Date Issued: August 20, 2021

The U.S. Food and Drug Administration (FDA) is reminding patients and health care 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. 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.

Recommendations for Patients and Caregivers

Before you have surgery to prevent or treat breast cancer, ask whether the surgeon expects to use robotically-assisted surgery. If so, you should:

• Be aware that the safety and effectiveness of using RAS 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 your health care provider to make the most informed treatment decisions.
• Before choosing a surgeon for robotically-assisted surgery, the FDA recommends you ask the surgeon about:
  • Their training, experience, and patient outcomes with RAS device procedures.
  • The number of robotically-assisted surgical procedures like yours they have performed.
  • Potential short-term and long-term complications, and whether they are due to the mastectomy procedure, cancer prevention, cancer treatment, or an associated breast reconstruction-and how often they happen.

If you had treatment with a RAS device for breast cancer or any cancerous condition and experienced a complication, the FDA encourages you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Recommendations for Health Care Providers

• Be aware that RAS 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.
• The FDA recommends you get appropriate credentialing and training for the specific RAS device procedures you intend to perform.
• Talk to your patients about your experience and training as well as clinical outcomes expected with the use of RAS devices.
• Discuss the benefits, risks, and alternatives of all available treatment options with your patients to help them make informed treatment decisions.
• File a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program if your patients experience adverse effects or complications with a RAS 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, please refer to the FDA's Investigational Device Exemption website.

Recommendations for Institutional Review Boards (IRBs), Clinical Investigators, and Study Sponsors

The FDA considers clinical studies performed in the United States involving RAS devices for mastectomy and the prevention and treatment of cancer to be significant risk studies. These clinical studies require FDA oversight under an approved investigational device exemption.

• Be aware that clinical studies for mastectomy and for the prevention or treatment of breast cancer using RAS devices must include monitoring of long-term clinical outcomes, such as:
  • Cancer recurrence
  • Disease-free survival
  • Overall survival

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.

Device Description

RAS devices enable surgeons to perform a variety of surgical procedures through small cuts (incisions) in a patient's body. This type of surgery may help reduce pain, blood loss, scarring, infection, and recovery time after surgery in comparison to traditional surgical procedures.

Computer and software technology enable a surgeon to precisely control surgical instruments attached to mechanical arms through small incisions while viewing the surgical site in three-dimensional high definition.  

For more information, see the Common uses of Robotically-Assisted Surgical (RAS) Devices section on the Computer-Assisted Surgical Systems page.

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.

FDA Actions

The FDA is working to assure device manufacturers, investigators, clinical study sponsors, and IRBs are aware of the FDA’s expectations for an investigational device exemption and clinical endpoints for use of RAS devices for the prevention or treatment of patients with cancer.

The FDA continues to monitor adverse events reported to the FDA to inform our understanding of the benefits and risks of RAS devices when used for specific indications.

The FDA continues to encourage academic and research institutions, professional societies, RAS device experts, and manufacturers to establish patient registries to gather data on the use of RAS devices for all uses, including the prevention and treatment of cancer.

The FDA will keep the public informed if significant new information becomes available.

Reporting Problems with Your Device

If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions?

If you have questions, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100.