On February 28, 2019, the FDA issued a safety communication regarding using robotically -assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer. The FDA advised healthcare providers that the safety and effectiveness of using robotically-assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer has not been established. However, the FDA became aware of scientific literature and media publications describing surgeons and hospital systems that use robotically-assisted surgical devices for mastectomy.
Robotically-assisted surgical 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 allow a surgeon to precisely control surgical instruments attached to mechanical arms through small incisions while viewing the surgical site in three-dimensional high definition.
Limited, preliminary evidence indicated 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. The FDA advised healthcare providers and patients to consider the benefits, risks, and alternatives to robotically-assisted surgical procedures and consider this information to make informed treatment decisions. Patients and healthcare providers should also be aware that the FDA encourages healthcare providers who use robotically-assisted surgical devices to have specialized training and practice in their use.
To date, the FDA’s evaluation of robotically-assisted surgical devices has generally focused on determining whether the complication rate at 30 days is clinically comparable to other surgical techniques. To evaluate robotically-assisted surgical devices for use in the prevention or treatment of cancer, including breast cancer, the FDA anticipates these uses would be supported by specific clinical outcomes, such as local cancer recurrence, disease-free survival, or overall survival at time periods much longer than 30 days.
The relative benefits and risks of surgery using robotically-assisted surgical devices compared to conventional surgical approaches in cancer treatment have not been established. The FDA became aware of peer-reviewed literature reporting clinical outcomes for the use of robotically-assisted surgical devices in cancer treatment including one limited report that compared long term survival after radical hysterectomy for cervical cancer either by open abdominal surgery or by minimally invasive surgery (which included laparoscopic surgery or robotically-assisted surgery). In this report, minimally invasive surgery appeared to be associated with a lower rate of long term survival compared with open abdominal surgery; however other researchers have reported no statistically significant difference in long term survival when these types of surgical procedures are compared.
The FDA has not granted marketing authorization for any robotically-assisted surgical device for use in the United States for the prevention or treatment of cancer, including breast cancer. The labeling for robotically-assisted surgical devices that are legally marketed in the United States includes statements that cancer treatment outcomes using the device have not been evaluated by the FDA.
See the FDA Safety Alert
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