FDA fails to Thoroughly Evaluate and Regulate Surgical Robotic Devices
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
By Lisa S. Cummings
As a litigation firm, we have been dealing with cases involving injuries rising from robot assisted surgery. Most reported problems from these surgical devices involve accidental tears, burns to internal organs, continued repairing surgeries and even deaths. We recently discussed how many advertisements on websites have failed to reveal this device's risks.
However, can we fault other entities for this issue, other than hospitals, marketers of the medical device and undertrained surgeons who help promote surgical robots? In a report, Bloomberg news stated how surgical the U.S. Food and Drug Administration is sometimes unsuccessful when regulating surgical robots. The article states that the FDA has only two full-time employees taking their time evaluating robotic surgery as compared to them having more than 60 persons supervising over prescription drug promotions within a full office. Only after 70 deaths since 2009 has the FDA was surveying surgeons about the robots. One professor of law at the University of Arkansas at Little Rock named Robert Steinbuch states that "hospital advertising is essentially a free-for-all". He agrees that the safety and efficacy claims of the medical devices are difficult to examine or evaluate. This might also be an idea of why some advertisements of surgical robots mislead patients, hospitals or surgeons.