DePuy May Have Known of ASR Issues Since 2005

Updated on: 11/11/2019

It is possible that DePuy Orthopaedics was well-aware of the safety hazards associated with their metal-on-metal ASR hip replacement devices as far back as 2005, according to an investigation conducted by the British Medical Journal (BMJ).

In 2005, the FDA gave DePuy – a division of Johnson & Johnson – special clearance to bring the ASR devices to market without a clinical trial period to determine risk factors.

But in 2010, the National Joint Registry of England and Wales (NJR) released data revealing that one out of every eight recipients of the ASR replacements had reportedly undergone revision surgery less than five years after the implant. In general, hip replacement systems are designed to function properly for approximately 15 years before any repair or replacement is necessary.

“Hundreds of thousands of patients around the world may have been exposed to toxic substances after being implanted with poorly regulated and potentially dangerous hip devices,” says Deborah Cohen of the BMJ.

DePuy Hip Replacement Statistics

Upon receiving the statistics from the NJR in 2010, DePuy initiated a worldwide voluntary recall of the hip replacement devices. However, in an apparent attempt to rebound from the obvious financial loss that came from the recall, DePuy promoted its metal-on-metal hip replacement devices “as an alternative for the majority of patients.”

Eyebrows raised after it became known that DePuy’s promotion of the device as a safe alternative option came approximately one year after Japanese surgeons had attempted to contact the company to report issues they had experienced with the device.

According to an internal DePuy email, the Japanese surgeons reportedly noticed that the device “generated metal debris between stem taper and head, and final necrosed tissue.” In another internal email, a senior DePuy executive stated he felt “the problem is emerging as more serious than first thought.”

It is estimated that over 500,000 patients have received an all-metal replacement hip, and that 75 percent of the complaints filed have been connected to DePuy’s ASR. In 2011, the FDA received over 5,000 complaints regarding DePuy’s ASR device – more than they had received in the previous four years combined.

Patients Suffering From Injuries