The FDA is warning patients and health care providers that some clinical studies using robotically-assisted surgical devices for mastectomies may not have the proper regulatory supervision.
The FDA said it is “aware of allegations that clinical studies are being conducted using RAS devices to perform mastectomies for the prevention or treatment of cancer without the FDA oversight required for such significant risk studies.”
The agency has cleared robotically-assisted surgical devices for use in hysterectomies, prostatectomies and colectomy based on 30-day follow-ups with patients, but cautioned that it “has not evaluated the safety or effectiveness of RAS devices for the prevention or treatment of cancer, based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.”
The FDA did not name specific device manufacturers, but its Aug. 20 safety communication came about a month after the publication of a MedScape report highlighting safety concerns and questioning whether clinical trials are adequately collecting data to determine long-term safety and efficacy.
The trials under question include a five-center study sponsored by da Vinci robot maker Intuitive Surgical (NASDAQ: ISRG). Sunnyvale, Calif.–based Intuitive has an Investigational Device Exemption from the FDA for U.S. clinical investigation into the safety and effectiveness of robotic-assisted surgery in prophylactic nipple-sparing mastectomy.
“Intuitive believes any treatment or medical intervention should be informed by discussions between surgeons, clinicians and patients that consider all options, the associated risks and benefits, the surgeon’s or clinician’s own training, experience and outcomes,” the company said in response to the FDA safety communication.
An FDA spokesperson did not have more information to share about the safety notice, such as specific allegations, device makers, trials or other events that spurred the agency to issue the safety notice.
Medtronic’s Hugo soft tissue robotic-assisted surgery system is not used for breast cancer/mastectomies, said a spokesperson for the company.