- Although the safety and effectiveness of robotically assisted procedures to prevent or treat breast cancer have not been established, FDA is aware of allegations that unapproved clinical studies are underway using robotic devices to perform mastectomy procedures, the regulator said in a safety communication Friday.
- Studies of robotic devices intended for use in mastectomy procedures must be conducted under FDA oversight, after an approved investigational device exemption has been obtained, to help assure that patients are protected, the agency stressed.
- FDA did not name any robotic surgical system manufacturer in its communication. Industry leader Intuitive Surgical does not market or promote use of its da Vinci robot for mastectomy. However, the company is studying its da Vinci Xi surgical system in prophylactic nipple-sparing mastectomy procedures. An Intuitive spokesperson confirmed in an emailed statement that the company’s clinical trial has been approved by the FDA under an IDE.
FDA's safety communication updates its February 2019 warning that sought to make clear the agency has not granted marketing authorization to any robotic system specifically for the prevention or treatment of cancer, including mastectomy procedures.
The agency is again sounding an alarm to patients and healthcare providers that there is little evidence to back the safety and effectiveness of robot-assisted procedures to perform mastectomy, the surgical removal of one or both breasts, for cancer prevention or treatment.
Robotic devices have been cleared for use in some procedures performed in patients with cancer, such as hysterectomy, prostatectomy and colectomy, based on 30-day patient follow-up. However, FDA has not evaluated robotic surgery for preventing or treating cancer based on long-term clinical outcomes including overall survival, recurrence and disease-free survival, the agency reiterated in its safety communication.
When FDA issued its 2019 alert, the agency said it had become aware that some healthcare providers were using robotic devices for cancer prevention and treatment in patients.
Intuitive followed that release with a statement pointing out that FDA has cleared its da Vinci systems through the 510(k) process for many surgical indications, including procedures that are performed because the patient has cancer. Among those surgeries are radical prostatectomy, radical hysterectomy, lobectomy, colectomy, pancreas removal and others. The company said FDA's safety communication does not change those clearances.
Noting that the surgical approach to mastectomy using robots is different from conventional surgical approaches, FDA emphasized in its latest communication that the impact of those differences has not been determined. In addition to long-term patient follow-up to monitor outcomes, clinical studies for mastectomy must include safeguards such as rules for when to stop the study as well as periodic reporting to the FDA, the agency said.
FDA has cleared robot-assisted surgical devices for use by trained physicians in an operating room for laparoscopic surgical procedures in general surgery, cardiac, colorectal, gynecologic, head and neck, thoracic and urologic surgical procedures. Some common procedures performed with robotic surgery are gall bladder removal, hysterectomy and prostatectomy.
FDA said it is continuing to monitor adverse event reports to understand the benefits and risks of robotic surgery for specific indications, and it recommends robotic surgery device registries to collect real-world evidence. The agency said academic and research institutions, professional societies, robotic surgical device experts and manufacturers should establish patient registries to gather data on robotic surgery systems for all uses, including the prevention and treatment of cancer.
FDA's safety communication comes as new competitors prepare to challenge Intuitive's dominance in robotic surgery. Medtronic recently gained FDA clearance for a clinical trial to study for use of its Hugo system in urologic procedures.
This story was updated to include a statement from Intuitive Surgical.