publication date: Apr. 27, 2016
How Medical Devices Do Harm
By Matthew Bin Han Ong
(*) Asterisk denotes supplementary coverage
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.
Reed’s “minimally invasive” hysterectomy, a routine procedure, was performed at the Brigham and Women’s Hospital, a teaching hospital of Harvard Medical School.
Alas, Reed’s uterus contained an occult sarcoma, which the morcellator proceeded to spread through her abdominal pelvic cavity. Over ensuing months, as Reed battled to stay alive, her husband, Hooman Noorchashm, a cardiothoracic surgeon and, at the time, a lecturer at Harvard, waged a national campaign to put an end to the practice of power morcellation.
Conversation with The Cancer Letter
*Challoner: We Recommended FDA Replace 510(k) Clearance
The Cancer Letter asked David Challoner, emeritus vice president for health affairs at the University of Florida, to discuss FDA’s 510(k) medical device clearance process.The process has come under scrutiny after laparoscopic power morcellation procedures were found to spread previously undetected sarcomas inside benign fibroids.Challoner chaired an Institute of Medicine committee tasked by FDA and Congress in 2009 to review the 510(k) approval process.
|*Bertagnolli: Why Brigham Stopped Making Morcellation Available Outside of a Registry Trial |
“We know that this improves patient care,” Bertagnolli said in an interview with Matthew Bin Han Ong, a reporter with The Cancer Letter.
“In a case such as this one, close communication between the oncology and general gynecology communities is a key requirement for reducing morbidity and deaths due to uterine sarcomas.”
In a heated two-day hearing, several members of an FDA advisory panel on medical devices expressed low confidence in power morcellation as a treatment for uterine fibroids, and focused on alternative methods for performing hysterectomies and fibroid removal.
There was no formal consensus on either an outright ban on power morcellators or issuance of a “black box” warning label.
Photo: Families harmed by power morcellation pose on FDA’s White Oak campus July 11, following a two-day hearing on the controversial surgical procedure
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.
“Immediately review inventory to determine if you have any Ethicon Morcellation Devices which are the subject of this market withdrawal,” the company wrote in a letter to hospitals worldwide.
“If you have provided Ethicon Morcellation Devices to any hospital within your system, you are responsible for notifying the appropriate parties immediately,” said the letter dated July 31.
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.
Setting decorum aside, Hooman Noorchashm has been haranguing FDA, Congress, and the gynecology and oncology profession into partial abandonment of the procedure. Though he hasn’t sued anyone, several law firms are looking for women harmed by the procedure who would be willing to take part in litigation.
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.
And here is what we don’t know: What will FDA do about it?
The agency is under pressure to respond to the growing outcry from patient advocates, who want a ban on the device.
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.
Using a new authority that bypasses public comment, the agency stopped short of imposing an outright ban on the device, but severely restricted its use.
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.
Reed’s leiomyosarcoma, which had been in remission after a massive surgery and post-morcellation chemotherapy, has spread to her lumbar vertebrae.
*FBI Probes Who Knew What and When in Power Morcellation Imbroglio
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. According to the Wall Street Journal, the FBI’s Newark, N.J. office interviewed three people, including Robert Lamparter, a retired pathologist who alerted Ethicon, a J&J subsidiary, about potential problems with morcellators in 2006.
*GAO to Investigate Power Morcellation Harms
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. The GAO’s Sept. 4 move comes after 12 members of Congress wrote a letter requesting an investigation.
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.
Earlier this week, Brigham provided care to Amy Reed, who needed an emergency surgery for a cancer recurrence. However, her husband, Hooman Noorchashm, had to submit to being searched and accompanied by a security guard.
Both Reed and Noorchashm are physicians. She is an anesthesiologist who was formerly employed at Beth Israel Deaconess Medical Center, and he is a cardiothoracic surgeon who had practiced at Brigham.
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.
Noorchashm had to submit to being tailed by a security guard while his wife was undergoing an urgent cancer surgery Nov. 2.
“As Dr. Reed’s and Dr. Noorchashm’s Representative in Congress, I am deeply concerned about what appears to be an effort to retaliate against their advocacy and silence their First Amendment Rights,” Fitzpatrick (R-Pa.) wrote in a letter Nov. 5 to Ron Walls, executive vice president and chief operating officer at Brigham.
With Letters From:
*Rep. Mike Fitzpatrick: Brigham Retaliated Against My Constituents
Dr. Walls, As you may be aware, my constituent Dr. Amy Reed has been courageously battling an aggressive leiomyosarcoma that was spread throughout her body by a dangerous medical device known as a laparoscopic power morcellator. This device has taken the lives of hundreds, if not thousands, of women since it was allowed on the market by the Food and Drug Administration. This tragic reality hangs over this mother of six’s head every single day.
*Ron Walls: Noorchashm’s “Campaign of Distortions”
Dear Congressman Fitzpatrick: I am in receipt of your letter dated November 5. I appreciate your interest in this matter, but want to be very clear that the security measures taken during Dr. Noorchashm’s visit were the direct result of the fear and anxiety expressed by faculty and staff on learning that Dr. Noorchashm would be returning to the hospital. Since December 2013, Dr. Noorchashm has sent thousands of emails to faculty and staff at Brigham and Women’s Hospital, many of which contained language that recipients found disturbing and threatening.
*Amy Reed: Please Stop This Craziness, Dr. Walls
Dear Dr. Walls, Hello. My name is Amy Reed. Last week I had surgery at BWH by an excellent surgeon who works at your hospital. The surgery, as I’m sure you know, went very well and we were able to return home to our family mid-week. Your hospital has some of the best doctors in their fields. Between visits to my oncologist, who we have a wonderful relationship with, specialists and sub-specialists, including surgeons, who have now operated on me twice, I can’t begin to count the number of times we have pulled up Francis Street to the front of BWH.
*Hooman Noorchashm: Nice Try, Professor Walls
Dear Editor, Thank you for forwarding Dr. Walls’ letter of Nov. 10, 2015, in response to Pennsylvania Congressman Rep. Mike Fitzpatrick, to me. I assure you that the BWH corporate leadership requires public exposure—because this leadership is ethically corrupted and protectionist in a way unbecoming of trusted physicians at one of the most powerful hospitals in our nation.
The House Committee on Energy & Commerce has stepped into a key role in the controversy over power morcellation.
At a hearing earlier this week, Rep. Tim Murphy (R-Pa.), chairman of the Subcommittee on Oversight and Investigations questioned whether Johnson & Johnson and Brigham & Women’s Hospital violated federal law by not reporting adverse outcomes resulting from power morcellation.
At the Nov. 17 hearing by the Subcommittee on Health, Murphy quizzed Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, in an apparent effort to determine whether manufacturers of power morcellators as well as hospitals that used these devices had failed to notify FDA that patients were being harmed.
FDA: Federal Law Requires Reporting of Morcellation Adverse Events, But None Were Brought to Agency’s Attention For 8 Years
FDA officials said the agency didn’t receive any reports of adverse outcomes resulting from power morcellation prior to December 2013. “Of note, prior to December, the FDA had received no MDRs specifically on cancer and upstaging/dissemination,” the agency said in response to questions from The Cancer Letter. “Since then, the agency has become aware of about two dozen that have discussed ‘cancer’ and ‘upstaging or dissemination’ as of November 2014. All of these reports pertained to procedures that took place prior to December 2013.”
|J&J Says There Were No Reportable Morcellation Events; Whistleblower Disagrees—and Produces Letters |
Johnson & Johnson officials said the company was unaware of any reportable adverse events resulting from the use of power morcellators prior to 2013.
“[J&J subsidiary] Ethicon was not aware of any reportable events related to morcellators and the possibility of upstaged cancer prior to December 2013,” a company spokesman said to The Cancer Letter. “Since that time, we have filed reports with the FDA for all reportable events that have come to our attention.”
Ethicon responded to The Cancer Letter’s questions after the Nov. 17 hearing by the Subcommittee on Health, where Rep. Tim Murphy (R-Pa.) noted that the company had received a report about the dangers of power morcellators.
Friends call him The Hoomanator, a darkly comical conflation of his first name, Hooman, and morcellator, the medical device he has aggressively campaigned against.
Enemies—who are great in number—call him much worse.
Over the past two years, Hooman Noorchashm, a cardiac surgeon at Thomas Jefferson University Hospital, has been accused of launching a “campaign of distortions,” threatened with legal action, subjected to security searches and publicly chastised.
Over a two-year investigation, The Cancer Letter tracked Noorchashm and his wife, Amy Reed, as they challenged FDA, Congress, hospitals, the gynecology profession and manufacturers of medical devices. Their struggle began with a routine hysterectomy, during which a device called a power morcellator disseminated Reed’s undetected sarcoma. Today, as Amy’s aggressive disease spreads, the couple continues to draw public attention to the blind spots in the U.S. medical device regulatory system.
| ||Two Docs Who Broke the Code|
Hooman Noorchashm sends out several scathing emails each day.
Consider the subject lines of some recent emails that went to hospital administrators, with copies to members of Congress and the press: “Your ethical lapse and negligence.” “Outrageous!” “Your corruption.” “The Fouled Ethics of Your Specialty.” “Do read with care.”
“The time for diplomacy has passed,” Noorchashm said to The Cancer Letter. “I have no time to play politics. I have a wife with advanced cancer and six young children.”
His wife, Amy Reed, is battling advanced leiomyosarcoma. Since her undetected cancer was spread via power morcellation performed at Brigham & Women’s Hospital in October 2013, Reed has been in treatment for metastatic disease.
“Every time I see her go through these different phases and I think about the implications of it, it gives me a little bit more resolve to look at the root cause of this thing and hit it as hard as I can,” Noorchashm said.
The Root Causes of Harm From Medical Devices
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. These devices, widely used to shred uterine tissue in minimally invasive gynecological surgery, are now known to upstage undetected cancers that, according to FDA, occur in one of about 350 patients undergoing hysterectomies and myomectomies. It took over two decades for the agency to realize that thousands of women may have died from metastatic uterine sarcoma upstaged by power morcellators, Rep. Mike Fitzpatrick (R-Pa.) wrote in a Dec. 18 letter to the agency.
Conversation with The Cancer Letter *
Vodra: 510(k) Process Does Not Assess Risk; Needs to Be Broken Up Into Multiple Risk Groups
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. Instead, the 510(k) process relies on “substantial equivalence” to predicate devices, thereby allowing subsequent iterations of a device to introduce risk without active FDA surveillance. “A huge variety of devices are now in Class II, and they pose extraordinarily different kinds of risk,” Vodra said. “The current test for clearance of a 510(k) is, ‘Is the proposed device substantially equivalent to another device (the predicate device or device chain) that has been marketed?’ “The answer may be yes, but that does not tell you much about risk of the proposed device or its predicates.”
*Pilot: Don’t Change 510(k), Put More Money Into Enforcing Reporting Laws
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. There is no need to revamp the 510(k) process, Pilot said. The agency should instead enforce existing laws to make device manufacturers and user facilities report adverse outcomes. “It’s a good system we have now, but FDA needs to allocate more resources to enforcement, especially for user facilities,” Pilot said. “That’s why FDA, with its authority, and this opportunity to put the emphasis on reporting to the user facility required by law, and then by specific regulation, should be going for money penalties for user facilities that do not abide by the reporting requirement.”
*Daniel: FDA Does Not Have a Reliable Surveillance System for Medical Devices
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. “Without having such a data system that can be used for active safety surveillance—i.e., safety monitoring that doesn’t rely on reporting of adverse events by providers or manufacturers—it is challenging to quickly identify potential safety issues with devices early on,” Daniel said.
Clearly, Lisa Rosenbaum wanted to trigger a heated discussion—but not of the sort she ended up with.
Rosenbaum, a national correspondent at the New England Journal of Medicine, focused on the demise of power morcellation, a once widely used gynecological procedure, which in some cases ended up disseminating undetected uterine sarcomas.
In a paper published in the March 10 issue of the journal and titled “N-of-1 Policymaking—Tragedy, Trade-offs, and the Demise of Morcellation,” Rosenbaum alleges that Amy Reed, a high-profile opponent of power morcellation, had stage IV cancer before her hysterectomy.
NEJM Editors: There Will Be No Clarification For Disputed Power Morcellation Story
The New England Journal of Medicine said it stands by the story that has triggered investigations of a potential breach of patient confidentiality.
In a paper that criticized FDA’s regulatory actions that effectively ended power morcellation in gynecology, Lisa Rosenbaum, an NEJM national correspondent, made a statement that some readers interpreted as suggesting that she had access to confidential patient information (The Cancer Letter, March 18).
Rosenbaum is a cardiologist at Brigham & Women’s Hospital, the institution where Amy Reed—a patient who brought national attention to the harm associated with the procedure—underwent her ill-fated hysterectomy.
FDA Allows Containment Bags for Power Morcellators; Paper Reports Leakage
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.
Gynecologists will soon be able to use the containment system—designed to prevent dissemination of potentially cancerous tissue—with specific models of power morcellators to conduct laparoscopic surgery in a limited population of women.
FDA Inspects Hospitals for Morcellation Harm; Congressman Draws VP Biden’s Attention to Issue
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.
In a March 29 letter to Rep. Mike Fitzpatrick (R-Pa.), the agency said it “takes these issues very seriously.”
“In recent months, we have conducted inspections of hospitals highlighted in your letter, including Brigham & Women’s Hospital, Rochester General Hospital, and the University of Rochester Medical Center,” FDA officials wrote, responding to a Dec. 18, 2015, letter from Fitzpatrick to the agency’s Office of Criminal Investigations.
Brigham Does Not Contest Plaintiffs’ Offers of Proof as Morcellation Cases Proceed
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.
Safety Bills on Morcellators, Essure Introduced in House
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.