The FDA has issued a warning to patients and medical professionals about the use of robotically-assisted surgical devices for cancer surgeries, including mastectomy for breast cancer and other procedures.
Computer-assisted surgical systems enable surgeons to control instruments with mechanical arms and operate through smaller-than-normal incisions. Potential benefits include reduced blood loss, less post-operative pain and scarring, and a lower infection risk. But these devices have not been approved by the FDA for treatment of cancer.
Using surveillance methods like medical device reports, patient registries, and scientific literature that to monitor and identify problems with medical devices as they occur, the agency has learned that U.S. surgeons have been using robotic devices for mastectomies and other cancer surgeries for which the safety and effectiveness of the devices hasn’t been established. Not only that, there have been a number of reports of poor patient outcomes surrounding their use, including a lower long-term survival rate in women undergoing robotically-assisted hysterectomies instead of traditional surgery for cervical cancer.
The FDA recommendations also urge medical professionals to complete appropriate training for the robotically-assisted surgical procedures they perform. They suggest you talk to your health care provider about the benefits, risks, and alternative options so you can make informed decisions before surgery. Don’t be shy about asking your doctor about his or her training, experience, and surgical outcomes.