The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Robotically-Assisted Surgical Devices in Women's Health.
Since robotically-assisted surgical devices became available, robotically-assisted surgical procedures were widely adopted because they may allow for quicker recovery and could improve surgical precision. However, the FDA is concerned that health care providers and patients may not be aware that the safety and effectiveness of these devices has not been established for use in mastectomy procedures or the prevention or treatment of cancer.
According to the FDA, there is limited, preliminary evidence that the use of robotically-assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be associated with diminished long-term survival. Health care providers and patients should consider the benefits, risks, and alternatives to robotically-assisted surgical procedures and consider the available information to make informed treatment decisions. Patients and health care providers should also be aware that the FDA encourages health care providers who use robotically-assisted surgical devices to have specialized training and practice in their use.
Robotically-assisted surgical devices are novel and complex systems and the FDA reviews each robotically-assisted surgical device system individually, based on the complexity of the technology and its intended use.
The FDA is monitoring adverse events in the literature and reported to the FDA to inform our understanding of the benefits and risks of robotically-assisted surgical devices when used for specific indications.
The FDA encourages academic and research institutions, professional societies, robotically-assisted surgical device experts, and manufacturers to establish patient registries to gather data on the use of robotically-assisted surgical devices for all uses, including the prevention and treatment of cancer. Patient registries may help characterize surgeon's learning curves, assess long-term clinical outcomes, and identify problems early to help enhance patient safety.
The FDA will update the communication if significant new information becomes available.
The FDA is alerting patients and health care providers with recommendations.
For details, please refer to the following FDA website:
https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm632142.htm
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 1 March 2019