrative data can be incomplete and not always reliable. In the absence of clinical registries, she called for improved research methodology that can be used for improving the quality of surgical outcomes.
"Owing to lack of information regarding the risk of occult uterine malignant neoplasms in reproductive-age women and possible tumor dissemination during myomectomy, with or without morcellation, the magnitude of harm is unknown," Dr Nezhat writes. "Consequently, not only morcellation, but the prevalence of malignant and premalignant uterine lesions in younger patients, calls for investigation."
He emphasizes, "[M]yomectomy remains the surgical treatment of choice in reproductive-age women with symptomatic uterine fibroids. Patients prefer minimally invasive surgery because the benefits outweigh the risks when performed appropriately. The [US Food and Drug Administration] black box warning on power morcellators must not cause a reversal to laparotomy or increase in the number of hysterectomies for uterine tumors."
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Uterine cancer low in myomectomy with power morcellation
Feb 19, 2015 | Family Practice News
By Jennifer Shepphird
The prevalence of uterine cancer was 0.09% among women who underwent myomectomy with electric power morcellation, according to the results of a large database study, lower than for women who underwent myomectomy without power morcellation.
But the prevalence of uterine cancer increased with age, the researchers reported on Feb. 19 in JAMA Oncology.
Dr. Jason D. Wright
“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,” Dr. Jason D. Wright and his colleagues at Columbia University, New York, wrote (JAMA Oncol. 2015 Feb.19).
Electric power morcellation facilitates the excision of uterine leiomyoma in minimally invasive surgery. Its use has received increased scrutiny after a patient underwent hysterectomy with electric power morcellation for presumed benign leiomyoma that was, in fact, a uterine sarcoma, which was disseminated. The case has prompted an evaluation of electric power morcellation safety in performance of hysterectomy and myomectomy.
The Food and Drug Administration also entered the debate last year, issuing a safety alert for electric power morcellators in November and warning “against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.”
The Columbia University researchers examined the prevalence of cancers and precancerous abnormalities of the uterus in women who underwent myomectomy from 2006 to 2012 using administrative data from the Perspective database.
Among 38,557 women who underwent myomectomy without electric power morcellation, uterine cancer prevalence was 0.19% or 1 in 528, and prevalence of any pathologic abnormality was 0.67% or 1 in 150.
For women who underwent the procedure with electric power morcellation, uterine cancer prevalence was 0.09% or 1 in 1,073, and prevalence of any pathologic abnormality was 0.43% or 1 in 230.
Age was the strongest risk factor for uterine cancer and other abnormalities.
Comparing women aged 50-59 years to women 60 years and older who had myomectomy without morcellation, the prevalence of uterine cancer increased from 0.62% to 3.40%. In women who had power morcellation, the prevalence of uterine cancer was 0.97% in women aged 50-59 years and 0% in those 60 years or older.
The researchers reported similar trends for endometrial hyperplasia and overall adverse pathologic findings.
The researchers reported having no financial disclosures.
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Know the Risks of Your Uterine Fibroid Surgery
Feb 19, 2015 | Daily Rx News
By Katie Chamberlain
Not all patients face the same risks from the same surgeries. Such is likely the case with surgeries to remove benign uterine tumors.
A recent study found that electromechanical morcellation (EMM) use during a myomectomy had little effect on adverse outcomes like cancer. Older patients undergoing this surgery may face a raised cancer risk, however.
A myomectomy is a surgical procedure to remove a benign uterine tumor. An EMM tool is sometimes used during the procedure to break up tissue, but the use of EMM has been questioned.
Lead study author Jason D. Wright, MD, of the Department of Obstetrics and Gynecology at Columbia University in New York City, and colleagues wrote that "The frequency of use of electric power morcellators for gynecologic surgery first increased rapidly with a relative lack of data and then abruptly decreased after an adverse outcome in a young woman. These events highlight the difficulty of evaluating, using and marketing surgical devices."
Uterine fibroids can cause a variety of symptoms, such as heavy menstrual bleeding and discomfort. There are some noninvasive treatments, but surgery is sometimes the best option. A myomectomy is often preferred over a hysterectomy (removal of the entire uterus) to preserve fertility.
To study the risks of using EMM, Dr. Wright and team looked at the outcomes of myomectomies with and without EMM. Nearly 42,000 women were included in this study. Of these, more than 3,200 had EMM used in their procedure. These procedures took place from 2006 to 2012.
Uterine cancer occurred in 0.19 percent of women who underwent myomectomy without EMM (1 in 528). It occurred in 0.09 percent of women with EMM (1 in 1,073).
"The prevalence of cancers and precancerous abnormalities of the uterus in women who undergo myomectomy with or without electric power morcellation is low overall, but risk increases with age," rather than EMM use, Dr. Wright and team wrote.
Dr. Wright and team said doctors should use EMM with caution in older women.
This study was published online Feb. 19 in JAMA Oncology.
National Cancer Institute grants and a fellowship funded this research. Dr. Wright and team disclosed no conflicts of interest.
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