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.
When Surgical Innovation Kills
How do novel surgical techniques and innovative devices enter the standard of care? Do they undergo a rigorous vetting process before they are approved and adopted?
Four years into The Cancer Letter’s investigation of the hazards of power morcellation (How Medical Devices Do Harm), reporter Matthew Ong broadened his examination to include new surgical techniques for the treatment or prevention of cancer and cancer-related surgical outcomes.
From hysterectomies to mastectomies, The Cancer Letter found blind spots in the scientific process—a dearth of epidemiological studies to assess risk and prevalence, a drive to innovate and adopt cutting-edge technologies without prospective trials that account for cancer-related surgical outcomes, and insufficient regulation of devices at FDA based on those outcomes.
The Cancer Letter’s coverage contributed to an February 2019 advisory by FDA recommending rigorous follow-up for device manufacturers looking to market surgical tools for use in the prevention or treatment of cancer. Sponsors and researchers are now required to study long-term oncologic endpoints in surgical trials “for time periods much longer than 30 days.”
More on this award-winning series here.
I think that it probably represents a failure in our health care system. It just points out an opportunity, from a quality improvement standpoint, to make sure that everybody who is going to have a hysterectomy has the appropriate assessment for the risk of cancer preoperatively.
You want to pay attention to everybody, but who are the ones that you really want to pay attention to? And I think what the study’s telling you, older women, women who are obese—you need to really pay attention to.
I think you’d have to overcome all those problems before you could say that women with fibroids ought to have a biopsy before they’re morcellated. Which, as I say, sounds like a good idea. I think the better idea is don’t morcellate the damn thing. That would solve the problem.
We hope that our study increases the awareness and discussion of occult cancer risk in the thousands of women undergoing hysterectomy and myomectomy annually. Morcellation of a specimen allows for the dissemination of cancer, having an informed conversation with patients preoperatively is essential to this process.
There are a lot of gynecologists who are not gynecologic oncologists who live in rural areas, who don’t have access to oncologists, or who just have big egos, who will operate on patients with known premalignant disease or early stage cancer—regardless of the fact that they know that it is cancer.
Robert Redfield, director of the Centers for Disease Control and Prevention, said the agency is reviewing the methods gynecologists use to identify women at risk of uterine cancers.
Despite reporting such a staggering frequency of “missed” gynecological cancer, it is concerning that the Yale authors, like most gynecologists, appear quite relaxed about this level of risk in their paper’s discussion—foremost because this level of oncological risk in women undergoing non-oncological operations is an iatrogenic mortality risk.
Gynecologic oncologists need to reduce oncologic risk, but it's not going to happen without knowing why minimally invasive radical hysterectomies decrease survival of patients with cervical cancer, said Joshua Kesterson, chief of the Division of Gynecologic Oncology at Penn State Cancer Institute.
When cervical cancer patients were referred to MD Anderson Cancer Center for a prospective, phase III trial testing for noninferiority of minimally invasive vs. open abdominal radical hysterectomy, many requested the minimally invasive approach, because their referring physicians said it was better, said Pedro Ramirez, a professor of gynecologic oncology at MD Anderson.
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.
Brian SlomovitzDirector, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Miami, Miller School of Medicine Co-leader, Gynecologic Cancers Site Disease Group, Sylvester Comprehensive Cancer CenterThe primary objective of these studies is survival or recurrence rates—we can’t overlook those objectives and those findings, even if robotic surgery can give you a shorter length of stay.
Device manufacturers looking to market surgical tools for use in the prevention or treatment of cancer may now be required to study long-term oncologic endpoints in surgical trials, according to a safety communication published by FDA on Feb. 28.
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.
The Breast Surgical Service at Memorial Sloan Kettering Cancer Center has decided not to adopt—or study—robotic surgical devices in mastectomies, said Laurie Kirstein, a breast surgical oncologist at MSK.
Robotic mastectomy deserves to be studied, because the procedure may improve cancer-related outcomes, surgeons at MD Anderson Cancer Center say.
The University of Pennsylvania was planning a short-term trial for robotic mastectomies, but after an FDA advisory, investigators decided to revise that protocol to include assessment of cancer-related outcomes, said Ari Brooks, director of endocrine and oncologic surgery, director of the Integrated Breast Center at the University of Pennsylvania Health System, and professor of clinical surgery at Penn Medicine.
Using a da Vinci robot for breast cancer surgery? Is it safe? Effective?
Our investigative story this week is an outgrowth of a correction.
As the team lead by surgeon Stephen Chagares prepared a protocol for robotically-assisted mastectomy, the Institutional Review Board at Monmouth Medical Center provided guidance “every step of the way,” said Nicholas Fotopoulos, a research coordinator and an undergraduate at Princeton University in his sophomore year.
I write, again, compelled by emerging scientific facts regarding a serious systemic error of negligence on the part of the main American gynecological societies, AAGL and ACOG, and their member practitioners—though the problem I highlight here also affects overseas gynecological counterparts, specifically the RCOG in the United Kingdom.
Stephen A. Chagares, a New Jersey general surgeon who recently set off a national debate by using a robotic surgical device to perform mastectomies, has filed a lawsuit claiming defamation and violation of federal and state antitrust laws on the part of Monmouth Medical Center.
