Saturday, December 29, 2012

Younger, Taller and Heavier Patients More Likely to Require Hip Revision Surgery

Drug Watch

People who are younger, taller and heavier are more likely to need revision surgery after a primary total hip replacement surgery, according to a new study. The study is the first of its kind in the United States.

The results of the study were published in the December issue of Arthritis Care & Research, a journal of the American College of Rheumatology. The study authors – Dr. Elizabeth Wright and colleagues – reviewed the Medicare claims of people from 29 states that had a primary total hip replacement between July 1995 and June 1996 and followed up with these patients through December 2008.

The results revealed that people who received a cemented femoral component and were age 75 or younger, taller and heavier had the greatest chance of needing a revision surgery. Other factors that increased the need for revision surgery were undergoing a prior contralateral primary total hip replacement or other prior orthopedic surgery and living with others.

According to the authors, “Effects of age and body size on revision risk should be addressed by clinicians with patients considering primary total hip replacement.”

High Rates of Revision Surgery in Recalled Implants

In 2010, there were almost 460,000 hip replacement surgeries performed in the United States – and 58,000 of those were revision surgeries. Normally, natural wear and tear is the primary reason why people need hip revision surgery, but a number of metal-on-metal implants like Johnson &Johnson’s DePuy ASR XL Acetabular System are implicated in premature revision surgery rates.

This device was used in almost 100,000 hip replacement procedures globally. Johnson & Johnson recalled the DePuy ASR in August 2010 after reports of premature device failure from loosening, metal poisoning called metallosis that caused tissue death around the joint and a host of other problems. In the United States, about 37,000 of the devices were recalled after being implanted.
Studies on the failure rate revealed an abnormally high 12 percent revision rate in the device, the highest in the industry.

First J&J Hip Lawsuits Settle

The first three of about 8,000 DePuy ASR lawsuits settled in August 2012. According to Bloomberg, the plaintiffs who alleged the implants were defective will get $200,000 each.

The plaintiffs claimed that the metal-on-metal design of the DePuy ASR caused harmful levels of metal debris to be released into the blood stream. They required revision surgery for pain and other harmful side effects. Tests showed bone damage and health problems resulting from the metal debris in all three plaintiffs.

The recall of the DePuy ASR reportedly cost Johnson & Johnson about $800 million. The company may spend as much as $2 billion to resolve thousands of pending faulty hip lawsuits, according to experts. Any cases not settled will go to trial.

Because of the high number of federal cases, the suits were consolidated into multidistrict litigation (MDL) in the U.S. District Court for the Northern District of Ohio (Toledo).

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