FDA urges caution if using robotically-assisted surgical devices for mastectomy and other cancer-related surgeries
Patients and healthcare providers are being urged by the Food and Drug Administration (FDA) to use caution when using robotically-assisted surgical devices for mastectomy and other cancer related surgeries. In a safety communication released yesterday, FDA acknowledges the benefits of using this type of surgery: reduced pain, blood loss, scarring, infection and recovery time after surgery in comparison to surgical procedures that do not use these devices. However, FDA says it did not grant marketing authorization for any robotically-assisted surgical devices for use in mastectomy or for the treatment or prevention of cancer.
The FDA points to scientific literature and other media that has reported negative outcomes for patients, including “one limited report that describes a potentially lower rate of long-term survival when surgeons and hospital systems use robotically-assisted surgical devices instead of traditional surgery for hysterectomy in cases of cervical cancer.” A small number of patient injuries were also reported to FDA when the devices were used in cancer-related procedures.
Because the safety and effectiveness of robotically-assisted surgical devices for mastectomy and any cancer-related surgery has not been established, said the agency, healthcare providers are urged to complete the appropriate training that correlates specifically to the robotically-assisted surgical procedures they intend to perform.
