Risks for Aggressive Cancers in Women. The U.S. Food and Drug Administration (FDA) recently issued a warning concerning power morcellators, a medical device used during fibroid removal surgery that has been tied to the spread of malignant cells to other areas of the body.
Parker Waichman is accepting cases and is investigating the filing of lawsuits against the makers of these devices.
Power morcellators are often used to excise fibroid or uterine tissue into pieces and are used in laparoscopic or robotic hysterectomies, as well as fibroid removal surgeries. Those pieces of bodily tissue are then removed through incisions that are made in the abdomen.
At issue is that, according to the FDA, about one in every 350 women who are diagnosed with fibroids may also have an unknown, undiagnosed uterine sarcoma (cancer), such as leiomyosarcoma. When that cancerous tissue is sliced and moved through the body for removal, cancer may spread and the patient’s long-term survival rate may be minimized.
Each year, about 500,000 hysterectomies are performed. Of these, approximately 11 percent involve the use of a power morcellator by way of laparoscopic surgery, according to federal regulators.
According to the FDA, uterine fibroids (leiomyomas) are typically benign (non-cancerous) growths that develop from the uterine lining’s smooth muscle tissue; the National Institutes of Health (NIH) indicates that most women will develop uterine fibroids at some point in their lives.
Uterine fibroids typically present no symptoms, according to the FDA
Uterine fibroids typically present no symptoms, according to the FDA. Also, according to the NIH, the majority of uterine fibroids do not lead to very serious health issues; however, Some leiomyomas do lead to symptoms that include heavy or prolonged menstrual bleeding, pelvic pressure or pain, and/or frequent urination.
In these cases, medical or surgical intervention may be required, including traditional surgical hysterectomy, performed vaginally or abdominally and myomectomy, laparoscopic hysterectomy, and myomectomy without morcellation.
In April 2014, the FDA issued a physician caution concerning morcellators and urged that these medical devices not be used during laparoscopic surgeries that involve uterine fibroid removal. The FDA warned that use of this popular surgical technique may unexpectedly spread cancerous tissue into patients’ abdomens.
The FDA warning directed surgeons to consider other treatment methods in women diagnosed with symptomatic fibroids who must undergo laparoscopic myomectomy (fibroid removal) or hysterectomy (uterus removal).
Following the FDA announcement, Johnson & Johnson announced it was stopping the sale of its power morcellators; however, a recall was not implemented and the devices have not been removed from the market. The Johnson & Johnson power morcellator devices are:
- Gynecare Morcellex
- Morcellex Sigma
- Gynecare X-Tract
Also in response to the FDA announcement two hospitals—The Cleveland Clinic and Brigham and Women’s—announced that they were suspending the use of morcellator procedures in their facilities. Additional, similar announcements are expected.
In addition to Johnson and Johnson, a number of power morcellators remain on the market, including:
- Ethicon Gynecare: X-Tract System, Morcellex Tissue, Morcellator Morcellex Sigma
- FemRx: Diva Morcellator
- Hologic: MyoSure
- Interlace Medical: Hysteroscopic Morcellator
- Karl Storz GmBH: Rotocut G1, G2, Steiner, and Sawalhell Supercut Morcellator
- LiNA Medical: Xcise Cordless Laparoscopic Morcellator
- Lumenis Incorporated: VersaCut Morcellator
- Nouvag: Morcellator TCM3000BL
- Morce-Power:2306 Electronic Morcellator
- Olympus Corp.: Gyrus PKS PlasmaSORD
- Richard Wolf GmbH: Morce – Power 2306
- Smith & Nephew: Trueclear Hysteroscopic Morcellator
- Blue Endo: MOREsolution Tissue Morcellator
Power Morcellators Cleared Without Clinical Testing Through the FDA’s 510(k) Route
“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” said William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.
“There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their healthcare professionals,” Maisel added.
Maisel noted that surgeons should also bear in mind the way in which power morcellators received approval in 1995, under the FDA 510(k) route in which clinical and human trials are not conducted in a device is found to be similar to a previously approved device.
Medical studies and literature have long highlighted the increased cancer risks associated with morcellators since the devices were approved and the FDA’s database on medical device problems—Manufacturer and User Facility Device Experience (MAUDE)—contains thousands of reports concerning the power morcellator going back as far as the 1990s.
Yet, it took until December 2013 for those reports to be associated with increased risks for uterine cancer. The older reports discussed malfunctions and occasional injuries, according to a report issued by The Wall Street Journal.
The agency only began to look more closely into morcellator cancer risks after a Boston, Massachusetts’s patient’s case was made public through The Wall Street Journal. The patient, a woman who was 52 at the time of her death in September 2009, died of cancer following a morcellation procedure.
Now, the FDA is preparing to hold hearings in Maryland on the device’s future
Now, the FDA is preparing to hold hearings in Maryland on the device’s future. Critics argue that the power morcellator reveals significant weaknesses in the FDA’s medical device post-approval surveillance activities.
Following a review of medical records and physician interviews, The Wall Street Journal identified at least 2-dozen cases prior to December in which morcellators likely worsened a woman’s cancer. Medical journals and researchers also identified a number of cases since the devices were approved.
MAUDE is meant to be reviewed to analyze problems; however, although hospitals and device makers are mandated by the FDA to report such cases that tie devices to serious injuries and deaths, physicians—while encouraged—are not required to report issues.
In fact, according to The Wall Street Journal, the agency indicated it has long known that morcellators may spread uterine cancer, but it was the new attention to the matter in December 2013 that led to revised analysis, which revealed the greater-than-expected risk.
The FDA indicated that it was unclear as to why it did not receive reports tying the devices to cancer prior but did note that physicians would have to have made a connection between advanced cancer cases and a prior morcellator procedure.
In some cases, the association was made, but not reported. For example, Brigham and Women’s Hospital in Boston confirmed two cases, including the case highlighted by The Wall Street Journal; however, while the hospital indicated that it routinely files device reports, its risk managers did not see this as a reportable case, according to a Brigham and Women’s spokeswoman.
Regulatory experts say the hospital should have reported the cases and note that lax enforcement provides a minimal incentive to hospitals and physicians.
More than 20 morcellator-cancer reports have been received by MAUDE since December 2012 by patients, physicians, and, even Johnson & Johnson. The J&J reports were prompted by lawsuits and news stories, according to a company spokesman.
J&J is the largest morcellator maker
J&J is the largest morcellator maker. According to The Boston Globe, more than two-dozen reports of morcellator devices spreading cancer have been filed with the agency since December 2013.
New research has found that the cancers seen following uterine surgeries in which power morcellators are used may spread more cancer types that initially believed, according to a report by The Wall Street Journal. The study appears in the Journal of the American Medical Association.
In early July 2014, the FDA held a two-day hearing on the issue and will be releasing its decision before year-end 2014 regarding restriction, or a ban, of morcellator use. Physicians not involved in the study agreed that the findings clarify that the device places some female patients at risk.
“This just confirms it,” said David Mutch, chief of gynecologic oncology at Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis, reported The Wall Street Journal.
The authors of the new study utilized a database containing insurance information and found more than 36,000 women were treated with a power morcellator at 500 U.S. hospitals over seven years. As with the FDA report, this research discovered hidden cancer risks with use of the devices and also found that use of power morcellators presents increased risks for spreading cancers other than uterine sarcomas.
The study included every case involving women diagnosed with uterine cancer following a morcellation procedure and included endometrial cancers. The study’s key author, Jason D. Wright, is also director of gynecologic oncology at the Columbia University College of Physicians and Surgeons, wrote The Wall Street Journal.
Sarcomas can be mistaken as benign fibroids and present diagnosing and treatment challenges. Physicians may test prior to surgery for endometrial cancer, which originates in the uterine lining; however, endometrial cancer is not always detectable, especially when there are minimal symptoms, said Dr. Wright.
“I think this provides important information showing that there is certainly a risk of cancer, not only sarcomas, but endometrial cancer at the time of morcellation,” Dr. Wright told The Wall Street Journal, adding that other types of gynecologic cancer and precancerous tissue were found to have been missed prior to morcellator procedures.
Johnson & Johnson Recalls its Power Morcellators
Johnson & Johnson’s Ethicon Unit issued a recall of is power morcellator devices in late July 2014 following the FDA warning and citing increasing concerns regarding risks of the devices spreading occult cancers.
A statement issued by a Johnson & Johnson Ethicon spokesperson indicated that “Due to this continued uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk,” according to Reuters.
Power morcellators used during laparoscopic (minimally invasive) hysterectomy (uterine removal) and myomectomy (uterine fibroid removal) procedures may lead to the spread of hidden cancerous tumors, including to areas of the body outside of the uterus, such as the pelvis and abdomen, the FDA warned in an updated Safety Communication issued on November 24, 2014.
The agency believes that “the risk is higher than previously understood” for the spread of hidden cancers during procedures in which power morcellators are used.
The agency also advises that laparoscopic power morcellators should not be used in most women who are undergoing hysterectomy or myomectomy for uterine fibroids and that “health care providers and patients should carefully consider available alternative treatment options for the removal of symptomatic uterine fibroids.”
FDA review of current data indicates a much greater risk than previously believed. According to the agency, no reliable method exists to predict or test if a woman with fibroids may have a uterine sarcoma.
The agency recommended new boxed warnings and issued two new contraindications against the use of this surgery in most female populations.
According to November 25, 2014, The New York Times report, the devices are used during uterine surgery in approximately 50,000 women annually in the United States. When these sarcomas are pulverized and the tissue spread through the body, the disease may rapidly advance, becoming deadly.
Meanwhile, the new recommendations do not cover an emerging technique in which the procedure is conducted by enclosing the tissue to be morcellated within a bag during the surgery for the purpose of capturing cancer cells.
According to Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, while the approach “makes sense,” it is not a guarantee; the bags limit what physicians are able to see, and not all surgeons understand how to use the bags.