When any of us require surgery for whatever the reason – we should be able to expect that the surgical equipment used by our surgeons will be FDA approved – correct?
But is that always the case?
Sadly – no.
Case in point: a company called OtisMed and their product called the OtisKnee. The concept behind this surgical product was to use magnetic resonance imaging and three-dimensional software to create surgical guides at an OtisMed facility that were then shipped to hospitals. The guides were supposed to direct the angle of each surgeon’s cuts so that artificial knees could be properly aligned. In theory, the device was expected to help surgeons tailor bone cuts to a patient’s specific anatomy.
Sadly – it was sold to doctors as a chance to reduce surgery times and increase revenues – but was never thoroughly tested.
And it didn’t work as advertised leaving innocent patients badly damaged. What’s more – the device was never even cleared by the FDA.
The FDA gives companies latitude in classifying their devices. In the case of the OtisKnee, OtisMed officials told doctors and hospitals that its cutting guides were a so-called Class I device (Class I devices — bandages, dental floss, forceps and the like — must be registered but don’t require premarket review because they present a low risk. They can be sold without any other FDA involvement.) and didn’t need FDA approval or clearance. How did OtisMed reach that odd conclusion? That’s a mystery.
According to the Justice Department, OtisMed also worked closely with medical device company Stryker to market the OtisKnee. Stryker makes knee replacement components that worked with the OtisKnee and it was Stryker that ultimately requested that OtisMed apply for FDA clearance to market the OtisKnee, which the company did in October 2008.
A year later – the FDA issued a warning the devices were in fact unsafe. Despite that fact – the company knowingly continued to ship the defective devices to surgeons for a period of time – 218 in total. What’s more – the company sold $27 million dollars worth of the defective devices prior to the FDA ruling.
Sadly – Justice Department papers fail to reveal the number of patients that have been harmed by the OtisKnee equipment and the total number of medical malpractice cases that have been filed against OtisMed is unknown.
An FDA spokesman has admitted that the agency learned in late 2007 that the OtisKnee was being sold without proper clearance and opened an investigation. That investigation was then dropped after OtisMed sought approval in 2008.
Diana Zuckerman, president of the National Center for Health Research, an FDA watchdog group, issued this strong condemnation of the FDA. The FDA’s “surveillance system is so flawed and so weak and so subjective and so inadequate,” Ms. Zuckerman said, “that there are no automatic red flags going up when something happens.”
What can you do as a patient to avoid these problems?
If you have time, do your homework first. Ask your surgical team lots of questions about the procedure and the risks. And ask them what to expect in recovery. If you continue to have questions – always seek a second opinion.