Da Vinci Robot Lawsuit News: New Report Points to Medical Journal Study Questioning Shortage of FDA Complaint Reports
Kaiser Health News became the latest news source in November to shine light on concerns about a healthcare technology now at the heart of an ongoing FDA safety investigation and mounting da Vinci robot lawsuit filings.
Less than a month earlier, the United Kingdom’s Daily Mail published a similar report that highlighted the facts of robotic procedures aided by the da Vinci Surgical System, including a study released by the Journal of Healthcare Quality that found a shortage of adverse event report filings from patients who underwent surgeries using the remote-controlled device. Over a 12-year period, just 245 complaints—of 71 deaths and 174 non-fatal injuries—associated with the da Vinci were logged in the U.S. Food and Drug Administration (FDA)’s database, the research showed.
Meanwhile, a regulatory filing in October showed Intuitive Surgical’s involvement in at least 50 da Vinci lawsuit filings, which are currently pending in courts throughout the U.S.
37% of Hospitals Fail to Mention Robotic Surgery Complications, Journal of Healthcare Quality Finds
First approved in 2000 for laparoscopic, gynecologic and urologic procedures, Intuitive has marketed the da Vinci as a tool that results in smaller incisions, less pain during surgery and shorter patient recovery periods. The variety and number of procedures aided by the da Vinci have also increased exponentially since then. In recent years, the Journal of Healthcare Quality reported that 75 percent more da Vinci robots were installed in U.S. hospitals—jumping from 800 in 2007 to 1,400 in 2011.
In its findings, the Journal concluded it to be “essential that device related complications be uniformly captured, reported and evaluated,” so the medical community fully understands “the safety of the new technology,” according to the Kaiser’s Nov. 1 report.
An associate professor of surgery and health policy and management at Johns Hopkins University, who helped lead the study, also said that “among the 37 percent of U.S. hospitals that describe robotic surgery on their hospital website, none mentioned any potential risks or complications.”
Makary and his co-authors noted an earlier finding that “among the 37 percent of U.S. hospitals that describe robotic surgery on their hospital website, none mentioned any potential risks or complications.”
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