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Morcellation Media Monitoring 3/19/2015
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Warning Prompts Shift In Surgeries on Women
Mar 16, 2015 | Wall Street Journal
By Jennifer Levitz
Gynecologists in the U.S. have changed the way they perform hysterectomies now that they no longer can readily use a popular medical device that was found to spread hidden cancers in some women, according to doctors, hospitals and a new study. -
Saying Goodbye to a Once-Popular Hysterectomy Device
Mar 17, 2015 | QMed
By Chris Newmarker
Despite worries that limits placed on laparoscopic power morcellators would cause major shifts to open surgery, doctors have found other noninvasive ways to perform hysterectomies, according to The Wall Street Journal. -
Ethicon Hit With Morcellator Cancer Wrongful Death Lawsuit
Mar 17, 2015 | Top Class Actions
By Amanda Antell
Pennsylvania plaintiff Arthur J. filed a power morcellation lawsuit against Johnson & Johnson’s subsidiary, Ethicon Inc., for the wrongful death of his wife, Jonel D. Arthur claims in his power morcellation cancer lawsuit that as a direct result of using the Ethicon’s power morcellator device, a uterine sarcoma inside the Jonel had been ruptured and had allowed the spread of deadly cancer cells. -
Studies Focus on Risk of Spreading Cancer with Morcellators
Mar 19, 2015 | Drug Watch
By Michelle Llamas
Two new research studies added to mounting evidence that surgery tools calledpower morcellators can spread hidden uterine cancer. The medical devices already face scrutiny from the U.S. Food and Drug Administration (FDA), which has warned about the cancer risk and imposed restrictions on their use. -
Uterine Fibroid Removal Cancer Risk is “Substantially Higher” Than Originally Presumed
Mar 19, 2015 | About Lawsuits
By Irvin Jackson
A Boston doctor whose wife is battling leiomyosarcoma cancer spread by a power morcellator, is sharply criticizing recent media reports that suggest the incidence of cancer among women undergoing uterine fibroid removal is “low”. -
New Jersey Medical Malpractice Lawsyers Warn of Increased Uterine Morcellation Risks
Mar 16, 2015 | Lawyers.com
By Barry R. Eichen
Surgeons perform over 600,000 hysterectomies each year in the United States. One of the most common medical devices used during this procedure is a power morcellator, a surgical tool used to slice through bodily tissue. Power morcellators allow tissue to be removed through tiny abdominal incisions. They are frequently used during gynecological surgeries to avoid the need for large abdominal incisions which can cause increased pain, longer recovery times and a greater risk of bleeding or infection.
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Warning Prompts Shift In Surgeries on Women
Mar 16, 2015 | Wall Street Journal
By Jennifer Levitz
Gynecologists in the U.S. have changed the way they perform hysterectomies now that they no longer can readily use a popular medical device that was found to spread hidden cancers in some women, according to doctors, hospitals and a new study.
While some surgeons remain dismayed about new limits imposed on the tool, called a laparoscopic power morcellator, concerns that its loss would lead to major problems or a dramatic shift to open surgery don’t appear to have materialized. Instead, doctors say they have turned to alternatives for one of the most common operations performed on American women.
“There was kind of this grim-reaper prediction that there would be lots of problems, but indeed it hasn’t turned out that way because people adjusted,” said Robert Graebe, the chairman and program director of the Department of Obstetrics and Gynecology at Monmouth Medical Center, a New Jersey hospital that no longer uses the device.
The morcellator was used in tens of thousands of minimally invasive procedures annually to remove benign uterine growths called fibroids, in most cases as part of hysterectomies, in which the uterus is removed.
But in November the U.S. Food and Drug Administration strengthened a warning it had given in April: that an estimated 1 in 350 women undergoing surgery to remove fibroids instead have a hard-to-detect cancer that can be spread by the tool, which typically employs a fast-rotating blade to cut tissue that is removed through small incisions. The agency advised doctors not to use the device on the vast majority of women.
The FDA began reviewing morcellators in December 2013 after a Wall Street Journal article detailed the case of a Boston doctor whose own cancer was worsened by the device. Many hospitals halted or curbed use of the device, and Johnson & Johnson, the largest U.S. manufacturer, pulled its models from the market in July 2014.
As of next month, UnitedHealth Group Inc., the nation’s largest health insurer, will require pre-authorization for all hysterectomies except outpatient vaginal procedures, which don’t require the device.
Changes in clinical practice have been harder to quantify, but interviews with dozens of doctors, hospital systems and a new study by Yale University researchers indicate a broad transformation. The study showed that among 43 high-volume minimally invasive gynecologists and fellowship faculty members at large U.S. teaching hospitals, 78% had switched methods after the FDA warning.
The doctors are now most often choosing a “mini-laparotomy,” in which the uterus is removed through a small incision above the pubic bone. The incision is typically between 1 1/2 inches and 3 inches, versus roughly 1/2 -inch to 3/4 -inch incisions in procedures using the morcellator. The study will be published by the American Journal of Obstetrics & Gynecology in May.
“One thing that’s really important is that we’ve been able to continue the benefits of minimally invasive surgery,” said Vrunda Bhavsar Desai, an assistant professor at Yale School of Medicine and a study author.
Still, she said, anytime an incision grows, the risk of infection rises. Dr. Desai said it is still unclear what the changes mean for health-care costs and overall recovery times and complications.
A quarter of the surgeons who changed their approach told Yale researchers they sometimes performed traditional abdominal hysterectomies, which remain one of the most common methods of the procedure. The operation uses an incision some 5 to 7 inches long.
Compared with minimally invasive surgery, open hysterectomies entail longer hospital stays, more blood loss, higher infection risk and a slower return to normal activities, the FDA said. Laparoscopic procedures may lengthen surgeries while raising the risk of urinary-tract injuries.
But the agency said last year it was unclear whether evidence shows a higher risk of death in open surgery, as some gynecologists have said. There aren’t current published studies comparing the mortality risks of morcellation, including the possibility of worsened cancer, with those of open surgery.
Allan Katz, chief gynecologist at Memorial Hermann-Texas Medical Center in Houston, believes that his hospital is seeing more open surgeries since it banned the morcellator about a year ago. “Now [patients] have a big incision and the recovery takes a little bit longer and the pain is higher,” said Dr. Katz, who disagrees with the FDA’s warning. He said he expects fewer open surgeries as doctors start using minimally invasive alternatives.
Other doctors and hospitals said concerns in the field that complications and open surgeries would rise sharply after the FDA warning aren’t bearing out.
Since suspending morcellation in May, Trinity Health, a Michigan-based Catholic system with 86 hospitals in 21 states, hasn’t had complaints from doctors or patients and isn’t aware of changes in complication rates, a spokeswoman said.
Legacy Health, a six-hospital system in Oregon and Vancouver, Wash., said that instead of using the morcellator, doctors are cutting fibroids manually inside surgical bags so the tissue can be removed through small incisions. The hospital said the technique adds time but that patients are doing well.
In Rochester, N.Y., doctors at Unity Hospital, where the device is banned, are performing mini-laparotomies, removing the uterus intact through the vagina, and in the case of very large fibroids, doing open surgery.
“It’s still how we do C-sections these days, you know, and people are fine,” said gynecologist Sareena Fazili, speaking for Unity. She added that the morcellator didn’t always work on large fibroids, forcing doctors to make a large incision anyway.
Still, the loss of the morcellator has been widely felt. Minimally invasive surgeons “used this device routinely and now they are having to change their method of doing the same operation and are working on ways of making it better,” said John Schorge, chief of gynecology at Massachusetts General Hospital. He believes the controversy will lead to new national standards for hysterectomies.
Damian Alagia, chief medical officer at KentuckyOne Health, a 13-hospital system, said he told his gynecologists to return to their roots and learn to work without a morcellator. Now, doctors there use laparoscopic tools to operate, and then remove the uterus through the vagina or mini-laparotomy incisions.
Suffering from fibroids, Amanda Varga, a 54-year-old marketing executive in Lake Mary, Fla., sought help last fall from Steven McCarus, chief of gynecological surgery at Florida Hospital Celebration Health. The hospital has banned morcellation for fibroids.
Dr. McCarus suggested a laparoscopic mini-laparotomy. “I was on board right away,” recalled Ms. Varga. “If there is a possibility it could be cancer for some women, I don’t want to be that possibility.”
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Saying Goodbye to a Once-Popular Hysterectomy Device
Mar 17, 2015 | QMed
By Chris Newmarker
Despite worries that limits placed on laparoscopic power morcellators would cause major shifts to open surgery, doctors have found other noninvasive ways to perform hysterectomies, according to The Wall Street Journal.
Citing soon-to-be-published research out of Yale University, the Journal reports that among gynecologists and fellowship faculty members at large U.S. teaching hospitals who performed many of the procedures, 78% have switched away from power morcellators. Most are instead engaging in a “mini-laparotomy” that involves removing the uterus through a tiny incision above the pubic bone.
A mini-laparotomy typically involves an incision 1 ½ to 3 in., while themorcellator procedure incision was generally ½ to ¾ in. The larger incision could increase risk of infections, but it isn’t the shift back to open hysterectomies some predicted.
The Wall Street Journal first raised concerns about morcellators in late 2013. By April 2014, FDA had its own warning out. By November, FDA was advising physicians not to use power morcellators to remove the uterus (hysterectomy) or uterine fibroids (myomectomy) from patients who are peri- or post-menopausal, or are candidates for removing tissue intact through the vagina or a minilaparotomy incision.
Over the summer, Johnson & Johnson’s Ethicon subsidiary pulled its morcellators from the market, including theGynecare Morcellex Tissue Morcellator, Morcellex Sigma Tissue Morcellator System and the Gynecare X-tract TissueMorcellator.
The issues surrounding the morcellators have not only effected the companies that make them, such as Ethicon, but also companies such as Intuitive Surgical, which makes surgical robots for the early stages of hysterectomies, beforemorcellation takes place.
FDA estimates that 1 in 350 women undergoing either a hysterectomy or myomectomy to treat fibroids has an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. There is no reliable way to predict or test whether a woman with fibroids may have a uterine sarcoma, the agency said.
“If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival,” FDA said last year. “While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood.”
For its part, Minnetonka, MN–based UnitedHealth Group, the nation’s largest health insurer, has placed new restrictionson its coverage of hysterectomies.
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Ethicon Hit With Morcellator Cancer Wrongful Death Lawsuit
Mar 17, 2015 | Top Class Actions
By Amanda Antell
Pennsylvania plaintiff Arthur J. filed a power morcellation lawsuit against Johnson & Johnson’s subsidiary, Ethicon Inc., for the wrongful death of his wife, Jonel D.
Arthur claims in his power morcellation cancer lawsuit that as a direct result of using the Ethicon’s power morcellator device, a uterine sarcoma inside the Jonel had been ruptured and had allowed the spread of deadly cancer cells.
Jonel allegedly opted to use the power morcellator device because it has been advertised and proven to be less invasive than traditional hysterectomy procedures, as well as requiring less hospital recovery time. With these benefits, Jonel underwent her first complete robotic procedure on June 19, 2012, to remove unwanted uterine fibroids.
There were no ill side effects to this first surgery because her surgeon used an endoscopic bag to contain the removed tissue. In previous studies, surgeons who used these bags have had fewer complications and injury reports indicating the spread of cancer, because these bags are able to contain any potential sarcoma.
However, Jonel had not been aware of the cancer risk at the time of her first power morcellator surgery and had not been at the time of her second surgery either, according to the power morcellator lawsuit.
On Aug. 2, 2012, Jonel had once again gone under the power morcellator knife, for a complete lymphadenectomy where she had been under heavy medical observation and received cancer screening. It is important to note that an endoscopic bag was not reportedly used for this second surgery, the power morcellator lawsuit claims.
On Jan. 9, 2013, Jonel underwent a diagnostic laparoscopy procedure, where malignant cells akin to leiomyosarcoma, or uterine fibroid cancer, had been discovered. At this point, the disease had progressed to a latent stage, leaving treatment options minimal and life expectancy drastically shortened.
Jonel ultimately died on Feb. 6, 2013, according to the power morcellation lawsuit.
Arthur allegedly did not discover that his wife’s death could have been prevented or that the devices had a tendency to rupture uterine sarcomas, until a televised advertisement announced these complications in June 2014.
At no point before or after his wife’s surgeries or deaths, did the Ethicon inform the Arthur or Jonel of these possibilities and provided no surgical instructions to physicians, the morcellation lawsuit alleges. This discovery was allegedly not made until a date within the applicable statute of limitations for Arthur’s lawsuit.
Arthur’s power morcellation lawsuit states that Ethicon had the responsibility to warn his wife and other women of all potential risks associated with its power morcellator devices. The charges against Ethicon include: negligence, false advertising, concealing information, and misrepresenting a product.
This Power Morcellator Cancer Lawsuit is Arthur J. v. Ethicon Inc., Case No. 2:15-cv-00553-JHS, in the U.S. District Court for the Eastern District of Pennsylvania.
Overview of Powered Morcellator Complications
Every year, it is estimated that 650,000 women will undergo a laparoscopic surgery to remove uterine fibroids in the United States. In the last few decades, women have opted for power morcellator devices to perform their hysterectomy procedures because of their ability to make accurate, delicate incisions in the surgical area, and removing the uterine fibroid with minimally invasive effort.
These devices work by removing the uterine fibroids in parts, because the tiny blades attached to the morcellators cut up the fibroid, allowing for easy removal. Unfortunately, it is this very mechanism that has caused so much controversy over power morcellators and has resulted in such morcellator lawsuits against manufacturing companies.
Medical experts explain that once these uterine fibroids are ruptured, any hidden uterine sarcoma cells would then be released inside the patient, allowing for the formation of uterine cancer. Surgeons have reported seeing better results when using the endoscopic sacs mentioned in the morcellation cancer lawsuit above, because it contains potentially cancerous cells.
It is important to note that most power morcellators were approved through the FDA’s 510(k) process, which allows the device to go to market without thorough preclinical studies. As long as a device or drug proves to work at similar efficiency to a similar product already on the market, then these products are eligible for this policy.
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Studies Focus on Risk of Spreading Cancer with Morcellators
Mar 19, 2015 | Drug Watch
By Michelle Llamas
Two new research studies added to mounting evidence that surgery tools calledpower morcellators can spread hidden uterine cancer.
The medical devices already face scrutiny from the U.S. Food and Drug Administration (FDA), which has warned about the cancer risk and imposed restrictions on their use.
A University of Michigan study published last month in Obstetrics & Gynecology found that one in 368 women undergoing a hysterectomy or fibroid removal had undetected uterine sarcoma. Cells from these cancers, including a deadly type called leiomyosarcoma, could be spread throughout the abdomen during morcellation. The effect can upstage the cancer, making it more difficult to treat. Researchers gathered information from nearly 7,500 women who had hysterectomies.
“No reliable predictors of uterine sarcoma exist and caution is warranted in preoperative planning for hysterectomy,” study authors said.
A second study, published last month in the Journal of the American Medical Association (JAMA) Oncology, revealed that women who undergo morcellation for hysterectomies have a greater risk of undetected cancer than women who undergo fibroid removal. The study confirmed what the FDA already had announced, that risks increase with age.
Younger women who still desire children shy away from hysterectomies and opt for fibroid removal than older women do. Study authors said the device “should be used with caution” in older women.
“Some women certainly would not want to take the risk of having a potential cancer disseminated,” said Dr. Jason Wright, lead author of the JAMA study.
Power morcellators – drill-like surgical tools used to shred and remove tissue in surgeries such as hysterectomies, fibroid removal and other gynecological operations – faced scrutiny in 2013 when several women suffered upstaged uterine cancer after routine surgeries performed with the devices.
Some women died from their upstaged cancers, and their families filedlawsuits against device manufacturers.
Doctors Using Alternatives to Morcellators
The FDA did not ban the devices but did impose strict restrictions on their use. It also added a black box warning to the device’s label for the risk of spreading cancer. That is the FDA’s strongest warning.
Morcellator manufacturers stand by their products despite legal claims from patients and families. However, Johnson & Johnson pulled three of its morcellators off the market.
Doctors are divided on the issue of morcellator safety. Many proponents say minimally invasive surgery with morcellators allows for faster healing and less infection risk.
Regardless of that surgeon support, health care providers and hospitals are taking the FDA warning seriously.
HCA Holdings Inc., a for-profit hospital chain with about 160 hospitals and 115 surgery centers across 20 states, became the first hospital chain to ban morcellators in December 2014. Other hospitals followed suit, including renowned Temple University Hospital in Philadelphia.
According to Enrique Hernandez, the hospital’s top gynecologist, the new studies support Temple’s decision to ban morcellator use.
“I think it’s too big a risk,” Hernandez told The Wall Street Journal.
He isn’t alone. In a Yale University study, researchers interviewed 43 high-volume gynecologists and faculty members at large U.S. teaching hospitals and found 78 percent of them changed their surgical methods after the warnings, the Journal reported.
UnitedHealth Imposes Tighter Restrictions on Morcellator Coverage
Insurance companies also reacted to the risk posed by the devices.
In a January bulletin, UnitedHealth, the country’s largest insurer, announced it would require doctors to obtain authorization before performing most hysterectomies. Only vaginal hysterectomies would not require pre-approval. Hysterectomies are among the most common procedures for American women with 50,000 performed each year – many used morcellators.
The FDA’s morcellator warning factored heavily into insurer’s decision, Dr. Sam Ho, chief medical officer of UnitedHealth, told the Journal.
“We needed to do more on behalf of our members to ensure that they would get the safest and most effective method,” Dr. Ho said.
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Uterine Fibroid Removal Cancer Risk is “Substantially Higher” Than Originally Presumed
Mar 19, 2015 | About Lawsuits
By Irvin Jackson
A Boston doctor whose wife is battling leiomyosarcoma cancer spread by a power morcellator, is sharply criticizing recent media reports that suggest the incidence of cancer among women undergoing uterine fibroid removal is “low”.
A Bloomberg News article picked up by several media outlets over the past week features the headline “Cancer Risk Low in Women With Fibroids Removed Using Morcellators.” However, Dr. Hooman Noorchashm has described the headline as “extremely misleading” and dangerous to public health.
The reports outline the findings of a study published last month in the medical journal JAMA Oncology, which examined the incidence of unsuspected cancer among women who underwent uterine fibroid removal surgery, with or without the use of power morcellators.
The controversial devices have been widely used during laparoscopic uterine fibroid removal, to provide a minimally invasive surgery. However, over the past few years, concerns have emerged about the risk that power morcellators may spread undiagnosed cancers throughout the body, rapidly upstaging aggressive uterine cancers like leiomyosarcoma or endometrial stromal sarcoma.
In a comment posted on a version of the Bloomberg News report published by the Daily Herald, Dr. Noorchashm indicates that “[t]his article has done a grave disservice to many women by its undeniable mischaracterization, using the word “low” risk in referring to morcellation.”
Noorchashm points out that until late 2013, the gynecological community widely assumed that only about 1 in 10,000 women with symptomatic uterine fibroids may have unsuspected sarcoma, leading to the assumption that fibroids are benign. However, this has lead to deadly consequences for many women, and Noorchashm indicates that the actual risks are “astronomically higher (up to 60 times higher) than previously assumed.”
The underlying study published in JAMA Oncology found that uterine cancer was present in 1 out of 528 women who underwent myomectomy procedures without the use of power morcellators, and in 1 out of 1,073 who did undergo uterine fibroid removal with morcellation. They found that the rate of any pathologic finding, such as cancer, endometrial hyperplasia or questionable tumors, in women who did not get morcellation was 1 in 150 and 1 in 230 for women who did get morcellation.
The researchers also concluded that the prevalence of cancer in women who undergo uterine fibroid removal appears to increase with age, leading to the recommendation that power morcellators should be used with caution.
Noorchashm began fighting against the use of power morcellators after his wife, Dr. Amy Reed, was diagnosed with leiomyosarcoma following uterine fibroid removal with morcellation. The couple has launched a petition calling for morcellator recalls to be issued, which has garnered tens of thousands of signatures.
Uterine Fibroid Morcellation Cancer Risk
Concerns about the risk of morcellators spreading cancer following a laparoscopic hysterectomy or uterine fibroid removal gained widespread attention within the medical community in April 2014, when the FDA announced that it was investigating the risk and warned doctors to avoid uterine fibroid morcellation after estimating that 1 out of every 350 women may have unsuspected sarcoma.
An FDA advisory panel was convened over the summer to evaluate the available data on the controversial devices, which resulted in a determination that there is no way to make power morcellators safer. However, the panel was split on whether to recommend morcellators be recalled or that stronger warnings be placed on the devices.
In a widely criticized move, the FDA announced in November that it will allow hysterectomy morcellators to remain on the market with substantially stronger warnings about the risk of cancer and more limited indications for appropriate use of the devices.
Many hospitals have already announced that they will no longer perform a hysterectomy with morcellation, and many experts agree that the vast number of prior procedures performed involving the device are no longer appropriate.
In recent months, a growing number of women and families nationwide have been filing uterine fibroid removal cancer lawsuits against the manufacturers of these devices, alleging that inadequate warnings have been provided for patients and the medical community for years.
Plaintiffs allege that the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine 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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New Jersey Medical Malpractice Lawsyers Warn of Increased Uterine Morcellation Risks
Mar 16, 2015 | Lawyers.com
By Barry R. Eichen
Surgeons perform over 600,000 hysterectomies each year in the United States. One of the most common medical devices used during this procedure is a power morcellator, a surgical tool used to slice through bodily tissue. Power morcellators allow tissue to be removed through tiny abdominal incisions. They are frequently used during gynecological surgeries to avoid the need for large abdominal incisions which can cause increased pain, longer recovery times and a greater risk of bleeding or infection.
Several recent medical studies have highlighted the increased safety risks associated with the use of power morcellators during gynecological surgery. Research recently conducted by both Columbia University and the University of Michigan has raised questions regarding the increased risk that an undetected uterine cancer will be spread and even worsened by the use of a power morcellator. The U.S. Food and Drug Administration now requires strict warning labels on morcellation devices including language that power morcellators “may spread cancer and decrease the long-term survival of patients.” Published statistics indicate that the risks of a woman undergoing power morcellation for presumed benign problems having undetected uterine cancer are between one in 1,000 and one in 350.
Despite the risks associated with the use of power morcellators, advocates for the use of this surgical device argue that no surgical methods can guarantee the non-spread of undiagnosed cancer. Critics of power morcellators argue that defective tissue extraction bags in morcellation greatly increases the risk of undetected or precancerous tissues from spreading during the surgical procedure. If you or your loved one has been diagnosed with uterine cancer including leiomyosarcoma after undergoing a surgical procedure in which a power morcellator was used, compensation may be available for your injuries
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