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12/23/2010

Important Information about Hip Implant Recall

DePuy Orthopaedics, Inc., a subsidiary of Johnson and Johnson, has recently issued a voluntary recall of their ASR Hip Implant. A large British study determined that the DePuy implants were failing at a much higher and quicker rate than other manufacturers. DePuy issued a statement to their patients explaining that additional testing and monitoring may be necessary to ensure the implant is functioning properly and, in some cases, additional surgery may be required.

According to data gathered during the study, five years after implantation, approximately 13% of patients who received the ASR total hip replacement needed to have additional surgery. Symptoms for those affected include recurring pain, swelling and problems walking. Inflammation and tissue death can occur around the joint and problems affecting the heart and nervous system, although rare, can develop from toxins entering the blood, the FDA said.

In a 12-month period from 2005 to 2006, nearly 40,000 metal-on-metal hip replacements were performed in the USA, accounting for 32% of all hip replacements during that time, the American Society of Hip and Knee Surgeons said. About 500,000 people are estimated have them. About 285,000 hip replacements are performed a year, the Agency for Healthcare Research and Quality said.

Although the group released a technology review in December saying metal-on-metal implants have higher revision rates than other implants, "the majority of patients who have them have had good results," said Joshua Jacobs, chairman of orthopedic surgery at Rush Medical College in Chicago.

Many implants now are made of other components: metal and plastic, metal and ceramic, and all ceramic. Metal-on-metal implants designed to last 15 years were sometimes failing within several years.

The use of metal-on-metal implants has "decreased dramatically," Jacobs said. "It's important for anyone with a metal-on-metal implant to follow up with their orthopedic surgeon."

Signs of failure include pain, swelling or onset of a limp. Among other findings:

.33% of patients in a study from the Netherlands (202 of 614) had adverse reactions in soft tissue. Authors recommend "close monitoring of all patients with metal-on-metal hips."

.A study from England found that 24% of patients who had revision surgery after a metal-on-metal implant had "worsening symptoms." A third of those had more surgery. "Disease progression (around the joint) was confirmed in all cases of re-revision," the authors wrote.

.Orthopedic surgeon Douglas Padgett, of the Hospital for Special Surgery, said a study in which he was involved found 98% of the cups and 93% of the balls showed "moderate to severe scratching" in 46 retrieved metal-on-metal implants.

DePuy has indicated that it will cover reasonable and customary costs of monitoring the implant, as well as treatment for services.

Patients who received the implant are to receive recall notices from their physicians in the mail; it is anticipated that the recalls will expand to include additional hip implant models. If you have questions regarding this recall program, you may contact attorney Jim Klick at jklick@hhkc.com, or call (504) 581-4892.

 

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