Considering da Vinci robotically assisted surgery? The reported risks may not tell the whole story.
The popular da Vinci device used in robotic gynecological surgeries is being connected with injuries — including serious damage to the colon and other organs — that are not being reported to the Food and Drug Administration, according to a consumer report by The New York Times.
The da Vinci robotic equipment, manufactured by Intuitive Surgical, Inc., has been heavily marketed and on the market for more than a decade. Thousands of mishaps have been reported, including 71 deaths linked to da Vinci surgery, the Times reports.
Still, some reports of da Vinci injury — which healthcare providers are required to make to the FDA within 30 days of an “adverse event” — are not getting public scrutiny. Johns Hopkins researchers comparing da Vinci law suit facts against FDA reports concluded that adverse events associated with da Vinci were “vastly under-reported.”
Diana Zuckerman, president of the National Research Center for Women and Families, was quoted as saying the FDA reports represent just “the tip of the iceberg” of the injuries and other complications caused by devices such as da Vinci.
The FDA is the agency responsible for determining whether the risks of using a device outweighs its benefits. What does this say if the FDA is not getting complete information about a da Vinci’s safety?