For people suffering from arthritis pain or severe joint damage, hip implant replacement surgery can work wonders. However, the ASR hip implant replacement devices have proven that advancing medical technology can also have its draw backs, such as having the best of intentions but giving the worst of results. In 2005, the FDA allowed DePuy, a subsidiary of Johnson & Johnson, to market their ASR metal-on-metal hip implant replacement devices without clinical trials. By 2010, reports showed that DePuy’s hip replacement implant devices had a failure rate as high as 33% (and 13% for all-metal devices on average). Why is the failure rate so high? Listed below are three of the most-related factors identified as the primary cause for such a high failure rate.
Lack of Clinical Trials
One of the biggest contributing factors in the high failure rate of the ASR hip implant replacement device is the absence of examination by the FDA. DePuy bypassed the FDA through a process called the 510k, where companies can opt to prove that their new product is substantially equivalent to an older product. This is logical to some degree and can speed up the process for many companies for the better. However, it is has been made clear in this case that the 510K procedure should be re-evaluated and have stricter guidelines imposed.
The compatibility of DePuy’s hip implant replacement device with the human body is the most direct contributing factor with the highest amount of impact on patients. Originally, the metal-on-metal device was meant to be stronger and more durable, but unfortunately it was not without side effects. Because of the motions the hip implant replacement device is subjected to, metal debris is created and released into the blood stream of patients. In many cases, metallosis was a common side effect that caused local inflammation and scarring. Metallosis also caused bone loss and necrosis in many patients as well. As a result of the severe negative backlashes of the ASR device, countless patients had to get revision surgery.
After thorough examination, many engineers have noted that the implant is much shallower than other hip implants, which greatly increased the difficulty of surgically attaching the replacement. DePuy was fully aware of this flawed design but did not make any effort to rectify this, aside from recommending extremely precise surgery. The surgery was precise to the point where only a small amount of surgeons would be able to install the implant properly. Not only was the implementation of the implant flawed, but the cup and socket also did not fit properly. This is was the primary cause for the increased friction that resulted in excess amounts of metal debris being released into the bloodstream.
Few Last Words
Because of DePuy’s oversight, many patients paid doubly for its mistakes – making it twice as hard to make a hip implant recovery. It is especially unfortunate for those who had hip implant surgeries around the time DePuy made the recall in 2010, since DePuy should have initiated a recall after getting a high volume of complaints within 3 years of the release of the device. As new advances are made in medical technology, both patients and professionals should be careful when deciding which procedure and devices to use.
[box type=”info”]The Parker McDonald law firm & the firm of Harrison, Davis, Steakley, Morrison have composed a team of legal professionals focused on defending patient rights against negligent medical corporations. The Hip Implant Recovery team specializes in lawsuits related to failed hip implant systems. For more information about recalled and failed hip implants visit our blog.[/box]