Are misleading robotic surgery ads slipping past the FDA?

All too often, dangerous medical devices are touted as safe and effective in advertisements and press releases. While the marketing of medical devices is regulated by the U.S. Food and Drug Administration, some argue that the regulation is insufficient.

One of the reasons is that the FDA reportedly has just two employees who are devoted to fact-checking medical device ads while more than 60 people concentrate on promotions involving prescription drugs. Another reason is that medical devices are extremely complex, which can result in misleading ads slipping past the FDA.

A recent report by Bloomberg suggested that while robotic surgery devices are being advertised and promoted as a better option for patients, the scary truth is that they are leaving many patients injured or killed.

For example, one Colorado doctor who was promoted as being the first in his region to offer gull bladder surgery using one of the million dollar surgical robot devices is now facing a complaint from the state medical board after ten patients were seriously injured during the surgeries between 2008 and 2011.

Additionally, the FDA announced in February that it was investigating robotic surgical devices, which essentially allow surgeons to perform an operation using a video game-like counsel, after noting a spike reports of adverse events related to the products, including 70 deaths.

Ultimately, hospitals, manufacturers and doctors could all potentially face liability in civil lawsuits for promoting a product without giving patients a proper warning about its risks. Hopefully, in the meantime the FDA will find a better way to regulate ads involving these medical devices and others before too many patients are misled.

Source: ClaimsJournal.com, “Robot Surgery Damaging Patients Rises With Misleading Marketing,” Robert Langreth, Oct. 8, 2013