Robotically-assisted surgical devices are not cleared by the FDA to prevent or treat cancer.
The U.S. Food and Drug Administration (FDA) today issued a safety warning to patients and healthcare providers about being cautious when using robotically-assisted surgical devices for mastectomy and other cancer-related surgeries.
While robotically-assisted surgical devices could help reduce pain, blood loss, scarring, infection and recovery time after surgery when compared to procedures that do not use these devices, the FDA has not granted marketing authorization for any such devices for use in the treatment or prevention of cancer.
>> READ: FDA Report Says Unregulated Digital Health Tools' Benefits Outweigh Risks
The agency has received reports of patient injury when robotically-assisted surgical devices are used in cancer-related procedures and is aware of publications and a report that describes a lower rate of long-term survival when surgeons use these devices for hysterectomy.
The FDA issued the safety communication so that healthcare providers and patients better understand that the safety and effectiveness of these devices in mastectomy procedures or in the prevention or treatment of cancer has not been established. However, the agency has evaluated robotically-assisted surgical devices and cleared them for use in other types of surgical procedures.
In the notice, the FDA recommends that the healthcare providers who use these devices should have specialized training and practice in their use. Providers should also talk about the benefits, risks and alternative treatment options with their patients to help them make more informed decisions.
As for patients, the agency suggests asking a few questions before having robotically-assisted surgery to prevent or treat cancer.
Patients should ask their surgeon about their training, experience and patient outcomes with these types of procedures, along with possible complications and how often they happen. It is also important to ask how many robotically-assisted surgery procedures the surgeon has performed.
The FDA will continue to monitor events reported to the agency to better its understanding of the benefits and risks of robotically-assisted surgical devices when used for specific procedures.
“This safety communication issued today reflects the agency’s commitment to enhancing our oversight of device safety as part of our Medical Device Safety Action Plan, as well as the agency’s ongoing commitment to advancing women’s health,” said Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA’s Center for Devices and Radiological Health.
Get the best insights in healthcare analytics directly to your inbox.
Global Investigation into Medical Devices Exposes Flaws in FDA, International Regulators
FDA Bets on Real-World Evidence