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Dr. Richard Berger and Dr. Craig Della Valle, both surgeons at Rush University Medical Center in Chicago, and former consultants for the giant orthopedic implant maker Zimmer Inc, have begun a study against their alleged faulty product NexGen CR-Flex knee replacement device. The F.D.A. has not required the company to study this product in patients before selling it, so no data was available to the patients.

According to an article written on June 19, 2010 in the New York Times, Surgeon vs. Knee Maker: Who’s Rejecting Whom? Dr. Richard A. Berger designed surgical tools and artificial joints for Zimmer Holdings, and trained hundreds of doctors to use its products. It also states that he received $8 million over the decade while Zimmer portrayed him as a master surgeon.

In 2006, Dr. Berger began complaining to Zimmer that the replacement device was prematurely failing, and urged them to take it off the market. The knee replacement was supposed to last about 15 years, but this product is showing a high failure rate. Even though Dr. Berger was still a consultant for Zimmer in 2007, Berger stopped using the NexGen CR-Flex.

Because cement like adhesive can break down and cause device failure, some surgeons like Berger, try to avoid adhesives. Zimmer sells an un-cemented version of the CR-Flex that relies on the bone to naturally fuse with the implant. However, some X-rays showed lines where the implant met the thigh bone indicating that the device could be loose and that full fusion did not take place.

In March 2010, information was presented at an American Academy of Orthopedic Surgeons conference, which showed 36 percent of the Zimmer NexGen patients examined, had signs of the replacement knee loosening in less then 3 years. The study also found that just about 9 percent of those patients examined after 2 years actually required revision knee surgery due to the loosening and pain.

Zimmer has placed the blame for these failures on the surgeons, stating there were errors with the surgical techniques. These are the same techniques that were promoted and taught to other surgeons; the same techniques that Zimmer claimed Berger as a master surgeon.

It is amazing that these mega medical device companies would sell these products to be put into patients without any patient testing trials. When these companies refuse to take responsibility and regulators won’t or haven’t yet held them accountable, it is up to the public to demand justice to ensure these defective products can’t hurt any more people. At a minimum, at least do trials to get a better understanding of the risk factors, so that doctors and patients can make appropriate decisions based on their condition and medical need. It is only fair to be able to make these choices from truth not greed.

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