Two years after the FDA first issued a safety notice outlining the lack of clinical evidence to support the use of robotic-assisted surgery systems in mastectomies, the agency is doubling down.
An updated safety notice published this month takes an even firmer stance on the matter, noting that surgical robots still have yet to be proven to be a safe and effective tool to perform mastectomies and other procedures to prevent and treat breast cancer.
Even so, the FDA said that it’s aware of ongoing clinical studies that are allegedly using robotic technology to perform those procedures “without the FDA oversight required for such significant risk studies.” Those requirements include, first and foremost, submitting an investigational device exemption application for the robotic-assisted surgery system in question before the study starts.
Additionally, while the agency has cleared the use of robotics in some surgical procedures that are often performed on cancer patients—such as hysterectomies, prostatectomies and colectomies—those clearances have largely been based on the 30-day complication rate of each procedure, rather than their long-term abilities to prevent or treat cancer.
In the initial 2019 safety notice, the FDA suggested that in order to obtain clearance for surgical robots to perform mastectomies and other procedures billed as cancer prevention tools, the developers of the devices would need to submit clinical data demonstrating the robots’ positive impact on factors like “local cancer recurrence, disease-free survival or overall survival at time periods much longer than 30 days.”
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Though the agency didn’t name names, its updated safety communication came about a month after a Medscape report listed several ongoing clinical studies of robotically assisted mastectomies in the U.S.—all of which are reportedly focusing only on short-term survival and complication rates, rather than the longer-term outcomes that the FDA previously suggested would be necessary to gain clearance.
The largest of these studies is a five-center trial backed by Intuitive Surgical, which has led the surgical robotics industry with its da Vinci system for the past two decades.
In response to the FDA’s safety notice, Intuitive issued a statement of its own, confirming that “Intuitive’s ongoing U.S. clinical investigation on the safety and effectiveness of robotic-assisted surgery in prophylactic nipple-sparing mastectomy has been approved by the FDA under an investigational device exemption.”
The company also reiterated that the FDA has not yet cleared any robotic devices based on long-term, cancer-related outcomes, but stopped short of confirming whether its own ongoing study would evaluate its surgical robots based on those endpoints.
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With these clinical parameters—and the continued lack of any robotic systems cleared for use in procedures to prevent or treat breast cancer—in mind, the agency recommends that healthcare providers who choose to use surgical robots in these operations anyways speak openly with patients about the risks and lack of clinical evidence associated with the devices.
Patients are also recommended to question surgeons about their training and experience with robotic-assisted surgery systems and discuss other treatment options. Any individuals who have experienced complications after being treated for breast or any other cancers with robotics are encouraged to file a report with the FDA’s MedWatch adverse event database.