Power Morcellator Overview
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. 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.
After a warning letter was issued by the United States Food and Drug Administration (FDA) in 2014, warning of an increased risk of cancer involved in use of power morcellators, people began filing lawsuits. Most of these lawsuits have been filed against Johnson & Johnson who is the largest manufacture of power morcellators through their Ethicon medical device division.
Power Morcellator Lawsuits
In April of 2014, the FDA issued a statement warning practitioners about the use of power morcellators in gynecological treatment, at this time the Johnson & Johnson “suspended sales” of their power morcellators. In May of 2014, Health Canada issued a similar warning and requested that physicians stop using the machines. In July of 2014, study results published in JAMA showed increased uterine pathology (disease) after power morcellator procedures.
In the same month, after the JAMA article was published, Ethicon, the subsidiary of Johnson & Johnson issued a “voluntary recall” of all 3 Ethicon Power Morcellator versions from the market however as the recall is not binding, some machines may still be in use.
While Johnson & Johnson is the largest company who manufacturers Power Morcellators for gynecological and other uses, similar machines are manufactured by:
- Lumenis Ltd.
- Karl Storz GmbH
- Richard Wolf GmbH
- Cook Urological Inc.
- Smith & Nephew
- LiNA Medical
- Blue Endo
Ethicon, LiNA, and Blue Endo have been specifically named in lawsuits surrounding injuries and deaths caused by the spread and development of uterine cancers including leiomyosarcoma, endometrial stromal sarcoma, endometrial adenocarcinoma, and carcinoma after power morcellator use.
Power Morcellator Warnings
Some evidence shows that Johnson & Johnson was aware of serious risks of power morcellators as early as 2006. A letter was reportedly sent to Johnson & Johnson from Dr. Robert Lamparter, 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.
The FDA conducted an Advisory Committee meeting in July of 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 warning to product packaging or changing the tools classification to the higher “Class III” device category which would require extensive safety and effectiveness studies.
Some individual hospitals and medical centers have banned the use of power morcellators all together including notables such as Brigham & Young Women’s Hospital, Tufts Medical Center, Massachusetts General Hospital, and Boston Medical Center.
Power Morcellator Cancer Risk
Despite the fact that morcellators 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 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 leading to “disseminated” disease in two-thirds of leiomyosarcoma cases which is potentially fatal.
Leiomyosarcoma is a malignant grown 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 the 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.
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 have 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 they 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 global revenue of over $71 billion in 2013 and is currently the subject of a number of lawsuits filed relating to Power Morcellator use.
Power Morcellator Uses
Power morcellators were developed to aid in tissue removal in cases where laparoscopic surgery techniques may present less surgical exposure and risk to the patient. Traditional surgery involving a single large incision is invasive and often requires a significantly longer surgery, longer healing time and may cause more pain than a less invasive procedure performed through laparoscopic surgery.
Laparoscopic surgery allows the surgeon to make a series (usually 2 to 4) incisions of one inch or so to insert “laparoscopic” tools which use camera technology to allow the surgeon to see into the abdominal cavity and use small instruments to perform surgical techniques without exposing the whole abdomen.
Laparoscopic surgery has been of use in a number of abdominal surgeries such as hysterectomy, splenectomy, gall bladder removal and has been particularly useful in the obstetrical and gynecological arena. Surgeons have been able to perform tubal ligations, refine diagnostics, perform partial hysterectomies – and remove growths or fibroids from the uterine tissue.
Unfortunately, in some of those cases, the growths, thought to be benign fibroids have turned out to be benign leiomyomas or the more serious, malignant Leiomyosarcoma. Breaking up the growth releases tissue, and individual cells to possibly spread throughout the abdominal tissue.
Power Morcellator Recalls
Manufacturers including Johnson & Johnson through their subsidiary, Ethicon, face multiple lawsuits regarding cancer development and death after power morcellator use, however other manufacturers also have made power morcellators.
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
- 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
- Blue Endo
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.
Power Morcellator Risks
There are multiple risks of the use of Power Morcellators. While power morcellators can be used in many cases without severe complications, there are side effects. Common side effects that are not severe but may impact a patient’s quality of life and may warrant medical treatment may include:
Over 600 thousand hysterectomies are performed each year in the U.S. alone. Many of these procedures are done after a patient is beyond childbearing age and has an enlarged uterus. Over ten percent of the hysterectomies done in the past several years involved tissue morcellation.
Uterine fibroids are a common occurrence in women over the age of 50 and are the most common cause of having an enlarged uterus. Fibroids are non-cancerous tumors, also known as leiomyomata and account for up to 40 percent of hysterectomies. Other causes commonly include adenomyosis or a different type of non-cancerous growth which causes the uterine walls to become thickened. In these cases, it is assumed that the cancer risk is known and minimal.
Despite the lack of severe risks – power morcellation procedures do have some side effects such as:
- Localized bleeding
- Pain at incision site
- Oozing from incision site
- 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.
Severe Risks of Power Morcellators
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.
Leiomyosarcoma is an aggressive from of uterine sarcoma with a poor prognosis. The best treatment for leiomyosarcoma is clean removal of the tumor tissue and a wide margin of healthy tissue without rupture of the tumor. Power morcellation does not allow for 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.
Increased risks for uterine cancer including 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
Leiomyoma is a non-cancerous or benign growth from the uterine muscle tissue and is what often makes up “fibroids”. Despite the fact that 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.
In February 2016, the FDA announced approval of a containment system for use of power morcellators. This is a device which 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. No information is yet available about actual results with use of these devices.
Power Morcellator Claims
Johnson & Johnson through their subsidiary, Ethicon, along with other manufacturers face lawsuits alleging the spread of cancer and related death after power morcellation gynecological procedures. These lawsuits currently include:
- A lawsuit 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 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 filed in Florid by a female patient with no signs or symptoms of cancer who underwent hysterectomy to remove fibroids. After the procedure, it was discovered that power morcellation spread endometrial stromal sarcoma cancer throughout her abdominal cavity. Her life expectance and quality of life has 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.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.