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Morcellation Media Monitoring 12/17/2015
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The Defense of Morcellation: An “Expert” Letter to FDA
Dec 14, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm and Amy Reed
Recently, a group of 48 gynecological surgeons, headed by William Parker of UCLA, and a few women’s health advocates, including Carla Dionne of the National Uterine Fibroid Foundation (NUFF.org), published a letter in the journal Obstetrics and Gynecology. -
Power Morcellator Lawsuits Consolidated; More Lawsuits Filed
Dec 15, 2015 | LawyersandSettlements.com
By Heidi Turner
As more power morcellator lawsuits are filed, the US Judicial Panel on Multidistrict Litigation has consolidated more than 20 lawsuits into a multidistrict litigation. The MDL - number 2652 - was approved in October and as of December 15, 2015, held 30 lawsuits consolidated for pretrial proceedings. Those lawsuits allege women were put at increased risk of serious complications due to the use of morcellation for myomectomy. -
New Power Morcellator Research Adds to Growing Cancer Concerns
Dec 17, 2015 | Top Class Actions
By Melissa LaFreniere
Research performed by scientists at the University of Michigan suggests that one in every 368 women undergoing a hysterectomy or myometomy to remove uterine fibroids has undetected uterine cancer. -
FDA Safety Warning On Power Morcellation And Uterine Cancer Prompts University Study
Dec 15, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on a study which has been conducted by the University of Michigan. The study was designed to evaluate the overall impact of the U.S. Food and Drug Administration’s 2014 warning regarding power morcellation use on uterine fibroids. The safety statement issued indicated that the devices should no longer be used during gynecological surgeries involving uterine fibroids due to the possibility of spreading previously undetected cancer cells. -
Power Morcellator Lawsuit Plaintiffs Claim Tool Spreads And Upstages Uterine Cancer
Dec 16, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on a recent surge in lawsuits filed against various manufacturers of laparoscopic power morcellators, all which similarly allege that the tools can spread and accelerate cancer cells when shredding uterine fibroids during gynecological surgeries.
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Full Text of Stories Below
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The Defense of Morcellation: An “Expert” Letter to FDA
Dec 14, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm and Amy Reed
Recently, a group of 48 gynecological surgeons, headed by William Parker of UCLA, and a few women’s health advocates, including Carla Dionne of the National Uterine Fibroid Foundation (NUFF.org), published a letter in the journal Obstetrics and Gynecology.
You can read about this here and here.
This letter was directed to the Food and Drug Administration (FDA) and was written in defense of morcellation, used routinely by gynecologists when performing hysterectomies or myomectomies in women. It involves mincing up, and nearly emulsifying, the enlarged and diseased uterus inside a woman’s abdominal cavity in order to avoid a larger incision.
You can read about morcellation here.
The trouble is that if the minced up tissue contains cancer, it will spread. This is called “upstaging” of a cancer and it could be deadly.
Ironically, in the same issue of Obstetrics and Gynecology another group of gynecologists wrote that the number of unsuspecting women having surgery who are at risk of cancer upstaging from morcellation is one in 276.
In medicine, this is considered a very high risk when it comes to an avoidable mortality hazard.
But, until December 2013, most gynecologists, including Dr. Parker of UCLA, were assuming this risk was far lower -- one in 10,000 women.
Over the past two years, the much higher incidence of hidden cancers has been confirmed by several other studies - including this recent study from Boston Medical Center (BMC).
As a result of this high risk, and because many women put in harm’s way went public, in November 2014 FDA significantly restricted use of the power morcellator).
But Dr. Parker argues that the FDA analysis "was flawed, inadequate, and misleading" and that "their recommendations were not based on science, but rather on emotional and anecdotal information".
We believe that Parker's statements intend to divert the conversation into a discussion of statistical uncertainty, instead of admitting that when it comes to an incorrect and avoidable surgical practice, it is not acceptable to put women at risk, whether they number one in 156 or one in 10,000.
Parker compares the unavoidable risks of all surgery--wound infections, blood clots, or perioperative heart attacks - with the avoidable risk of spreading a cancer using morcellation. This position is at best, incorrect, and at worst, unethical.
In addition, for nearly 20 years many women were having their cancer spread by morcellation. But, not a single gynecologist, hospital or morcellator manufacturer bothered to comply with a specific federal law requiring them to “self-report” such hazards to the FDA.
FDA has confirmed that the first time it heard about adverse outcomes using power morcellators was in December 2013 - and it wasn't from the gynecologists or the manufacturers.
Recently, US Congressman Tim Murphy of PA, chairman of the House of Representatives’ subcommittee on Oversight and Investigations, questioned the FDA’s medical device center’s chief about this, and the interchange is available onthis video.
The FBI and the GAO also are investigating.
It appears that the U.S. Congress, federal law enforcement and the civil court system are poised to hold many accountable for their failure to protect precious lives across the United States. Still, the recent expert letter to FDA is a disservice to the specialty of gynecology – and to all future women at risk - by not admitting how damaging and deadly this practice has been.
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Power Morcellator Lawsuits Consolidated; More Lawsuits Filed
Dec 15, 2015 | LawyersandSettlements.com
By Heidi Turner
As more power morcellator lawsuits are filed, the US Judicial Panel on Multidistrict Litigation has consolidated more than 20 lawsuits into a multidistrict litigation. The MDL - number 2652 - was approved in October and as of December 15, 2015, held 30 lawsuits consolidated for pretrial proceedings. Those lawsuits allege women were put at increased risk of serious complications due to the use of morcellation for myomectomy.
Power morcellation is used in a non-invasive hysterectomy or myomectomy. The procedures are done to break down benign uterine fibroids. The US Food and Drug Administration (FDA) has warned that around 1 in 350 women who are diagnosed with benign fibroids actually have uterine sarcoma. Uterine sarcoma, however, can’t be diagnosed prior to the hysterectomy.
During power morcellation, the patient’s uterine tissue is broken down into smaller pieces so it can be removed through a smaller incision. Power morcellation is used in place of traditional surgery to remove fibroids because it involves a smaller incision and typically has lowered risk of blood loss and infection. In women with uterine sarcoma, breaking up of the tissue can increase the risk that cancerous tissue will spread throughout the patient’s abdomen and pelvis. This puts the patient at a greater risk of death from aggressive cancer.Lawsuits have been filed against the makers of some power morcellation devices, alleging women developed serious, aggressive cancer known as leiomyosarcoma throughout their body as a result of power morcellation. Among the companies facing lawsuits is Johnson & Johnson, whose Ethicon division makes the Ethicon Gynecare Morcellex Tissue Morcellator. That device has reportedly been withdrawn from the market, although morcellators made by other companies are reportedly still in use. Around 45 lawsuits have been filed in state or federal court.
Following the filing of lawsuits, the US Government Accountability Office (GAO) announced it was investigating the use of laparoscopic power morcellators. Citing the deaths of “hundreds, if not thousands of women in America,” 12 members of Congress wrote to the GAO requesting it look into the matter.
“Morcellators and nearly all other devices were authorized under a system that has long been criticized as too lenient, while the FDA has defended the process as a good balance between innovation and safety,” The Wall Street Journal (8/7/15) reported. -
New Power Morcellator Research Adds to Growing Cancer Concerns
Dec 17, 2015 | Top Class Actions
By Melissa LaFreniere
Research performed by scientists at the University of Michigan suggests that one in every 368 women undergoing a hysterectomy or myometomy to remove uterine fibroids has undetected uterine cancer.
This new report adds to the growing concern associated with power morcellator use for these minimally invasive procedures, which use the medical device to shred and grind uterine tissues before removal.
The recent morcellation study backs up a similar finding from the U.S. Food and Drug Administration which estimates that one in 350 women who use the power morcellator during a gynecological laparoscopic surgery will eventually be diagnosed with uterine sarcoma.
Uterine Cancer Overview
According to the American Cancer Society, nearly 55,000 women will be diagnosed with a form of uterine cancer this year, while 10,000 will die this year from the cancer. The society reports that “The average chance of a woman being diagnosed with this cancer during her lifetime is about 1 in 37.”
In 2014, the FDA released a safety warning regarding the use of power morcellators linked to an increased risk of uterine cancer when the devices are used on undiagnosed uterine cancer tissues. The FDA states that “At this time, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma.”Power Morcellator Complications
Power morcellators were once considered a medical breakthrough for patients undergoing hysterectomies, as they allowed patients to have a much shorter recovery time when compared to the traditional abdominal surgery.
Power morcellators are inserted into a woman’s abdomen through a small incision, where they spin tiny blades designed to shred uterine and fibroid tissue. However, the FDA reports that shredding undetected cancer cells can cause uterine cancer to spread throughout the abdominal cavity.
The threat of spreading cancer tissues through morcellation spurred the U.S. Food and Drug Administration to issue a “black box” warning on all new and pre-existing power morcellators. An FDA black box warning is the strongest precaution the federal agency will issue before removing the product from the market.
After the agency determined power morcellators needed a black box warning, some of the largest health insurance companies in the U.S. decided to change the way the medical tool is classified, therefore making it extremely difficult for patients to obtain insurance coverage.
Companies like Cigna, Aetna Inc., UnitedHealth Group Inc. and many others are choosing not to cover the power morcellator due to the cancer risks associated with the device.
Morcellation Cancer Lawsuits
There are currently two dozen morcellation lawsuits pending in federal court and the numbers only continue to grow. A typical morcellation lawsuit states that power morcellator manufacturers failed to warn of the life-threatening cancer risks linked to using the medical device. Some plaintiffs allege that power morcellator makers were aware of the cancer risks linked to the device but downplayed any health concerns.
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FDA Safety Warning On Power Morcellation And Uterine Cancer Prompts University Study
Dec 15, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on a study which has been conducted by the University of Michigan. The study was designed to evaluate the overall impact of the U.S. Food and Drug Administration’s 2014 warning regarding power morcellation use on uterine fibroids. The safety statement issued indicated that the devices should no longer be used during gynecological surgeries involving uterine fibroids due to the possibility of spreading previously undetected cancer cells.
This FDA warning is supported by decades of research, and estimates showing that approximately 1 in every 350 women who undergo these procedures may have uterine sarcomas they are unaware of. These statements and the research that supports them have led to changes in many prominent medical facilities. Even Ethicon, a large power morcellator manufacturer (and subsidiary of Johnson & Johnson) has completely stopped production of the devices, and recalled those currently on the market.
Researchers from the University of Michigan attempted to find out how surgeons had reacted to these FDA warnings, and to see how their reactions may be affecting patient outcomes. Their study evaluated women who had undergone laparoscopic hysterectomies via power morcellation at hospitals located in the statewide Michigan Surgical Quality Collaborative. Data analyzed was from 9,597 of the procedures which were performed over a 16-months following the initial FDA warning and another 5,775 which were performed up to 8 months after the warning was released.
As predicted, findings indicated that laparoscopic hysterectomies with the use of power morcellator devices had decreased by 4.1%. This caused an overall increase in abdominal and vaginal hysterectomies, without the use of power morcellation. Additionally, instances of abdominal hysteretomies increased by 1.7% and vagnial hysterectomies increased by 2.4%.
Although data seemed to highlight the decrease they assumed they would find, authors were surprised that the decrease was not greater. After further research, however, they noted that when observing strictly supracervical laparoscopic hysterectomies (which are specifically associated with power morcellation), they noted a decline of 59% in use, which seemed much more in line with their expectations.
Power morcellator devices and the likelihood that they may spread cancer cells are the subject of more than just FDA warnings and studies. They have become the topic of a growing number of lawsuits which have now been consolidated to form multidistrict litigation number 2652. Plaintiffs involved in these lawsuits all commonly allege that power morcellation on uterine fibroids can spread cancer in patients, causing these patients to be diagnosed with aggressive, widespread cancers post-surgery, and threatening their lives.
The attorneys at Tracey & Fox are currently working to ensure that anyone who has undergone laparoscopic power morcellation and who has subsequently been diagnosed with cancer will be able to explore their full legal rights. These individuals may be entitled to substantial compensation, and Tracey & Fox is offering free consultations to those affected.
To request additional information concerning power morcellation, or to ask questions, please contact Tracey & Fox by calling 713-322-5375.
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Power Morcellator Lawsuit Plaintiffs Claim Tool Spreads And Upstages Uterine Cancer
Dec 16, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on a recent surge in lawsuits filed against various manufacturers of laparoscopic power morcellators, all which similarly allege that the tools can spread and accelerate cancer cells when shredding uterine fibroids during gynecological surgeries.
Manufacturers named in the lawsuits include Ethicon (a subdivision of Johnson & Johnson), Lumenis Ltd., Olympus, Karl Storz GmbH, Blue Endo, Richard Wolf GmbH, Cook Urological Inc., Smith & Nephew, and LiNA Medical. Lawsuits which were filed against manufacturer Ethicon have since been consolidated by the JPML to form multidistrict litigation number 2652 in Kansas.
The U.S. Food and Drug Administration issued a 2014 safety warning discussing power morcellation, and indicating that most women should refrain from undergoing the procedure on their uterine fibroids due to the risk of uncovering and disseminating cancer cells which were previously undiscovered. The FDA estimates indicated that nearly 1 in every 350 women who undergo these gynecological surgeries on their uterine fibroids may have hidden cancer cells which, prior to surgery, are virtually undetectable.
A power morcellator works much like a drill. It enters the abdomen through a tiny incision where it rapidly spins blades in order to shred troublesome uterine fibroid tissue. The tissue can then be pulled up a tube on the front of the morcellator to be removed from the body. As many plaintiffs allege and several studies support, however, while it is doing this, the device can expose and spread cancer encapsulated within the fibroids. This causes a significant cancer diagnosis for the patient post-surgery, which can greatly impair their life expectancy.
They attorneys at Tracey & Fox understand the seriousness of this issue. They are working to ensure that anyone who has undergone laparoscopic power morcellation on uterine fibroids and who has been subsequently diagnosed with cancer will be able to explore their legal rights. These women may be entitled to compensation. The attorneys at Tracey & Fox are currently offering free legal consultations to those affected.
To ask questions or request additional information on power morcellation lawsuits, please contact the attorneys at Tracey & Fox by calling (713) 322-5375.
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