Pharmaceutical

Artificial hip recall leads to FDA review of metal-on-metal hip implants

Michael Stieler’s hip replacement surgery brought him relief from the pain he suffered when the cartilage in his right hip had worn down. But a year after surgery, Michael’s pain returned, with a vengeance.

“It hurt. I couldn’t even walk on it,” he told the Sacramento Bee.

It wasn’t until two years later that Michael learned that the problem with his metal-on-metal hip implant was not uncommon. The company that made his artificial hip, DePuy Orthopaedics, notified Michael last September that it was recalling the implants because of early failure rates and the potential for leaching of high levels of cobalt and chromium into the bloodstream.

About 93,000 people are affected by the recall. Many patients who received the defective implants suffered pain and disability from the devices dislocating, loosening or fracturing the bones they were attached to. Many had to undergo revision surgery to have their hip implant replaced.

Traditional hip implants are made of ceramic and metal parts, but some newer devices use metal-on-metal parts with the idea that the metal implants will provide more durability and last longer. The problem is that when the metal parts rub together, they can cause bits of metal to shed into the joint space and bloodstream. This causes inflammation that can lead to problems with the implant. It can also cause a type of blood poisoning known as metallosis, which may lead to renal problems and cancer.

The DePuy recall last fall led the Food and Drug Administration (FDA) to order a review all metal-on-metal implants, manufactured by 21 different companies. The companies are being asked to monitor the recipients of their metal-on-metal devices and assess how they react to the implant.

Patients who have received metal-on-metal implants should discuss any concerns with their doctors, but should also report any problems with their artificial hip to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

The FDA says it will review the data and will determine what recommendations, if any, to make at that time.

Source: Sacramento Bee