After Much Controversy, Popular Hip Implant to be Phased Out
Posted on Mar 26, 2012 1:00pm PDT
When the manufacturer of a popular hip implant made the decision to "phase out" their device and sell the remaining shares in 2009, many believed that this defective medical device was finally going to be pulled from operating rooms and patients will no longer have to suffer. A letter from the United States Food and Drug Administration, or FDA, in this same year revealed pertinent safety data about the implant and asked the company to begin removing this product from the market. The agency had told the company of the hip implant that blood tests of patients who have received the device revealed a "high concentration of metal ions" in addition to other issues that labeled this product as "concerning" to the agency. Officials from other countries also wrote in showing the company that their implant had performed "somewhat more poorly" than the data that was submitted by the company's original studies and had a relatively high premature failure rate.
Johnson & Johnson's DePuy Orthopaedics all-metal hip implant is the allegedly defective medical device currently in question, and has been the center of many heated debates for several years. The FDA confidentially provided information to Johnson & Johnson to reveal that they were going to turn down the company's application to sell the product in the United States, with the letter focusing mainly on the problems with the study data submitted by DePuy to support the safety and effectiveness of the artificial hip implant. The letter requested that DePuy should add additional safety data if it wished to continue any further on their application.
Although the letter was sent in 2009, no action was taken until August 2010. The company did not issue a recall for this device or the companion model for a year, although reports indicate that the company began issuing a strategy to phase out the devices just a month after receiving the letter and selling the remaining stocks for use in patients both in the United States and foreign countries. While there is not an exact number that reveals how many patients in total have had this model of the hip implant, called the articular surface replacement or ASR, records show that nearly 93,000 patients across the entire world have received this model in an eight year period.
Not only is this product deemed dangerous due to its high rate of premature fail within several years (it is supposed to be effective for up to 15 years), but it has also been known to cause debilitating injuries sometimes caused by the wearing of the metal implant. However, the company insisted that they are phasing out the product not due to a lack of safety, but due to the decrease in sales of this product. Company representatives insist that they have acted in an appropriate and timely manner by recalling the implant when they did, stating that they did not have sufficient information to prove that the model was not performing as well as other competing implants.
If you or someone you know has been harmed due to the DePuy hip implant or a similar medical device, you need the help of a medical malpractice attorney. Only a lawyer in your area will be able to help you file a claim in relation to medical injuries or conditions that were acquired due to a defective medical product, such as this hip implant. When a company puts a new product out on the market, they are expected to have undergone extensive investigation and testing procedures to ensure the safety of patients who may be using this product. If not, they may be held liable for their failure to maintain the safety of the public. Don't hesitate to contact your local medical malpractice lawyer right away if you need help with filing a claim!