The U.S. Food and Drug Administration (FDA) issued a safety communication to remind patients and healthcare providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. The communication was released on August 20, 2021.
In addition, the FDA 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 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. 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.
The FDA continues to monitor adverse events reported to the FDA to inform its understanding of the benefits and risks of RAS devices when used for specific indications.
This safety communication provides:
- Recommendations for patients and caregivers.
- Recommendations for health care providers.
- Recommendations for institutional review boards, clinical investigators, and study sponsors.
- Background on the issue and the FDA’s actions to address the issue.
- Instructions for reporting problems with RAS devices to the FDA.UPDATE: Caution with Robotically-Assisted Surgical Devices in Mastectomy: FDA Safety Communication
In addition, the FDA 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.
RAS devices have been cleared for use in certain types of surgical procedures commonly performed in patients with cancer, such as hysterectomy, prostatectomy, and colectomy. These clearances are based on short-term (30 day) patient follow up. The FDA 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 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. 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.
In addition to long-term patient follow up, clinical studies for mastectomy and the prevention and treatment of breast cancer include safeguards such as study stopping rules and periodic reporting to the FDA. For further information, see Investigational Device Exemption (IDE).
Be aware that studies of RAS devices intended for the prevention and treatment of other cancers also require an IDE. The FDA recommends the development of RAS surgery device registries for the collection of real-world evidence. Please contact the FDA for information on whether your RAS device registry requires Investigational Device Exemption through the pre-submission (Q-Sub) program.
Concerns about Safety and Effectiveness of RAS Devices in Cancer Prevention or Treatment
While robotically-assisted surgery is an important treatment option that is safe and effective when used appropriately and with proper training, the FDA has not granted marketing authorization for any RAS device system for use in the United States specifically for the prevention or treatment of cancer.
There is little evidence on the safety and effectiveness of the use of RAS devices in patients undergoing mastectomy for the prevention or treatment of breast cancer, and the FDA has not granted any RAS system marketing authorization for mastectomy. For patients undergoing mastectomy, the surgical approach used with RAS devices differs from conventional surgical approaches. The impact of these differences on prevention of cancer, overall survival, recurrence, and disease-free survival have not been established.
