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- Have you or a loved one undergone laparoscopic hysterectomy or large fibroid removal?
- Was a power morcellator used?
- Were you or a loved one later diagnosed with cancer?
You may be entitled to compensation for your injuries.
What are Laparoscopic Power Morcellators?
First approved by the FDA in 1995, laparoscopic power morcellators (LPMs) are medical devices used for the removal of uterine fibroids, as well as for hysterectomies.
Essentially, morcellators are tubes with blades.
Surgeons make a small incision (called a port incision) in the patient’s abdomen.
The morcellator is inserted through the port incision and the device grinds or cuts up tissues, such as uterine fibroids, or the whole uterus if being used for a hysterectomy.
The ground tissues are removed via the port incision. The procedure is labelled as minimally invasive and the smaller incision lowers the amount of recovery time needed, as well as reducing the risk of infections and other complications.
Morcellators and Manufacturers
- FemRx – Diva Morcellator
- Hologic – MyoSure
- Lumenis Inc. – VersaCut Morcellator
- Ethicon Gynecare – X-Tract
- Ethicon Gynecare – Morcellex Tissue Morcellator
- Ethicon – Morcellex Sigma
- Interlace Medical – Hysteroscopic Morcellator
- Smith & Nephew – Trueclear Hysteroscopic Morcellator
- Olympus – PlasmaSORD
- Olympus – Gyrus PKS PlasmaSORD
- Nouvag – Morcellator TCM3000BL
- Blue Endo – MOREsolution Tissue Morcellator
- LiNA Medical – Xcise Cordless Laparoscopic Morcellator
- Karl Storz – Rotocut G1, G2, Steiner, and Sawalhell Supercut Morcellator
- Richard Wolf – Morce-Power 2306 Electronic Morcellator
What are Uterine Fibroids?
Uterine fibroids are benign tumors growing in the uterine wall. Also known as leiomyomata, uterine fibroids vary in size and number by patient. Infertility, miscarriages and early onset labor often go hand-in-hand with uterine fibroids.
Certain studies show that most American women will have fibroids at some point in their lives. In fact, studies show that by age 50, roughly 70% of Caucasian women and 80% of African American women had fibroids.
Quite often, fibroids don’t cause noticeable symptoms and the women who have them may not even know it.
Treatment Of Uterine Fibroids
According to the National Institutes of Health (NIH), there are numerous ways of treating symptomatic fibroids. However, when uterine fibroids are present in high numbers or are causing the patient pain, doctors often recommend surgery. Quite often this means hysterectomy. Over 200,000 hysterectomies due to uterine fibroids are performed every year, with annual direct health care costs in excess of $2.1 billion.
If you or someone you know has been injured or impacted by a laparoscopic power morcellator, contact Amber Pang Parra for a free consultation at (855) 452-5529 or pharma@justinian.com.
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What Is The Problem With Laparoscopic Power Morcellators?
Quite often, morcellation leaves small pieces of ground up tissue in the patient’s abdomen. Studies suggest that around 1 out of every 350 women who have a myomectomy (surgical removal of uterine fibroids) or hysterectomy using a laparoscopic power morcellator could have an undiagnosed sarcoma (cancer).
If this is the case, the cancerous tissue is ground up along with the fibroids and/or the uterus and this tissue is spread throughout the patient’s abdominal cavity. Sadly, this can cause what may have otherwise been a containable, controllable cancer to aggressively spread. This increases the possibility that women may die as a result of the undiagnosed cancer that would not have spread but for the use of a morcellator.
There Are Various Types Of Cancer Linked To Morcellation
- Leiomyosarcoma (LMS)
- Uterine cancer
- Endometrial stromal sarcoma
- Uterine sarcoma
- Parasitic myomas
Laparoscopic Power Morcellators And The Risks To Women
Roughly 1 in 350 women have undiagnosed uterine cancer.
The U.S. Food and Drug Administration estimates that 1 in 500 women have the highly-aggressive cancer, leiomyosarcoma.
The Agency’s estimates are supported by a study published by the Journal of the American Medical Society (JAMA) in 2014. The study examined data from 233,000 women who underwent LPM hysterectomies between 2006 and 2012.
Why have doctors favored Laparoscopic Power Morcellators if they are dangerous?
Only 1 in every 10,000 women in the general population has undiagnosed uterine cancer, leading doctors to believe that morcellation, especially using the tissue containing bags, was a low-risk procedure.
Unfortunately, women who undergo hysterectomies are a subset of the general population. They often experience pain and bleeding, symptoms of large fibroids and also symptoms of cancer. At present, there isn’t a reliable method of determining if a woman having a hysterectomy with morcellation has cancer until post-surgery, when it is often too late.
Some Physicians and Researchers Raise Concern Over Power Morcellators
Amy Reed, MD and Hooman Noorchashm, MD
Not all doctors are pro-morcellation. In fact, two doctors are working hard to inform the public of the risks involved with morcellators:
Dr. Amy Reed underwent myomectomy with morcellation and was diagnosed with cancer in 2013. She and her husband, Dr. Hooman Noorchashm, are working to prevent others from enduring the difficulties they are facing.
American Congress of Obstetricians and Gynecologists (ACOG)
In 2011, the American Congress of Obstetricians and Gynecologists (ACOG) issued a committee opinion that “vaginal hysterectomy is the approach of choice whenever feasible, based on its well-documented advantages and lower complication rates.”
FBI Investigation of Power Morcellator Manufacturer
In May 2015, the FBI began investigating one LPM manufacturer, Johnson & Johnson’s Ethicon division, to determine how much the company knew about the risks involved with LPM use before the company pulled its products from the market in July 2014.
Congressional Action Over Power Morcellator Dangers
Rep. Mike Fitzpatrick (R-PA), an advocate for women’s health issues, wrote a letter to the FDA demanding answers as to the Agency’s lack of action when Ethicon and three hospitals failed to report deaths that were linked to LPM use.
The Dangers of Laparoscopic Power Morcellators Have Been Known For Decades
Shockingly, a study conducted in 1998 showed that laparoscopic power morcellators did spread ground up tissue throughout the patient’s abdominal cavity during morcellation.
Despite the fact that this risk has been known since at least 1998, LPM manufacturers have not adequately warned patients or doctors of the risk.
Instead, LPM risks have been described to doctors or patients as merely “side effects.”
Some Insurance Companies Will Not Cover Power Morcellation
Perhaps in response to increased awareness of the dangers of laparoscopic power morcellators, even insurance companies are beginning to drop coverage for procedures involving LPMs. They include Aetna, Inc. and HCA Holdings. Collectively, these insurers cover over 123 million people.
Food And Drug Administration Action On Laparoscopic Power Morcellators
The U.S. Food and Drug Administration (FDA) regulates all types of consumer products, including medication and medical devices such as LPMs.
The FDA agency has take a number of actions to address potential injuries by LPMs:
Tissue Containment Bags
In April 2016, the U.S. Food and Drug Administration (FDA) approved tissue containment bags for use with laparoscopic power morcellators (LPMs) in an attempt to mitigate their risk.
However, the FDA warned that the bags may not necessarily be effective in reducing the risk of spreading cancerous tissues during morcellation.
Additionally, the use of tissue containment bags carries its own set of risks:
- Infection
- Organ Damage
- Additional / Longer Surgeries
FDA Safety Communication On Laparoscopic Power Morcellators
In April 2014, rthe U.S. Food and Drug Administration issued a safety communication warning doctors not to use morcellation in the “vast majority” of myomectomies and hysterectomies.
The warning read in part:
“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 likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
FDA Obstetrics and Gynecology Devices Panel
On July 10, 2014 the FDA Obstetrics and Gynecology Devices Panel met to evaluate the risks and benefits of using LPMs for minimally invasive hysterectomies for symptomatic uterine fibroids and for myomectomies.
This risk/benefit evaluation led to uncertain results and the recommendation that the devices not be used due to:
- The unreliable methods and difficulty for doctors to diagnose cancers before the LPM procedure;
- The risk of spreading unsuspected malignant tissue during morcellation;
- The complexity of finding methods to mitigate the risk.
November 24, 2014, FDA Warning
In April, 2014, the Agency reiterated its original warning against using LPMs in the vast majority of women undergoing myomectomies and hysterectomies.
It also recommended, in an Immediately in Effect (IIE) guidance, that LPM makers add a Black Box warning and two contraindications to their product labels with specific safety statements.
- FDA Black Box Warning. A black box warning is the FDA’s strictest warning for drugs and medical devices for sale to the public. Black box warnings inform the public and health care providers can have the most serious side effects, including severe injury and death.
This IIE guidance allowed the Agency to continue to issue recommendations in an expeditious manner to address a serious public health issue. In part, the update read:
“The boxed warning informs health care providers and patients that:
- Uterine tissue may contain unsuspected cancer
- The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.
- Laparoscopic power morcellators are contraindicated (should not be used) for:
- Removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal, or candidates for en bloc tissue removal (removing tissue intact) through the vagina or mini-laparotomy incision.
(These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.) - Gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.”
- Removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal, or candidates for en bloc tissue removal (removing tissue intact) through the vagina or mini-laparotomy incision.
Some Laparoscopic Power Morcellators Pulled from the Market
J&J’s Ethicon division stopped all global sales of LPMs shortly after the April 2014 FDA warning.
Then on June 30, 2014, Ethicon withdrew its LPMs from the market. The company called the action a “worldwide market withdrawal” as opposed to an official recall.
The devices affected by this voluntary market withdrawal included:
- Gynecare Morcellex
- Morcellex Sigma
- Gynecare X-Tract
Laparoscopic Power Morcellator Personal Injury Lawsuits
The majority of suits filed are against Ethicon, but injured women have also sued Olympus Corporation, Lina Medical, Richard Wolf, Karl Storz and Gyrus ACMI.
These Personal Injury Lawsuits Address Cancer Allegedly Linked To Laparoscipic Power Morcellation
Several of the injured women have been diagnosed with leiomyosarcoma, which is a particularly aggressive form of uterine cancer. These women were diagnosed with cancer following robot-assisted, morcellator hysterectomies.
Many of the injured women only learned of the increased risk of cancer through conducting their own research into the issue. They believe, rightly so, that the manufacturers failed to properly warn them and their doctors of this risk.
They allege that the LPM makers knew or should have known of the risks, but did nothing.
Texas Power Morcellator Personal Lawsuits And Multi-District Litigation (MDL)
When a person or company hurts a group of people in similar ways, those people can sometimes combine their lawsuits. One way of doing that is called a multi-district litigation (MDL).
In an MDL, the people suing (the plaintiffs) are often in different districts. But an MDL allows them to share the cost of a lawsuit. The court handles all of the cases’ pre-trial proceedings (discovery, etc.) at once.
- There are several lawsuits to recover for injuries like cancer that patients were diagnosed with after the use of laparoscopic power morcellators.
- The lawsuits have been centralized in a multi-district litigation (MDL) in the U.S. District Court for Kansas, Judge Kathryn H. Vratil presiding.
We are experienced in dealing with dangerous medical device suits and MDLs and we will fight for you.
Why You Should Seek Legal Assistance
Laparoscopic Power Morcellator Injury Lawsuits Can Be Complex to Prove
Winning a mass tort lawsuit for injuries caused by laparoscopic power morcellators can involve proving that manufacturers like Johnson & Johnson or Ethicon did not properly warn people taking it of the potential risks.
That can include investigating medical studies, corporate publications and using testimony from experts on how the medication caused an injury. This is not easily done, particularly when drug companies show up with an army of lawyers.
But battling bullies is what Justinian & Associates does.
We Are Warriors For The Injured
Our Austin and San Antonio mass tort lawyers have successfully represented many victims injured by defective medical products. That’s exactly why we were founded.
As our record demonstrates, Justinian & Associates has the legal knowledge, experience, resources, attorneys and trained investigators to take on adversaries of any size.
All we do is fight for injured victims.
Our only goal is justice for our clients, whatever that means for them.
We do not accept defeat. Unless we get you monetary compensation for your injuries, you won’t pay us a dime.
Your Rights Can Be Lost If You Wait
Lawsuits for injuries caused by Laparoscopic Power Mocellators are going on across the country, in many state and federal courts.
There are laws that limit how much time you have to file a lawsuit after being injured. They are known as statutes of limitation. They may apply to your lawsuit to recover for your power morcellator injuries. The countdown may already have begun.
Additional limitations may be imposed pursuant to certain settlement agreements with the various device manufacturers.
If you or a loved one have been diagnosed with cancer after a myomectomy or hysterectomy using a laparoscopic power morcellator, now is the time to seek legal assistance.
If you are not sure whether or not you qualify to receive damages, don’t worry. Call, text or email us for a free consultation, with no obligation.
Speak to an Austin personal injury attorney from Justinian & Associates (not a “screener” or paralegal) to understand your rights.
We’re here for you and will do everything we can to help you receive the compensation you deserve. We’re on your side.
