February 9, 2015 — The OtisMed knee implant is responsible for complications, including early failure and revision surgery in several dozen patients, according to the New York Times.
The Times highlighted the case of Carla Muss-Jacobs, a woman who needed revision surgery. She suffered from terrible pain, was unable to walk or work, and ultimately declared bankruptcy due to medical bills.
Between May 2006 and September 2009, OtisMed sold more than 18,000 cutting guides and made over $27 million. The revolutionary products used MRIs and 3D software to create custom cutting guides for each patient.
The OtisKnee was marketed as a time-saver in the operating room that would simplify surgery and bring in extra revenue from extra MRI scans. They also claimed the OtisKnee would preserve more of the patient’s bone a ligaments, improving fit and longevity. However, these statements were not evaluated by the FDA.
In fact, OtisMed marketed the cutting guides as Class I devices — the same class as dental floss and band-aids. The OtisMed knee was registered with the FDA, but never subject to premarket review or clinical trials.
Unfortunately, the cutting guides were actually a Class III (“high-risk”) medical device, much more dangerous than dental floss.
A study published in 2008 described four case reports of misalignment, with authors warning about a “high risk of early failure.” According to ProPublica, by the end of 2009 there were 58 reports of malfunctions. No one knows how many people have been injured.
In 2009, the FDA rejected approval of the OtisMed knee because the company failed to show that it was safe and effective.
In December 2014, the Justice Department announced an $80 million settlement. OtisMed and its former CEO pled guilty to criminal charges of distributing medical devices without FDA approval from 2006-2009.
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