DePuy Hip Implants
DePuy hip implants are medical devices manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. DePuy Orthopaedics was the top-selling manufacturer of hip implant systems with its DePuy ASR XL Acetabulator Hip System. DePuy also offered a hip resurfacing system, the DePuy ASR, which was never formally approved for use in the United States but was implanted in some U.S. patients in clinical trials or abroad.
As with all metal-on-metal hip implant systems, patients who had a DePuy ASR XL Acetabulator Hip System used in their surgery may experience a host of complications. Thousands of patients who are coping with pain and problems from the DePuy products have taken legal action against the company.If you or a loved one has been harmed, you too may be able to make a claim against DePuy. An experienced metal-on-metal hip implant attorney at Roberts & Roberts can help.
About DePuy Hip Implants
DePuy metal-on-metal hip implants were brought to market under a special FDA provision called 510(k), which allows a manufacturer to obtain fast-track approval of a medical device or product. Products can be brought to market under the 510(k) rules if there is already a similar approved medical product or device.
The FDA approved products based on prior approved devices even when there were known problems with the approved devices, as long as there had been no mandatory recall.
DePuy hip implants work similarly to all metal-on-metal hip implants. The head of the femur fits into an indentation in the pelvis called the acetabulum. The hip implant procedure involves carving out the femur and inserting a stem upon which sits a newly-created femoral head. A cup is inserted into the acetabulum and the newly created hip joint fits inside it.
Traditionally, the cup and the joint were made of a variety of different kinds of non-metallic material. The cup that fit inside the acetabulum, the acetabular cup, was often made of polyethylene. The replacement femur head might have been made of metal or ceramic.
In the mid 2000s, however, a wave of metal-on-metal hip implant devices came to market to serve as an alternative to traditional hip implants. The devices are called metal-on-metal because the acetabular cup is made of metal and the replacement joint is also made of metal.
The metal-on-metal devices were heavily marketed from 2006 to 2009 as a longer-lasting and better alternative to hip implants and the right choice for younger people.
During this time, the British Medical Journal estimates that around 50 percent of hip implant procedures performed on patients under age 50 used metal-on-metal products. When considering all age groups, around 10 percent of patients had a metal-on-metal product implanted. DePuy was the top seller among the metal-on-metal devices, and around 93,000 people throughout the world received a DePuy hip implant system.
Complications with DePuy Hip Implants
Problems with DePuy hip implants developed almost immediately. By 2008, the FDA had received numerous complaints about complications related to metal-on-metal hip devices, especially those manufactured by DePuy. An internal DePuy Orthopaedics memo in 2008 also indicated that the manufacturer knew of potential risks to patients but failed to act.
Researchers began to investigate complaints and found a high failure rate.Arthritis Today indicated that experts believed that one out of every eight patients who had a DePuy hip implant would experience a failure or complications within five years, necessitating a revision surgery. This would be a 12 percent failure rate, which Arthritis Today reported was around twice the industry average.
Data from the British Hip Society Annual Conference, on the other hand, indicated a much higher failure rate with an estimated 49 percent of patients experiencing failure of a DePuy product. The British Hip Society reported the industry-wide average failure rate, including all brands of metal-on-metal devices,was between 12 and 15 percent.
The complications for patients are very serious. When a hip implant device fails, most patients will need to have the device removed, a complicated process since the acetabular cup can fuse to the pelvis and be very difficult to remove. In many cases, an extensive reconstruction is required as part of the revision surgery.
Patients can also experience a variety of different symptoms and medical problems arising from a failed hip implant device.
For example, patients may experience:
- Aseptic loosening, which means that the implanted components of the hip implant device are coming loose. Usually, the acetabular cup is the part of the hip replacement system that comes loose. When the loosening occurs, patients may experience a lot of pain and are at risk of developing an infection.
- Metallosis, a build-up of metal ions inside the body,happens when the metal components of the hip implant device rub against each other.The FDA and the British Medical Journal both warn about the complications of the build-up of metal ions in the body. These ions could damage the heart, thyroid, nervous system, liver, lymph nodes and kidneys.
- Pseudo-tumors result when metal ions from the breakdown of the hip implant device become loose in the body. Patients can develop a collection of fluid and metal pieces that looks like a tumor.
- Osteolysis, which is loss of bone resulting from the release and/or build-up of metal in the body. The American Academy of Orthopedic Surgeons warns that the number of people needing a revision procedure because of osteolysis is likely to go up dramatically over the next decade.
When the metal in the body gets into the bloodstream, patients can also experience a host of neurological problems. The consequences of the damage to the nervous system can run the gamut from having a bad taste in the mouth or ringing in the ears to having terrible headaches or experiencing problems with memory or cognitive function.
Sometimes, even removal of the defective hip implant device will not resolve these or other health problems. This means patients could be left with permanent injuries from DePuy hip implant devices. There is also some evidence suggesting that there may be a link between the buildup of metal in the body and an increased risk of cancer.
Side Effects from a DePuy Hip? Our Defective Medical Device Lawyers Can Help
There is a serious cost associated with the development of problems in DePuy hip implants. In addition to the expense and pain of additional surgical procedures, you may have to take time off of work, and you may never recover 100 percent from the damage done to your body.
If you or a loved one has suffered complications related to a DePuy metal-on-metal hip implant or a metal-on-metal hip replacement, you could be entitled to compensation.
The defective medical device attorneys at Roberts & Roberts are currently investigating claims related to hip implants and hip replacements. For a free, confidential review of your claim, call us today at 903-597-6000 or 903-597-6000 or contact us online. The call costs you nothing … It could mean everything.