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Morcellation Media Monitoring 12/10/2015
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Doctors dispute FDA’s ruling on uterine surgery technique
Dec 8, 2015 | Reuters
By Will Boggs
Doctors are arguing that the U.S. Food and Drug Administration (FDA) relied on a flawed analysis when it ruled last year that noncancerous growths in the uterus could no longer be removed using mechanical devices that chop them into small pieces for extraction by minimally invasive surgery. -
FDA Recommendations on Fibroid Surgical Tool Are 'Irresponsible,' Leading Physicians Say
Dec 9, 2015 | Newsweek
By Jessica Firger
A group of physicians in gynecology and related specialties are calling on the U.S. Food and Drug Administration (FDA) to reverse its stance severely limiting the use of a device for minimally invasive surgery to treat uterine fibroids for nearly all women. -
Top gynecologists oppose FDA advice on morcellators
Dec 8, 2015 | Philadelphia Inquirer
By Marie McCullough
A group of physicians and women’s health advocates on Tuesday sent a letter asking the U.S. Food and Drug Administration to rescind or revise its 2014 warning that curtailed the use of a tissue-slicing device in minimally-invasive gynecological surgeries. -
Doctors Rally in Support of Fibroid Device Curbed by FDA
Dec 8, 2015 | U.S. News & World Report
By Dennis Thompson
Dozens of gynecologists, cancer doctors and women's health experts are challenging a U.S. Food and Drug Administration warning on a power device used to remove fibroid growths from a woman's uterus. -
Doctors Dispute FDA Ruling On Device To Remove Uterine Fibroids
Dec 10, 2015 | Tech Times
By Angela Laguipo
A team of gynecologists urge the U.S. Food and Drug Administration to revise its 2014 ban on the use of morcellator, a device designed to remove uterine fibroids. They argue that the regulatory agency relied on flawed analysis when it decided to ban the use of mechanical devices that chop fibroids into small pieces during surgery. -
Top gynecologists push back at FDA crackdown on power morcellator devices
Dec 9, 2015 | Fierce Medical Devices
By Emily Wasserman
Plus, the FDA restricting power morcellator devices could result in fewer options for women undergoing fibroid removal. Patients would be forced to have open surgery through a larger incision, potentially increasing complications or risks, the doctors said in the journal article. -
Leading Physicians Refute FDA Warning on Morcellation
Dec 8, 2015 | Medscape
By Troy Brown
A group of 49 physicians disagrees with recent restrictions placed by the US Food and Drug Administration (FDA) on the use of power morcellators during minimally invasive surgery in women with uterine leiomyomas. -
Experts Call on FDA to Rescind or Revise Power Morcellator Warning
Dec 9, 2015 | Regulatory Focus
By Zachary Brennan
Leading gynecology experts sent an open letter to the US Food and Drug Administration (FDA) Tuesday calling on the agency to rescind or revise a warning it issued that restricted use of a device in minimally invasive procedures to treat uterine fibroids. -
Ethicon Power Morcellation Cancer Lawsuits Centralized in MDL
Dec 10, 2015 | Top Class Actions
By Joanna Szabo
A number of laparoscopic power morcellation cancer lawsuits have been filed against Ethicon, and a panel of federal judges has consolidated them into a multidistrict litigation. -
Power Morcellator Lawsuit Claims Device Spread Fatal Uterine Cancer In Patient
Dec 7, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on a lawsuit recently filed against Ethicon and the power morcellator device they manufacture. This particular suit was filed by the family of a woman who has passed away, on her behalf. According to allegations in the complaint, the family attributes the woman’s death to the use of laparoscopic power morcellation during her gynecological surgery.
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Doctors dispute FDA’s ruling on uterine surgery technique
Dec 8, 2015 | Reuters
By Will Boggs
n">Doctors are arguing that the U.S. Food and Drug Administration (FDA) relied on a flawed analysis when it ruled last year that noncancerous growths in the uterus could no longer be removed using mechanical devices that chop them into small pieces for extraction by minimally invasive surgery.
Based on its review of the medical literature, the FDA said 1 in 485 women with so-called uterine fibroids could also have a potentially lethal hidden cancer, called leiomyosarcoma, which might be spread by the use of the devices, known as power morcellators.
But Dr. William H. Parker from UCLA School of Medicine, Los Angeles, California told Reuters Health by email that the FDA’s analysis of how commonly this kind of cancer is lurking in women having surgery for presumed fibroids “was flawed, inadequate, and misleading.”
“Their recommendations were not based on science, but rather on emotional and anecdotal information,” he said.
Writing in Obstetrics and Gynecology, Parker and other top gynecologists in the Leiomyoma Morcellation Review Group say the FDA’s review included studies that lacked credibility. Also, they say, three leiomyosarcoma cases were included that don’t satisfy current definitions of cancer.
If those three cases and the information in the other unreliable studies are excluded, there were only eight cases of leiomyosarcoma among the 12,402 women having surgery for fibroids (leiomyomas, in medical terms). That’s one in 1,550, or 0.07 percent.
Parker and colleagues say the FDA’s restrictions would eliminate all the minimally invasive operations for uterine fibroids and leave open abdominal surgery as the only option.
These doctors claim that forcing women to have open surgery, through a larger incision, instead of laparoscopic surgery could increase surgery-related deaths and complications. They back up their claim with recent information that shows higher rates of surgical complications and hospital readmissions since the FDA put these restrictions in place in November 2014.
Nearly four dozen physicians signed an open letter to FDA that concludes, “Women have a right to self-determination. Modification of the FDA's current restrictive guidance regarding power-morcellation would empower each woman to consider the pertinent issues and have the freedom to undertake shared decision-making with her surgeon in order to select the procedure which is most appropriate for her.”
Dr. Jason D. Wright from Columbia University College of Physicians and Surgeons in New York City, who wrote an editorial related to this report, thinks the FDA is unlikely to change its policy in the near term. “I think as more data becomes available the FDA should ultimately readdress this topic,” he told Reuters Health.
“I think physicians should understand that there is certainly a safety concern with morcellation and they need to use caution to minimize the risk of inadvertently morcellating a precancerous or cancerous lesion,” Wright said. “The corollary is that in some women the benefits of morcellation may outweigh the risks.”
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FDA Recommendations on Fibroid Surgical Tool Are 'Irresponsible,' Leading Physicians Say
Dec 9, 2015 | Newsweek
By Jessica Firger
A group of physicians in gynecology and related specialties are calling on the U.S. Food and Drug Administration (FDA) to reverse its stance severely limiting the use of a device for minimally invasive surgery to treat uterine fibroids for nearly all women.
On Monday, 48 physicians in the fields of gynecology, oncology and surgical oncology, along with women’s health advocates, sent an open letter to the FDA, urging officials to rescind its ruling that prevents the use of power morcellators, which have been linked to leiomyosarcoma (LMS), a rare form of female cancer.
Additionally, the journal Obstetrics & Gynecology on Tuesday published a related article online by members of the expert group, self-identified as the Leiomyoma Morcellation Study Group.
In September 2014, The Wall Street Journal began to investigate the device’s safety in a series of articles, prompted by the story of Amy Reed, a woman who underwent minimally invasive surgery to remove fibroids. Reed’s surgeon used a power morcellator in the procedure, which caused the malignant tissue from her fibroids to spread elsewhere and develop into LMS. She launched a campaign to end the use of the device, and the story set off a firestorm of reaction and prompted federal officials at the FBI and FDA to conduct an investigation into the device’s safety, while Johnson & Johnson, the device’s largest manufacturer, halted sales of the device.
Some health insurance companies began refusing to pay for use of the device, and physicians were left with no other option than to stop using power morcellators in the surgical procedure. By November, the FDA had issued a high-level official warning that the tool shouldn’t be used on most women.
The Leiomyoma Morcellation Study Group argues that the FDA’s decision was based on an inaccurate analysis of research and clinical data on the risks associated with the device. The analysis led the agency to conclude that 1 in every 458 women who undergo fibroid surgery with power morcellation develops LMS. But the group says the calculations were highly inaccurate since the FDA didn’t include research with findings that power morcellators are not associated with cancer risk.
In addition, the FDA included cases of LMS that do not meet the clinical criteria for the disease. The group says that when you add in that missing research and take out the inaccurately categorized cases, the risk for LMS related to power morcellation would be approximately 1 in 1,550, or 0.064 percent. Additionally, the group says some newer research shows the risk is even smaller: around 0.051 percent, or 1 in 1,960.
“The FDA did a really bad job of analyzing this data. The recommendations are irresponsible, and it's really a disservice to women,” says Dr. William Parker, lead author on the journal article and director of minimally invasive gynecology surgery at the University of California, Los Angeles, Medical Center in Santa Monica. “Every procedure has risk and benefits. Our feeling is we need to know the right risks.”
The American College of Obstetrics and Gynecology issued a statement on Tuesday in support of the group’s efforts: “Without question, morcellation of an undiagnosed sarcoma can disseminate malignant tissue. However, by allowing some women to avoid the higher morbidity and mortality associated with open abdominal surgery, morcellation can also save lives.”
Uterine fibroids are growths that can develop in the muscle tissue of the uterus. The condition is very common; estimates from the National Institutes of Health suggest 70 percent of white women and between 80 and 90 percent of African-American women will develop fibroids at some point in their lifetime. Most are benign and don’t cause any symptoms. However, for some women fibroids can cause extreme discomfort, with symptoms including heavy bleeding, pelvic pressure and urinary problems. In these cases physicians recommend removing fibroids.
Uterine fibroids can grow as large as a grapefruit, which makes them difficult to remove. A power morcellator helps solve the problem and makes minimally invasive surgery possible by allowing a physician to cut up the fibroids into pieces so they can be removed laparoscopically through much smaller incisions.
Each year in the U.S., approximately 210,000 women undergo hysterectomies as a result of the condition, and 50,000 receive myomectomies, or surgical fibroid removal. Surgeons perform the procedure laparoscopically to reduce the risk for potential complications—such as hemorrhaging and infection—and speed up the recovery time.
“I would say it should not be a banned procedure but [should] still be allowed in select cases, [on] patients that have had a thorough preoperative evaluation,” says Dr. Leslie Bradford, an assistant professor of obstetrics and gynecology at the University of Massachusetts Medical School. Bradford was not involved in the physician group’s efforts to petition the FDA. “It’s like any other tool when used by experienced physicians,” she says.
Bradford adds that the FDA’s decision has forced some of her colleagues to suggest patients undergo a more invasive hysterectomy through the abdomen—which has a higher risk for complications than laparoscopic surgery and, of course, means that a woman cannot become pregnant.
Rather than ban the device outright, the group of physicians recommends the FDA create stringent guidelines that help determine which patients are good candidates for laparoscopic surgery in which a power morcellator is used. This includes limiting the device’s use in older post-menopausal women who have a greater risk for LMS. Though not 100 percent reliable, presurgery screening measures can also improve safety, including an endometrial biopsy, which can detect LMS before surgery, or an MRI to detect certain fibroid abnormalities.
Additionally, more care should be taken to ensure that fibroid tissue fragments are not left in the pelvis or abdominal cavities that could potentially implant and grow as cancerous cells. The group also urges the FDA to fund additional research on the safety and proper use of the device.
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Top gynecologists oppose FDA advice on morcellators
Dec 8, 2015 | Philadelphia Inquirer
By Marie McCullough
A group of physicians and women’s health advocates on Tuesday sent a letter asking the U.S. Food and Drug Administration to rescind or revise its 2014 warning that curtailed the use of a tissue-slicing device in minimally-invasive gynecological surgeries.
The device, an electric morcellator, enables uterine tissue to be cut up and removed through tiny abdominal incisions. But the FDA concluded the device could accidentally spread and worsen a hidden uterine cancer called leiomyosarcoma in as many as 1 in 350 women who have a hysterectomy to treat fibroids – common benign growths that can cause abnormal bleeding. The FDA recommended against the use of power morcellation in most women, prompting most hospitals and insurers to restrict or ban it.
In their open letter to the FDA, 48 experts in gynecology and related specialties argued that without power morcellation, tens of thousands of women with fibroids may have to undergo major surgery with large abdominal incisions each year. The more invasive operations require longer hospital stays, longer recovery time, and increase the risk of complications such as infection. (Gynecological medical groups have also taken the position that morcellators still have a valuable role in patient care.)
The letter cited studies that estimate the risk of spreading a leiomyosarcoma during surgery for presumed fibroids to be between 1 in 1,960 to 1 in 4,360 – lower than the FDA’s estimate.
“The FDA’s estimate appears to overstate the risk,” said obstetrician-gynecologist William Parker, who spearheaded the plea to the agency. He is director of minimally invasive gynecologic surgery at UCLA Medical Center, Santa Monica.
Parker also is the lead author of a commentary opposing the FDA morcellation guidance that will be published in the January issue of the journal Obstetrics & Gynecology.
The list of signers of the open letter includes: gynecologic specialists from Yale, Johns Hopkins, Duke and Baylor Universities; women’s health activist Judy Norsegian, co-founder of Our Bodies, Ourselves; esteemed breast cancer surgeon Susan Love; and Carla Dionne, founder of National Uterine Fibroid Foundation.
In response to the open letter, the FDA said in an email that its guidance was formulated after an advisory committee meeting at which patients, health care providers, researchers, device manufacturers and others testified. “At this time, the Agency’s recommendations have not changed. We welcome the continued scientific dialogue concerning the available evidence about benefits and risks associated with power morcellation, and will notify the public if our recommendations change,” the FDA emailed.
The FDA issued its 2014 guidance in response to a campaign calling for a complete ban on morcellators. The campaign was launched two years ago by Amy Reed, a University of Pennsylvania anesthesiologist, and her husband Hooman Noorchashm, a cardiac surgeon at Jefferson University Hospital.
Reed’s hidden leiomyosarcoma was spread when she had a hysterectomy with morcellation in October 2013 in Boston, where the couple and their six children lived at the time. She has been battling the aggressive cancer since then, and has had three recurrences.
Noorchashm has harshly criticized gynecological medical groups and their leaders for not totally rejecting morcellation, calling their position “unethical” and “negligent.”
Read more at http://www.philly.com/philly/blogs/healthcare/Top-gynecologists-oppose-FDA-advice-on-morcellators.html#VkOpx5wuylgZHict.99 -
Doctors Rally in Support of Fibroid Device Curbed by FDA
Dec 8, 2015 | U.S. News & World Report
By Dennis Thompson
Dozens of gynecologists, cancer doctors and women's health experts are challenging a U.S. Food and Drug Administration warning on a power device used to remove fibroid growths from a woman's uterus.
The tool -- a laparoscopic power morcellator -- grinds up fibroid growths during minimally invasive surgery. The group of experts claim that curbing its use may force patients to undergo riskier, more invasive procedures.
The FDA issued a "boxed warning" label on the devices last year. The agency had concluded that in about one out of every 458 cases, the morcellator chews up an undiagnosed cancerous growth and floods the woman's abdomen with cancer cells.
But a review group of 46 experts says the FDA got its facts wrong. The likelihood that power morcellation would grind up a cancerous growth is actually much lower, they contend.
"The best case scenario would be for the FDA to recalculate the prevalence estimates to make them more accurate, because they did an absolutely horrible job with them," said Dr. William Parker, director of minimally invasive gynecologic surgery at University of California, Los Angeles Medical Center in Santa Monica.
Parker is the lead author of a new paper published Dec. 8 in the journal Obstetrics & Gynecology that criticizes the FDA's action. The authors have also issued an open letter to the FDA asking it to change course.
Benign fibroids, also called leiomyomas, can be found in about 75 percent of all women in their lifetime, the article says. These fibroids result in an estimated 210,000 hysterectomies and 50,000 surgical fibroid removals each year in the United States.
Because of the FDA warning, doctors and women have turned from minimally invasive laparoscopic surgery to full-fledged abdominal surgery to remove fibroids, the review authors contend.
Major surgery entails longer hospital stays and drastically increases risk of complication and death. A group of 100,0000 women undergoing laparoscopic surgery to remove uterine fibroids would be expected to experience 20 fewer deaths, 150 fewer dangerous blood clots in their blood vessels and 4,800 fewer wound infections than an equal number of women having abdominal surgery, the report states.
"Doctors are taking the FDA at their word, and patients take the FDA at their word," Parker said. "So I think the FDA needs to reconsider what they've done and do it better."
The FDA stands by its decision, the agency said in a statement responding to the new paper.
"At this time, the agency's recommendations have not changed. We continue to believe that inclusion of a boxed warning and contraindications to the use of power morcellation for uterine fibroid removal in the majority of women is both appropriate and necessary," the statement reads.
"We welcome the continued scientific dialogue concerning the available evidence about benefits and risks associated with power morcellation and will notify the public if our recommendations change," it concludes.
The review group contends that the FDA's data is flawed because the agency only included studies that evaluated cases of fibrous growths that turned out to be cancerous. Using those strict guidelines, the FDA found only seven studies upon which to make its analysis, Parker said.
However, an independent analysis that included all uterine growths, cancerous or not, uncovered 133 studies that were relevant, Parker said. That larger study revealed the risk of coming across a cancerous growth was actually one in 1,960, much lower than the FDA's estimate of one in 458.
Another recently published large study found two cancerous growths among 8,720 women having surgery for fibroids, the report adds.
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Doctors Dispute FDA Ruling On Device To Remove Uterine Fibroids
Dec 10, 2015 | Tech Times
By Angela Laguipo
A team of gynecologists urge the U.S. Food and Drug Administration to revise its 2014 ban on the use of morcellator, a device designed to remove uterine fibroids. They argue that the regulatory agency relied on flawed analysis when it decided to ban the use of mechanical devices that chop fibroids into small pieces during surgery.
In April 2014, FDA issued a public warning against the use of laparoscopic uterine power morcellation on women with non-cancerous growths that develops from the muscular tissue of the uterus. Federal regulators claim that uterine fibroids may have potentially-fatal hidden cancer dubbed as leiomyosarcoma. This might be spread by the use of morcellators.
Seven months after the initial public warning, FDA issued an Immediately in Effect (IIE) guidance to order manufacturers to include warnings and contraindications in product labeling. FDA included that this method is contraindicated in patients with uterine fibroids to prevent cancer spread.
"The FDA's primary concern is the safety and well-being of patients and taking these steps will help the agency's safety recommendations to be implemented as quickly as possible," Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health said.
FDA announced the ruling after the analysis of available data. According to the agency, an estimated one in 350 women who underwent either hysterectomy or myomectomy developed an unsuspected uterine sarcoma called leiomyosarcoma.
According to 48 gynecologists in their open letter, if morcellation will be banned, tens of thousands of women with fibroids may undergo major surgical operations with large incisions in the abdomen each year. They also cited that major surgeries will require longer hospital stays, longer recovery time and increased risk of adverse complications.
Aside from the open letter addressed to FDA, the group also published a study in the journal Obstetrics & Gynecology.
"Our research finds that morcellation can be a safe, effective, minimally invasive treatment option for fibroids,"said Dr. Daniel Clarke-Pearson, chair of UNC's Department of Obstetrics and Gynecology at UNC's School of Medicine
"We believe the FDA failed to identify important information that has led to inaccurate conclusions that would negatively impact the health of many women across the country," he added.
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Top gynecologists push back at FDA crackdown on power morcellator devices
Dec 9, 2015 | Fierce Medical Devices
By Emily Wasserman
Last November, the FDA ramped up its oversight ofpower morcellator devices, recommending against using the tools in most women undergoing a hysterectomy or uterine fibroid removal after finding that the devices may spread hidden cancer in some patients. But not everyone is on board with the agency's move and now some gynecologists are pushing back at its decision, saying that regulators used flawed data to evaluate the device's safety.
The FDA's analysis of women's risk of having a hidden cancer that could be spread by power morcellator tools "was flawed, inadequate, and misleading," Dr. William Parker of the UCLA School of Medicine, told Reuters in an email. And the agency's "recommendations were not based on science, but rather on emotional and anecdotal information," Parker said. Parker and about 48 other top gynecologists are taking the agency to task over its crackdown on morcellator devices, writing an open letter to the FDA and penning a recent article about the issue in the Obstetrics & Gynecology journal.
After reviewing medical literature last year, the FDA found that women having minimally invasive surgeries to remove uterine fibroids had a 1 in 350 risk of having uterine sarcoma and that power morcellator tools could spread cancerous tissue. The agency ordered manufacturers to add boxed warnings and two contraindications for the devices in their product labels that inform patients and providers about morcellator risks. Regulators also said that power morcellators should not be used in older women or patients who could have tissue removed intact through the vagina or a mini-laparotomy incision.
But Parker and other gynecologists in the Leiomyome Morcellation Review Group don't see things in quite the same light. The FDA's analysis of power morcellator devices relied on studies that lacked credibility and included three cases that don't meet the definition of cancer, the physicians said in the journal article.
And recent studies point to a much lower risk of women having hidden cancer who are undergoing uterine fibroid removal, the doctors said. One study found that the risk of finding hidden cancer in women having fibroid surgery was 1 in 1,960, or 0.051. Another study turned up two hidden cancers in 8,720 women having surgery for fibroids, a 1 in 4,360 risk.
Plus, the FDA restricting power morcellator devices could result in fewer options for women undergoing fibroid removal. Patients would be forced to have open surgery through a larger incision, potentially increasing complications or risks, the doctors said in the journal article.
"Our research suggests that, rather than abandon the clear benefits minimally invasive surgery affords women, future research efforts out to focus on better preoperative identification and new techniques, such as placing specimens in bags before removing them," Dr. Matthew Siedhoff, director of UNC Chapel Hill's minimally invasive gynecologic surgery division, said in a statement.
Other doctors are heeding the FDA's advice. Earlier this year, Yale University researchers interviewed 43 high-volume minimally invasive gynecologists and fellowship faculty members at large U.S. teaching hospitals, and found that 78% of physicians switched to mini-laparotomy procedures after the FDA issued its updated warning about power morcellator devices.
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Leading Physicians Refute FDA Warning on Morcellation
Dec 8, 2015 | Medscape
By Troy Brown
A group of 49 physicians disagrees with recent restrictionsplaced by the US Food and Drug Administration (FDA) on the use of power morcellators during minimally invasive surgery in women with uterine leiomyomas.
"We disagree with the methodology the FDA used to determine the prevalence of leiomyosarcoma among women presumed to have benign leiomyomas and the subsequent restrictions placed on the use of the morcellator, which currently deny many women the benefits of minimally invasive surgery," William H. Parker, MD, and colleagues for the Leiomyoma Morcellation Review Group write in a commentary published in the January issue of Obstetrics & Gynecology.
"This guidance was prompted by concern that if a patient had an undiagnosed leiomyosarcoma the morcellator might inadvertently spread tumor cells within the peritoneal cavity," the authors write.
"By focusing exclusively on the risk of leiomyosarcoma, the FDA failed to take into account other more common risks associated with surgery," they add. "Reduced mortality and fewer complications represent well-established benefits of laparoscopic surgery."
The FDA's restriction on morcellation, they say, unnecessarily put women at risk for these more common complications when other mechanisms, including preoperative assessments, could be used to reduce the real but small risk for leiomyosarcoma associated with morcellation.
The American Congress of Obstetricians and Gynecologists (ACOG) released a statement today coinciding with the publication by Dr Parker and colleagues. "The conclusions of the paper's authors largely reflect positions that ACOG has reiterated during the ongoing discussion about potential safety concerns with morcellation as well as its value in facilitating minimally invasive gynecologic surgery," said Hal C. Lawrence, MD, executive vice president and chief executive officer.
"Without question, morcellation of an undiagnosed sarcoma can disseminate malignant tissue. However, by allowing some women to avoid the higher morbidity and mortality associated with open abdominal surgery, morcellation can also save lives," he continued.
"As a result of the continuing conversation about morcellation, obstetrician-gynecologists are better able to evaluate each individual woman's risk of an undiagnosed sarcoma, and to counsel her to receive the right approach for her own unique medical needs."
A Faulty Analysis?
According to Dr Parker and colleagues, the FDA's warning was based on an analysis of nine studies that concluded that 1 in 458 women undergoing surgery for leiomyomas would have occult leiomyosarcoma. However, Dr Parker and colleagues note that the FDA's literature review included only published articles that referred to both "uterine cancer" and "hysterectomy," and thus selected studies that reported cancer findings and excluded those that did not.
The group also said that one report included in the agency's analysis was a non-peer-reviewed letter to an editor, which should not have been included, and that other cases in the analysis do not meet current pathological criteria for leiomyosarcoma. When Dr Parker and colleagues reanalyzed the data, excluding those questionable data, they estimated a rate of 1 (0.064%) in 1550 for occult leiomyosarcomas. Furthermore, a more recent meta-analysis of 133 studies found a prevalence of leiomyosarcoma of 1 (0.051%) in 1960, which is lower than the FDA's finding.
Dr Parker and colleagues acknowledge that there is a real, if small, risk for leiomyosarcoma and suggest that rather than doing away with morcellation altogether, clinical caution could be used to carefully select patients for laparoscopic surgeries. For example, they recommend exercising greater caution before recommending morcellation procedures for older postmenopausal women, in whom the risk for leiomyosarcoma is higher, and performing a preoperative endometrial biopsy on women aged 35 years and older who have irregular bleeding and presumed leiomyomas. Also, ultrasound and magnetic resonance imaging can be used to look for large irregular masses with areas of potential necrosis, which may suggest a leiomyosarcoma, and postoperative inspection of tissue fragments and irrigation of the pelvic and abdominal cavities after morcellation could be used to reduce the risk.
Not Everyone Is Convinced
Not everyone is convinced by the arguments of Dr Parker and colleagues, however. "The authors make a compelling case that the FDA overestimated the potential risk of leiomyosarcoma. However, despite the strength of the authors' arguments, there are also a number of important caveats to consider," Jason D. Wright, MD, from the Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital, New York City, writes in an accompanying editorial.
The available studies have significant limitations, he notes. Most did not specifically study women who underwent morcellation. Studying the risk associated with apparent leiomyomas provides useful information, and that risk should not be judged equivalent to the risk associated with electric power morcellation specifically, Dr Wright writes.
"Second, a few of the studies were specifically designed for pathologic analysis of leiomyomas. This has the potential to result in undercapture of abnormalities if apparent leiomyomas are not thoroughly sampled and in the misclassification of smooth muscle tumors that are relatively uncommon in general," Dr Wright explains. "Finally, for those women who did undergo some type of morcellation, pathologic examination of morcellated specimens is difficult owing to fragmentation, again potentially undercapturing pathology."
Risk May Be Higher, New Study Suggests
In addition, a new study published alongside the article by Dr Parker and colleagues suggests the risk may not be as small as those authors estimate. Tina Raine-Bennett, MD, MPH, from the Division of Research, Kaiser Permanente Northern California, Oakland, and colleagues conducted a population-based cohort study in which they analyzed data from Kaiser Permanente's electronic health record and regional claims systems. They included northern California, southern California, and Colorado.
Between 2006 and 2013, 34,728 women underwent hysterectomies preformed for leiomyomas. During the same period, 321 women received a diagnosis of uterine sarcoma, 293 of whom were women who had had a hysterectomy. Among the women who underwent hysterectomy for leiomyomas, the incidence of occult uterine sarcoma was 1 of 278, or 3.60 (95% confidence interval [CI], 2.97 - 4.23) per 1000, hysterectomies, and the incidence of leiomyosarcoma was 1 of 429, or 2.33 (95% CI, 1.83 - 2.84) per 1000, hysterectomies.
After adjustment for race and ethnicity, the risk for occult uterine sarcoma and leiomyosarcoma in those patients aged 50 years and older was significantly higher compared with that in younger women. In addition, women aged 60 years and older had a significantly greater risk for occult low-grade and endometrial stromal sarcomas and high-grade endometrial sarcomas compared with women who were younger.
The unadjusted probability of 3-year disease-free survival for those with stage I leiomyosarcomas was 0.54 (95% CI, 0.42 - 0.64) with no morcellation, 0.19 (95% CI, 0.01 - 0.54) with power morcellation, and 0.51 (95% CI, 0.30 - 0.69) with nonpower morcellation.
"Although the plots suggest decreased probability of survival for power morcellation, there was no significant difference among all groups (P=.15) or between power morcellation and no morcellation (P=.29) or between nonpower morcellation and no morcellation (P=.88)," the researchers write.
The unadjusted probability of 3-year overall survival for those with stage I leiomyosarcoma was 0.64 (95% CI, 0.52 - 0.74) for no morcellation, 0.75 (95% CI, 0.31 - 0.93) for power morcellation, and 0.68 (95% CI, 0.46 - 0.83) for nonpower morcellation.
The researchers found no significant difference among all of the groups, between the power morcellation and no morcellation groups, or between the nonpower morcellation and no morcellation groups.
The authors have disclosed no relevant financial relationships.
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Experts Call on FDA to Rescind or Revise Power Morcellator Warning
Dec 9, 2015 | Regulatory Focus
By Zachary Brennan
Leading gynecology experts sent an open letter to the US Food and Drug Administration (FDA) Tuesday calling on the agency to rescind or revise a warning it issued that restricted use of a device in minimally invasive procedures to treat uterine fibroids.
The warning on laparoscopic power morcellators (LPM) followed FDA concerns that if a presumed benign fibroid is later found to be a malignancy called a leiomyosarcoma, fragments of the cancer will be scattered by a LPM, increasing the risk of spread. The agency issued new restrictions in November 2014, outlined in its guidance document, Product Labeling for Laparoscopic Power Morcellators, to "promote the safe and effective use of LPMs when used for gynecologic surgeries.”
But now, 48 gynecologists, gynecologic oncologists, surgical oncologists, department chairs and women’s health advocates said in the letter that they believe the agency’s decision, although well-intentioned to protect against the spread of a rare form of uterine cancer, was based on incorrect data, and it could require tens of thousands of women with benign fibroids to undergo major abdominal surgery each year.
In addition to the letter, the Leiomyoma Morcellation Study Group published a related editorial Tuesday in Obstetrics & Gynecology, and another study from the same journal notes that there was “a significant decrease in the proportion of minimally invasive hysterectomies and myomectomies performed during the 8 months after the FDA warning statement on the use of power morcellation.”
William Parker, the editorial’s lead author and director of minimally invasive gynecologic surgery at UCLA, said: “We believe the FDA failed to identify important information, leading to inaccurate results. We hope the agency will take a second look so that women will continue to have effective, minimally invasive treatment options for fibroids.
“The FDA’s estimate that 1 in every 458 women having surgery for presumed fibroids actually has LMS appears to overstate the risk,” Parker added, noting that a recent analysis of 133 studies determined that the risk of finding a leiomyosarcoma among women having surgery for presumed fibroids was actually 1 in 1,960, or 0.051 percent.
He also told Reuters that FDA’s recommendations “were not based on science, but rather on emotional and anecdotal information.”
The group also offered six clinical recommendations for FDA:
– Greater caution should be exercised before recommending morcellation procedures for post-menopausal women.
– Women 35 or older with irregular bleeding and presumed fibroids should have a biopsy of the lining of the uterus and normal Pap smear results.
– Certain ultrasound or MRI findings should increase suspicion of leiomyosarcoma.
– Women considering procedures involving morcellation for fibroids should be informed of the potential risk if leiomyosarcoma is found, and open surgery should be offered to all women considering minimally invasive procedures.
– Following morcellation, doctors should carefully inspect for retained tissue fragments and irrigate the pelvic and abdominal cavities thoroughly.
– Research projects should be initiated to find ways to noninvasively, preoperatively identify leiomyosarcoma and to discover how tissue fragments and cells are able to spread, implant and grow.Hal Lawrence, executive vice president and CEO of the American College of Obstetricians and Gynecologists, also put out a statement saying that the commentary largely reflects the positions of the group.
- See more at: http://www.raps.org/Regulatory-Focus/News/2015/12/09/23741/Experts-Call-on-FDA-to-Rescind-or-Revise-Power-Morcellator-Warning/#sthash.lcelaTW5.dpuf
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Ethicon Power Morcellation Cancer Lawsuits Centralized in MDL
Dec 10, 2015 | Top Class Actions
By Joanna Szabo
A number of laparoscopic power morcellation cancer lawsuits have been filed against Ethicon, and a panel of federal judges has consolidated them into a multidistrict litigation.
More than two dozen Ethicon power morcellator lawsuits will be centralized in the District of Kansas as part of this MDL before Judge Kathryn H. Vratil. This allows for coordinated discovery during pre-trial proceedings.
While power morcellation cancer lawsuits have been filed against other manufacturers, only Ethicon power morcellation lawsuits are being considered as part of this MDL.
Ethicon is a subsidiary of pharmaceutical and medical device giant Johnson & Johnson, and was the leading manufacturer of laparoscopic power morcellators. In the past decade, these devices have become increasingly popular during hysterectomies and myomectomies, due to their minimally invasive nature.
What is a Power Morcellator Used For?
The power morcellator has been in use by surgeons across the U.S. since 1991, when it was first approved by the U.S. Food and Drug Administration. Power morcellation is a process by which unwanted tissue is cut and shred in the body cavity, in order that it may be removed in smaller, more manageable pieces.
During a hysterectomy or myomectomy, a power morcellator cuts up uterine fibroids for removal. If the uterus or uterine fibroids contain some form of uterine cancer, the power morcellator, cutting tissue into tiny pieces, can actually spread cancer cells throughout the body.
Power Morcellation and Cancer Risks
However, once knowledge of the risk of potentially spreading cancer throughout a patient’s body came to light, the process has been largely abandoned by the medical community. This scenario would not occur with a patient who has been diagnosed with cancer in the uterus, but for a patient who has undiagnosed cancer cells in her uterus, power morcellation can be dangerous.
According to the FDA, approximately one out of every 350 women who undergo surgery for symptomatic uterine fibroids may have undiagnosed cancer cells within the uterus. In these cases, power morcellation would pose significant danger, spreading the cancer at an unnatural rate and moving a patient to an advanced and often fatal stage of cancer.
Power Morcellation Cancer Lawsuits
Women involved in these power morcellation cancer lawsuits allege that the medical device, used during surgery, caused undetected uterine cancer to spread to different parts of their bodies.
Power morcellation cancer lawsuits allege that Ethicon either knew or should have known about the risk of cancer posed to patients undergoing power morcellation procedures, and despite this knowledge failed to adequately warn the medical community and/or the patients about this risk.
Similar lawsuits have been brought against other manufacturers of power morcellators, including Gyrus ACMI, Richard Wolf Medical Instruments, and Karl Storz.
Ethicon has decided not to manufacture the devices any longer, determining there is no way to make them safer for patients. Power morcellators are allowed to remain on the market, but must include much stronger warnings about the potential cancer risks.
Despite the devices not technically being banned, many hospitals and doctors have sworn off using power morcellators, stating there is no way to justify the significant risk given the acceptable alternatives.
If you or someone you know has undergone a surgery where a doctor has used a power morcellator, and have since developed uterine or other cancer, you may be able to file a power morcellation cancer lawsuit.
The Ethicon Power Morcellator MDL is In Re: Power Morcellator Products Liability Litigation, MDL No. 2652, in the U.S. District Court, District of Kansas.
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Power Morcellator Lawsuit Claims Device Spread Fatal Uterine Cancer In Patient
Dec 7, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on a lawsuit recently filed against Ethicon and the power morcellator device they manufacture. This particular suit was filed by the family of a woman who has passed away, on her behalf. According to allegations in the complaint, the family attributes the woman’s death to the use of laparoscopic power morcellation during her gynecological surgery.
The lawsuit’s details explain that the woman underwent her gynecological surgery in order to remove painful uterine fibroids. To accomplish this, surgeons used an Ethicon (Johnson & Johnson) brand power morcellator device. The power morcellator was inserted into the woman’s lower abdomen through a small incision. Once inside, the tool spun small blades in order to shred the woman’s uterine fibroid tissue into small pieces which could be removed from her body. In doing this, however, the family alleges that the device also exposed previously encapsulated cancer cells and spread them throughout her body. Allegedly, this accelerated the cancer and caused the woman to be diagnosed with a high-grade, widespread cancer shortly after the surgical procedure was completed.
The complaint states that the woman died less than 2 years after her surgery due to metastatic uterine cancer which had spread and would not respond to treatments. They state that the power morcellator ultimately caused this death, because if it had not exposed and spread the previously undetected cancer cells, the cancer may have been able to be contained and more successfully treated.
The United States Food and Drug Administration has also stepped forward to issue a safety warning regarding power morcellator devices. They noted that most women should avoid undergoing laparoscopic power morcellation procedures on uterine fibroids due to the risk of spreading uterine cancers. The FDA estimated that approximately 1 in every 350 women undergoing these gynecological surgeries may have hidden cancer cells. When these cells are encapsulated in a uterine fibroid, they are virtually impossible to detect before surgery.
Lawsuits claiming that power morcellator devices are exposing and spreading cancer cells and therefore significantly impairing the life expectancy of many women have begun to appear across the United States. The many suits filed to date have been consolidated to form multidistrict litigation number 2652 in the U.S. District of Kansas. They are being overseen by the Honorable Judge Kathryn H. Vratil.
As these cases await trial, the attorneys at Tracey & Fox are working to ensure that everyone affected by laparoscopic power morcellation and post-surgical cancer diagnoses will be able to explore their legal rights. These individuals and their families may be entitled to significant compensation. To better assist these people, the attorneys at Tracey & Fox are offering free legal consultations.
To ask questions regarding power morcellation lawsuits, or to request additional information on the subject, please contact Tracey & Fox by calling (713) 322-5375.
Read more: http://www.digitaljournal.com/pr/2767987#ixzz3tw6mQU9G
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