A recent article in The New York Times offers an inaccurate perspective on robotic-assisted surgery for hernia repair and specifically for a relatively rare and very complex approach to hernia repair (component separation) and how surgeons train for complex procedures.
Patient safety and clinical benefit are Intuitive’s guiding principles. Our mission is to develop innovative, outcomes-focused tools that can offer clinical benefits for patients and the surgeons and hospitals who choose to use them. We take this responsibility seriously. To date, there have been more than 12 million robotic-assisted procedures performed with the da Vinci surgical systems, with more than 34,000 scientific articles published that, in aggregate, support the safety and effectiveness of Intuitive products.
The evidence is clear. The main reason for the adoption of any surgical modality is the clinical benefits it provides. Robotic-assisted surgery has been broadly adopted across a vast range of procedures, and offers demonstrated clinical benefit. RAS with the da Vinci platform can provide equal or better outcomes for patients, measured in shorter recovery times, fewer complications, less blood loss, and other quality-of-life metrics compared with the same procedure done via open surgery. It is for these reasons, and not the reasons asserted by The Times, that RAS has been broadly adopted across a number of indication areas. It is now the standard of care for prostatectomy and is used extensively in gynecology, urology, thoracic, trans-oral and general surgery procedures.
Decisions on the course of treatment are made by physicians in consultation with their patients. Surgeons and hospitals make healthcare treatment decisions based on a variety of factors, with clinical benefit as the primary factor. Intuitive’s products, which have been cleared for use by regulatory bodies worldwide, are used by clinicians and hospitals because they provide clinical and economic benefit. To assert otherwise – or suggest that medical professionals’ clinical decision-making is largely based on videos, social media or marketing –does a disservice to healthcare professionals and their patients.
There is an essential distinction between technology training and the practice of medicine. Surgeons attend medical school and receive additional training in their fields through residencies, fellowships, and continued medical education. Hospitals, medical institutions, and medical boards have responsibility and discretion over surgeon credentialing and hospital privileges. Intuitive makes clear to our customers and participants that our technology training does not convey certification, credentialing, or privileging for any medical procedures. The New York Times conflates and confuses the role of medical device manufacturers, and the responsibility of surgeons and hospitals.
Intuitive provides comprehensive technology training for surgeons on the use of the da Vinci surgical system for certain procedures. Our training consists of programs focused on core technology as well as a progressive, surgeon-led series focused on clinical skill advancement. The purpose is two-fold: first, to provide technical knowledge development for the da Vinci surgical system through hands-on education with an Intuitive trainer; and second, to provide opportunities for interested surgeons to apply technical knowledge to specific clinical applications through peer-to-peer interaction, hands-on lab work, and other educational opportunities.
By regulation, Intuitive does not provide instruction on the practice of medicine. The introduction of any new technology requires careful management. As with any technology-based tool in the medical profession and elsewhere, users need appropriate training to learn how to operate the da Vinci system safely and effectively.
Complications may arise in any hernia surgery regardless of modality and may happen for a number of reasons, including patient comorbidities and medical history, and the type and location of the hernia. This is true for all surgical approaches and for all surgeons.
Robotic-assisted complex hernia repair using the component separation approach is a relatively rare and complex procedure for patients with difficult hernias—but its complication rate has been shown to be roughly half that of open surgical TAR procedures. The studies the newspaper cited were primarily focused on open surgical procedures, not robotic-assisted cases. Furthermore, peer-reviewed scientific publications demonstrate additional clinical benefits from robotic-assisted component separation include shorter length of hospital stay, less blood loss, and less discomfort for patients.
Component separation procedures comprise a small proportion of robotic-assisted hernia surgeries. From 2016-2022, more than 1.3 million robotic-assisted hernia procedures were performed using the da Vinci surgical systems, and fewer than 13,000 of those utilized a TAR approach – which represents 1 percent of all robotic hernia procedures, and just 0.15% of the 8.6 million robotic-assisted procedures performed during this period.
Intuitive has a robust, multi-stage process for selecting and vetting surgeons who lead clinical courses. Requirements for surgeon educators include a baseline of minimum case experience and volume, which varies by surgical specialty, as well as a record of significant and appropriate usage of da Vinci technology. Surgeon educators must demonstrate clinical benefit to their patients. Intuitive routinely monitors educator performance and collects feedback from course participants.
For those surgeons interested in robotic-assisted TAR, Intuitive offers surgeon-led training courses conducted by experienced surgeons, to learn how to use the da Vinci platform in this procedure. Surgeons teaching this course often require participating surgeons to have significant prior experience in open component separation cases. Over the past six years, 366 surgeons have participated in higher-level training on robotic-assisted TAR. By comparison, there are more than 66,000 robotic-assisted trained surgeons globally.
This article is missing important context and contains many mischaracterizations, both of which can deter patients from getting needed counsel or care. Readers – and patients - deserve a much deeper understanding of how surgeons earn the right to operate on patients and how robotic-assisted technologies have improved patient outcomes.