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Power Morcellators

 

Laparoscopic Power Morcellators and Cancer

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.

A laparoscopic power morcellator; image courtesy of www.MedPageToday.com.

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, they 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.

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.

What is the problem?

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. Equally sad is the fact that, despite the fact that this risk has been knows since at least 1998, manufacturers have not adequately warned patients or doctors of the risk.

List of the types of cancer linked to morcellation

  • Leiomyosarcoma (LMS)
  • Uterine cancer
  • Endometrial stromal sarcoma
  • Uterine sarcoma
  • Parasitic myomas

In an attempt to mitigate the risk, the FDA approved tissue containment bags for use with LPMs in April 2016. However, the agency 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, such as infection, organ damage and longer surgeries.

What is the risk to women?

As mentioned earlier, roughly 1 in 350 women have undiagnosed uterine cancer and, according to the FDA, 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 LPMs? 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.

Not all doctors are pro-morcellation, though. 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.

Believe it or not, even insurance companies - typically interested only in profits - are beginning to drop coverage for procedures involving laparoscopic power morcellators. Some of the insurers taking a stand against morcellation include Aetna, Inc., HCA Holdings and others. These insurers cover over 123 million people.

FDA and Others Get Involved

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.”

The U.S. Food and Drug Administration issued a safety communication in April 2014 warning doctors not to use morcellation in the “vast majority” of myomectomies and hysterectomies. In part, the warning read:

“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.”

On July 10, 2014 the FDA Obstetrics and Gynecology Devices Panel met. The purpose of the meeting was evaluation of 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.

Once again, on November 24, 2014, the FDA issued another warning. In this update of the April 2014 warning, 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. 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.

The two contraindications advise of the following:

  • 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.)
  • Laparoscopic power morcellators are contraindicated (should not be used) in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.”

?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.

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.

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

Study

Shockingly, a study conducted in 1998 showed that laparoscopic power morcellators did spread ground up tissue throughout the patient’s abdominal cavity during morcellation.

Retained Myoma after Laparoscopic Supracervical Hysterectomy with Morcellation.

Hutchins, et al. 1998

Yet, despite this early knowledge, LPM manufacturers did nothing to warn doctors or patients of this “side effect.”

Laparoscopic Power Morcellator 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. 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.

The lawsuits have been centralized in a multi-district litigation (MDL) in the U.S. District Court for Kansas, Judge Kathryn H. Vratil presiding. The purpose of the MDL is to handle all of the pre-trial proceedings (discovery, etc.) at one time, thus saving the parties time and money and avoiding the risk of contradictory pre-trial decisions.

Don’t Wait! The Time is now to Seek Legal Assistance!

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. The Statute of Limitations, the time period during which you can file a lawsuit, may already be running. If you wait too long, you will be forever barred from seeking the justice you deserve. Contact the experienced attorneys at Justinian and Associates now for a free case consultation. We are experienced in dealing with dangerous medical device suits and MDLs and we will fight for you.

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