The U.S. Food and Drug Administration (FDA) is reminding patients and health-care providers that the safety and effectiveness of robotically assisted surgical devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. In addition, the FDA is aware of allegations that clinical studies are being conducted using robotically assisted surgical devices to perform mastectomies for the prevention or treatment of cancer without the FDA oversight required for such significant-risk studies.
Robotically assisted surgical 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 robotically assisted surgical devices for the prevention or treatment of cancer based on cancer-related outcomes such as overall survival, disease recurrence, and disease-free survival.
The FDA continues to expect study sponsors to obtain FDA approval of investigational device exemptions (IDEs) for studies of robotically assisted surgical devices intended for use in mastectomy procedures for the prevention or treatment of breast cancer. Studies with a potential for significant risk to study participants, such as the use of robotically assisted surgical devices for mastectomy procedures or in the prevention or treatment of breast cancer, may only be conducted under an approved IDE. This helps ensure adequate protections of the health, safety, and welfare of the participants.
Recommendations for Patients and Caregivers
The FDA advises patients that before they have surgery to prevent or treat breast cancer, they should ask whether the surgeon expects to use robotically assisted surgery. If so, they should:
- Be aware that the safety and effectiveness of using robotically assisted surgical devices in mastectomy procedures or in the prevention or treatment of breast cancer have not been established.
- Discuss the benefits, risks, and alternatives of all available treatment options with their health-care provider to make the most informed treatment decisions.
In addition, before choosing a surgeon for robotically assisted surgery, the FDA recommends patients ask the surgeon about:
- Their training, experience, and patient outcomes with procedures using such devices
- The number of similar robotically assisted surgical procedures they have performed
- Potential short-term and long-term complications; whether they are due to the mastectomy procedure, cancer prevention, cancer treatment, or an associated breast reconstruction; and how often they happen.
The FDA encourages patients who have had treatment with a robotically assisted surgical device for breast cancer or any cancerous condition and experienced a complication to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Recommendations for Health-Care Providers
The FDA recommends that health-care providers:
- Be aware that robotically assisted surgical devices have been evaluated by the FDA and cleared for use in certain types of surgical procedures, but not for mastectomy or for the prevention or treatment of breast cancer
- Get appropriate credentialing and training for the specific robotically assisted surgical device procedures they intend to perform
- Talk to their patients about their experience and training as well as clinical outcomes expected with the use of robotically assisted surgical devices
- Discuss the benefits, risks, and alternatives of all available treatment options with patients to help them make informed treatment decisions
- File a report through MedWatch if patients experience adverse effects or complications with a robotically assisted surgical device.
- 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. For further information, refer to the FDA's Investigational Device Exemption website.
Recommendations for Institutional Review Boards, Clinical Investigators, and Study Sponsors
The FDA considers clinical investigations performed in the United States involving robotically assisted surgical devices for mastectomy and the prevention and treatment of cancer to be significant-risk studies. These clinical studies require FDA oversight under an approved IDE.
Be aware that clinical studies for mastectomy and for the prevention or treatment of breast cancer using robotically assisted surgical devices must include monitoring of long-term clinical outcomes, such as cancer recurrence, disease-free survival, and overall survival. In addition, 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.
Studies of robotically assisted surgical devices intended for the prevention and treatment of other cancers also require an IDE. The FDA recommends the development of robotically assisted surgical device registries for the collection of real-world evidence. Contact the FDA for information on whether a robotically assisted surgical device registry requires an IDE through the presubmission (Q-Sub) program.
FDA Actions
The FDA is working to ensure device manufacturers, investigators, clinical study sponsors, and institutional review boards are aware of the FDA’s expectations for an IDE and clinical endpoints for use of robotically assisted surgical devices for the prevention or treatment of patients with cancer. The agency continues to monitor adverse events reported to the FDA to inform its understanding of the benefits and risks of robotically assisted surgical devices when used for specific indications.
The FDA continues to encourage academic and research institutions, professional societies, robotically assisted surgical device experts, and manufacturers to establish patient registries to gather data on the use of these devices for all uses, including the prevention and treatment of cancer. Finally, the agency will keep the public informed if significant new information becomes available.
