Johnson & Johnson recalls 93,000 defective hip implants, promises to bear patients' expenses

By Surojit Chatterjee: Subscribe to Surojit's

August 26, 2010 6:56 PM EDT

World's largest maker of healthcare products Johnson & Johnson (NYSE.JNJ) announced, Thursday, a massive recall of two hip replacement implants after many patients complained they needed to undergo a second hip replacement as the company's implants had failed to work properly.

DePuy Orthopaedics, a unit of J&J, said it was recalling 93,000 units of two hip replacement products - the ASR XL Acetabular System, a total hip replacement system that is sold worldwide; and the ASR Hip Resurfacing System, a partial hip replacement designed to preserve more bone, approved for sale only outside the United States.

The ASR XL Acetabular System is a concave metal piece used to provide a smooth lining for the acetabulum, the bowl-shaped socket in the pelvis. The ASR Hip Resurfacing System replaces the ball portion of the hip and has a metal stem that fits into the top of the hip bone, or femur.

According to Lorie Gawreluk, DePuy spokeswoman, majority of the hip replacements using ASR products had been successful. However, a small number of patients complained they needed a second hip replacement even after using ASR.

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DePuy has advised patients who have used the recalled ASR implants to visit their surgeons for evaluating how the implants are working.

The company said it will bear the expenses of these patients, including costs of medicines and new hip replacement operations.

"We regret that this recall will be concerning for patients, their family members and surgeons," DePuy President David Floyd said in the statement. "We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the costs of doctor visits, tests and procedures associated with the recall."

Last year DePuy said it will phase out the ASR implants because of slowing sales. Earlier this year in March it warned doctors that the implants could have a high failure rate in some patients.

Though internal company information and clinical trials had reported lower rates of second hip-replacement compared to similar devices by other companies, DePuy said new data from the UK shows about 12 to 13 percent of patients, or 1 in 8, are needing a corrective surgery within 5 years of using the ASR implants. A corrective surgery, also known as "revision surgery," is needed when an artificial joint doesn't fit perfectly, causing pain and trouble in walking.

The news came as a blow to J&J as DePuy has received a warning earlier from the US Food and Drug Administration (FDA) for selling two products without getting the regulators' approval.

In a letter, FDA chastised DePuy to for selling TruMatch Personalized Solutions Systems, a new surgical guidance system for knee-replacement surgeries, without getting clearance from the regulators. It also directed the company to "immediately cease marketing" the Corail Hip System, a hip device, for uses that have not been approved.

The hip implant recall also dealt a serious blow to J&J, which is already struggling with a string of recalls relating to its best-known products, including children's Tylenol and over-the-counter (OTC) drugs such as Benadryl and Rolaids, in the US.

The healthcare giant is also under the FDA's scrutiny for implementing poor quality control measures at its plants. A FD probe found some of the J&J products could have more active ingredients than stated while others could contain tiny metallic particles. The probe also found some drugs contained bacteria.

Failure to take corrective steps had also forced J&J to shut down a plant of its unit McNeil Consumer Health Care in Ft. Washington, Pennsylvania.

J&J was also forced to recall millions of 1Day Acuvue TruEye contact lenses sold in Japan and other Asian countries after some users complained of a stinging sensation or pain in their eyes after using the lenses.

At 2.43PM (EDT), shares of the New Brunswick, New Jersey-based company were trading flat at $57.94.

This article is copyrighted by International Business Times, the business news leader
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