May 12, 2015 - The DePuy ASR recall and subsequent litigation could represent one of the biggest medical device failures in recent history. DePuy, a subsidiary of Johnson & Johnson, recalled the ASR in 2010 because of an extremely high failure rate as well as many consumers reporting symptoms of metallosis and metal toxicity. Just a few years ago, metal-on-metal hip devices like the ASR accounted for at least one in three hip devices implanted in the U.S. Now, they reportedly account for less than 10%, due to the many problems associated with the all-metal hips.
There were approximately 93,000 of the DePuy ASR hip devices implanted across the globe, beginning in 2005 when the FDA approved the DePuy ASR hip implant, based on its substantial similarity to the DePuy Pinnacle hip implant. Less than a year later, problems began arising with the ASR, especially in women and those with weaker bone structures. In 2009, Australian officials discontinued sales of the implant; the official statement of DePuy and Johnson & Johnson was that the implant was pulled in Australia due to a decline of sales, not for safety reasons.
The ASR Design and DePuy ASR Hip Dangers
The ASR hip implant design was believed to reduce the risk of dislocation, and was marketed as being particularly good for the younger, more active patient. DePuy noted that although there had been “theoretical concerns” regarding excessive metal ion debris release from metal-on-metal implants, no definitive data existed to support those theories. In fact, it was later found that during periods of activity, the metal components of the ASR hip implant chafed against one another, causing tiny cobalt and chromium ions to release into the bloodstream and the hip tissues.
DePuy ASR Hip Metallosis and DePuy ASR Hip Metal Toxicity
When the metal ions delve into the surrounding hip tissues, symptoms of metallosis can occur. These symptoms include inflammation, chronic pain in the hip, groin and thigh, deterioration and destruction of tissue and bone, failure of the hip implant and the necessity for the patient to undergo hip revision surgery. When the cobalt and chromium ions of the DePuy ASR enter the bloodstream, metal toxicity or metal poisoning can occur. Symptoms of metal poisoning include irritability, anxiety, depression, vision and hearing loss, cardiovascular issues, chronic pain, reproductive disorders, renal and thyroid problems, skin rashes, DNA disruption, the formation of pseudo-tumors and neurological disorders.
Failure Rates of the DePuy ASR Hip
Prior to the August, 2010 recall of the ASR, the National Joint Registry of England reported a failure rate of about 13% within five years of implantation—a number that is considered very high. By 2011, however, following the recall, the same organization updated their findings, raising the failure rate of the ASR to 33% within five years of implantation. Depending on which research you believe, the failure rate could be as high as 65%, which means that fully half of all those with a DePuy ASR could suffer failure of their ASR hip implant, and require revision surgery.