publication date: Aug. 9, 2019

When Surgical Innovation Kills

This story is part of our 2019 Summer Reading Series. You can read the whole series here.

 

Over the past six years, The Cancer Letter has been investigating the hidden hazards in minimally invasive surgery, finding that in some cases, machines and surgical techniques that inadvertently spread cancer cells go into routine use without anyone bothering to ask life and death questions.

Reporter Matthew Ong’s coverage has saved lives, resulted in action by several federal agencies, and contributed to changes in FDA regulation.  His investigative work has altered the way in which surgical devices—including power morcellators and robotically-assisted surgical devices—are used, and potentially, approved.

The Cancer Letter’s investigation first focused on power morcellation, a surgical procedure routinely used to break up uterine tissue into fragments. This procedure was adopted before gynecologists appreciated a risk that might have been obvious: that devices that work along the same principles as food processors would spew out tissues that are, in fact, undiagnosed cancers, letting malignant cells fly through the patients’ bodies. This procedure was popular, yes, but it has also been proven to be deadly.

While power morcellators have largely been abandoned in part as a result of our coverage, minimally invasive surgeons are now turning to other ways to mince up tissues that should be taken out intact. The basic principles of cancer surgery taught in medical schools hold, in part, that tumors and other at-risk masses should be presumed malignant.

In some cases, gynecologists have been reported to use manual methods for pushing tissue closer to the body surface and cutting uteri into strips, thus breaking up undiagnosed cancers and unwittingly causing stage IV disease.

Gynecologic oncologists—physicians who specialize in treating uterine cancers—are learning that their routine minimally invasive surgical techniques for treating cervical cancers are shortening the lives of many women, causing great suffering.

Now, other surgical specialists are adopting minimally invasive devices—notably, the da Vinci Surgical System, a robot with multiple arms—and using them to operate on breast cancer, without data on whether the procedure or technique would be safe for cancer patients and patients who are at high risk of having an undetected cancer.

In medicine, the standard approach to innovation is to ensure that novel treatments and procedures are at least as good as conventional approaches—before offering them to patients. Building on years of investigative work, Ong demonstrates in 2018 and 2019 that minimally invasive surgeons are prone to doing the exact opposite: entire specialties have been adopting new, potentially harmful procedures as the standard of care before ascertaining safety and noninferiority in prospective clinical trials.

As it appears, many minimally invasive surgeons practice in a culture that prioritizes innovation over safety of patients even in a setting where a cancer has been diagnosed—bolstered by a multibillion-dollar industry that produces surgical devices that aren’t rigorously tested and regulated.

On Feb. 28, 2019, FDA issued a safety advisory aimed at tightening regulation of robotic devices in minimally invasive surgery. Now, device manufacturers looking to market surgical tools for use in the prevention or treatment of cancer may be required to study long-term oncologic endpoints in prospective surgical trials—to establish noninferiority of robotic procedures and demonstrate cancer-related safety and effectiveness.

In 2018 and 2019, Ong showed how five years of unpleasant surprises—and painstaking reporting in The Cancer Letter—changed how gynecologists, oncologists, and surgeons think about the role of cancer in minimally invasive surgery, proving that cancer-related outcomes should no longer be treated as an afterthought.

Ong’s series, which have won 10 awards from seven organizations, are posted here:

 

Notable stories:


Harvard physician, whose cancer was spread through morcellation, seeks to revamp FDA regulation of medical devices

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.

Read more


Urgent FDA action turns power morcellators into rarely used gynecological procedure

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.

Read more


How Medical Devices Do Harm

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.

Read more


FDA finds lapses in reporting of patient harm, deaths resulting from medical devices in hospitals nationwide

After a broad survey of reporting standards at hospitals across the U.S., an FDA investigation recently concluded that the vast majority of the 17 institutions inspected did not file timely reports of injuries and deaths caused by medical devices.

The inspections earlier this year were triggered by public scrutiny of power morcellation, a surgical procedure known to spread undetected uterine cancer via the device’s spinning blades, as well as by reports of infections associated with contaminated duodenoscopes, flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine.

Read more


GAO: Power morcellation is a unique case study in patient harm

Hundreds died over two decades as reporting requirements were ignored.

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.

Read more


Amy Reed, physician and patient who ‘moved mountains’ to end widespread use of power morcellation, dies at 44

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.

The final phase of her medical education began on Oct. 17, 2013, when Reed, then 41, checked in at Brigham & Women’s Hospital—her husband’s workplace at that time—to undergo a common gynecological procedure that would fundamentally redefine her career, and, ultimately, consume her life.

Read more


Gynecology’s deadly surprise: Cancers are frequently missed prior to routine procedures

As they reach for surgical tools, gynecologists vastly underestimate the probability that their patients have undiagnosed uterine cancers, a study by Yale University researchers found.

Read more


Minimally invasive surgery lowers survival in cervical cancer, new studies show

Women who were subjected to minimally invasive surgery for early-stage cervical cancer were four times more likely to die from that disease within three years, three times more likely to have a recurrence within three years, and had shorter overall survival, compared to women who underwent open surgery, according to two groundbreaking studies published in The New England Journal of Medicine Oct. 31.

Read more


Using a robot to perform mastectomies, a New Jersey surgeon sets off a firestorm over surgical outcomes

How much rigor should be required when surgeons innovate? FDA’s advisory asks for long-term cancer-related data.

Last August, Stephen A. Chagares, a breast surgeon, made an announcement that startled some of his colleagues at New Jersey’s Monmouth Medical Center.

At internal meetings and in a press release, Chagares declared that he would perform a robotic mastectomy—a new and relatively untested minimally invasive surgical procedure. According to the press release, his first patient, Yvonne Zucco, 56, was being treated for stage IIa breast cancer.

Read more

 

This story is part of our 2019 Summer Reading Series. You can read the whole series here.

Copyright (c) 2018 The Cancer Letter Inc.