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Killer Surgical Robot - When Surgical Innovation Kills
Tue - August 13, 2019 11:40 am  |  Article Hits:1084  |  A+ | a-
Killer DaVinci Robot
Killer DaVinci Robot
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 the safety of patients even in a setting where 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:

How Medical Devices Do Harm (2014-2017)

When Surgical Innovation Kills (2018-2019)


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