FDA warns surgeons against experimental robot-aided cancer operations
The federal Food and Drug Administration finally has pushed back at surgeons and hospitals for experimenting on patients, spending $3 billion a year for surgical robots. The devices should not be used for mastectomies and other cancer-related procedures without caution, regulators warn.
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.
Hooman Noorchashm — a physician-scientist and patient advocate who faults laparoscopic surgery for spreading his late wife’s cancer — called out a New Jersey community hospital for its experimenting with robot-assisted mastectomies, arguing they were unsupported by evidence as to their safety and benefit. The procedures have been pioneered in Europe and are becoming more popular there because surgeons assert that they have cosmetic and convenience attributes.
But concerns are growing that robots and minimally invasive procedures may spread cancer — by failing to visualize and fully remove diseased tissue and by spreading cancer cells around. Research already has questioned robot-assisted surgeries for increasing patients’ risks by requiring them to stay longer on the table and under anesthesia.
Surgeons and hospitals, meantime, have gotten themselves into a spending and spin war with their local competitors, claiming, without actual evidence, that minimally invasive procedures and costly robotic devices give them a quality edge in treating patients. It is, without doubt, contributing to rising costs of hospital care.
One company dominates the market for OR robots, which cost hospitals more than $1 million to acquire and much more to maintain and use. The company limits the number of procedures that can be performed on its devices and charges hefty fees for collateral equipment needed — costs that far exceed what surgeons and hospitals might pay, for example, for a tray of tools for large-incision operations.
Patients end up footing big bills for this dubious surgical innovation, as well as suffering harms when the devices not only fail to deliver promised outcomes but cause injuries during procedures, recent media investigations have shown. The deep digs have raised further questions about the training and expertise surgeons have when using OR robots. It may be scant and any requirements for it is little regulated or overseen.
In my practice, I see the harms that patients suffer while seeking medical services, and their struggles to access and afford safe, efficient, and excellent medical care, especially when hospitals and doctors insist on making them pay unacceptable costs for sketchy, shiny new treatments with defective and dangerous products aka too many medical devices.
Medical device makers, like Big Pharma, have complained long and loud to pro-industry lawmakers and have pushed the FDA to ease up its oversight of myriad gadgets and hardware in medicine, such that this area has become, as one patient safety advocate has denounced it, a “Wild, Wild West.” The FDA, in fact, wants to speed up its handling of requests to let yet more medical devices flood the market with even fewer safety checks.
The agency has proposed a regulatory reform that critics decry as too little too late — a move to tighten up its so-called 510K process. Under that mechanism, in effect since the FDA took authority over medical devices and grandfathered thousands of them, makers may point to existing products on the market, claim theirs offer only slight variances that don’t affect their safety and performance, and, shazam, their tools or appliances may be widely sold and distributed. It’s akin, however, to Elon Musk launching satellite-carrying rockets, relying on the Wright Brothers’ planes.
In its latest crack back at surgical robots — which take up big digs in so many hospitals under 510K approvals — the FDA has suggested that it might raise the bar for medical device oversight, including requiring more rigorous, longer-term evidence of their safety and effectiveness. That would be a welcome step for what has been a lamentable lapse, most especially for the health and safety of too many women patients who have been medically mistreated with experiments by doctors and hospitals.