Pharmaceutical

DePuy’s tests on metal artificial hip system failed to show potential dangers of device

DePuy ASR hip recall 435x369 DePuys tests on metal artificial hip system failed to show potential dangers of deviceOrthopedic doctors were optimistic when metal-on-metal hip replacement systems were first introduced around the world. They offered a seemingly more durable alternative to traditional ceramic or plastic artificial hips. The devices were especially attractive to younger recipients, who wanted to go back to a more active lifestyle.

DePuy Orthopaedics, a subsidiary of Johnson & Johnson, introduced the DePuy ASR metal-on-metal hip replacement system and hip resurfacing system. The hip replacement system was quickly approved in the United States without prior human testing because it was similar to devices already on the market. However, the Food and Drug Administration (FDA) refused to approve the resurfacing system until more data was available. Health Canada approved both of the DePuy ASR hip systems.

Instead of safety data on human patients, DePuy presented “more than 60 tests on the devices, including lab tests, wear tests, torque testing and many others,” DePuy Canada representative Jennifer Goode told The Globe and Mail. The company also used “hip simulators that ran five million cycles of motion, representing 2 ½ years of use by a patient.” Goode added that DePuy’s efforts “exceeded the international standard.”

Unfortunately, it wasn’t enough to reveal the potential dangers posed by the all-metal implant. Shortly after the devices were marketed worldwide, reports of premature failures began mounting. Hip implants are expected to last 20 years or more, but for hundreds of people, the DePuy device was failing within a matter of years.

What’s worse is that the metal device was corroding inside some patients, leeching chromium and cobalt into the bloodstream, causing a type of blood poisoning known as metallosis. No one is entirely sure of the long-term effects of metallosis, but researchers say it can damage DNA which can lead to serious health problems including cancer.

The first of more than 10,000 lawsuits against DePuy was recently tried, and jurors awarded $8.3 million to the plaintiff in that case.

Source: The Globe and Mail