An unnerving study by researchers at Johns Hopkins found multiple examples of botched operations that were not reported to the FDA. The investigators, headed by Dr. Martin A. Makary an associated professor of surgery at Johns Hopkins , accomplished this by combining news reports and court records, and concluded that such cases were vastly underreported. The reporting mandate that requires medical device manufacturers and hospitals to report every device-related death and serious injury to the FDA within 30 days simply is dysfuntional or worse. It is well-known, for example, that reports made to the FDA represent only a tip of the iceberg-this includes events related to drug reactions, drug deaths, device failures, and other significant, serious or catastrophic results of medical treatment. The “true” reporting rate for drug reactions and misadvnetures has been rated at 10%, but this is clearly a wild understatement considering that drug deaths alone, not counting suicides, exceeded auto accidents, at 40,000 a year.
Robotic-assisted surgery has taken off, increasing more than 400% in the U.S. between 2007-2011. A leading company, Intuitive Surgical Inc. the manufacturer of da Vinci systems sold over 1,400 such systems costing between $1.5million-$2.5 million to scores of hospitals according to Intuitive’s Investor Reports. Between January 2000 and 2012 thousands of mishaps were reported to the FDA. Among reports were 174 injuries and 71 deaths related to the da Vinci surgery system.
Reported in the New York Times, Sept. 10, the expansion of robotic surgery “has occurred without proper evaluation and monitoring of results,”said Dr. Makary, and senior author of the above study, who added, “We adopt expensive new technologies, but we don’t even know what we’re getting …if it’s for good value or harmful…Because the reporting mandate has no teeth, he said, we have this haphazard smattering of reports that relies on voluntary self-reporting with no oversight, no enforcement, and no consequences.”
This is unfortunately true for other implanted devices, in particular cardiac stents and pacemakers. See my previous blog 11/6/2009. “Medical Devices: Disturbing News” (blog page 4). As for medical devices in general and their poor oversight by the FDA because of failures of reporting, how about reducing the excise taxes on them to satisfy anti-Obamacare politicos?