One of Johnson & Johnson’s subsidiaries, DePuy Orthopedics, Inc, announced a recall of two kinds of hip implants this past Thursday. This comes after more than two years when the Food and Drug Administration began receiving complaints about the hip replacement implants made by DePuy Orthopaedics.
The company actually received a warning letter from FDA on August 19, 2010. FDA told DePuy Orthopaedics that they were marketing products without the required marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act. Additionally, FDA said, “a review of our records reveals that you have not obtained marketing approval or clearance before you began offering the TruMatch Personalized Solutions System for sale, which is a violation of the law.”
The two products subject to the hip implant recall are the ASR XL Acetabular System, a hip socket used in traditional hip replacement, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur. A DePuy spokeswomane, Lorie Gawreluk said that about 93,000 of these devices have been implanted worldwide.
According to a recent NY Times article written by Natasha Singer, DePuy had sales of about $5.4 billion. Beginning in 2008, FDA received about 400 complaints from patients in the United States who received the devices. The devices first came under scrutiny over the last few years because the devices were part of a category of implants called metal-on-metal bearings. These bearings can generate debris from wear, causing inflammation and damage for certain patients.
On DePuy’s website, the company recommends what you should do if you have received the ASR XL Acetabular System or DePuy ASR Hip Resurfacing System:
• Schedule an appointment with your surgeon. Your surgeon will be able to evaluate how your ASR Hip System is functioning.
• If you are experiencing pain, difficulty walking, or other symptoms, your surgeon may want to take x-rays of your hip. X-rays will allow your surgeon to evaluate how the ASR Hip System is positioned, if there is any damage to the bone and if the ASR Hip System has remained attached to the bone. If the x-rays show problems with your ASR Hip System, your surgeon may recommend surgery to replace it.
• In some cases, your surgeon may order additional blood testing or imaging to ensure your ASR Hip System is functioning well.
• The evaluation may include a blood test that indicates the level of microscopic metal particles around your hip. If the blood test indicates a high level of these particles, your surgeon may want to do a second blood test three months later. These levels may be high even if you are not experiencing any symptoms, so this blood testing is very important.
• If the second blood test still indicates a high level of these particles, your surgeon may want to do an MRI or ultrasound test of your ASR Hip System. If such tests show a reaction to the particles, your surgeon may recommend surgery to replace your implant. This is a decision that you and your surgeon need to discuss based on your own personal health needs.
• If you do not have any symptoms or test results that suggest you may need to have your implant replaced, then you should follow your surgeon’s recommendations for continued follow-up.
• If you do need to have an additional surgery, several options are available and your surgeon will select the appropriate implant system for you.
If you or a loved one has received the DePuy ASR XL Acetabular System or DePuy ASR Hip Resurfacing System and have experienced some type of hip pain, additional hip surgery, or some type of failure with your hip replacement, you may want to contact CSS Firm for a free case evaluation and consultation. Our experienced team of defective hip implant lawyers will work closely with you and see to it that you are compensated for your injuries.