FDA Issues Warning on Utilization of Robotically-Assisted Surgical Devices in Mastectomy

The FDA issued an updated safety communication to remind the community that the safety and effectiveness of robotically-assisted surgical devices for use in mastectomy procedures or in the prevention or treatment of patients with breast cancer have not been established.¹

Moreover, the regulatory agency noted that they are aware of allegations that certain clinical trials are utilizing these devices to perform these procedures for the prevention or treatment of cancer without their oversight, which is needed for research efforts that have such significant risk.

Robotically-assisted surgical devices have been greenlit for use in certain surgical procedures like hysterectomy, prostatectomy, and colectomy that are frequently performed in patients with cancer. The clearances of these procedures are supported by short-term follow-up of patients.

Notably, the agency has not examined the safety or efficacy of these devices for the prevention or treatment of patients with cancer based on cancer-associated outcomes like overall survival (OS), recurrence, and disease-free survival (DFS).

The agency stated that it expects study sponsors to obtain approval of investigational device exemptions (IDE) for any clinical studies examining the use of robotically-assisted surgical devices that are intended for use in mastectomy procedures as either breast cancer prevention or treatment.

“Studies with a potential for significant risk to study subjects, such as the use of [these] devices for mastectomy procedures or in the prevention or treatment of breast cancer, may only be conducted under an approved IDE,” the agency wrote in the communication. “This helps assure adequate protections of the health, safety, and welfare of study subjects.”

The FDA recommended that providers be aware that although these devices have been examined by the agency and have received clearance for use in certain surgical procedures, they have not been cleared for mastectomy or for breast cancer prevention or treatment.

The agency recommends that appropriate credentialing and training are obtained for the specific robotically-assisted surgical procedures that should be performed. Discussions should be held with patients regarding experience and training, as well as anticipated clinical outcomes with these devices. Moreover, the risks, benefits, and alternatives of all available options should also be discussed so that informed clinical decisions can be made.

“Be aware that clinical studies conducted in the United States involving a legally marketed device investigating a new intended use are subject to FDA oversight,” the FDA wrote.

The agency also shared recommendations for institutional review boards, clinical investigators, and study sponsors. Clinical trials examining robotically-assisted surgical devices for mastectomy and cancer prevention and treatment are considered to be significant-risk studies. As such, they require oversight from the agency under an approved IDE.

Studies for mastectomy and breast cancer prevention or treatment using these devices must include the monitoring of long-term clinical outcomes like cancer recurrence, DFS, and OS. These studies also include safeguards like study stopping rules and periodic reporting to the FDA.

The agency recommends the development of robotically-assisted surgical device registries so that real-world evidence could be collected.

“The FDA is working to assure device manufacturers, investigators, clinical study sponsors, and institutional review boards are aware of the FDA’s expectations for an IDE and clinical end points for use of robotically-assisted surgical devices for the prevention or treatment of patients with cancer,” the agency stated.

Reference

1. UPDATE: Caution with robotically-assisted surgical devices in mastectomy: FDA safety communication. News release. FDA. August 20, 2021. Accessed August 23, 2021. https://bit.ly/3ychpcM