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Morcellation Media Monitoring 09/17/2015
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Michigan hysterectomy study examines end of morcellator use
Sep 20, 2015 | The Philadelphia Inquirer
By Marie McCullough
Have hysterectomies gotten riskier for some of the hundreds of thousands of U.S. women who undergo these procedures each year? Researchers are trying to answer that question now that gynecologists have mostly stopped removing women's uteruses with the help of a tissue-slicing device called an electric morcellator. -
Power Morcellators used in Surgery Can Spread Cancer
Sep 18, 2015 | US Recall News
A power morcellator is a tool used in "minimally invasive" hysterectomy and uterine fibroid removal surgery. Your doctor may not have mentioned the tool or may have been vague about the details because the description of how it works is fairly horrifying. But the real danger is that it can spread previously undetected cancer cells throughout the pelvis, abdomen and other organs, making survival much less likely. The U.S. Food and Drug Administration (FDA) now recommends against using the device in most women. -
Third Power Morcellator Lawsuit Filed In Philadelphia
Sep 18, 2015 | The Legal Herald
By Laurence Banville
A woman in a Philadelphia county has filed the third Pennsylvania lawsuit against the manufacturing company Olympus. On Friday, September 11th, a manufacturing company named Olympus was hit with a new lawsuit. The lawsuit alleges that the power morcellator manufactured by Olympus called the PKS PlasmaSORD Bipolar Morcellator spread the uterine cancer of a Philadelphia woman. -
Facing Power Morcellator Lawsuit, Device Maker Threatens Legal Action Against Doctor
Sep 17, 2015 | The Legal Herald
By Laurence Banville
The Karl Storz group has threatened two doctors with legal action if they continue to speak to the public about the dangers of morcellation. The Karl Storz Group has made it clear that they are taking a firm stance in the debate over the risks associated with power morcellators. -
Power Morcellator Litigation May Soon Receive MDL Status
Sep 17, 2015 | Top Class Actions
By Amanda Antell
The U.S. Judicial Panel on Multidistrict Litigation is scheduled to hear oral arguments to determine if consolidating similar power morcellator lawsuits is appropriate. Attorneys for both sides will present oral arguments on Oct. , at the Daniel Patrick Moynihan U. S. Courthouse in New York City. -
Fewer Power Morcellator Procedures, More Complications Since FDA Warning
Sep 17, 2015 | Righting Injustice
By Jennifer Walker-Journey
In the months since the Food and Drug Administration (FDA) warned that surgical tools called power morcellators used in laparoscopic hysterectomies could cause the spread of undetected uterine cancer and, thus, worsen the woman’s odds of survival, the number of minimally invasive hysterectomies has dropped, according to a study conducted by the University of Michigan and published in the American Journal of Obstetrics & Gynecology. The report also found a near-quarter increase in hospital readmissions and 27 percent increase in major postoperative complications after hysterectomies.
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Michigan hysterectomy study examines end of morcellator use
Sep 20, 2015 | The Philadelphia Inquirer
By Marie McCullough
Have hysterectomies gotten riskier for some of the hundreds of thousands of U.S. women who undergo these procedures each year?
Researchers are trying to answer that question now that gynecologists have mostly stopped removing women's uteruses with the help of a tissue-slicing device called an electric morcellator.
Introduced in 1993, the device enables uterine tissue to be removed through tiny abdominal incisions. This reduces the complications and recovery time of traditional surgeries, which require large horizonal or vertical belly incisions. But, as the Food and Drug Administration warned last year, morcellation can also spread and worsen a rare, hidden uterine cancer called leiomyosarcoma.
That's what happened in October 2013 to Amy Reed, 42, a Philadelphia-area anesthesiologist and mother of six. She and her husband, Jefferson University Hospital heart surgeon Hooman Noorchashm, have since pushed for a total ban on the device.
Last week, a University of Michigan study suggested that curtailing its use has had downsides, as gynecological medical groups had predicted. The study found that after the FDA's April 2014 warning, there was a shift from small-incision to open-abdomen hysterectomies, and the rates of major complications increased from 2.2 percent to 2.8 percent. Hospital readmissions - defined as having to return within 30 days of discharge - also increased, from 3.2 percent to 4.2 percent.
However, the analysis has limitations. The researchers had no data on power-morcellation usage, only on whether the uterus was removed vaginally, through large incisions, or through small incisions (not all laparoscopic hysterectomies use a morcellator).
And the analysis of 15,300 Michigan hysterectomies covered such a short time span - the 15 months before the FDA warning, and the eight months afterward - that many findings were hard to interpret. In particular, the rise in abdominal hysterectomies and related complications such as infections, blood clots, and readmissions were not statistically significant, meaning the small increases could be due to chance.
Even so, obstetrician-gynecologist John Harris and coauthors said patients should be warned.
"The additional risks associated with changes in surgical practice over time, possibly due to a decline in the use of morcellation, must be discussed with patients in order to provide comprehensive informed consent," they wrote in the American Journal of Obstetrics and Gynecology.
In May, the same journal published a small poll of minimally invasive surgeons that found less use of morcellators and more use of larger incisions - but the survey had no data on complications.
Hal C. Lawrence, executive vice president of the American College of Obstetricians and Gynecologists (ACOG), said he wasn't surprised by the Michigan findings.
"It has been well-documented that minimally invasive surgery decreases the complication rate, especially for patients with obesity, diabetes, or renal disease," he said. "We had discussed that with the FDA."
Arnold P. Advincula, president of the minimally invasive surgeons' group, the American Association of Gynecological Laparoscopists, was also unsurprised by the Michigan trends - even though Columbia University, where he practices, hasn't seen such changes in practice pattern or complications.
"Although we don't use morcellation, we have come up with tissue-extraction methods to offer" minimally invasive operations, he said.
Evaluating the fallout of the morcellator storm is difficult because the prevalence of morcellation before Reed and Noorchashm sounded alarms, as well as the risk of morcellating a leiomyosarcoma, remain unclear.
Experts estimate that about 400,000 women a year now undergo hysterectomies, about 40 percent to treat heavy bleeding caused by benign uterine fibroids. That's far fewer than the almost 600,000 who underwent the procedure annually more than a decade ago, but it remains the second-most-common surgery among American women, behind C-sections.
Preoperative tests can't distinguish fibroids from leiomyosarcomas, which are rare - diagnosed in fewer than one in 100,000 women a year, studies show - but ferocious. Even when the malignancy is found while confined to the uterus, about half of patients die within five years, according to National Cancer Institute data. (Reed, who had intensive treatment for her stage-four disease, has had two recurrences.)
ACOG has estimated that 11 percent of all hysterectomies involved morcellation before the controversy, but rigorous data are lacking.
As for morcellating a leiomyosarcoma, estimates vary widely. The FDA reviewed 18 studies and concluded that the risk could be as high as one in 350 women undergoing hysterectomy. But a review of 133 studies led by Wisconsin researchers - and presented to the FDA last year - estimated the risk to be one in 2,000 to one in 8,300 surgeries.
"I do believe it needs to be relooked at," Advincula said, to explain "how you can have such discrepant numbers."
Read more at http://www.philly.com/philly/health/20150920_Michigan_hysterectomy_study_examines_end_of_morcellator_use.html#mBglPKqm2FzyScDP.99 -
Power Morcellators used in Surgery Can Spread Cancer
Sep 18, 2015 | US Recall News
A power morcellator is a tool used in "minimally invasive" hysterectomy and uterine fibroid removal surgery. Your doctor may not have mentioned the tool or may have been vague about the details because the description of how it works is fairly horrifying. But the real danger is that it can spread previously undetected cancer cells throughout the pelvis, abdomen and other organs, making survival much less likely. The U.S. Food and Drug Administration (FDA) now recommends against using the device in most women.HOW IT WORKS AND HOW IT SPREADS CANCER
Laparoscopic surgery is considered minimally invasive surgery because the incision required is very small. The point is to reduce recovery time and minimize the risk of complications as compared to traditional, open surgery.
In laparoscopic power morcellation a small bladed power tool is inserted through the small incision, typically in the naval, and used to cut up the uterus or fibroids into tiny pieces that can be removed through a narrow tube.
Yes, it is basically a tiny held-held blender, and if you have used a hand-held blender, you know where this is going. After morcellation, the majority of the minced tissue is removed, but during morcellation tiny bits of tissue are spread throughout the abdomen. If there is cancer in those tiny bits, then the cancer is spread.
POWER MORCELLATION IS UNNECESSARY
Doctors know not to use the tool when cancer is suspected, but it is often not suspected and only discovered after surgery when the removed tissue is examined by a pathologist. Morcellation makes the tissue more difficult for a pathologist to evaluate, making it more likely that existing cancer will also go undetected after surgery, prolonging diagnosis and treatment and allowing the now-disseminated cancer to flourish unchecked.
But there is no need to use the dangerous device. There are several other surgical techniques that are safe and effective, including minimally invasive procedures. Since there is no way to know for sure that no cancer is present, a power morcellation is simply too risky.
DEADLY CONSEQUENCES
When cancer is localized, it is much easier to treat and treatment is much more likely to be successful. When it has spread the prognosis is much worse, and the likelihood of survival drops significantly. When undetected cancer is spread artificially, by the power morcellator, the women who have it do not even know they are at risk. The end result is not catching the cancer until it is in a late stage when it is difficult or impossible to treat.
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Third Power Morcellator Lawsuit Filed In Philadelphia
Sep 18, 2015 | The Legal Herald
By Laurence Banville
A woman in a Philadelphia county has filed the third Pennsylvania lawsuit against the manufacturing company Olympus.
A woman in a Philadelphia county has filed the third Pennsylvania lawsuit against the manufacturing company Olympus.
On Friday, September 11th, a manufacturing company named Olympus was hit with a new lawsuit. The lawsuit alleges that the power morcellator manufactured by Olympus called the PKS PlasmaSORD Bipolar Morcellator spread the uterine cancer of a Philadelphia woman.
This complaint is the third filed in Pennsylvania against this company. Each case claims the same thing – that the company knew, or should have known that the use of a power morcellator during a gynecological surgery had the potential to spread undetected uterine cancer.A Look Back At The Power Morcellator
The power morcellator was first approved by the U.S. Food and Drug Administration several decades ago under a 501(k). Manufacturers were able to forgo the usual safety testing and clinical trials that are required of new surgical tools, because the 501(k) allows devices that are “substantially equivalent” to previously approved devices to bypass the testing.
The morcellator is widely used in laparoscopic surgeries. It is inserted into the body cavity via small incisions, where it uses cutting jaws to saw through the offending tissue intended for removal. The tissue is then pulled through the hollow tube of the morcellator so that the initial incision does not need to be widened.
In women, the device is often used to perform hysterectomies and myomectomies. These surgeries are often the recommended course of treatment for uterine fibroids. While most uterine fibroids are benign, there is currently no reliable testing method to determine if the fibroid contains uterine cancer. If a morcellator cuts through a fibroid containing uterine cancer, there is a chance that the cutting jaws will disseminate the cancer cells throughout the body cavity.
After several decades, the FDA acknowledged this risk and published a safety warning for the medical community and the public. The warning stated that “Based on an FDA analysis of currently available data, we estimate that approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.”
It further stated that “ 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.” and “Because of this risk and the availability of alternative surgical options for most women, the FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.”
After being slammed with numerous lawsuits, Johnson and Johnson voluntarily withdrew all of its available power morcellators from the market in 2014. Other manufacturers have gone in a different direction, threatening legal action against those who speak out against the use of their power morcellators.
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Facing Power Morcellator Lawsuit, Device Maker Threatens Legal Action Against Doctor
Sep 17, 2015 | The Legal Herald
By Laurence Banville
The Karl Storz group has threatened two doctors with legal action if they continue to speak to the public about the dangers of morcellation.
The Karl Storz Group has made it clear that they are taking a firm stance in the debate over the risks associated with power morcellators.
In a strongly worded letter which was sent to Dr. Hooman Noorchashm, the group stated that, “We will no longer tolerate unfounded and unproven allegations such as the ones contained in your previous emails and we will hold you responsible. Should we get to know further public statements from you that our device and/or management would be responsible for your wife’s or any other women’s uterine cancer, and/or any aggravation of their cancerous situation, we would not hesitate to take appropriate legal actions to protect our good name and our rights.”
Dr. Noorchashm and his wife, Dr. Amy Reed, launched a campaign to educate the public and the medical community about the dangers associated with the use of the power morcellator during gynecological surgeries. The pair had chosen to do so because Dr. Reed was diagnosed with leiomyosarcoma which metastasized to other areas of the body after undergoing a procedure to remove uterine fibroids. While the couple has decided to not file a lawsuit, they allege that Dr. Reeds leiomyosarcoma was spread by the use of a morcellator.
Other patients have filed a lawsuit against several morcellator manufacturing companies, including The Karl Storz Group. One of the companies, Ethicon, which is a subdivision of Johnson & Johnson, voluntarily withdrew their devices from the market in 2014, and urged doctors to return the device after the possible risk factors were made known to the public.
In response, Dr. Noorchashm has indicated he has no intentions of stopping his campaign. He stated “This letter exemplifies an entire industry’s sentiments towards a deadly iatrogenic women’s health hazard—namely, upstaging of gynecological cancers using morcellators. Clearly, almost all morcellator companies, including Storz, had recognized that their devices have the potential to spread and upstage cancerous tissues—many of their user’s manuals stated as such.”The FDA’s Safety Warning About Power Morcellators
On November 24th, 2014, the U.S. Food and Drug Administration updated a safety warning that they had previously issued in April of 2014. The updated warning, which addressed the use of power morcellators during gynecological surgeries, reads, “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. While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood.”
The FDA estimated the number of women that had undiagnosed uterine cancer and were undergoing hysterectomies and myomectomies to be 1 in 350 where a power morcellator was used.
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Power Morcellator Litigation May Soon Receive MDL Status
Sep 17, 2015 | Top Class Actions
By Amanda Antell
The U.S. Judicial Panel on Multidistrict Litigation is scheduled to hear oral arguments to determine if consolidating similar power morcellator lawsuits is appropriate.
Attorneys for both sides will present oral arguments on Oct. , at the Daniel Patrick Moynihan U. S. Courthouse in New York City.
The power morcellator lawsuits claim that women developed an aggressive form of uterine cancer after undergoing hysterectomy or myomectomy procedures in which a power morcellator was used.
Power morcellators are medical devices commonly used for laparscopic surgeries. They enable surgeons to accurately make a small, precise incision, leading to a less invasive surgery and a shorter recovery time. The devices have rotating blades that essentially shred uterine fibroids, which the surgeon then suctions out through a tube.
While popular among patients and the medical community for a time, not all patients have had a good experience with the devices.
A large number of women are suing the power morcellator manufacturers, alleging that the products caused devastating side effects, and some hospitals have stopped using the devices for hysterectomies and myomectomies following numerous injury reports and scientific studies indicating that these devices may be unsafe.
The risk comes from undetected uterine sarcoma, a particularly aggressive form of cancer. At this time, there is no way to pre-diagnose uterine sarcoma before using a power morcellator in surgery.
The blades of the device rupture the sarcoma and cause the cells to rapidly spread throughout the abdominal cavity, and women are often diagnosed soon after surgery.
Scientists estimate that about one out of every 350 women undergoing power morcellator surgeries suffer from undiagnosed uterine sarcoma.
By the time the cancer is diagnosed, the condition is already typically at a latent stage, with few treatment options and short survival expectancy.
Despite the severity of these risks, a number of manufacturers have decided against including this complication on the products’ warning labels.
Overview of Power Morcellator Allegations
The device’s link with uterine sarcoma and the manufacturer’s reluctance to provide adequate warning labels have spurred numerous patients to take legal action against the power morcellator manufacturers, leading to the upcoming decision whether to consolidate power morcellator lawsuits into a multidistrict litigation.
In June 2015, a group of plaintiffs filed a motion to centralize all power morcellator lawsuits under one judge in the federal court system, giving the suits multidistrict litigation (MDL) status.
There are currently at least 21 lawsuits filed in 16 different district courts in the United States, with each raising similar product liability allegations.
The plaintiffs state that there a number of benefits to consolidating the lawsuits, including conserving litigation resources and streamlining the litigation process.
Furthermore, consolidating these suits under one judge will help avoid duplicate discovery and conflicting rulings from different judges.
Many of the power morcellator manufacturers are opposed to the consolidation. Johnson & Johnson’s Ethicon subsidiary, which sold a large majority of the power morcellators, stated that there are too few lawsuits to justify MDL status. Johnson & Johnson also urged the panel to reject the possibility of establishing separate MDLs for different manufacturers.
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Fewer Power Morcellator Procedures, More Complications Since FDA Warning
Sep 17, 2015 | Righting Injustice
By Jennifer Walker-Journey
In the months since the Food and Drug Administration (FDA) warned that surgical tools called power morcellators used inlaparoscopic hysterectomies could cause the spread of undetected uterine cancer and, thus, worsen the woman’s odds of survival, the number of minimally invasive hysterectomies has dropped, according to a study conducted by the University of Michigan and published in the American Journal of Obstetrics & Gynecology.
The report also found a near-quarter increase in hospital readmissions and 27 percent increase in major postoperative complications after hysterectomies.
Power morcellators are surgical tools fitted with a tube-like blade that shreds uterine fibroids or entire uteruses inside the uterine cavity and removes them through a small incision in the abdomen. The procedures have been preferred over open surgeries by some doctors because they are minimally invasive and leave less scar tissue and offer shorter recovery.
The FDA first raised safety concerns with power morcellation for hysterectomies and myomectomies(uterine fibroid removal) in April 2014, and in November, the agency warned that women had a 1 in 350 chance of having uterine cancer. Power morcellation can send cancerous tissue throughout the abdomen, seeding new cancer growths and making the disease more difficult to treat.
In the months since the FDA raised concerns about power morcellation, many hospitals have restricted the use of the devices. As a result, the study found that fewer power morcellator procedures are being performed.
The flip side is that more invasive procedures are being done to remove uteruses and uterine fibroids, which has resulted in more hospitalizations, some of which have been for major postoperative complications, the study found.
The study did not examine whether any of the women who had undergone power morcellation had been diagnosed with uterine cancer, nor did the study compare whether the same patient was more or less likely to receive a more invasive surgery. However the study did suggest that fewer women were having less invasive power morcellation following the FDA’s warning.
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