On Oct. 17, 2013, a surgical instrument called a power morcellator tore into the uterus of Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center, pulverizing what were believed to be benign fibroids.
How Medical Devices Do Harm
In 2013, a Harvard-affiliated physician, Amy Reed, needed to have her symptomatic fibroids removed. Armed with the best surgeons and standards of care Harvard could offer, she agreed to undergo a widely used surgical procedure called power morcellation—involving a device with spinning blades to pulverize the uterus for extraction—not knowing it would contribute to the dissemination of her undetected uterine cancer.
Reed and her husband, Hooman Noorchashm, knew her days were numbered, learning that she wasn’t the only woman to experience adverse outcomes. Disappointed and outraged by the recalcitrance of the gynecological establishment, they fought to save other women from the same fate.
The Cancer Letter’s award-winning series, led by reporter Matthew Ong, tracked each development, provided policy analyses and examined the root causes of harm—triggering congressional investigations and federal action—and contributed to the evolution of an entire medical field’s approach to minimally invasive surgery and surgical innovation (When Surgical Innovation Kills).
Reed died from complications related to sarcomatosis on May 24, 2017, less than four years after she underwent morcellation.
More on this award-winning series here.
The Cancer Letter asked David Challoner, emeritus vice president for health affairs at the University of Florida, to discuss the intricacies and effects of the FDA's 510(k) medical device approval process, and the parties that influence it.
Current controversy over power morcellation points to the importance of multidisciplinary education and consultation, said Monica Bertagnolli, chief of the Division of Surgical Oncology at Brigham and Women's Hospital, and professor of surgery at Harvard Medical School.
There was no formal consensus on either an outright ban on power morcellators or issuance of a “black box” warning label.
More women would die from open surgery each year if the FDA decides to ban power morcellation, said Jubilee Brown, an associate professor at MD Anderson Cancer Center and a spokesperson of the American Association of Gynecologic Laparoscopists.
Ethicon, the Johnson & Johnson subsidiary that manufactures nearly three-quarters of laparoscopic power morcellators on the market, has requested a withdrawal of the controversial devices.
A German company that makes devices now under FDA scrutiny for their potential to spread sarcoma threatened legal action against the U.S. surgeon whose wife's cancer cells were disseminated during routine surgery to remove fibroids.
Here is what we know: A surgical device used to perform about 100,000 hysterectomies and myomectomies every year in the U.S. has been shown to spread cells from undetected or missed uterine cancers—rapidly upstaging the disease.
An interview with Amy Reed, formerly an anesthesiologist at Beth Israel Deaconess Medical Center, and Hooman Noorchashm, formerly a cardiothoracic surgeon at Brigham & Women's Hospital.Debate Over Brigham's Containment Bag StudyFDA's other option is to mandate creation of a post-market surveillance study combining power morcellators with a containment system or bag, which would be used to prevent the dissemination of any tissue, benign or malignant.
As an oncologist who treats sarcoma, George Demetri has seen the adverse consequences of power morcellation, the surgical technique widely used to perform laparoscopic hysterectomies and remove putative fibroids.
The power morcellator should no longer be used for hysterectomies or fibroid removal in the vast majority of women getting these procedures, FDA declared in a highly anticipated guidance document Nov. 24.
The Brigham & Women's Hospital has halted a controversial study that combined power morcellators with “containment bags” intended to capture tissue during minimally invasive gynecological surgery.
An interview with patient activists Amy Reed and Hooman Noorchashm, first published July 4, 2014.Nearly a year and a half after a surgical tool routinely used by gynecologists disseminated her undiagnosed sarcoma, Amy Reed found herself back in the operating room—this time for removal of a second metastasis.
The Federal Bureau of Investigation is reportedly trying to establish whether Johnson & Johnson—one of the largest manufacturers of power morcellators—knew as early as nine years ago that the gynecological device can disseminate uterine cancers.
The U.S. Government Accountability Office said it would investigate the controversy stemming from wide use of power morcellators, gynecological devices now known to spread undetected cancers during hysterectomies and myomectomies.
A Boston judge ruled Nov. 3 that Brigham & Women's Hospital had violated the First Amendment rights of a couple who led an aggressive national campaign to stop power morcellation, a surgical procedure routinely used by gynecologists.
Rep. Mike Fitzpatrick accused top leaders of Brigham & Women's Hospital of retaliating against patient advocates Amy Reed and Hooman Noorchashm when a hospital administrator declared the couple a security threat and subjected them to a physical search.
The text of Rep. Mike Fitzpatrick's Nov. 5 letter to Ron Walls, executive vice president and chief operating officer at Brigham & Women's Hospital, follows:
The text of Ron Walls's Nov. 10 response to Rep. Mike Fitzpatrick's (R-Pa.) letter follows. Walls is executive vice president and chief operating officer at Brigham & Women's Hospital.
The text of Amy Reed's Nov. 13 letter to Ron Walls, executive vice president and chief operating officer at Brigham & Women's Hospital, follows. Reed is an assistant professor of anesthesia and critical care medicine at the Hospital of the University of Pennsylvania.
The text of Hooman Noorchashm's Nov. 13 letter to the editor of The Cancer Letter follows. Noorchashm is an assistant professor and cardiac surgeon at Thomas Jefferson University Hospital.
The House Committee on Energy & Commerce has stepped into a key role in the controversy over power morcellation.
FDA officials said the agency didn't receive any reports of adverse outcomes resulting from power morcellation prior to December 2013.
Johnson & Johnson officials said the company was unaware of any reportable adverse events resulting from the use of power morcellators prior to 2013.
Friends call him The Hoomanator, a darkly comical conflation of his first name, Hooman, and morcellator, the medical device he has aggressively campaigned against.
The FDA Office of Criminal Investigations is being asked to determine why the agency has failed to detect the upstaging of cancers in women who had been operated on with a power morcellator.
FDA's Class II 510(k) clearance process for medium-risk devices—a category that includes the power morcellator—is inadequate, because it does not focus on risk assessment, according to Bill Vodra, a former associate chief counsel for drugs at FDA.
Patients are being harmed because FDA doesn't commit sufficient resources to enforce federal requirements for hospitals and manufacturers to report adverse outcomes caused by medical devices, according to Larry Pilot, one of the original authors of FDA's 510(k) device clearance process.
Devices aren't tracked with the same rigor as drugs, because FDA does not have a data system that can reliably track medical devices and identify potential safety problems, according to Gregory Daniel, fellow and managing director of the Center for Health Policy at Brookings Institution.
Update: The New England Journal of Medicine's subsequent response after this article is published is appended at the end.
The New England Journal of Medicine said it stands by the story that has triggered investigations of a potential breach of patient confidentiality.
FDA granted permission to an Irish company to market the “PneumoLiner,” a first-of-its-kind containment system indicated for isolating and containing uterine tissue during a minimally invasive hysterectomy or myomectomy. The agency announced its action April 7.
FDA has conducted inspections of several hospitals—including Brigham & Women's Hospital—based on allegations that physicians and administrators did not report patient harm and deaths resulting from power morcellators.
BRIGHAM & WOMEN'S HOSPITAL chose not to contest the plaintiffs' offers of proof in two medical malpractice lawsuits against the Boston hospital at a Massachusetts tribunal May 13.
Two House measures introduced earlier this week aim to strengthen federal requirements for reporting adverse outcomes caused by medical devices and to increase access to legal recourse for patients harmed by Class III high-risk devices.
Rep. Mike Fitzpatrick (R-Pa.), a staunch advocate for mandating individual reporting of adverse events by physicians
In a 17-institution inspection sparked by reports of patient harm and death resulting from power morcellators and contaminated duodenoscopes, FDA found that nearly all hospitals surveyed either failed to report adverse events or didn't have proper reporting and documentation procedures in place.
FDA's passive reliance on self-reporting by hospitals and device manufacturers allowed harm caused by power morcellators to go unnoticed for over two decades—likely contributing to injury and deaths of hundreds of women, according to the U.S. Government Accountability Office said.
Hundreds of women were injured or have died from upstaging of unsuspected uterine cancer by power morcellation because FDA didn’t know the actual risk of cancer in fibroids, and hospitals failed to report harm, according to the U.S. Government Accountability Office.Between 1991 and 2014, FDA cleared 25 submissions for power morcellators to be marketed in the U.S. The GAO report notes that FDA had been aware of the device's potential for spreading tissue since 1991.
When Amy Reed enrolled at the University of Pennsylvania medical school in 2001, she could not have possibly imagined that she would save more lives as a patient than as a physician.
Hooman Noorchashm, the cardiac surgeon who, with his late wife, ran a campaign against power morcellation, is stepping up his family's legal complaint against Karl Storz and Brigham & Women's Hospital.
A recent proposal to delay reporting of device malfunctions to FDA will weaken the already inadequate medical device reporting system at the agency, said Rita Redberg, a professor of medicine and cardiologist at the University of California San Francisco.
About one in 225 to one in 580 women who undergo surgery for fibroids may have hidden uterine cancers, FDA concluded in a recent review of medical studies published over the past four years.
An award-winning investigative documentary film about power morcellation—a once-popular “minimally invasive” surgical procedure—is now available on major streaming platforms.
