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Wright Conserve—Latest Hip Implant to Disappoint

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New York, NYMetal-on-metal hip replacements are "under the microscope these days," says attorney Felecia Stern. A partner in Bernstein Liebhard's mass tort group in New York City, Stern says the firm is currently evaluating lawsuits alleging Wright Conserve hip implants are designed defectively. "We are starting to get calls from Wright Conserve implant patients and we are still in the process of dealing with the ASR and Pinnacle cases. In the past, we have turned away the Wright Conserve implant cases, but we are starting to look at them more seriously," says Stern.

The ASR and the Pinnacle implants are also metal-on-metal implants manufactured by Johnson and Johnson. The Wright Conserve hip implant devices are manufactured by Wright Medical Technology headquartered in Tennessee.

"Although each of these products are metal-on-metal hip implants, they are often designed differently. For example, the Pinnacle implants have a liner, whereas the ASR implants do not. We are hearing the same kinds of complaints from those contacting us about problems with the Wright Conserve implants as we have from our ASR and Pinnacle clients. We are still reviewing medical records, so I can't speak generally about the levels of cobalt and chromium in the Wright Conserve patients."

"However, when you have metal grinding against metal as you do with certain of the Wright implants, we anticipate seeing the same kinds of injuries from the metal ion debris as we have found with other metal-on-metal hip implants. These include pseudo tumors, infections, loosening of the implant and pain," says Stern. "And, there is also the question of the long-term consequences of exposure to high levels of cobalt and chromium. Are these patients at a great risk of developing cancer?"

A recent study published in The Lancet found that metal-on-metal implants had such a high failure rate that they should not be used. A University of Bristol study reported 6.2 percent metal-on-metal hip implants failed within five years. That compared to a 1.7 percent failure rate for metal-on-plastic and a 2.3 percent rate of failure for ceramic-on-ceramic.

The ASR, Pinnacle and Wright Conserve implants were all approved through what has become known as "the 510 (k) loophole." FDA rules say any product that is "substantially equivalent" to another product already approved by the FDA must be given the okay—no further testing is needed.

"It allows manufacturers to avoid clinical testing if they are simply able to show the product is substantially similar," says Stern. "There is a bill being proposed in Congress right now to change the whole process."

According to the experts, as much as 90 percent of all the medical products on the market were given FDA approval using the 510 (k) loophole. Lawmakers are trying to close up the hole in the law, but so far it hasn't happened.

Felecia Stern is a partner in the mass torts practice at Bernstein Liebhard LLP in New York City. Her practice is focused on mass torts and consumer protection. Currently, she is litigating cases involving defective DePuy ASR hip replacement devices, as well as cases concerning injuries stemming from the usage of the popular osteoporosis medication Fosamax and the implantation of transvaginal mesh. She graduated cum laude from the University of Pennsylvania Law School in 1992 and received her bachelor's degree in 1989 from Cornell University.


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