Power Morcellator Cancer Risk

What Is a Power Morcellator?

A power morcellator is a medical device used to reduce the invasiveness of surgeries. It cuts up larger tissue masses into smaller pieces, meaning that they can more easily be removed through a small incision. Without a power morcellator, a much larger incision would have been required to remove the entire tissue mass at once. Using a power morcellator in surgery has become controversial in some surgeries, particularly in hysterectomies and other gynecological surgeries because the device has been linked to an increased risk of spreading undetected cancerous tissues.

Who Manufacturers Power Mortecellators?

Johnson & Johnson is the largest manufacturer of power morcellators through their Ethicon medical device division. The technology was introduced in 1993, initially for uterine extraction. Use was later expanded to include other organs. In recent history, there were at least 11 medical power morcellators on the U. S. market.

What Is the Power Morcellator Used for?

A power Morcellator is a surgical instrument that was developed to remove tissue during a laparoscopic procedure. The word “morcellator” refers to “morcellation” or the rendering of tissue into smaller pieces (essentially morsels) that are more easily removed through a small surgical incision. Morcellation was developed to create small samples that can be drawn out of the abdominal cavity.

What Are the Risks of Using a Power Morcellator?

Even though morcellator tools have been in use for over two decades, there is still little understanding of the complications that can arise from morcellator use. Concerns about potential damage have risen relating to surrounding organs such as the bladder, kidney, intestines, pancreas, spleen, and vascular (veins and arteries) tissue. A longer-term issue has emerged due to the potential growth of retained tissue, leading to parasitic growth and potential lesions. More significantly, a severe risk of leiomyosarcoma leads to “disseminated” disease in two-thirds of leiomyosarcoma cases which is potentially fatal.

What Is Leiomyosarcoma?

Leiomyosarcoma is a malignant growth of smooth muscle connective tissue, also known as “LMS”. Power morcellator use to remove leiomyosarcoma has been shown to spread the cancer into other areas. Leiomyoma is a benign form of growth, but it may also be spread through the use of morcellators and though it is not thought to increase the risk of death, it is usually inoperable once spread.

How Is Leiomyosarcoma Treated?

The best treatment for leiomyosarcoma is to clean and remove the tumor tissue and a wide margin of healthy tissue without rupturing the tumor. Power morcellation does not allow for the clean removal of a non-ruptured tumor but instead “minces” or “morcellates” the tissue into small pieces. This allows for small tumor cells to escape into the abdominal cavity where upon implantation may begin to grow additional tumors or sarcomas. Leiomyosarcoma is fatal in at least two-thirds of all cases, spreading the cancer cells greatly increases the risk of decreased lifespan or death. According to the FDA, nearly 1 in 350 women who undergo power-morcellation myomectomy procedures may suffer uterine sarcoma after the procedure.

What Are the Symptoms of Leiomyosarcoma?

The symptoms of leiomyosarcoma may include:

• Nausea
• Fever
• Chronic fatigue
• Severe pain
• Swelling of the tumor

Who Is at Increased Risk of Leiomyosarcoma?

People who are at an increased risk for uterine cancer or leiomyosarcoma include:

• Women over the age of 60
• Black or African American Heritage
• Long-term use of tamoxifen (to treat breast cancer)
• Pelvic irradiation
• Women who had childhood retinoblastoma

What Is Leiomyoma?

Leiomyoma, similarly, has been said to be an after-effect of using the power morcellator. It is a non-cancerous or benign growth from the uterine muscle tissue and is what often makes up “fibroids.” Even though it is not malignant, rupture of the benign tumor has also been shown to spread tissue cells which may begin implanting and growing ectopically on abdominal tissue. As the tumor cells are now spread diffusely, they are not removable through surgery and can cause extensive pain and reoccurrence of fibroids.

What Are the Symptoms of Leiomyoma?

The symptoms of leiomyosarcoma may include:

• Vaginal bleeding
• Pain and pressure in the abdomen 
• Abnormal cramping
• Pressure in the pelvic region

What Are the Severe Side Effects of Power Morcellation Procedures?

The severe side effects after using a power morcellation device are:

• Localized bleeding
• Pain at the incision site
• Oozing from the incision site
• Soreness
• Bruising
• Infection and abscess
• Fibroid reoccurrence
• Damage to surrounding organs
• Pelvic and abdominal pain

In most cases side effects are expected, easily treatable, and will subside after a period of healing. However, power morcellator procedures may cause unexpected side effects that are more severe and may increase the risk of death.

What Porter Morcellator FDA Health Warnings Are There?

The FDA conducted an Advisory Committee meeting in July 2014 and concluded that physicians using power morcellators should make their patients more aware of the risks of the use of the machines. The committee suggested adding additional, serious warnings to product packaging or changing the classification of the tools to the higher “Class III” device category which would require extensive safety and effectiveness studies. Some individual hospitals and medical centers have banned using power morcellators altogether including notables such as Brigham & Young Women’s Hospital, Tufts Medical Center, Massachusetts General Hospital, and Boston Medical Center.

Has the Power Morcellator Been Recalled?

Johnson & Johnson and its Ethicon division recalled three of their models, however, the FDA has not issued a wholesale recall and the Ethicon recall was “voluntary”. This may mean that many devices, including those manufactured by Johnson & Johnson, are still in use. These companies and their devices include:

• Ethicon / Johnson& Johnson
• Gynecare Morcellex
• Gynecare X Tract
• Morcellex Sigma
• Diva by FemRx
• Lumenis Ltd.
• VersaCut+Tissue Morcellator
• Olympus
• PKS PlasmaSORD
• VarioCarve Morcellator
• Karl Storz GmbH
• KSE Steiner Electromechanic Morcellator
• Richard Wolf GmbH
• Morce Power Plus
• Cook Urological Inc.
• Cook Tissue Morcellator
• Smith & Nephew
• TRUCLEAR Morcellation System
• LiNA Medical
• Xcise
• Blue Endo
• MOREsolution

Three of the companies, Ethicon, LiNA, and Blue Endo have been named in lawsuits regarding injuries or deaths caused by the development of cancer after power morcellator devices were used in hysterectomy procedures. Cancers caused or spread by power morcellators may include leiomyosarcoma, endometrial stromal sarcoma, endometrial adenocarcinoma, and carcinoma.

What Is the PneumoLiner Containment?

In February 2016, the FDA announced the approval of a containment system for the use of power morcellators. This is a device that uses a containment bag to collect the morcellated tissue so that it may not spread throughout the abdominal cavity. It was initially only authorized for certain populations however, use has been expanded to additional patients including women with or without fibroids under certain conditions. The agency also updated guidance documents regarding the safe and proper use of power morcellators and PneumoLiner systems. Information is yet to be available about the actual results of the use of these devices.

Have Power Morcellator Sales Been Suspended?

On April 17, 2014, the Food and Drug Administration (FDA) issued a warning letter stating that power morcellator use may spread cancers when used for fibroid tumor removal. Johnson & Johnson, the largest medical products company in the world, initially suspended sales but has now withdrawn their three versions of the Power Morcellator produced by their subsidiary, Ethicon. The sales were suspended in April, after the FDA notice and withdrawn from the market after the July 2014 issue Journal of the American Medical Association (JAMA) published results from a study regarding increased uterine pathology following morcellator use.

Johnson & Johnson reported a global revenue of over $71 billion in 2013 and is currently the subject of several lawsuits filed relating to power morcellator use. In 2016, Johnson & Johnson has been working to settle their lawsuits according to the Wall Street Journal. There have not been any news updates related to the device allegations in recent years, however many patients are still suffering the health consequences today.

What Power Morcellator Lawsuits Are There?

Johnson & Johnson through their subsidiary, Ethicon, along with other manufacturers faces lawsuits alleging the spread of cancer and related death after power morcellation gynecological procedures. These lawsuits include:

• A lawsuit was filed in March of 2014 in the U.S. District Court, Eastern District of Pennsylvania, by the husband of a 53-year-old woman who died from uterine cancer less than a year after having a hysterectomy using the power morcellator to treat uterine bleeding.
• A lawsuit was filed in the U.S. District Court for the District of New York, by a woman who was diagnosed with occult uterine leiomyosarcoma as cancer after having a hysterectomy using a power morcellator.
• A lawsuit was filed in Florida by a female patient with no signs or symptoms of cancer who underwent a hysterectomy to remove fibroids. After the procedure, it was discovered that power morcellation spread endometrial stromal sarcoma cancer throughout her abdominal cavity. Her life expectancy and quality of life have been dramatically reduced.

The plaintiffs and representing lawyers claim that the company knew of and failed to warn patients and the medical community of the increased risk of cancer development following power morcellator use. Plaintiffs also claim that the companies failed to make the devices safe for their intended use. In 2017, there was also a case of death filed concerning the power morcellator device. There are still pending lawsuits today regarding the severe health effects of the device.

Why Did People File Power Morcellator Lawsuits?

Some evidence shows that Johnson & Johnson was aware of the serious risks of power morcellators as early as 2006. A letter was reportedly sent to Johnson & Johnson from Dr. Robert Lamparter, a pathologist at Evangelical Community Hospital in Lewisburg PA requesting that the company “reconsider the risk” as the devices “may lead to dissemination of malignant tissue.” The company responded by including a labeling precaution in use instructions but did not examine the issue further. Additional complaints were dismissed.

Power Morcellator gynecological procedures such as treatment for uterine fibroids or adenomyosis are common. Unfortunately, power morcellators have shown an increased risk of spreading undetected cancers including a deadly form of cancer: leiomyosarcoma. It is also thought that their use may spread tissue from other tumors including benign leiomyoma. Uterine cancers and cervical cancer may also be causes for hysterectomy and it is not known how many power morcellator procedures may have been done on known cancer cases. The lawsuits reported were in response to the dismissal of the risks by Johnson & Johnson.

What Power Morcellator Lawsuit Settlements Are There?

There have been over a hundred cases of power morcellator lawsuits against Johnson & Johnson, and the settlements ranged from a few hundred thousand dollars to one million dollars in case compensation. In 2015 there was a lawsuit settlement for a woman who had gotten a case of leiomyosarcoma after surgery with the power morcellator device. The settlement amount was undisclosed, and there are still other pending lawsuit cases against Johnson & Johnson for the device.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.