August 24, 2010—Johnson & Johnson's joint replacement business, DePuy Orthopaedics, Inc., announced a voluntary recall of its ASR™ XL Acetabular System hip replacement following a report published in Great Britain which revealed that about one in every eight patients required corrective surgery within five years of implantation. Specifically, the revision rate for the ASR™ Hip Resurfacing System is 12 percent and for the ASR™ XL Acetabular System is 13 percent.
Since early 2008, the Federal Food and Drug Administration (FDA) has received hundreds of complaints about DePuy ASR™ Implants. Most of these patients required removal and replacement of the devices following their implantation.
Orthopedic experts say the problem with the DePuy implant rests primarily in the design of the ASR™ hip replacement cup. It is more shallow that other hip replacement devices. In addition the ASR™ cup has been found to be more difficult for surgeons to implant at the proper angle.
Because the DePuy Implants are metal-on-metal total hip replacement units, they can produce metallic particles as they age and wear. The result in some patients is severe inflammatory reaction which may damage surrounding soft tissue.
Both DePuy hip replacement devices were implanted in patients between 2003 and 2009, when Johnson & Johnson ceased production of them. More than 90,000 DePuy hip implants were sold worldwide before production was discontinued. Based on the documented failure rates for the devices, it is anticipated as many as 11,000 patients will eventually require painful and disabling hip replacement surgeries to remove the defective DePuy implants and replace them with other units. Many patients who received the ASR™ hip implants are likely to eventually require explantation of the devices even though they are presently symptom free. All patients with these DePuy implants are encouraged to promptly consult their physicians for evaluation and to arrange for future monitoring.
In connection with the recall, DePuy announced it will reimburse implant patients for reasonable medical expenses, but only if they sign medical release forms giving the company broad access to their personal and otherwise private medical records. Furthermore, these reimbursements are greatly limited in that they extend only to out-of-pocket costs that are not covered by the patient's medical insurance. There is no compensation for pain and suffering, disability, nerve or tissue damage or any loss of income associated with the defective DePuy hip implants.
For these reasons, we encourage all DePuy hip replacement patients to consult with a lawyer who is experienced in dangerous medical device litigation before attempting to deal directly with DePuy or Johnson & Johnson. |
