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Power Morcellators

A power morcellator is a surgical instrument used in less-invasive abdominal procedures, such as laparoscopic hysterectomies and myomectomies, and liver and spleen surgeries. The FDA alerted the medical community that morcellators may be responsible for spreading cancerous tissue. Women undergoing uterine fibroid removal or a hysterectomy should understand the risks before receiving these procedures.

Did you develop cancer after laparoscopic hysterectomy or other morcellator surgery? You might be entitled to compensation.

What is a Power Morcellator?

A power morcellator is an electric surgical device used to cut up large chunks of tissue into smaller pieces. Surgeons use them during procedures such as a laparoscopic hysterectomy or a myomectomy. The devices resemble a drill with sharp blades at the end. Doctors insert the long, tube-like portion into small incisions in the abdomen, perform morcellation of the uterus or fibroid by chopping up the tissue and vacuum it out of the body.

Morcellation means to cut into smaller pieces. A morcellator is a surgical tool that doctors use to cut up bigger chunks of tissue into smaller ones, usually during laparoscopic surgery.

These devices allow surgeons to make minimally invasive incisions of less than 2 centimeters in size and remove fibroids and other tissue through the small incision. These smaller entry points to the body mean doctors do not have to make large cuts through core stomach muscles. This allows quicker patient recoveries, less post-operative pain and fewer wound complications.

Power Morcellation Device

Power morcellation may sometimes be confused with vaginal morcellation. In laparoscopic power morcellation, a surgeon uses an electric tool with blades to cut and remove tissue through the abdomen. Vaginal morcellation does not usually involve a power morcellator. Instead, the surgeon cuts the tissue up with a scalpel and removes it through the vagina. In this technique, after morcellation of the uterus or fibroids, doctors put the tissue into a protective bag before cutting. Without the spinning blades of the power morcellator, tissue that may contain cancerous cells is not spread around the abdominal cavity. The tissue is removed in a protective bag, also minimizing risk.

Morcellation for Minimally Invasive Procedures

In addition to hysterectomies and uterine fibroid removals, power morcellators may also be used in other minimally invasive procedures performed with laparoscopic surgery. Some examples include gallbladder surgery, removal of the spleen or surgeries involving the liver. Because these surgeries are done through small incisions, there is less blood loss and a quicker recovery time.

While power morcellators assist surgeons in performing some laparoscopic surgeries, it is important to note that there are several minimally invasive procedures where morcellators are not used. For example, tubal ligation and other diagnostic surgeries like biopsies may be performed laparoscopically without morcellators because surgeons do not need to cut up large bits of tissue.

Power Morcellator Side Effects

In addition to the risk of developing cancer, some of the common side effects associated with power morcellators include:

  • Bleeding or infection
  • Bowel obstruction
  • Bruising
  • Fibroid reoccurrence
  • Oozing at incision site
  • Organ damage
  • Pain at incision site
  • Pelvic and abdominal pain
  • Muscle soreness
  • Abscess

In some morcellator procedures, benign or cancerous tissue can spread to the abdomen in women or men, causing problems. Recent medical evidence shows the removal of broken up fibroids and tissues may not be 100 percent effective. If any of those tissues contain cancer cells and do not get removed, they get spread to other areas, leading to the development of cancerous tumors.

 
Dr. Christopher Walker, Urogynecologist, explains the risk of power morcellators.
Devices produced by Johnson & Johnson's Ethicon division:
Gynecare Morcellex Tissue Morcellator Morcellex Sigma Tissue Morcellator System Gynecare X-Tract Tissue Morcellator

Morcellation in Hysterectomy

Hysterectomies

Doctors perform approximately 600,000 hysterectomies a year in the United States. Nearly half of those procedures, in which a woman’s uterus is removed, are minimally invasive. Surgeons utilize tissue morcellation in a growing percentage of those surgeries. No standard of exact figures exists, but some estimates put it between 11 and 12 percent.

Morcellation

According to the Society of Gynecologic Oncology, morcellation was developed to reduce the size of an enlarged uterus so that it may be removed through small laparoscopic incisions or through a woman’s vaginal canal. The instrument and technique allows women to avoid a traditional, open and more invasive hysterectomy.

Uterine Fibroids

Uterine fibroids, which occur in as many as 80 percent of women by age 50, are the most common cause of an enlarged uterus. These fibroids – non-cancerous tumors – account for about 40 percent of hysterectomy cases, making it the most frequent reason for a woman to have one. Other causes of an enlarged uterus include adenomyosis, which are non-cancerous growths that can cause the uterine walls to thicken, and uterine or cervical cancer.

Fibroid Surgery

Surgeons also use laparoscopic power morcellation during minimally invasive surgeries to remove uterine fibroids, which affect about 250,000 women each year. The risk of developing fibroids – also called leiomyomas – increases after age 50, but young women can get them. By removing fibroids, doctors can relieve pain, bleeding and other uncomfortable symptoms without removing a woman’s uterus. This type of surgery is called a myomectomy.

According to estimates by the U.S. Food and Drug Administration (FDA), morcellators are used in about 60,000 hysterectomy and myomectomy procedures annually.

While often benign, fibroids may also harbor undetected cancer cells. This cancer is notoriously difficult to detect before surgery. Because morcellators work by shredding tissues, fragments of cancerous cells may spread throughout the abdominal and pelvic cavity and lodge in other tissues, causing the disease to spread. This makes the cancer more serious and difficult to treat.

Morcellators can also spread non-cancerous tissue fragments in the body. These fragments can cause growths on other organs and tissues, causing pain and swelling. When that happens, these masses require surgery.

Power Morcellators Used in 60,000 Procedures Annually

Types of Laparoscopic and Hysteroscopic Morcellators

Surgeons typically perform two morcellation techniques: laparoscopic and hysteroscopic. Each type of surgery uses a specific kind of device made by manufacturers.

The FDA believes that, "when used in accordance with current indications and instructions for use, hysteroscopic morcellators do not pose the same risk as the devices addressed in this guidance because any sarcomatous tissue present does not enter the peritoneal cavity."

Laparoscopic

The FDA warning applies specifically to the laparoscopic procedure, also called "open morcellation." In this technique, surgeons insert the drill-like device through a small incision in the abdomen, shred and remove the tissue. However, because the shredding occurs in an open environment, bits of tissue – including cancerous cells – can spray into the abdominal and pelvic cavity. The majority of morcellators fall into this category.

Hysteroscopic

In contrast, hysteroscopic morcellators are designed with tissue traps or collecting pouches. This surgical technique is newer, and studies so far revealed it not linked to increased cases of cancer. When surgeons grind up tissue, it is trapped in a pouch for testing. These devices also use mechanical versus electric energy to both cut and collect the tissue.

Laparoscopic Models

Blue Endo

  • MOREsolution

Cook Urological, Inc.

  • Cook Tissue Morcellator

Ethicon, Inc.

  • Gynecare Morcellex
  • Morcellex Sigma
  • Gynecare X Tract

Ethicon of FemRx

  • Diva

LiNA Medical

  • Xcise

Lumenis, Ltd.

  • VersaCut+ Tissue Morcellator

KSE America

  • KSE Steiner Electromechanic Morcellator

Karl Storz GmbH & Co.

  • ROTOCUT G1, G2
  • Swalhe II SuperCut Morcellator

Olympus

  • PKS PlasmaSORD
  • VarioCarve Morcellator

Richard Wolf GmbH

  • Morce Power Plus

Risk of Leiomyosarcoma Cancer

Women with uterine fibroids are routinely screened for various forms of uterine cancer before undergoing these surgeries to minimize the risk of spreading cancer throughout the body via power morcellators. However, while doctors can diagnose most forms of cancer before an operation, a rare and aggressive form, called leiomyosarcoma or uterine sarcoma, may mimic the appearance of benign uterine fibroids in medical imaging and is often undetectable in preoperative testing.

Frequently, leiomyosarcoma is diagnosed post-surgery after tissues are examined by a pathologist. Unfortunately, if a power morcellator was used to extract that tissue, the hidden cancer may have been spread, becoming metastatic leiomyosarcoma, which significantly worsens the patient’s likelihood of long-term survival. The rate of five-year survival drops from 50 percent to a 4 to 16 percent.

FDA Intervention

In April 2014, the FDA issued a safety communication discouraging the use of laparoscopic power morcellators for the removal of the uterus and uterine fibroids. Based on an analysis of currently available data, it cited a risk of the spread of unsuspected cancerous tissue.

Uterine Sarcoma

The agency stated that analysis indicated that about one of every 350 women who undergo hysterectomy or myomectomy for uterine fibroids have uterine sarcoma, and there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma.

Sales Suspended

In response, Johnson & Johnson immediately suspended worldwide sales of its laparoscopic power morcellators. The FDA intends to convene a public meeting of the agency’s Obstetrics and Gynecological Medical Device Advisory Committee to discuss the possibility of further action.

Resources for Women and Families

A diagnosis of uterine cancer — especially the aggressive leiomyosarcoma — can be devastating financially, but emotional hardship is also a concern. It can be overwhelming not knowing where to turn for support. Fortunately, there is no shortage of online support. There are a number of nonprofit organizations that provide support groups and great tips as well as invaluable information about what to expect after diagnosis.

Here are a few things to keep in mind while trying to cope with uterine cancer:

  • Take charge of your own care plan. Being involved in care can be empowering and decrease feelings of hopelessness.
  • Get a second or third opinion. Having a doctor that understands you, listens and works with you to come up with a personalized treatment plan is important. If your current doctor isn't giving you what you need, look for another one. Remember, you are in charge of your own treatment and have a right to care that you feel is right for you.
  • Be willing to ask for help. Don't be afraid to reach out to family and friends for help, and it's okay to speak up when people provide help you don’t need. It's important to communicate your needs.
  • Cancer is a disease, not a punishment. Sometimes, people can take on guilt after a cancer diagnosis. They wonder what they could have done "to deserve it." The important thing is not to dwell on what you could have done in the past, but to take charge of the present and future.
  • It's okay to cry. Don't feel bad about being emotional. It is a normal coping response in times of stress. Luckily, you can share your feelings with others, in-person or online. There is support available, just reach out and don’t force yourself to face it alone.
  • Treatments have side effects. Unfortunately, no treatments are without risk. But doing nothing is just as bad for you. Make sure you weigh the risks and benefits of any treatment plan. Medications and surgeries have different pros and cons. There may also be clinical trials you can participate in that will allow access to experimental treatments. Make sure you know you are well informed about the trial before making a decision.

Financial Support for Cancer Treatment

Uterine cancer treatment can cost hundreds of thousands of dollars. What most people don’t know is that there are a few organizations that offer financial support, particularly for people suffering from sarcoma cancers like leiomyosarcoma. There are also a few things patients and their families should consider when planning treatment plans.

Paying for Clinical Trials

Many cancer patients consider participating in clinical trials. The National Cancer Center breaks down the costs into two categories: patient care costs and research costs. Patient care costs may be covered by health insurance, while research costs are usually paid by the trial's sponsor. Insurance companies are mandated by federal law to cover routine costs in clinical trials and cannot refuse to let you take part. Your doctor and a member of the research team for the trial should be able to help figure out your out of pocket costs.

Travel and Other Expenses

Other non-profits also pay a limited amount for child care, travel to doctor's offices, medication, home care and other smaller expenses related to treatment.

Prescription Assistance

Some drug companies offer prescription assistance programs. The Pharmaceutical Research and Manufacturers of America (PhRMA) keep a list of participation companies and instructions on how to request assistance on their site.

Alternatives to Open Power Morcellation

Since the FDA warned that power morcellation may spread undiagnosed uterine cancer, many patients are now looking for alternative to the risky procedure.

There are a few different types of surgery that a patient and doctor may consider:

Power Morcellation in a Bag. Surgeons insert a plastic bag into the abdominal cavity to enclose the space where surgery will take place. Surgeons then grind up the tumor with a power morcellator in the bag to reduce the risk of spreading bits of cancerous tissue.

Manual Morcellation in a Bag. This technique also uses a bag inserted through the abdomen. Surgeons cut out fibroids or tumors with a scalpel inside the bag and take the specimen out of the body in the bag through small incisions.

Vaginal Hysterectomy. In this technique, surgeons use scalpels to cut the entire uterus and remove it through the vagina, avoiding the spread of cancerous cells. If the uterus is too big to remove through the vagina, the surgeon will cut it into smaller pieces using a scalpel and remove it.

Abdominal Hysterectomy and Myomectomy. Surgeons use these techniques to remove the uterus and fibroids whole through an incision in the abdomen, minimizing the chance of cancer spread. The main disadvantage to these procedures is a longer recovery time and greater chance of infection and pain because of the larger incisions.

En Bloc Resection. In cases of cervical or other cancer in the pelvis, doctors can cut out the uterus, cervix, bladder and part of the rectum. These organs are removed whole to avoid spreading cancer. Because it is major surgery, complications may be an issue.

Lawsuits and Claims

The cancer risks associated with these medical instruments has led to lawsuits and claims filed by injured women or by surviving loved ones.

hospital

Scott Burkhart

In one high-profile lawsuit filed in a Philadelphia federal court, Scott Burkhart of Reading, PA alleges his wife had no evidence of metastatic cancer before undergoing a morcellated hysterectomy and that she was not warned of the risk of seeding an undiagnosed sarcoma via the procedure. Less than a year later, she died of metastatic leiomyosarcoma.

Dr. Amy Reed

In another high-profile case, Dr. Amy Reed, an anesthesiologist and a mother of six, developed advanced cancer after a hysterectomy involving morcellation. She said she had dissemination of pre-existing uterine cancer that was not detected in preoperative testing. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are waging a campaign to stop use of power morcellators in gynecological surgeries.

Dr. Amy Reed - developed advanced cancer after a hysterectomy involving morcellation
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  1. U.S Food and Drug Administration. (2014, April 17.) Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication. Retrieved from http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm
  2. Tissue Extraction Task Force. (2014, May 6). Morcellation During Uterine Tissue Extraction. American Association of Gynecologic Laparoscopists. Retrieved from http://www.aagl.org/wp-content/uploads/2014/05/Tissue_Extraction_TFR.pdf
  3. ACOG Fellows. (2014, May). Power Morcellation and Occult Malignancy in Gynecologic Surgery. The American College of Obstetricians and Gynecologists. Retrieved from http://www.acog.org/Resources_And_Publications/Task_Force_and_Work_Group_Reports/Power_Morcellation_and_Occult_Malignancy_in_Gynecologic_Surgery
  4. Schneider, M. (2014, April 30). Johnson & Johnson halts power morcellator sales, for now. Ob.Gyn. News. Retrieved from: http://www.obgynnews.com/single-view/johnson-johnson-halts-power-morcellator-sales-for-now/2caa672cefc24d81f83d3734a07f5bc3.html
  5. McCullough, M. (2014, March 19). Widower sues medical-device maker over hysterectomy. The Philadelphia Inquirer. Retrieved from: http://articles.philly.com/2014-03-19/news/48334892_1_uterine-cancer-hysterectomy-leiomyosarcoma
  6. Sanfilippo, J. S. (2014, July 30). http://www.obgynnews.com/home/article/hysteroscopic-morcellation-a-very-different-entity/349693e988e0b61ff0708b1c17fe93b4.html
  7. Food and Drug Administration (FDA). (2014, November 25). Immediately in effect guidance document: Product labeling for laparoscopic power morcellators. Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM424123.pdf
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