Recall of hip replacement system was the right decision at the right time
When DePuy, a Johnson & Johnson company, decided to recall the Articular Surface Replacement (ASR) Hip System in August 2010, it was the right decision at the right time.
Only at that point did new data from a United Kingdom national joint registry report that 13% of patients were undergoing a second hip replacement surgery, called revision surgery, sooner than expected. We immediately recalled the product in every country where it was sold.
We regret that the ASR hip product did not meet the needs and expectations of some patients and, as a result, our own expectations. Our first priority is patients, and we immediately set up a help line and a program to reimburse patients for medical and out-of-pocket costs related to the recall.
So far, this program has assisted thousands of patients. To our knowledge, this was the first program of its nature and scale ever instituted by a medical device company.
More than 10 years ago, DePuy scientists, working with expert surgeons, set out to design an improved metal hip implant as an option for the increasing number of younger, active patients who needed hip replacement surgery. That is our mission at DePuy: to develop products that meet the needs of patients.
Following years of design and testing, the ASR Hip System was cleared for sale through the regulatory processes of various countries around the world. After the system was on the market, DePuy continued to study the device and closely watched how it was performing.
The company looked at data from a variety of sources around the world and sponsored studies in which doctors monitored patients and reported data about ASR. The company openly and rigorously evaluated the data on the device and shared information with surgeons and regulators.
We firmly believe that DePuy acted properly and responsibly with the information it had and that the full history of ASR shows DePuy is a company working to improve patients' lives through innovation, taking action when necessary and standing by patients today.
We remain dedicated to serving patients who need joint replacement surgery.
Pam Plouhar is the worldwide vice president for clinical research at DePuy.