FDA Issues Warning Over Use of Surgical Robots To Perform Mastectomies

Federal regulators are warning patients and healthcare providers that they have not confirmed the safety or effectiveness of surgical robots for mastectomy procedures, or for the treatment of breast cancer.

In safety communication issued on August 20, the FDA indicates it has become aware of claims that clinical studies are being conducted on the use of robot-assisted surgery (RAS) devices for mastectomy procedures as a means of preventing breast cancer. However, the agency warns that if such studies are being done, they are not being done with the required FDA oversight.

“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,” the FDA warns. “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.”

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Robotic surgery involves the use of complex, computerized machines which allow doctors to perform surgical procedures through small incisions to the patient’s body. They often can help reduce surgical pain, blood loss, scarring, infection, and limit recovery time after surgery when compared to traditional surgical procedures.

During these robotic surgeries, computers help guide the surgeon to precisely control surgical instruments attached to mechanical arms. The surgeon can create small incisions while viewing the surgical site in three-dimensional high definition.

Robotically-assisted surgery is often touted as a breakthrough and revolutionary treatment option, with hospitals and medical facilities touting a myriad of advantages. However, concerns have emerged among some consumer advocates in recent years that facilities may push wider use of robot surgery than is necessary, as part of an effort to recoup costs associated with the expensive devices.

The FDA’s safety communication notes that robotic surgical devices have been approved for some procedures which often involve patients suffering from cancer, including hysterectomies, prostatectomies and colectomies.

“These clearances are based on short-term (30 day) patient follow up,” the agency noted in its warning. “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 agency reminded study sponsors that they must obtain FDA approval of investigational device exemptions (IDE) for studies of robot surgery devices involving mastectomy procedures that aim to prevent or treat breast cancer. That is because these clinical trials could pose a significant risk to the study subjects, and the agency must assure there are adequate safety, health and welfare protections for the test subjects.

This is not the first time the FDA has issued a warning regarding mastectomies performed by robot surgery. The agency released a similar safety communication in February 2019, warning that individuals who undergo robot surgery for mastectomies or other cancer treatments may have reduced long-term survival rates.

In the latest warning, the FDA recommended patients and caregivers be aware RAS devices have not been approved for mastectomies for the prevention or treatment of breast cancer, and called on them to discuss the benefits, risks and alternatives of all available treatment options with their healthcare providers. The agency also urged patients and caregivers to ask the surgeons about their training, experience, patient outcomes, the number of similar robotically-assisted procedures they had performed, and about the potential short-term and long-term complications of such procedures.

The FDA also issued a series of recommendations for healthcare providers, calling on them to:

  • Be aware robotic surgical devices have not been approved for mastectomy or the prevention or treatment of breast cancer.
  • Get appropriate credentials and training for the specific RAS device they intend to use/
  • Discuss their experience, training and clinical outcomes with patients.
  • Discuss the benefits and risks of all available treatment options with their patients.
  • Be aware that clinical studies done in the U.S. involving a legally marketed device being tested for a new intended use are subject to FDA oversight.
  • File a report with the FDA MedWatch Adverse Event Reporting Program if any patient experiences an adverse effect or complication following robotic surgery.


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