A power morcellator is a surgical instrument used in less-invasive abdominal procedures such as laparoscopic hysterectomies and fibroid removal. The FDA alerted the public that laparoscopic morcellators may be responsible for spreading and upstaging undiagnosed uterine cancer.
A power morcellator is a surgical tool that doctors use to cut bigger chunks of tissue into smaller ones, usually during laparoscopic surgery. Surgeons use them mainly during gynecological procedures such as a laparoscopic hysterectomy (removal of the uterus) and myomectomy (fibroid removal). But surgeons also use them in gallbladder surgery, spleen removal and liver surgery. The devices resemble a drill with sharp blades at the end.
The U.S. Food and Drug Administration cleared the first electric morcellator for sale in 1991. The first laparoscopic morcellator hit the market in 1995. The agency classified the device as a class II and allowed it on the market through the 510(k) process. This process allows devices on the market without extensive clinical trials.
The first of these devices to hit the market was the Cook Tissue Morcellator. After Cook, Karl Storz and Johnson & Johnson released their morcellators based on Cook’s approval. These devices also hit the market without clinical trials. Since then, the FDA approved about a dozen more devices.
Doctors perform approximately 600,000 hysterectomies a year in the U.S. Before the FDA warning, surgeons used power morcellators in about 60,000 hysterectomies and myomectomies each year.
According to the Society of Gynecologic Oncology, morcellation was developed to reduce the size of an enlarged uterus so that it could 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 with more blood loss and potential complications.
But in 2014, the FDA warned that 1 in 350 women who undergo morcellation for hysterectomy or myomectomy may have undiagnosed uterine cancer. The power morcellator may shred cancerous tissue and spread it in the abdominal cavity, worsening the cancer. This means a tumor may go from stage 1 to 4 after morcellation, which makes the cancer difficult to treat and decreases the chances of long-term survival.
In 2017, the FDA reaffirmed its 2014 guidance for laparoscopic power morcellators. The FDA did not change its recommendations for clinicians or recommend a ban based on its findings.
After the FDA initial warning, some hospitals banned the device and some insurance companies stopped covering power morcellator hysterectomy and fibroid removal. Johnson & Johnson, one of the largest makers of morcellators, pulled its devices off the market.
The term “morcellate” means to cut into smaller pieces. These power morcellators allow surgeons to make minimally invasive incisions of less than 2 centimeters in length 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.
Doctors insert the long, tube-like portion of the device into the small incisions in the abdomen, chop up the fibroid or tissue into smaller pieces and vacuum it out of the abdominal cavity.
Power morcellation may sometimes be confused with vaginal morcellation. 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.
Surgeons typically perform two morcellation techniques: laparoscopic and hysteroscopic. Each type of surgery uses a specific kind of device made by manufacturers. The FDA warning for spreading cancerous tissue does not apply to hysteroscopic power morcellators.
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.”
|Cook Urological, Inc.||Cook Tissue Morcellator|
|Ethicon, Inc.||Gynecare Morcellex, Morcellex Sigma, Gynecare X Tract|
|Ethicon of FemRx||Diva|
|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|
In addition to the risk of spreading cancer, surgery with a morcellator has other risks. Even noncancerous fibroid tissue may be spread by a morcellator. Noncancerous fibroid tissue can attach to other tissues and organs in the abdominal cavity, causing more fibroids to grow.
While power morcellators spread undiagnosed uterine cancer — including leiomyosarcoma (LMS) — they do not cause it. LMS is a type of soft tissue sarcoma that is most common in the uterus, abdomen or pelvis. But it can also develop in muscle, fat, blood vessels and tissues that line or support organs.
MRIs, CT scans and even biopsies are not 100 percent reliable in detecting these hidden cancer cells. But, endometrial cancers are easier to find than more aggressive forms like LMS. Before undergoing surgery, women should have a biopsy of the uterine lining.
For example, the American Association of Gynecologic Laparoscopists reviewed one study of 1,091 power morcellator surgeries and found 12 women had irregular tissue samples not previously diagnosed. Ten of these women had malignant cancer cells. Types of cancer found included uterine myoma, endometrial stromal sarcoma (ESS) and leiomyosarcoma (LMS). LMS is particularly dangerous and aggressive; only 40 percent of women survive for five years.
In a pivotal study by Dr. Jason D. Wright and colleagues published in the September 2014 issue of JAMA, authors stressed the importance of screening hysterectomy or myomectomy patients for any history of cancer before laparoscopic power morcellation. Women with any history of cancer should not undergo morcellation.
Anita Austin had laparoscopic power morcellation surgery to remove a uterine fibroid. Doctors told Austin that the procedure would be less invasive and she would recover faster, but they did not inform her of the cancer risk, even though she had previously had thyroid cancer. Her cells were only Stage I, but the procedure sprayed the cells all over her abdomen, effectively advancing the cancer to a higher stage.
“The big issue for me is that no one mentioned cancer,” Anita Austin told Fred Hutch News, “Not at all. And I question things. I’d had thyroid cancer [in the early ‘80s], and I would have probably done something different. Given my history, honestly, I should have been advised not to do it.”
Frequently, LMS is diagnosed post-surgery after pathologists examine tissue samples. Unfortunately, if a power morcellator was used to extract that tissue, the hidden cancer may have spread, becoming metastatic LMS. This significantly worsens the patient’s likelihood of long-term survival. The rate of five-year survival drops from 40 to 50 percent to 4 to 16 percent.
Treatment for LMS typically involves a combination of surgery, chemotherapy and radiation therapy.
Uterine cancer occurs when cells within the uterus begin to grow abnormally, multiplying rapidly to form tissue masses known as tumors. It is the fourth most common cancer among women, behind breast cancer, lung cancer and colorectal cancer.
About 95 percent of uterine cancers are cancers of the endometrium, the inner lining of the uterus. Endometrial cancer is one of the most curable cancers, with five-year survival rates of more than 80 percent. The remaining 5 percent are sarcomas, which are much more aggressive.
While the exact causes of uterine cancer are not known, a number of risk factors have been identified that can increase a woman’s chances of developing the disease. Among these are high levels of estrogen in the body, being over age 40, obesity and a family history of the disease. The risk of uterine cancer rises with age. Women over age 65 had the most risk. The FDA does not recommend power morcellation for women in this age group.
Some drugs may increase risk as well, including those used in hormone replacement therapy and some medications used in the treatment of breast cancer.
When doctors diagnose cancer after morcellation, it is typically Stage III or IV — a very advanced stage with poor prognosis. A tumor is considered Stage IV when it has spread to the lymph nodes, bladder, rectum and/or distant organs. Some patients had LMS spread to their spine or lungs.
If tumors affect other organs or bones such as the spine, symptoms could include back pain or nerve issues.
In April 2014, the FDA first warned about the risk of power morcellators spreading cancer. The FDA reviewed data that showed the risk of spreading cancer was 1 in 350 — much higher than previously suspected rates of 1 in 10,000.
“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,” the FDA said in its safety communication.
After reviewing additional studies, in December 2017 the FDA published a white paper to reaffirm its 2014 decision and added that 1 in 225 to 1 in 580 women who undergo hysterectomy or fibroid removal may have uterine sarcoma. Its instructions for health care providers did not change, and it did not recommend a ban.
The FDA also found that morcellator use declined since the 2014 warning.
Immediately following the FDA’s announcement in April 2014, Johnson & Johnson withdrew its morcellators from the market. J&J’s subsidiary, Ethicon, was one of the largest manufacturers of the devices.
Critics questioned why the FDA took 23 years to warn about the risk of spreading cancer. A February 2017 report from the Government Accountability Office (GAO) revealed that the FDA knew about the risk as early as 1991.
Poor adverse event reporting systems and lack of reporting from doctors and hospitals contributed to the FDA’s inability to warn about the risk of power morcellators sooner, the GAO found.
Since the FDA warned that power morcellation may spread undiagnosed uterine cancer, many patients are now looking for alternatives to the risky procedure.
In April 2016, the FDA allowed the marketing of the first-ever containment system for use with certain laparoscopic power morcellators, called PneumoLiner. The purpose of the PneumoLiner is to isolate uterine tissue that is not suspected to contain cancer.
“The device consists of a containment bag and a tube-like plunger to deliver [PneumoLiner] into the abdominal cavity where the tissue to be removed is placed in the bag and the bag is sealed and inflated.”
The inflation during laparoscopic surgery allows a working space and visualization to help prevent breakage of the containment bag by the morcellator. Laboratory testing was conducted to simulate its actual use and worst-case scenario conditions and outcomes. Certain risks associated with PneumoLiner include distribution of the morcellated tissue, injury to surrounding tissues or organs, infections, and a prolonged surgery. Only physicians who have successfully completed the company’s training program are authorized to use the device.
Although the FDA confirmed that the device is effective for its intended use as a tissue containment system, the agency required its manufacturer, Advanced Surgical Concepts Ltd. located in Bray, Ireland, to warn patients and health care providers that “PneumoLiner has not been proven to reduce the risk of spreading cancer during these [limited gynecological laparoscopic surgical] procedures.”
This warning comes in the form of a black box warning (or boxed warning), similar to the recommended warning for laparoscopic power morcellators. The labeling for the device must also advise that PneumoLiner is contraindicated in certain patient populations where the patient is suspected of having tissue containing cancer (malignancy), or for the removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal or are candidates for full (in one lump, whole) tissue removal.
The FDA said that it reviewed PneumoLiner through its “de novo” classification process, which allows for sales of some new, low- to moderate-risk medical devices. Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said that the new device “does not change [the FDA’s] position on the risks associated with power morcellation.”
Maisel concluded that the FDA is “continuing to warn against the use of power morcellators for the vast majority of women undergoing removal of the uterus or uterine fibroids.”
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