Power Morcellators May Increase Risks for Aggressive Cancers in Women
Power Morcellators May Increase 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, the 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. 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.
Morcellator Injuries Prompt Federal Regulator Hospital Probe
After a comprehensive review of hospital reporting standards across the United States in 2016, an FDA investigation concluded that most of the 17 institutions inspected did not file timely reports of injuries and deaths associated with medical devices, according to a January 2017 The Cancer Letter report. The recent inspections followed public outcry over power morcellation and the way in which they are associated with the spread of aggressive cancers due to the devices' rotating blades. "While these events appeared to be the kind that would have fallen under our current medical device reporting requirements, we did not see corresponding adverse event reports in our adverse event (MAUDE) database," wrote Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health.
Meanwhile, the FDA did not impose any penalties against hospitals that neglected to follow reporting requirements. The agency's report was published just weeks before President Barack Obama signed the 21st Century Cures Act. The Act is a comprehensive health care reform and research funding measure that some have criticized for not including a medical device safety bill meant to speak to systemic lapses in the reporting of adverse events.
In a three-year investigative series, "How Medical Devices Do Harm," The Cancer Letter focused on hospitals and device manufacturers failure to report patient death and injury that were caused by power morcellators. Two cases in particular stood out.
The late wife of a Boston attorney underwent a morcellator procedure at the same hospital and over a year prior to the second woman, an anesthesiologist. The first woman died on December 7, 2013, from metastatic disease. The second woman, at the time an anesthesiologist at Beth Israel Deaconess Medical Center, underwent power morcellation at Harvard-affiliated Brigham & Women's Hospital on October 17, 2013. After she and her husband discovered that the morcellator contributed to the progression of her unsuspected leiomyosarcoma, they learned that they were not the first to be affected in this way. The woman learned that she may have avoided a procedure with power morcellation. The gynecologists at Brigham, who were aware of the risks, did not inform her or report the first woman's case to FDA. As the first woman was dying, the second woman was recovering from her first round of treatments.
Now, Brigham is defending itself medical malpractice lawsuits filed by the womens' husbands, one of whom is a former surgeon at Brigham and Thomas Jefferson University Hospital. Brigham opted against contesting the plaintiffs' offers of proof at a Massachusetts tribunal.
Since then, over 300 patients and their families have come forward alleging harm due to the use of morcellators. The FDA claims that it did not receive any reports of adverse events involving power morcellators prior to December 2013. During the 2016 inspection, the agency found that Brigham & Women's Hospital did not, once it became aware of patient injury or death, issue an adverse outcome report to the FDA or device manufacturers within the 10 federally mandated working days. A Brigham spokeswoman told The Wall Street Journal and The Boston Globe that the hospital contacted the FDA by telephone in March 2014 about the two women; however, officials at the hospital did not think the events required a report because the cases did not meet criteria for mandatory reporting, the spokeswoman said. "The device functioned as expected and was used in the way it was intended, although with unintended and tragic consequences," she wrote in an email, according to The Cancer Letter.
In 2016, federal regulators permitted the use of containment bags during surgery involving power morcellators to prevent spillage of morcellated tissue that may potentially contain cancerous tissue. The bags were developed by Advanced Surgical Concepts Ltd. of Bray, Ireland, and introduced on November 15, 2016 by Olympus America Inc.
Other hospitals were associated with patient harm due to power morcellators, including Rochester General Hospital and the University of Rochester Medical Center, which were found to not have written medical device reporting procedures and did not meet requirements for documentation and record-keeping requirements, he FDA report indicated. The inspection also found lapses at other hospitals including, Massachusetts General, UMass Memorial, New York Presbyterian Hospital, and UCLA Ronald Reagan Medical Center, which all "failed to provide all information concerning individual adverse event reports that is reasonably known to them, including information found in documents in possession of the user facility," according to the agency's report.
In 1990, Congress mandated hospitals (user facilities) report adverse event to add to device maker reporting. In 1997, Congress required that the FDA establish a reporting program to limit hospital reporting to a subset of representative user facilities. The FDA created a network of 300 hospitals, called MedSun (Medical Product Safety Network). With MedSun, all hospitals were mandated to continue reporting until FDA implements, via regulation, a program that limits user facility reporting to a subset of facilities, according to The Cancer Letter. "Based on the number of user facilities in the United States and the number of reports we receive, we believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals," Shuren wrote. "We want to work with all hospitals to address these issues."
This followed the House Committee on Energy on Commerce review of the FDA Office of Criminal Investigations (OCI) over "management concerns," insufficient performance measures, and morale issues. The House probe followed a Reuters report concerning how OCI managers forced FDA agents to pursue cases that involved mislabeled foreign-imported injectable drugs and not cases with greater potential to protect public health.
Concerning hospitals reviewed, FDA officials found that no "additional action with regard to these hospitals is necessary," despite being aware of the widespread noncompliance with federal reporting requirements. "For some hospitals with significant violations of the medical device reporting (MDR) regulation, FDA received a response that we determined was not adequate to address those violations, and we engaged with these facilities to facilitate an effective path to voluntary compliance," the agency indicated to The Cancer Letter. "These hospitals indicated their willingness to work with us and address the violations, and at this time, we do not believe any additional action with regard to these hospitals is necessary. Hospitals also expressed willingness to work with us on more efficient and effective ways to collect the information we need."
According to agency officials, serious injuries and deaths related to medical devices, such as power morcellators, that take place in hospitals and other device user facilities may involve complex circumstances. "For example, it may not be immediately apparent to health care providers that a patient's exposure to a device may have caused or contributed to that patient's death…. Sometimes a patient death could occur at the hospital, months or even years after a patient's treatment at the facility using the device at issue."
One of the women's husbands pointed out that, not taking action constitutes a "dereliction of duty" by the FDA. After his wife underwent her morcellation procedure in 2013, her husband implemented an determined campaign against power morcellation, The Cancer Letter reported. "If a federal agency finds a corporation in non-compliance with federal laws within their jurisdiction, especially when unsuspecting citizens have died or been severely harmed, I am not sure it is legal for the agency to not take any steps towards prosecution, at the very least," the husband told The Cancer Letter. "In the case of the power morcellator, there was clearly corporate negligence-at best professional lethargy-at work. He added that, "For FDA to just write a useless letter comes nowhere near the magnitude of pain this bad professional behavior has imposed on the many women and families affected. In the end, I think either the FDA or the Office of the Inspector General will act in accordance with their responsibility to publicly prosecute the culprit organizations-if for nothing else, to demonstrate that this type of legal non-compliance is not acceptable in the United States."
In December 2015, agency officials indicated that they were unaware of criminal prosecutions due to a failure to report adverse events, but noted that the agency plans to improve compliance through awareness and education programs. "We are seeking ways to improve this reporting system by increasing awareness of current medical device reporting requirements and challenges hospitals may face when trying to comply with those requirements," FDA officials said. "We plan to partner with hospitals to educate them on the agency's medical device reporting requirements in order to improve their reporting of device-related adverse events."
Shuren wrote that, "In order to effectively address these issues, we will work with the hospital community on what role they should play in assuring the safe use of medical devices…. This work will include how they can effectively participate in the National Evaluation System for health Technology (NEST), and whether or not current reporting requirements should remain, be modified, or eliminated in light of more effective modern tools, such as software tools to conduct active surveillance of electronic health information that contains unique device identifiers." NEST was developed as a collaboration between the agency and the Brookings Institution and is designed to tie and synthesize data from various sources involved with medical devices such as clinical registries, electronic health records, and medical billing claims.
"Although FDA has recognized that requiring all hospitals and other user facilities to report may provide limited added value and could entail unnecessary costs that take away from patient care, we have not yet established the program limiting reporting to a subset of user facilities," Shuren wrote. "In the past, we have not enforced universal reporting requirements for hospitals and other user facilities." Shuren added, "We feel certain there is a better way to work with hospitals to get the real-world information we need, and we should work with the hospital community to find that right path, especially in light of developments in the creation and evaluation of electronic health information."
In 2015, two years after the two men launched their campaign against power morcellation, their House member, representing Bucks County, Pennsylvania joined their cause, writing letters to hospitals and federal agencies. Representative Mike Fitzpatrick (Republican-Pennsylvania) served in the House for seven years. He rallied his colleagues on Capitol Hill, demanded answers, pushed for probes, and heavily lobbied for stronger reporting requirements.
Fitzpatrick and Representative Louise Slaughter (Democrat-New York) introduced two bills meant to strengthen federal requirements for adverse outcomes reporting caused by medical devices and increase access to legal recourse for patients harmed by Class III high-risk devices. One bill, the Medical Device Guardians Act, would mandate individual practitioners to report adverse outcomes, as well as statutes in place requiring hospitals and manufacturers to report. Representative Fitzpatrick told The Cancer Letter that he was working to include the bill's individual mandate in the 21st Century Cures Act. "This would codify a simple provision that's already in the Code of Ethics of the American Medical Association," Fitzpatrick said. "So it's already a responsibility of all physicians. I think it should be codified in federal law."
Sadly, Fitzpatrick's efforts to amend the Cures Act was not successful and he voted against the bill in disappointment. "It was a badly missed opportunity for some very prominent Congressional representatives and senators to provide an effective and relatively cost-neutral measure to bring some measure of security to medical device space," the husbands wrote in a joint statement to The Cancer Letter. "They missed this chance or floridly ignored it."
"There are some that definitely think the federal government shouldn't mandate reporting, and I would say, in the first instance, that if the reports were flowing into the FDA without that mandate, we would understand that," Fitzpatrick told The Cancer Letter. "In the case of the power morcellator, there were zero reports to the FDA until" the second female patient "stepped up and provided the first report as a patient. So something was wrong with the reporting. And then the second point is, if the mandate leads to safer devices, better therapies, more cures, patient safety, and something positive in the health care profession, we shouldn't just back down because it's another mandate. If it's a mandate that saves lives, it's a good mandate."
Among other things, the husbands said "We are also pressing ahead with all possible immunotherapy, adjunctive therapy and chemotherapy options to cure the leiomyosarcoma that has affected our family," according to The Cancer Letter.
FDA Issues Power Morcellator Warning, Johnson & Johnson Ceases Device Sale, Hospitals Cease Morcellator Procedures
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 health care 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 if a device is found to be similar to a previously approved device.
FDA Oversight Concerning Power Morcellators in Question
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. 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 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. According to The Boston Globe, more than two-dozen reports of morcellator devices spreading cancer have been filed with the agency since December 2013.
Morcellator Cancers Spread Beyond What Was Originally Believed
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 a 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.
Federal Regulators Update Safety Communication on the Use of Power Morcellators in Hysterectomy and Myomectomy Procedures
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 a 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.
Legal Help for Victims of Fibroid Morcellation Injuries
If you or a loved one has undergone fibroid removal or uterine surgery in which a power morcellator was used and cancer or other injuries resulted, you have valuable legal rights. Please fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529) to discuss your case with one of our experienced Fibroid Morcellation lawyers.