Intuitive Statement on the FDA’s Recent Safety Communication
On February 28, 2019, the U.S. FDA released a Safety Communication and Press Statement (“FDA In Brief”) regarding the use of robotically-assisted surgical devices in women’s health, including mastectomy and other cancer-related surgeries. Since the release of the Safety Communication, we have heard from surgeons, healthcare providers, and others in the surgical community who have expressed confusion and concern about the intent and scope of the communication.
The FDA has subsequently clarified its position via updated Questions and Answers content on its webpage on computer-assisted surgery – including robotically-assisted surgery.
Like the FDA, surgeons and hospitals, Intuitive’s first focus is patient safety. With this in mind, we encourage surgeons, hospitals, and patients to consider the following with regard to FDA’s Safety Communication and the use of robotic-assisted surgical devices in cancer-related and other surgeries.
Over the past 19 years, the FDA has cleared Intuitive’s da Vinci surgical systems through the 510(k) process for many surgical indications for use and associated specific procedures that fall under several surgical specialties. These clearances include many procedures that are performed because the patient has cancer: radical prostatectomy, radical hysterectomy, lobectomy, colectomy, pancreatectomy, and others. The FDA Safety Communication does not change or modify those clearances.
The FDA has clarified on its website that robotic-assisted surgical devices “have been evaluated by the FDA and cleared for use in certain types of surgical procedures commonly performed in patients with cancer, such as hysterectomy, prostatectomy, and colectomy. These clearances are based on short-term (30 day) patient follow up.” The FDA has not evaluated robotic-assisted surgical devices for the prevention and treatment of cancer based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.
Cancer treatment often involves other therapies in addition to surgery, including chemotherapy and radiation. An individual cancer patient’s clinical pathway may vary according to many factors, including the type, stage and grade of the cancer, the patient’s other medical conditions, and decisions in treatment pathways discussed and agreed upon between the patient and his/her doctors.
The FDA Safety Communication references a recent study, the Laparoscopic Approaches to Cervical Cancer (LACC) trial, published in the New England Journal of Medicine (NEJM) that compares minimally invasive surgery (both laparoscopic and robotic approaches) to traditional open surgery for cervical cancer. The LACC trial found worse cancer outcomes for the MIS patients compared to open surgical patients, concentrated in a minority of the participating sites and for patients with tumors larger than 2 cm. The MIS cohort included a small number of robotic-assisted patients, too few to establish statistically meaningful results for this cohort. NEJM published an additional retrospective database analysis that evaluated survival after minimally invasive radical hysterectomy for early-stage cervical cancer (not referenced by the FDA in its Safety Communication). This study included enough data on patients treated with robotic-assisted surgery. Both studies reflect findings that are significantly different from previous research. Therefore, while they must be considered carefully, further study is needed to understand the root cause of the findings. We agree that institutions and surgeons should be aware of their own outcomes, and counsel cervical cancer patients with all available data.
In addition to the articles cited above, there are more than 18,000 peer-reviewed, scientific articles on the use of da Vinci surgical systems. We believe it is imperative for medical professionals to understand the scope of the full body of literature before making a recommendation about medical/disease management options.
With regard to the use of robotic-assisted surgery in mastectomy, the FDA has not reviewed nor granted clearance for the use of robotic-assisted surgical systems in such procedures. In addition, Intuitive does not market, advertise, or promote use of the da Vinci surgical system for mastectomy. We will work with the FDA and other regulatory bodies regarding this potential use of robotic-assisted surgery as needed.
Intuitive wholeheartedly supports surgeons counseling patients about all options, and the risks and benefits associated with any medical intervention. We recommend that surgeons discuss all options with their patients and the risks associated with any surgery or surgical modality, including robotic-assisted surgery; and that patients ask surgeons about their training, and their patient outcomes.