Key points from article :
The FDA issued a safety alert for the use of robot-assisted surgical (RAS) devices in mastectomy procedures.
RAS devices have been cleared for use in some surgeries performed in cancer patients.
Medscape report that clinical trials on RAS devices for nipple-sparing mastectomy were not collecting outcomes data despite FDA warnings.
The FDA expects study sponsors to obtain approval of investigational device exemptions (IDE) for studies of RAS devices in mastectomy.
In 2019, the FDA said that use of RAS devices for mastectomies and other cancer surgeries was unproven, and could pose safety risks.
A study found low rates of survival with RAS devices to perform radical hysterectomies in women with cervical cancer.
RAS can allow surgeries to be performed through a smaller incision, reducing scarring, post-operative pain and blood loss, and potentially reducing recovery times.
Device manufacturers, investigators, sponsors and IRBs need to be aware of FDA expectations for IDE and clinical endpoints.
