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Morcellation Media Monitoring 10/13/2015
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Risks, benefits of power morcellation differ based on patient age
Oct 8, 2015 | Healio
By Jason D. Wright
Minimally invasive hysterectomies with electric power morcellation have varying risks and benefits depending on a woman’s age, according to results of a cohort stimulation modeling study. -
GAO to Investigate Morcellators, FDA Clearance Process
Oct 9, 2015 | Drug Watch
By Chris Elkins
In response to a request by 12 members of Congress, the U.S. Government Accountability Office agreed to open an investigation into the reason it took the U.S. Food and Drug Administration 20 years to warn of the risks power morcellators pose to patients. -
Power Morcellation at the Center of Yet Another Cancer Lawsuit
Oct 9, 2015 | LawyersandSettlements.com
By Gordon Gibb
Yet another Laparoscopic Power Morcellation lawsuit has been filed in Philadelphia, this time against the manufacturer of the PKS PlasmaSORD Bipolar Morcellator. The co-plaintiff in the case alleges that use of the device inadvertently spread cancer cells throughout her abdomen. -
Power Morcellator Lawsuit Frequently Asked Questions
Oct 13, 2015 | The Legal Herald
By Laurence P. Banville
With over 30 power morcellator lawsuits filed against manufacturers such as Johnson & Johnson, Richard Wolf GmbH, Karl Storz GmbH and Gyrus ACMI, the medical community and the public have numerous questions about the device, as well as the litigation.
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Risks, benefits of power morcellation differ based on patient age
Oct 8, 2015 | Healio
By Jason D. Wright
Minimally invasive hysterectomies with electric power morcellation have varying risks and benefits depending on a woman’s age, according to results of a cohort stimulation modeling study.
Overall, the risks associated with the procedure appeared greater in older women, whereas the benefits appeared greater in younger women.
Power morcellation grinds up uterine fibroids — or benign tumors within the uterus — and allows for their removal via a laparoscope. However, the FDA issued an “immediately in effect” guidance in November 2014 that warns against the use of morcellators in hysterectomies or myomectomies in the majority of women due to the potential that they can spread undetected uterine sarcomas.
“We know that while morcellation is associated with a risk of dissemination of occult cancer compared to abdominal hysterectomy, the ability to undergo a minimally invasive procedure is beneficial in that it is associated with fewer postoperative complications,” Jason D. Wright, MD, chief of the division of gynecologic oncology and associate professor of obstetrics and gynecology at Columbia University Medical Center, told HemOnc Today
Wright and colleagues used a state transition Markov cohort simulation model — which accounted for perioperative morbidity, mortality, risk of cancer and dissemination, and outcomes in women with an underlying malignancy — to compare the risks and benefits of three different hysterectomy modalities for presumed benign disease: total abdominal, laparoscopic and laparoscopic with a power morcellator.
The researchers found laparoscopic hysterectomy without morcellation was the most beneficial and cost-effective strategy. Per 10,000 women, laparoscopic hysterectomy with morcellation appeared more costly, decreased quality of life, and lowered overall life-years compared with laparoscopic hysterectomy without morcellation.
The procedure with power morcellation was associated with 80.83 (95% CI, 21.35-138.03) more intraoperative complications. However, that modality also was associated with 199.64 (95% CI, 301.70-107.52) fewer perioperative complications and 241.8 (95% CI, 257.50-227.25) fewer hospital readmissions than abdominal hysterectomy per 10,000 women.
Age matters
Wright and colleagues then evaluated the efficacy of each the procedures stratified by patient age.
Per 10,000 women aged younger than 40 years, power morcellation appeared associated with 1.57 more cases of disseminated cancer and 0.94 more cancer-associated deaths, but 0.97 fewer overall deaths than abdominal hysterectomy.
Excess cases of disseminated cancer with power morcellation compared with abdominal surgery increased with age from 3.75 cases per 10,000 women aged 40 to 49 years, to 12.97 cases per 10,000 women 50 to 59 years, and to 47.54 cases per 10,00 women aged 60 years or older. Compared with abdominal hysterectomy, these data equated to 0.3 (age 40-49), 5.07 (age 50-59) and 18.14 (age 60 and older) excess deaths per 10,000 women.
Results of a sensitivity analysis showed a 25% increase in cancer prevalence in each age group produced comparable mortality data. However, if a 25% reduction in cancer prevalence occurred, power morcellation would be the preferred treatment modality among women aged 40 to 49 years based on 0.05 fewer deaths per 10,000 women.
Laparoscopic hysterectomy with morcellation also became the preferred strategy in that age group if the risk for tumor dissemination was only 10%, based on 0.51 fewer deaths per 10,000 women than abdominal hysterectomy.
In a scenario analysis in which 75% of occult tumors were deemed to be sarcomas, morcellation appeared to be the more favorable option for women aged younger than 40 years, based on 0.93 fewer deaths per 10,000 women than abdominal hysterectomy.
“We noted that in women aged younger than 40 years, the benefits of morcellation compared to abdominal hysterectomy appear to outweigh the risks,” Wright said. “As the incidence of cancer increases with age, morcellation is associated with more harm than benefit in women 50 years of age or older. Women aged 40 to 49 represent a grey zone.”
In a cost-effectiveness analysis, morcellation was less costly than abdominal hysterectomy in all age groups. For every 10,000 women, use of laparoscopic hysterectomy with morcellation resulted in an increase of 4.49 life-years for women aged younger than 40 years, but 0.47 fewer life-years in the 40-to-49 age group, 20.64 fewer life-years in the 50-to-59 group and 91.19 fewer life-years in the 60-and-older group.
When considering quality of life, morcellation became a more favorable strategy for women in the 40-to-49 age group based on an improvement of 11.22 quality-adjusted life-years compared with abdominal hysterectomy.
Implications
These findings are in accordance with the FDA advisory statement that warned against power morcellation use in peri- and postmenopausal women, the researchers wrote.
Overall, age is a main consideration when deciding the best course of action for a hysterectomy, Wright said.
“Our findings suggest that morcellation may be beneficial in some young women who would otherwise require laparotomy for hysterectomy,” he said. “However, in older women — those aged older than 50 years — the procedure should be avoided.”
These data will help better define the risks for patients because researchers evaluated harms and benefits of each the three surgical modalities, David Mutch, MD, professor of obstetrics and gynecology and division chief of gynecologic oncology at Washington University School of Medicine in St. Louis, wrote in an accompanying editorial.
“More data, such as those produced here, are needed to better define the real risk so that women give informed consent before undergoing a procedure,” Mutch wrote. “Additionally, as other techniques such as morcellating the uterus in a containment bag become more common, we should obtain data on their safety and efficacy.”
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GAO to Investigate Morcellators, FDA Clearance Process
Oct 9, 2015 | Drug Watch
By Chris Elkins
In response to a request by 12 members of Congress, the U.S. Government Accountability Office agreed to open an investigation into the reason it took the U.S. Food and Drug Administration 20 years to warn of the risks power morcellators pose to patients.
Experts once believed power morcellators possessed a one in 1,000 risk of spreading uterine cancer during fibroid removal or hysterectomy surgery. The most recent statistic indicates the risk is one in 350.
According to the letter from the representatives, “Hundreds, if not thousands of women in America are dead because of a medical device known as the laparoscopic power morcellator.”
U.S. Reps. Mike Fitzpatrick and Louise Slaughter led the effort to request a GAO investigation.
“This device can take Stage 1 treatable cancer immediately to a Stage 4 terminal cancer,” the members of Congress wrote to the GAO in August. “For too many women, this routine procedure ended with a death sentence.”
The GAO managing director for congressional relations, Katherine Siggerud, told Fitzpatrick that the agency would begin an investigation “as work that is within the scope” of its authority, according to The Wall Street Journal. The investigation is expected to begin in five months.
The announcement comes two months after LiNA Medical settled the first power morcellator lawsuit before it could go to trial. About 20 other cases are scheduled to go to trial in 2015.
Experts expect hundreds of morcellator lawsuits to seek justice for women harmed, because manufacturers failed to warn of the risks of laparoscopic surgery.
Investigation Focuses on FDA 510(k) Clearance Process
The FDA cleared the first power morcellator in 1995 as a part of its 510(k) clearance process. The process is different from the FDA giving full approval, which would require clinical trials to prove a device is safe and effective.
Instead, manufacturers only have to prove that the device is similar enough to something already on the market before receiving FDA clearance to market it. The companies are supposed to monitor the device for any adverse events while it is on the market.
In their letter to the GAO, the members of Congress asked the agency to determine four things:
Did the FDA’s reliance on the 510(k) approval policies and procedures sufficiently identify risks of adverse events before the laparoscopic power morcellator was allowed to enter the market?
Were the medical device reporting regulations appropriately followed to protect patient safety in laparoscopic power morecellators by manufacturers, importers, user facilities and the FDA?
What activities or training did manufacturers provide to clinicians and what professional society standards, if any, apply to training on the use of these devices?
What steps is the FDA taking after issuing a black box warning to further determine whether the laparoscopic power morcellator is safe to remain on the market?
In November of 2014, the FDA issued a black-box warningindicating the risk of spreading unsuspected cancer is one in 350 and the devices should not be used in most women.
However, members of Congress pointed out multiple studies conducted in the ‘90s that showed the risk as high.A 1990 study indicated one out of every 200 women possesses hidden uterine sarcoma (cancer).
A 1994 study indicated the risk was one out of every 444.Various studies from 1999 to 2008 found the risk to be between one in 462 and one in 253.
The members of Congress wrote, “the FDA, the medical device industry, and many gynecologists pointed to the risk of a hidden cancer as being low, only one-in-10,000. How did they get it wrong for so long?”
The Federal Bureau of Investigation wants to know the answer too.
GAO Investigation Follows Reports of FBI Investigation
In May of 2015, the FBI began investigating information regarding power morcellators and manufacturer Johnson & Johnson’sknowledge of the potential dangers of the device, according to WSJ and New York Times reports.
J&J removed its morcellator from the market in July of 2014. The FBI’s Newark New Jersey office declined the WSJ and NYT’s requests for comment.
The newspapers reported FBI agents had interviewed three high-profile sources. One was retired pathologist, Dr. Robert Lamparter who reportedly warned J&J about the risks in 2006. Another was a highly-publicized doctor who developed cancer after a surgery involving power morcellators, Dr. Amy Reed. The third was a California physician’s assistant who had gathered almost 400 names of people harmed by the device.
The FBI could pursue criminal charges if it finds any evidence of wrongdoing. That would be in addition to the civil charges companies already face.
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Power Morcellation at the Center of Yet Another Cancer Lawsuit
Oct 9, 2015 | LawyersandSettlements.com
By Gordon Gibb
Yet another Laparoscopic Power Morcellation lawsuit has been filed in Philadelphia, this time against the manufacturer of the PKS PlasmaSORD Bipolar Morcellator. The co-plaintiff in the case alleges that use of the device inadvertently spread cancer cells throughout her abdomen.
Power morcellation is yet another adjunct of the increasing prevalence of endoscopy or minimally invasive surgery that dispenses with the need for large incisions (together with longer recovery times) in favor of scopes that contain tiny cameras, and through which surgeons can deploy instruments to perform surgical procedures through much smaller incisions.
This type of abdominal procedure is known as laparoscopy, and differs from arthroscopy only in that the latter involves joints such as knees and other skeletal joints. But the same idea holds true - rather than a large incision that exposes the entire joint (arthroscopy) or a large section of abdomen (laparoscopy), a small incision is made through which a scope with camera and instruments is inserted for minimally invasive surgery.
Think of it as an “inside job.”
Power morcellators fit into this category. The latter is a device capable of breaking up tissue such as fibroids through a scope. The problem for many patients is an inherent risk that laparoscopic procedures using Laparoscopic Power Morcellation could spread undetected cancerous cells throughout the uterus during a procedure to remove fibroids, for example, or during a laparoscopic power morcellation hysterectomy.
Some hospitals undertook steps to contain tissue during morcellation, preventing the spread of tissue and potentially cancerous cells. But most stopped using the morcellators altogether. Last November the US Food and Drug Administration (FDA) issued a warning that laparoscopic power morcellators, gynecological tools used to perform hysterectomy or uterine fibroid removal, should not be used in surgery that involves cancer or fibroids (laparoscopic power morcellation myomectomy).
The concern centered on Laparoscopy using a power morcellator that carried the possibility of spreading cancerous cells from unsuspected cancer in uterine tissue, negatively impacting the health and long-term survival of the patient.
That’s the basis for the Laparoscopic Power Morcellation lawsuit brought by plaintiffs Marlene and Joel Waltman. The lawsuit claims that use of the PKS PlasmaSORD Bipolar Morcellator during a gynecological procedure to remove what were thought to be benign tumors, succeeded in seeding and spreading cancer cells through Waltman’s abdomen.
“The PKS PlasmaSORD Bipolar Morcellator disseminated and seeded cancer throughout plaintiff’s abdominal cavity, thereby causing and accelerating the metastases and spread of her cancer, worsening the long-term prognosis and the natural course of her cancer,” the complaint said. “The spread of the life-threatening cancer suffered by the plaintiff was a direct result of the use of the PKS PlasmaSORD Bipolar Morcellator during her 2011 surgical procedure.”
The morcellator in this case is manufactured by Gyrus Acmi LP, a subsidiary of Olympus Corp.
The plaintiffs reference studies in medical journals as early as the 1990s that reported on the risk of spreading undetected cancer associated with use of the device. Olympus “knew or should have known that their laparoscopic power morcellators could cause malignant tissue fragments to be disseminated and implanted in the body,” the complaint said.In this way, a patient need not be already diagnosed with cancer, such as Ovarian cancer for example, for laparoscopic morcellation to be problematic. To that end, it is not a cancer surgery going in. However, or so it is alleged, undetected cancer cells stirred up by power morcellation can succeed in fostering a later diagnosis of cancer via a laparoscopic power morcellation myomectomy (fibroid removal).
Some power morcellators have been removed from the market altogether as more are viewing Laparoscopic Power Morcellation as a dangerous medical procedure.
In the meantime, the lawsuits keep coming. The Waltmans hold that even though Waltman’s procedure was in 2011, the statute of limitations should be tolled given that the plaintiffs only recently learned of the potential association between laparoscopic power morcellation myomectomy and her cancer.
The case is Marlene Kay Waltman et al. v. Gyrus Acmi LP et al., Case No. 150900680, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia. -
Power Morcellator Lawsuit Frequently Asked Questions
Oct 13, 2015 | The Legal Herald
By Laurence P. Banville
As power morcellator lawsuit numbers climb, questions regarding FDA approval's and safety emerge.
With over 30 power morcellator lawsuits filed against manufacturers such as Johnson & Johnson, Richard Wolf GmbH, Karl Storz GmbH and Gyrus ACMI, the medical community and the public have numerous questions about the device, as well as the litigation.
Why Is the Morcellator So Dangerous?
The power morcellator is a surgical instrument which is used during laparoscopic surgeries. The tool is inserted into the body cavity through tiny incisions where it cuts unwanted tissue into smaller pieces. Those smaller pieces are then extracted through a hollow tube in the morcellator.
The morcellator is often used during laparoscopic hysterectomies and myomectomies. The majority of these gynecological surgeries are performed due to the presence of uterine fibroids. Unfortunately, when these fibroids encapsulate uterine cancer, the cancer is virtually undetectable. Researchers have found that if a morcellator is used to cut through a fibroid, it has the potential to disseminate cancer cells throughout the abdominal cavity.
Why Was The Morcellator Approved By The FDA?The morcellator has been used by surgeons for decades. The U.S. Food and Drug Administration first granted approval for the morcellator in 1991, and the surgical tool was introduced into the U.S. market in 1993.
The alleged risks associated with morcellation were not discovered by the FDA because the tool was approved under a 501(k). The 501(k) is an approval process which allows companies to forgo safety testing if they are able to show that their device is “substantially equivalent” to a device the FDA previously approved.
What Studies Have Been Performed?What makes researchers question the FDA’s approval of the morcellator via a 501(k), is that even in 1991 there were studies claiming the morcellator could potentially spread and upstage cancer. One company, Vance Products Incorporated, designed a surgical tissue bag for surgeons to use with the device.
In their submission for a patent, Vance Products indicated that the problem “associated with the debulking, removal or morcellation of large tissue volumes is the concern for malignant or pathogenic tissue. The morbidity of patients significantly increases when malignant cells of such large volume tissue are permitted to come in contact with surrounding healthy tissue.”
Numerous other studies have been performed, all of which report that the morcellator has the potential to spread malignant cancer cells.
What Should I Do If A Morcellator Was Used During My Surgery?If you’ve undergone a gynecological surgery for the treatment of uterine fibroids, and your surgeon did not warn you of the alleged risks associated with the use of a morcellator, you may be entitled to compensation.
For questions regarding the ongoing power morcellator litigation, contact Banville Law at (917) 688-2632.
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