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Morcellation Media Monitoring 3/26/2015
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Sen. Casey seeks answers about surgical procedure
Mar 24, 2015 | Pittsburgh Business Times
By Kris B. Mamula
U.S. Sen. Bob Casey on Tuesday asked the head of a health insurance trade group to find ways of protecting women from the dangers posed by a surgical tool that is used in gynecological procedures. Casey, a Democrat from Scranton, sent a letter to America’s Health Insurance Plans President Karen Ignagni, asking whether an analysis of claims data was available to determine the number of adverse events caused by power morcellators. The device is used in hysterectomies, removal of benign uterine tumors and other procedures. -
Corrections & Amplifications
Mar 24, 2015 | The Wall Street Journal
A Yale University study found that 84% of gynecological surgeons at large U.S. teaching hospitals changed hysterectomy techniques after a federal warning on a device called a power morcellator. A March 17 Page One article about the surgeries incorrectly said 78% switched methods. -
Experts Divided On FDA's Approach To Medical Device Regulation
Mar 25, 2015 | Med Device Online
By Jof Enriquez
The U.S. Food and Drug Administration (FDA) attempts to walk the fine line between protecting public health safety and encouraging the development of innovative medical devices. There is no shortage of differing opinions on whether or not the FDA’s current regulatory approach towards medical devices should be overhauled, slightly tweaked, or stay the course. -
New study indicates laparoscopic hysterectomy with morcellation may be safer than abdominal procedure
Mar 24, 2015 | Medical Xpress
In a new study published in the American Journal of Obstetrics & Gynecology, researchers from The University of North Carolina at Chapel Hill compared the relative risks of laparoscopic hysterectomy (with morcellation) with abdominal surgery for hysterectomy in premenopausal women undergoing surgery for presumed uterine fibroids. Examining short- and long-term complications, quality of life, and overall mortality, they found that abdominal surgery carries a higher risk of complications, decreased quality of life, and death. -
Fibroid Morcellation Gets Boost From New Study
Mar 25, 2015 | MedPage Today
By Shara Yurkiewicz MD
A decision-tree analysis predicted fewer overall deaths, fewer surgical complications, and increased quality of life for women who underwent laparoscopic hysterectomy with morcellation compared with abdominal hysterectomy for presumed fibroid uterus, reported researchers. -
Laparoscopic hysterectomy with morcellation safer than abdominal procedure for treating presumed fibroid uterus
Mar 25, 2015 | News Medical
Decision Analysis Results Published in the American Journal of Obstetrics & Gynecology In a new study published in the American Journal of Obstetrics & Gynecology, researchers from The University of North Carolina at Chapel Hill compared the relative risks of laparoscopic hysterectomy (with morcellation) with abdominal surgery for hysterectomy in premenopausal women undergoing surgery for presumed uterine fibroids. Examining short- and long-term complications, quality of life, and overall mortality, they found that abdominal surgery carries a higher risk of complications, decreased quality of life, and death. -
Laparoscopic Hysterectomy Leiomyosarcoma Risks Balanced by Benefits Over Abdominal Surgery: Study
Mar 25, 2015 | About Lawsuits
By Irvin Jackson
As concerns continue to mount within the medical community about the risk of spreading leiomyosarcoma during a laparoscopic hysterectomy with morcellation, a recent study suggests that the minimally invasive procedures may still be safer than an abdominal hysterectomy when factoring in the risk of infections and other potentially life-threatening problems.
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Full Text of Stories Below
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Sen. Casey seeks answers about surgical procedure
Mar 24, 2015 | Pittsburgh Business Times
By Kris B. Mamula
U.S. Sen. Bob Casey on Tuesday asked the head of a health insurance trade group to find ways of protecting women from the dangers posed by a surgical tool that is used in gynecological procedures.
Casey, a Democrat from Scranton, sent a letter to America’s Health Insurance Plans President Karen Ignagni, asking whether an analysis of claims data was available to determine the number of adverse events caused by power morcellators. The device is used in hysterectomies, removal of benign uterine tumors and other procedures.
“While women are examined and tested for potential uterine cancers before such surgery, some sarcomas simply cannot be detected,” Casey wrote. The device minces tissue for easy removal during minimally invasive surgery, but can spread a deadly form of cancer.
"Our primary goal is to provide access to safe, effective care for patients," AHIP spokeswoman Clare Krusing said in a statement. "Given serious safety concerns surrounding the use of power morcellation, many health plans have taken important steps to protect women who are having hysterectomies and to ensure they get the safe, appropriate care they need."
Health insurer Highmark, the fourth largest Blues provider in the country, stopped paying doctors for procedures involving power morcellation in September after a series of storiesdetailing the problems of the procedure appeared in the Pittsburgh Business Times. A number of other insurers nationwide have followed suit in restricting or ending payment for the procedure.
The decision to stop reimbursement for morcellation came after a Highmark employee developed advanced cancer after the procedure, Highmark President and CEO David Holmberg said Monday, and the decision was the “right thing do do.”
The Food and Drug Administration has discouraged doctors from using the device and estimated that one-in-350 women undergoing the procedure see an isolated uterine tumor turn into a deadly form of cancer.
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Mar 24, 2015 | The Wall Street Journal
A Yale University study found that 84% of gynecological surgeons at large U.S. teaching hospitals changed hysterectomy techniques after a federal warning on a device called a power morcellator. A March 17 Page One article about the surgeries incorrectly said 78% switched methods.
The National Football League plans to show a game in the coming season on a national digital platform, bypassing national television. In some editions Tuesday, a What’s News item incorrectly said the plan involves a game next year.
One of the images accompanying a Personal Journal article Thursday about how exchange rates are making European hotels more affordable for American travelers showed the Marriott County Hall in London, which was incorrectly identified as another London hotel, Le Meridien Piccadilly. In addition, the latter hotel’s name was misspelled in the caption as Le Meridien Picadilly.
Most of the schools represented by the nonprofit group the Jewish Community Day School Network accept students from several denominations. An article on Monday about fire safety in the Jewish community incorrectly said the group connects day schools that specialize in different denominations.
Jena la Flamme learned about Preschool Mastermind from the program’s instructor. An article on Saturday about the adult preschool incorrectly said she learned about it on Facebook.
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Experts Divided On FDA's Approach To Medical Device Regulation
Mar 25, 2015 | Med Device Online
By Jof Enriquez
The U.S. Food and Drug Administration (FDA) attempts to walk the fine line between protecting public health safety and encouraging the development of innovative medical devices. There is no shortage of differing opinions on whether or not the FDA’s current regulatory approach towards medical devices should be overhauled, slightly tweaked, or stay the course.
When the Wall Street Journal recently talked to three experts about the topic in a roundtable discussion, their views reflect how divided stakeholders are on device regulation.
Scott Gottlieb, former FDA deputy commissioner, believes that the agency has deviated from its original mandate by overreaching in areas it was not designed to monitor.
In the interview, he says that the FDA has unfortunately shifted towards applying a “much more uniform and druglike approach to its regulation of medical devices,” instead of focusing on risks associated with a particular device. Gottlieb says that this approach has led to the creation of unnecessary hurdles for newly developed devices.
He also describes as “unethical” and “unnecessary” dummy surgical procedures that he says the FDA has asked manufacturers to conduct as part of the review process. According to him, such procedures place the patient at risk without clear benefits.
However, another expert interviewed by the WSJ says that those placebo-controlled device trials were not required by the FDA. Bradley Merrill Thompson, a device attorney with the firm Epstein, Becker & Green, says companies are actually the ones who suggest these trials, and the agency merely permits them.
Thompson also countered Gottlieb’s expressed view that the FDA is unnecessarily clamping down on low-risk consumer apps by treating them as medical devices.
“In the last couple of years, [FDA] has sought to reduce, not enlarge, its regulatory oversight,” Thompson told theWSJ. “For example, it has deregulated the hardware and software that takes data from medical devices like a blood glucose meter and transmits it for storage and display. That was a big step forward.” (For more on this topic, seeFDA Cuts Its Oversight Of Medical Device Data Systems.)
Rather than sweeping regulatory reform, Thompson is in favor of “continuous improvement guided by continuous review of agency performance data as well as marketplace and scientific trends.”
Meanwhile, a third expert in the discussion, Rita Redberg, a cardiology professor at the University of California, San Francisco (UCSF), says that only a few percent of all medical devices are required to undergo a pathway that lacks stringent evidence-based clinical trials.
“As a cardiologist taking care of patients every week, I see too many whose lives have been harmed and who have suffered greatly from untested or inappropriate devices,” she told the WSJ. She points out an increasing array of high-risk devices — morcellators, metal-on-metal hip implants, pelvic mesh implants, inferior vena cava filters — that were approved but were later shown to be dangerous and even lethal to many patients.
“Simply put, for the vast majority of medical devices, there is NO requirement to demonstrate safety and effectiveness,” says Redberg.
She suggests establishing national, publicly available registries of devices and procedures for tracking real-time outcomes and preventing catastrophic device failures.
All three experts lament the fact that device failures have caused deaths and injuries to many patients. However, Gottlieb and Thompson say that simply requiring manufacturers to perform larger and more clinical trials to prevent these occurrences will not ensure device safety, according to the WSJ.
“My concern is that a lot of the fundamental questions about device safety turn on issues of biomechanical performance,” says Gottlieb. “For example, some common questions are how resilient an implanted valve will be to the shearing effects of blood flow, a joint to constant stresses, or the durability of a pacemaker’s circuits.”
According to an FDA report cited by the WSJ, the number of defective devices that were recalled nearly doubled in the decade ending in 2012. However, Gottlieb and Thompson say that everyone must consider the overall picture.
“Out of all of the thousands of medical devices that the FDA clears each year, how many turn out to be unsafe or ineffective? Not many,” says Thompson. “But further, and equally importantly, how effective are alternative regulatory systems in approving important new medical devices in a timely way? Changing the system in a way that delays or even forecloses the sale of safe and effective breakthrough medical devices hurts patients, too.”
Gottlieb expressed the same view, saying, “Keep in mind that 99.8% of all medical devices have no serious adverse events associated with them. The U.S. is the gold standard when it comes to device safety.” He pointed out the implementation of the unique device identifier (UDI) as one initiative aimed at improving safety.
The U.S. Congress is working on separate measures to overhaul how the FDA regulates medical products. The nation’s largest medical device trade group, AdvaMed, also released a report that complements the language and scope of regulation over medical devices used in those legislative proposals, according to the Regulatory Affairs Professionals Society (RAPS).
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Mar 24, 2015 | Medical Xpress
In a new study published in the American Journal of Obstetrics & Gynecology, researchers from The University of North Carolina at Chapel Hill compared the relative risks of laparoscopic hysterectomy (with morcellation) with abdominal surgery for hysterectomy in premenopausal women undergoing surgery for presumed uterine fibroids. Examining short- and long-term complications, quality of life, and overall mortality, they found that abdominal surgery carries a higher risk of complications, decreased quality of life, and death.
Hysterectomy is the most common gynecologic procedure performed on non-pregnant women in the United States, and a diagnosis of fibroids (leiomyomata) accounts for many of these procedures. Minimally invasive surgery is being used more frequently because of its many advantages, including less pain and shorter length of hospital stay. But in some cases, the uterus cannot be removed without morcellation, or cutting it into pieces to fit through small incisions. However, morcellation has come under scrutiny because of concerns that if an undetected malignancy (leiomyosarcoma) is present, it may be dispersed into the pelvis and abdomen, resulting in the spread of cancer and increased mortality. This concern resulted in an FDA notification that discouraged morcellation during hysterectomy.
Given the rarity of leiomyosarcoma, a randomized trial comparing mortality after different types of hysterectomy is not feasible. Consequently, the UNC researchers used decision-tree analysis, which can compare the morbidity and mortality outcomes from a choice of surgical approaches, in this case laparoscopic versus abdominal surgery. The model evaluates outcomes according to the probability of complications specific to laparoscopic and abdominal surgery. Researchers used results from published studies, selecting inputs from the highest quality and most recent studies to reflect advances in surgical practice. Ten studies were used to estimate the incidence of malignant leiomyosarcoma in women undergoing surgery for presumed fibroids.
"Our decision analysis predicted lower overall mortality from laparoscopic hysterectomy with morcellation than abdominal hysterectomy for treating the presumed fibroid uterus in premenopausal women," explained lead investigator Matthew T. Siedhoff, MD, MSCR. "Laparoscopic hysterectomy with morcellation was also associated with fewer postoperative complications and improved quality of life."
Using a hypothetical cohort of 100,000 women over a five-year time horizon, the investigators found that, while there would be more deaths from malignant leiomyosarcoma with laparoscopic surgery (98 vs. 103 per 100,000), there were more hysterectomy-related deaths, for example, from blood clots after surgery, with the abdominal procedure (32 vs. 12 per 100,000).
Sensitivity analyses were performed to assess the robustness of the assumptions in the decision model, including surgical complications, the probability of leiomyosarcoma, and probability of death from hysterectomy. The range of clinical outcomes (e.g. transfusion, wound infection, etc.) was evaluated by varying the input for each clinical event to its minimum and maximum.
Editor-in-Chief for Gynecology of the American Journal of Obstetrics & Gynecology Ingrid Nygaard, MD, MS, Professor of Obstetrics and Gynecology at the University of Utah, commented that "No decision analysis is ever the 'final word' and this one in this month's AJOG is no different. New data will continue to be added to the literature and the conclusions might stand as they are or change. But, most importantly, Siedhoff et al remind us to keep the big picture in mind, to balance risks and benefits of different procedures, and to work vigilantly to decrease the impact of risks to the extent possible."
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Fibroid Morcellation Gets Boost From New Study
Mar 25, 2015 | MedPage Today
By Shara Yurkiewicz MD
A decision-tree analysis predicted fewer overall deaths, fewer surgical complications, and increased quality of life for women who underwent laparoscopic hysterectomy with morcellation compared with abdominal hysterectomy for presumed fibroid uterus, reported researchers.
But there were more deaths from leiomyosarcoma after laparoscopic hysterectomy, wrote Matthew Siedhoff, MD, an ob/gyn physician at the University of North Carolina School of Medicine in Chapel Hill, and colleagues, in the American Journal of Obstetrics and Gynecology.
Using morbidity and mortality data from 26 previous studies spanning several decades, researchers constructed a decision tree for a hypothetical cohort of 100,000 premenopausal women over a 5-year time period who had a hysterectomy for presumed uterine fibroids.
The goal of the study was to provide physicians with better estimates of health outcomes when considering surgical approaches for uterine fibroids, authors said.
The study is consistent with previous research, Hal Lawrence, MD, of Georgetown University Hospital in Washington, D.C., and executive vice president and CEO of the American College of Obstetricians and Gynecologists, told MedPage Today in an email.
"Obstetrician-gynecologists understand that total abdominal hysterectomy has higher rates of morbidity and mortality than less-invasive alternatives, including those conducted with morcellation. Based on previous data, we continue to assert that vaginal hysterectomy offers patients fewer complications and better outcomes for patients, so is the preferred route of hysterectomy when possible," he wrote.
"Of course, there is no one-size-fits-all solution for the treatment of fibroids. Not all women are indicated for vaginal hysterectomy, so it is essential that laparoscopic hysterectomy with morcellation and total abdominal hysterectomy continue to be available as treatment options," Lawrence added.
True informed consent is key, Diana Bitner, MD, an obstetrician/gynecologist and director of Women's Health Network at Spectrum Health in Grand Rapids, Mich., told MedPage Today in an email.
"I agree with the findings and think women deserve informed consent that, while cancer being spread is a risk of morcellation, most women do not have cancer to be spread and ... so many other risks [are reduced] with laparoscopic surgery," she said.
"As a pelvic surgeon, it will kill me to go backwards and go back to open surgery when minimally invasive could be so much safer, reduce hospital time, time off work, pain, and need for narcotics, etc.," she added.
The benefits of minimally invasive surgery have been well established for a long time, Michael Nimaroff, MD, vice chairman of obstetrics and gynecology and chief of minimally invasive gynecologic surgery at North Shore University Hospital in Manhasset, N.Y., told MedPage Today.
Previously Nimaroff's hospital had stopped using morcellation. But it is now re-introducing the procedure in a contained fashion by placing the tissue in specimen retrieval bags, he said.
"This can still be done, but we can do it in a better way," he added.
Warnings Over the Years
The findings add to the debate about the use of morcellation to remove uterine leiomyomas, which has embroiled the ob/gyn community for the last year and a half.
In April 2014, the FDA discouraged the use of power morcellators with hysterectomy because the devices posed "a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas."
A review published in the Journal of the American Medical Association in July 2014 quantified the risk. Looking at more than 200,000 cases, researchers found that one of every 368 women who underwent treatment with a power morcellator had unsuspected uterine cancer identified during or after the procedure.
In December 2013, the Society of Gynecologic Oncology (SGO) published aposition statement advising physicians and patients to have a thorough discussion of the risks and benefits of undergoing morcellation. The SGO added that the procedure is "generally contraindicated in the presence of documented or highly suspected malignancy and may be inadvisable in premalignant conditions or risk-reducing surgery."
Meanwhile, editors of the The Lancet took a harder line in a February 2014 editorial. "New techniques and devices should be proven safe before widespread acceptance, rather than being widely used until proven hazardous," they wrote.
Malignancy Estimates Mattered
With laparoscopic hysterectomy, the analysis by Siedhoff and colleagues predicted fewer overall deaths (98 versus 103 per 100,000), but more deaths from leiomyosarcoma (86 versus 71 per 100,000).
Researchers used an estimate of 0.0012 for occult leiomyosarcoma incidence among presumed uterine fibroid patients, derived from four sources.
"Limitations in the literature suggest our estimate was conservative, and updated estimates of leiomyosarcoma risk in the population are unlikely to alter the direction of our conclusions," authors wrote.
Outcomes varied with different estimates, they added.
Using the lowest estimate (0.0007), there were 11 to 19 more deaths with abdominal hysterectomy. With the highest (0.0049), there were 36 to 44 more deaths with laparoscopy.
Abdominal surgery was linked to more hysterectomy-related deaths (32 versus 12 per 100,000).
The laparoscopic group had lower rates of surgical complications, including:Transfusion (2,400 versus 4,700 per 100,000)Abdominal wound infection (1,500 versus 6,300 per 100,000)Venous thromboembolism (690 versus 840 per 100,000)Incisional hernia (710 versus 8,800 per 100,000)
The abdominal group had a lower rate of vaginal cuff dehiscence (290 versus 640 per 100,000).
Patients undergoing laparoscopy had 8,460 more quality-adjusted life years than those undergoing abdominal surgery (499,171 versus 490,711). This translated into an additional 0.85 quality-adjusted life years over 5 years.
Study authors noted limitations due to lack of data. "The model assumed that the behavior of a morcellated leiomyosarcoma would mimic that of a spontaneous disease spread. A better understanding of the impact of leiomyosarcoma morcellation could alter the conclusions of our model, either positively or negatively," they wrote.
Additional limitations included the unrandomized nature of the analysis and scarce data on the impact of complications on quality-adjusted life years, they said.
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Mar 25, 2015 | News Medical
Decision Analysis Results Published in the American Journal of Obstetrics & Gynecology
In a new study published in the American Journal of Obstetrics & Gynecology, researchers from The University of North Carolina at Chapel Hill compared the relative risks of laparoscopic hysterectomy (with morcellation) with abdominal surgery for hysterectomy in premenopausal women undergoing surgery for presumed uterine fibroids. Examining short- and long-term complications, quality of life, and overall mortality, they found that abdominal surgery carries a higher risk of complications, decreased quality of life, and death.
Hysterectomy is the most common gynecologic procedure performed on non-pregnant women in the United States, and a diagnosis of fibroids (leiomyomata) accounts for many of these procedures. Minimally invasive surgery is being used more frequently because of its many advantages, including less pain and shorter length of hospital stay. But in some cases, the uterus cannot be removed without morcellation, or cutting it into pieces to fit through small incisions. However, morcellation has come under scrutiny because of concerns that if an undetected malignancy (leiomyosarcoma) is present, it may be dispersed into the pelvis and abdomen, resulting in the spread of cancer and increased mortality. This concern resulted in an FDA notification that discouraged morcellation during hysterectomy.
Given the rarity of leiomyosarcoma, a randomized trial comparing mortality after different types of hysterectomy is not feasible. Consequently, the UNC researchers used decision-tree analysis, which can compare the morbidity and mortality outcomes from a choice of surgical approaches, in this case laparoscopic versus abdominal surgery. The model evaluates outcomes according to the probability of complications specific to laparoscopic and abdominal surgery. Researchers used results from published studies, selecting inputs from the highest quality and most recent studies to reflect advances in surgical practice. Ten studies were used to estimate the incidence of malignant leiomyosarcoma in women undergoing surgery for presumed fibroids.
"Our decision analysis predicted lower overall mortality from laparoscopic hysterectomy with morcellation than abdominal hysterectomy for treating the presumed fibroid uterus in premenopausal women," explained lead investigator Matthew T. Siedhoff, MD, MSCR. "Laparoscopic hysterectomy with morcellation was also associated with fewer postoperative complications and improved quality of life."
Using a hypothetical cohort of 100,000 women over a five-year time horizon, the investigators found that, while there would be more deaths from malignant leiomyosarcoma with laparoscopic surgery (98 vs. 103 per 100,000), there were more hysterectomy-related deaths, for example, from blood clots after surgery, with the abdominal procedure (32 vs. 12 per 100,000).
Sensitivity analyses were performed to assess the robustness of the assumptions in the decision model, including surgical complications, the probability of leiomyosarcoma, and probability of death from hysterectomy. The range of clinical outcomes (e.g. transfusion, wound infection, etc.) was evaluated by varying the input for each clinical event to its minimum and maximum.
Editor-in-Chief for Gynecology of the American Journal of Obstetrics & Gynecology Ingrid Nygaard, MD, MS, Professor of Obstetrics and Gynecology at the University of Utah, commented that "No decision analysis is ever the 'final word' and this one in this month's AJOG is no different. New data will continue to be added to the literature and the conclusions might stand as they are or change. But, most importantly, Siedhoff et al remind us to keep the big picture in mind, to balance risks and benefits of different procedures, and to work vigilantly to decrease the impact of risks to the extent possible."
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Laparoscopic Hysterectomy Leiomyosarcoma Risks Balanced by Benefits Over Abdominal Surgery: Study
Mar 25, 2015 | About Lawsuits
By Irvin Jackson
As concerns continue to mount within the medical community about the risk of spreading leiomyosarcoma during a laparoscopic hysterectomy with morcellation, a recent study suggests that the minimally invasive procedures may still be safer than an abdominal hysterectomy when factoring in the risk of infections and other potentially life-threatening problems.
Researchers from the University of North Carolina at Chapel Hill published a study this week in the American Journal of Obstetrics & Gynecology, which found that abdominal surgery to remove uterine fibroids carries a higher risk of complications and death than laparoscopic procedures involving the use of morcellators.
In recent months, the medical community has largely moved away from the use of power morcellators, which are able to cut up and remove tissue through a small abdominal incision. Since many women may have unsuspected sarcoma contained within their uterus, which doctors are unable to diagnose before the procedure, most experts now believe that the risk that morcellators may disseminate leiomyosarcoma or other uterine cancers is too great to justify the laparoscopic procedures.
In this latest study, researchers used a hypothetical model of 100,000 premenopausal women who underwent hysterectomies for uterine fibroid removal over a period of five years. It predicts that there would be 98 deaths per 100,000 women among those who underwent laparoscopic hysterectomy, but that there would be 103 per 100,000 women who died if they got an abdominal hysterectomy.
Researchers found there would be more deaths due to leiomyoscarcoma among women who underwent power morcellation, but that abdominal hysterectomies would result in more wound infections, needs for blood transfusions, incision hernias, and other risks.
“The risk of leiomyosarcoma morcellation is balanced by procedure-related complications that are associated with laparotomy, including death,” the researchers concluded. “This analysis provides patients and surgeons with estimates of risk and benefit on which patient-centered decisions can be made.”
Laparoscopic Hysterectomy Cancer Risks
In April 2014, the FDA issued a statement about the risk of power morcellators spreading uterine cancer, indicating that an estimated one out of every 350 women undergoing a hysterectomy or myomectomy may have unsuspected uterine sarcoma.
Following a safety review, the FDA announced in November that new “black box” warnings will be required for all morcellators, warning about the risk of spreading cancer and contraindicating the use of the devices on most likely patients.
While it is rare for women to have unsuspected leiomyosarcoma or other cancers, spreading the aggressive cells throughout the abdomen is a virtual death sentence for women, greatly reducing the chances for long-term survival and rapidly diminishing their overall quality of life. As a result, the medical community has been pulling away from the use of morcellation for uterine fibroid removal and a number of major insurance companies now say they will not cover the procedure, or will only do so under strict circumstances. In addition, a number of hospitals and health care networks are also eschewing the practice.
Manufacturers of the devices now face a growing number of morcellator cancer lawsuits, alleging that the devices were sold without adequate warnings about the risk of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers.
Plaintiffs allege that the rapid spread of cancers may have been avoided if any number of different alternative treatment options available for women with symptomatic uterine fibroids had been used, including traditional surgical hysterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.
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