It has now been eighteen months (August 2010) since the DePuy Acetabular Hip Replacement System (ASR Hip) was recalled. Approximately 37,000 DePuy Acetabular Hip Replacement Systems were implanted in the United States.There are many folks who had hip replacement surgery with these one of these devices but remain unaware of the recall or whether or not their hip is defective. It is important for all those who may have been affected—and their family members—to understand the DePuy hip recall and its potential affect on their life.
The DePuy hip recall involves 29 models of the ASR 100 and 300 Acetabular Implants in cup sizes ranging from 44mm to 70 mm.
The DePuy ASR is a metal-on-metal hip replacement system developed in 2005. Physicians have been warning about problems with metal-on-metal hip implants, which can release metal particles into the body, known as metallosis. The metal particles can damage soft tissue, cause inflammatory reactions and lead to bone loss.
The hip system includes “ball and cup” components to copy the socket and ball of the femur in the human hip. Most hip replacements include both metal and plastic parts. But, the ASR Hip that was recalled was unique in that it puts a metal “ball” component in direct contact with a metal “cup.” This metal-on-metal contact may be at the heart of the problem with the medical device. These new hips achieved U.S. Food and Drug Administration approval to market the devices for use in 2005. They used a shortened approval system (501(k) process) to obtain FDA approval without having to undergo clinical trials.
Fixing the problem usually required the patient to undergo a painful and risky second surgery to replace the replacement. Reports appeared in the media about the problem as early as 2007, and the DePuy device manufacturers knew well before that of the reported issues with the devices. Yet, even after this time, patients were still given the device. Doctors investigating the evidence have explained that the company had significant data early on which indicated that these devices were failing at a far higher rate than other devices.
It wasn’t long before it became known that the DePuy hip defect was likely design-related. In other words it was not a problem with the actual manufacturing of the device but the whole idea of the device itself. Great idea on paper, crappy idea in practice. Even the surgeon that designed the hip admitted in 2008 that the company knew that there were problems with the hip early on. Yet, despite this knowledge the company continued to sell the device—raking in more than $5.4 billion in 2009 alone. It wasn’t until August of 2010 that the device was officially recalled by the FDA. Upon notice of the recall, the company admitted that 13% of all those who received the device may need revision surgery. Approximately 93,000 DePuy ASR hips were implanted worldwide,this amounts to 10-15,000 patients with problems currently. And this number is likely to increase as the failure rate increases with time and may eventually involve all of the 37,000 patients in the US, if they should live that long.
Johnson & Johnson now faces about 3,500 DePuy ASR hip lawsuits and another 500 lawsuits over its DePuy Pinnacle hip system, which are both metal-on-metal hip replacements.
All suits filed in federal district courts throughout the country over problems with the DePuy ASR hip have been consolidated for pretrial proceedings in the U.S. District Court for the Northern District of Ohio as part of an MDL, or multidistrict litigation.
What a mess, I would encourage all patients who have been implanted with a Metal on Metal hip to seek medical opinion and close monitoring of their device. We have not seen the end of the DePuy story and in fact the current number of lawsuits, may represent the tip of the iceberg.