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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.
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 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.
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.
In addition to the risk of developing cancer, some of the common side effects associated with power morcellators include:
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.
|Devices produced by Johnson & Johnson's Ethicon division:|
|Gynecare Morcellex Tissue Morcellator||Morcellex Sigma Tissue Morcellator System||Gynecare X-Tract Tissue Morcellator|
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.
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, 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.
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.
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."
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.
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.
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.
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.
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.
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.
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:
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.
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.
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.
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.
Since the FDA warned that power morcellation may spread undiagnosed uterine cancer, many patients are now looking for alternative to the risky procedure.
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.
The cancer risks associated with these medical instruments has led to lawsuits and claims filed by injured women or by surviving loved ones.
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.
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.
Power morcellation during surgery can lead to serious side effects, including hysterectomy or cancer. If you or your loved ones were harmed by morcellators, you may have legal options. Tell us about your experience and we will provide you with a free case review.