What Is the DePuy ASR Hip Resurfacing System?
The DePuy Articular Surface Replacement (ASR) Hip Resurfacing System is a type of metal-on-metal hip replacement system. Metal-on-metal systems are a preferred choice for hip replacements because they allow for increased stability and range of motion in patients. Metal-on-Metal devices were intended to be longer-lasting and more stable, resulting in a decreased failure rate due to solid construction.
Are There Risks Associated with Metal-on-Metal Systems?
It was believed that metal-on-metal devices would not “wear out” as easily and would not shed plastic fragments into surrounding tissue as other devices did. However, the metal construction has turned out to be dangerous due to the chance that the metal pieces will grate against one another and release metal fragments into the surrounding tissue. The alloy used in the ASR devices is comprised of chromium, cobalt, and molybdenum, all of which can be toxic to tissues.
In addition to possible metal poisoning, some devices may have failed due to the device shape which may be too shallow. This may increase the risk of dislocation.
How Does the DePuy ASR Hip Resurfacing System Work?
In most hip replacement surgeries, the entire joint – including the “ball” and “socket” is removed and replaced with new, artificial joint devices. The ASR Hip Resurfacing products do not remove the “ball.” Instead, the bone is reshaped and capped with a metal prosthetic device to preserve bone tissue in patients that can benefit from bone preservation.
Traditional hip replacement with the removal of the entire joint has been thought to be a greater risk, causing more incidences of hip dislocation. Hip resurfacing was intended to reduce the chance of hip failure due to dislocation.
What Company Manufactures the DePuy ASR Hip Resurfacing System?
The Depuy ASR Hip Resurfacing System is manufactured by DePuy Orthopaedics. The company is a division of the worldwide pharmaceutical and healthcare products company, Johnson & Johnson. DePuy was the first orthopedics products manufacturer in the U.S. with estimated yearly revenue of $8 billion and has designed hundreds of joint replacement and other orthopedic medical devices.
Most of the DePuy products have been very successful, but several of their joint replacement devices, including three hip replacement systems, have caused severe medical injuries:
- the Pinnacle Hip Replacement devices,
- the ASR XL Acetabular System, and
- the ASR Hip Resurfacing System
These three devices have shown unexpectedly high failure rates, and DePuy is facing serious legal problems due to the injuries. Both the Pinnacle device and the ASR line were intended for younger patients with more active lifestyles. The devices were designed to be more stable and to last longer than other devices with an expected lifetime of over 15 years.
What Is a Hip Replacement?
A hip replacement is a surgical procedure that replaces all or part of the hip joint with a prosthetic like the DePuy ASR Hip Resurfacing System. A hip replacement is performed when the hip joint has been either worn down through wear and tear or damaged due to an injury and your ability to get around without pain has been affected.
A hip replacement is typically the treatment of last resort. Your doctor will likely only recommend hip replacement surgery, also known as hip arthroplasty, only when nothing else has worked to treat your pain.
When Would Someone Need a Hip Replacement?
Usually, your doctor will consider hip replacement surgery, which is also called hip arthroplasty, for you if have pain that:
- Continues despite taking medication
- Gets worse when you walk, even if you use a walker or a cane
- Prevents you from sleeping well
- Makes it difficult to walk up or down the stairs
- Prevents you from easily rising from a seated position
Why Would Someone Need a Hip Replacement?
There are a number of different reasons why you might need hip replacement surgery. Some injuries might necessitate such surgery. The most common reason for a hip replacement to be needed is certain types of arthritis, such as rheumatoid arthritis or osteoarthritis, or osteonecrosis.
What Is Rheumatoid Arthritis?
Rheumatoid arthritis is a condition in which your immune system attacks the linings of your joints. It can affect any joint as well as other systems within the body. This condition is classified as an autoimmune disease because the immune system is attacking a part of your own body when it shouldn’t. Those with rheumatoid arthritis experience swelling in the affected joint, pain, bone deformities, and the eventual erosion of the bone.
What Are the Symptoms of Rheumatoid Arthritis?
The symptoms of rheumatoid arthritis include:
- Joints that are
- Stiffness in the joints that’s worse in the mornings or after a period of not moving
- Loss of appetite
What Is Osteoarthritis?
Osteoarthritis is another form of arthritis. Instead of resulting from the body’s own immune system, in osteoarthritis, the problem comes from either an injury or wear and tear. This is the most common type of arthritis, affecting millions of people across the world. In people who have osteoarthritis, the protective cartilage that cushions the ends of the bones so they don’t rub against each other gradually wears away.
It’s possible for osteoarthritis to affect any joint in the body, but it most commonly impacts:
What Are the Symptoms of Osteoarthritis?
The symptoms of osteoarthritis can include:
- A grating sensation
- Hearing cracking or popping noises
- Bone spurs
- Loss of flexibility
What Is Osteonecrosis?
Osteonecrosis is also known as avuncular necrosis and is a condition in which bone tissue dies due to a loss of blood flow to the area.
This loss of blood flow can be caused by:
- Broken bone
- Dislocated joint
- Taking high-dose steroid medications
- Drinking too much alcohol
What Are the Symptoms of Osteonecrosis?
In its earlier stages, there are often no noticeable symptoms. As the condition progresses, however, you might experience mild to severe pain that gradually worsens over time. At first, the pain might only occur when you put pressure on the affected joint. Later on, however, the pain could occur even when not moving.
Is the DePuy ASR Hip Resurfacing System FDA-Approved?
The DePuy ASR Hip System was introduced in 2003 to markets outside of the U.S. It was never fully approved by the Food and Drug Administration (FDA) for use in the U.S., but a portion of the device was approved in 2005 for use in another system. This portion was approved through the FDA’s 510(k) approval process. This process is a shortcut that allows for pre-approval of any product that is “substantially equivalent” to similar, approved products that are already for sale. Obtaining approval through this process allows manufacturers to skip clinical testing in humans before making the device available to the public. The DePuy ASR devices were never fully tested in human subjects prior to release on the U.S. market.
By 2008, the FDA and international health authorities received hundreds of serious adverse event reports regarding the DePuy ASR Hip Resurfacing System.
Did the DePuy ASR Hip Resurfacing System Adverse Events Reports Lead to a Recall?
A British orthopedic surgeon presented a report at an international medical professionals’ meeting regarding the high failure rate, and the Australian Health Authority warned DePuy a number of times regarding the ASR failure rate. The ASR Resurfacing System was withdrawn from the Australian market in 2009, but there was not a recall for the U.S.-approved portion of the device until 2010. In addition, some patients may have received the full device system whose components were acquired outside of the U.S. In 2011, the FDA delivered two letters of warning to DePuy.
Did the DePuy ASR Hip Resurfacing System Cause Side Effects?
The metal-on-metal construction of the ASR Resurfacing system may be the main cause of many serious side effects caused by the device. Metal-on-metal devices have been shown to rub against one another and release metal fragments and metallic ions into the surrounding tissue. As the devices are made of cobalt, chromium, and molybdenum alloy, the metal ions are toxic and may be absorbed into the bloodstream. In addition, some patients have experienced device loosening and joint dislocation.
What Are DePuy ASR Hip Resurfacing System Severe Side Effects?
Severe side effects caused by the ASR Hip Resurfacing System have included:
- Dislocation of the hip joint from device loosening
- Localized metallosis or poisoning due to shedding metal fragments
- Systemic metallosis or poisoning due to the absorption of metal ions into the bloodstream
- Death or dissolution of bone and tissue (necrosis and osteolysis)
- Bone fractures due to damage caused by local tissue inflammation
Patients with these side effects have experienced pain and inflammation causing mobility issues and a requirement for the replacement of the joint. Some patients have required reconstruction surgeries to repair broken, split, or necrotic bone tissue. Additional surgeries for reconstruction or replacement may be much more painful and require longer recovery times than the original joint replacement surgery. In addition, patients who absorb cobalt and chromium into the bloodstream may experience symptoms such as chronic headaches, severe fatigue, rashes, and other inflammatory issues.
Is DePuy Facing ASR Hip Resurfacing System Lawsuits?
DePuy and the parent company, Johnson & Johnson face thousands of lawsuits regarding the ASR devices, including the hip resurfacing system.
More than 90 thousand ASR devices have been implanted worldwide. Experts estimate that up to 40 percent of the devices may fail in the first five years – despite the expected device life of 15 years. More than 10 thousand lawsuits have been filed, including more than 8,000 federal lawsuits in federal courts which have been consolidated into multi-district litigation in the U.S. District Court for the Northern District of Ohio. Thousands of additional cases remain at the state and local levels.
Has DePuy Agreed to Any ASR Hip Resurfacing System Lawsuit Settlements?
The first ASR device trial, filed in California resulted in a judgment of $8.3 million, and Johnson & Johnson, DePuy’s parent company, has agreed to settle the federal lawsuits for a total of $2.5 billion, but more lawsuits may be expected.
How Do I Find a DePuy ASR Hip Resurfacing System Attorney?
If you or a loved one received a hip replacement using the DePuy ASR Hip Resurfacing System and experienced serious side effects or complications, it may be best to speak with an experienced attorney. The team at Seeger Weiss, LLP, can provide you with a consultation to discuss your case and determine the next steps.