News In Brief

Robotic hysterectomy surgery is “not the only or the best minimally invasive approach for hysterectomy. Nor is it the most cost-efficient,” said James Breeden, president of the American Congress of Obstetricians and Gynecologists in a March 14 statement. ACOG issued the statement amid growing public questions about the cost-effectiveness and safety of robotic surgery procedures, primarily performed with Intuitive Surgical Inc.’s Da Vinci system. ACOG cites a study published several weeks ago in the Journal of the American Medical Association showing that laparoscopic hysterectomy is cheaper than the robotic procedure with a similar complication rate. (See Also see "Laparoscopic Hysterectomy Is Cheaper Than Robotic Version With Similar Results" - Medtech Insight, 25 February, 2013..) “Aggressive direct-to-consumer marketing of the latest medical technologies may mislead the public into believing that they are the best choice,” Breeden said. “Patients should be advised that robotic hysterectomy is best used for unusual and complex clinical conditions in which improved outcomes over standard minimally invasive approaches have been demonstrated.” In addition, FDA is scrutinizing adverse events associated with Da Vinci systems. (See in this issue, Also see "Regulatory News In Brief" - Medtech Insight, 18 March, 2013..)

The Senate is debating a continuing resolution appropriations bill that would provide FDA greater access to fiscal year 2013 user fees. The chamber hopes to pass the measure this week;...