FDA Warning About Breast Cancer Surgery
- The U.S. Food and Drug Administration (FDA) warns that Robotically-Assisted Surgery (RAS) has not been approved for breast cancer treatment or prevention.
- RAS devices have been cleared for use in certain types of surgical procedures commonly performed in patients with cancer, such as hysterectomy, prostatectomy and colectomy, the FDA says.
- If you are a patient who has received or is thinking about receiving RAS for breast cancer, the FDA offers recommendations.
The U.S. Food and Drug Administration (FDA) sent out a warning regarding robotically-assisted surgical (RAS) device use during mastectomy procedures and breast cancer surgeries. The FDA says it has not assessed the safety or effectiveness of RAS devices in treating or preventing breast cancer.
Read More RAS devices perform surgical procedures through small incisions that may help reduce scarring, infection, blood loss, and pain to shorten a patient’s recovery time following a procedure. These precise cuts are completed with computer and software technology which the surgeon can control. RAS devices have been cleared by the FDA for use in certain types of surgical procedures commonly performed in patients with cancer, such as hysterectomy (removal of the uterus), prostatectomy (removal of the prostate gland) and colectomy (resection of the colon). These clearances are based on short-term (30 day) patient follow up. The FDA says it “has not evaluated the safety or effectiveness of RAS devices for the prevention or treatment of cancer, based on cancer-related outcomes such as overall survival, recurrence and disease-free survival.” The FDA recommends the following steps for patients who have received or are thinking about receiving robotically-assisted surgery for breast cancer:
- Know that RAS devices in breast cancer treatments have not been screened or approved
- Discuss all benefits and risks of using RAS devices for treatment and talk about other treatment options
- If you are choosing a surgeon to use RAS devices ask about: their training and patient outcomes with RAS device procedures, the number of patients that have had treatments like yours, and the potential short-term and long-term side effects of complications
- If you have had robotically-assisted surgery for breast cancer and experienced any complications, file a report through the FDA Safety Information and Adverse Event Reporting Program
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