FDA Advises Caution With Use of Robotically-Assisted Surgical Devices for Mastectomy


The FDA issues a warning regarding the use of robotically-assisted surgical devices for mastectomy procedures related to breast cancer.

The FDA asserted that the safety and efficacy of robotically-assisted surgical (RAS) devices for mastectomy procedures as prevention or treatment of breast cancer have not be thoroughly established, according to a press release from the organization.

Notably, ongoing clinical studies that are examining the use of RAS devices in this capacity do not have the necessary FDA oversight that is needed for a significant risk study. RAS devices have been cleared for use in a number of surgical procedures based on short-term follow-up data. Notably, the safety and efficacy of the devices in the treatment of cancer and cancer-related outcomes such as overall survival (OS), recurrence, and disease-free survival (DFS) have not been properly evaluated by the organization.

“The FDA continues to expect study sponsors to obtain FDA approval of investigational device exemptions (IDE) for studies of RAS devices intended for use in mastectomy procedures for the prevention or treatment of breast cancer,” according to a statement from the agency in a press release. “Studies with a potential for significant risk to study subjects, such as the use of RAS devices for mastectomy procedures or in the prevention or treatment of breast cancer, may only be conducted under an approved IDE. This helps assure adequate protections of the health, safety, and welfare of study subjects.”

As such, the FDA listed several recommendations for stakeholders in the field:

Health care Providers

The FDA warns that although RAS devices have been evaluated in a number of surgical procedures and cleared for use based on those results, the same cannot be said for mastectomy for the prevention or treatment of breast cancer. The organization recommends providers seek appropriate credentials and training for performing procedures utilizing RAS devices. It is also important to properly communicate with patients about experiences, training, and clinical outcomes with RAS devices, as well as the risks, benefits, and alternative therapy options to ensure an informed decision. Should a patient experience adverse effects or complications associated with a RAS device, it is important to file a report through the FDA’s safety reporting program, MedWatch.

Clinical Trials

Those who are part of institutional review boards, clinical investigators, and study sponsors should be aware that clinical trials examining the use of RAS devices for mastectomies for the prevention/treatment of breast cancer should monitor long-term clinical outcomes, such as OS, DFS, and disease recurrence. Additionally, clinical trials examining RAS devices should have safeguards such as stopping rules and periodic reporting to the FDA. Other recommendations include awareness that RAS devices require an IDE when being examined in the prevention/treatment of other cancers. RAS device registries should also be developed in order to collect real-world evidence, according to the FDA.


UPDATE: Caution with robotically-assisted surgical devices in mastectomy: FDA safety communication. News release. FDA. August 20, 2021. Accessed August 24, 2021. https://bit.ly/3kjORcH

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