A million bucks of surgical machinery? It’s not proven better — at least for patients

bugatti-300x118If big hospitals really want to keep surgeons happy and provide them with greater comfort during procedures, why not build giant, sanitary glass garages next to operating rooms and let docs park their Bentleys, Lamborghinis, and Bugattis there for ogling and maybe even to take a break under the vehicles’ hoods?

Okay, maybe we’re being a bit too snarky.  Yet that hyperbolic scenario just might be cheaper and more medically justifiable than the sustained embrace by specialists and profit-seeking institutions of fancy robotic surgical devices costing more than $1 million annually — and for which patients, ultimately, pay. Here’s what the New York Times reported of yet another published meta-analysis of dozens of studies on the devices and their outcomes found:

“Surgical procedures performed with the aid of a robot is sometimes marketed as the ‘best’ form of surgery. But a recent review of 50 randomized controlled trials, testing robot-assisted surgeries against conventional methods for abdominal or pelvic procedures, suggests that while there may be some benefits to robotic surgery, any advantages over other approaches are modest … Some surgeons believe that these robots allow more precision during the operation, shorter recovery time, and generally better clinical outcomes for patients. But the review found that in many ways, compared outcomes from the robotic and conventional procedures showed little difference.

“For example, in 39 studies that reported the incidence of complications requiring further surgical interventions, up to 9% of conventional laparoscopies led to such problems, but so did as much as 8% of robotic operations. In studies of gastrointestinal surgery, life-threatening complications ranged from 0 to 2% for robot-assisted surgery, from 0 to 3% for laparoscopy and from 1 to 4% for open surgeries.”

For advocates of the devices, there’s still more research refuting their enthusiasms, the newspaper reported:

“Long-term outcomes of at least two years were reported in eight of the reviewed studies, and they found that mortality rates were similar in all three techniques. In up to 3% of robotic surgeries and 5% of open surgeries, the patient died. There were no deaths in laparoscopic procedures. The researchers did find some time differences between the procedures, however. In short, robot-assisted surgeries generally take longer. In studies of gynecological robotic surgeries, duration ranged as high as 265 minutes, compared with maximums of 226 minutes for laparoscopy and 187 for open procedures. In both urologic and colorectal operations, robot-assisted surgeries were consistently longer than comparable laparoscopic and open operations.”

The money quote in the newspaper report came from the lead author of this latest study on robot-assisted surgeries, Dr. Naila H. Dhanani, a surgical resident at UT Health in Houston, who told the reporter that “for a patient, there is no reason to choose robotic surgery over other modes:”

“Just because something’s new and fancy doesn’t mean it’s the better technique. Yes, robotic is safe, we’ve proven that. But we haven’t proven it’s better. There were four studies that showed a benefit with robotic surgery, so that’s quite modest. Forty-six showed no difference at all.”

Surgeons argued for the devices, telling the newspaper that robot assistance provides greater comfort to them during long procedures and may extend their careers due to their ergonomic advantages.

That may not be assuring to patients, who other sources have reported, foot the bills for longer procedures involving a pricey piece of gear — and without seeing markedly better outcomes. Critics also have drawn a starker picture of the risks posed by surgical robots, arguing they harm patients, particularly because doctors can jump on them and begin operating on people with such thin training.

The federal Food and Drug Administration has warned surgeons anew that robots should not be used — including in clinical trials — in mastectomies and breast cancer procedures, the Medscape Medical News site reported. This sharp reminder was issued, the site said, after it reported that several academic medical centers planned to launch clinical studies of robotically assisted nipple-sparing mastectomy.

The FDA in 2019 acted with surprising vigor to bar robot- and device-assisted gynecologic procedures. The FDA acted after studies have shown that minimally invasive procedures for early-stage cervical cancer, many robot-aided, were more likely than standard, large-incision surgeries to result in recurrences of the disease and deaths.

Regulators also may have been prodded by their poor history in halting harms to women with so-called keyhole procedures, particularly the nightmares the FDA was slow to react to involving minimally invasive hysterectomies and a tissue-grinding tool called a morcellator.

What exactly did respected institutions think had changed to allow them to flout the FDA directive and what will be the agency’s response, besides sharp words? If a motorist, including a surgeon, raced a Bugatti at 60 mph through a school zone, would law enforcement issue a mere warning or do something with more bite?

In my practice, I see not only the harm that patients suffer while seeking medical services, but also the damage that can be inflicted on them and their loved ones by defective and dangerous devices, notably those of the medical kind.

As treatments, prescription drugs, and medical devices become more complex, uncertain, and costly, patients — and doctors and hospitals, too — find themselves relying on the supposed expertise, experience, and judgment of FDA regulators. Taxpayers will fork over huge sums this year to fund the sprawling agency and its $6.5 billion budget. The bottom-line expectation is that FDA bureaucrats work for us, the people, and not to coddle, encourage, or further enrich wealthy corporations that make medical devices or prescription drugs or surgeons and hospitals that reap huge profits from them.

Doctors and hospitals should be allowed a fair return for excellent care when offered. But if specialists want comfort and pricey machinery, the general surgeon’s average salary of $364,000, plus $41,000 annual incentive bonus, could cover the cost of some pretty nice roadsters. The rest of us have much work to do to ensure that medical costs get more affordable and that we only pay for reasonable expenses that have real benefits to our health outcomes.

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