DePuy ASR Hip Implants
CANCER ALERT: Metal-on-Metal Hips and Prosthesis with Poorly Designed Metal Femoral Neck/Tapers Release Potentially Carcinogenic Cobalt Into Body
UPDATED INFO RELEASED NOVEMBER 2016:
On August 26, 2010, DePuy, a subsidiary of Johnson & Johnson (J&J), recalled its DePuy ASR metal on metal (MoM) hip system. The ASR MoM system was identified as causing increased incidents of metallosis or adverse tissue reactions (commonly referred to as ALVAL – short for aseptic, lymphocyte-dominated vasculitis-associated lesions). The patient’s immunological response often involves the creation of pseudotumors by which the body is attempting to wall off the insulting agent or toxic substance. After the ASR hip recall and commencement of litigation, metallosis relating to other MoM systems surfaced, including: the DePuy Pinnacle MoM system; the Wright Medical Technology Conserve system; the Biomet M2a Magnum or large diameter head system; and the DJO Encore MoM system. Litigation began relating to those allegedly defective hip systems largely premised upon a position that the metal on metal design itself, though touted as promoting longevity, did not provide benefits that outweighed the risks of metallosis and related injuries to patients. This was confirmed by the Food and Drug Administration (FDA) in its issuance of a 522 Post-Marketing Surveillance Study – by which these companies were required to initiate a study similar to a clinical trial to determine the true risk benefit profile and undergo proper scrutiny.
In addition to MoM systems, however, other metallosis problems surfaced in relation to the taper neck junction, stem and/or taper and trunnion connection. These connections by which the head or ball is affixed to the stem involve metal on metal configurations or combinations. Moreover, other manufacturers designed modular neck systems with an additional metal piece used to interface between the head/ball and top of the stem. These systems are likewise being litigated and allegations are made that the design and type of metals are defective. They include: Stryker Rejuvenate and ABG II modular neck system; Stryker Accolade TMZF; the Wright ProFemur; the Zimmer M/L taper with Kinectiv Technology; the Omnilife Apex Arc system; and Smith & Nephew SMF stem.
Scientists and physicians have published a significant body of literature associating MoM systems and those with metal on metal taper/trunnion corrosion and modular stem configurations with both localized hip related tissue death and cyst formation. Moreover, consensus has grown regarding systemic effects from the release of cobalt and chromium in the body of patients with a failing hip system, including: eye sight loss; hearing loss; cognitive impairment; cardiomyopathy and polycythemia. However, questions have always been raised about a potential for cancer secondary to failing hip systems. Early literature discounted this association. However, the U.S. Department of Health and Human Services have just published its 14th Report on Carcinogens which now includes the metallic element cobalt and cobalt compounds (that release cobalt ions in vivo). The National Institute of Health’s official announcement includes the following:
Cobalt and cobalt compounds that release cobalt ions in vivo are being listed as reasonably anticipated to be a human carcinogen. The listing for cobalt includes different types of cobalt compounds that release ions into the body. It does not include vitamin B-12, because cobalt in this essential nutrient is bound to protein and does not release cobalt ions. Cobalt is a naturally occurring element used to make metal alloys and other metal compounds, such as military and industrial equipment, and rechargeable batteries. The highest exposure occurs in the workplace and from failed surgical implants. The listing for this metal and its compounds is based largely on studies in experimental animals.
The Report on Carcinogens prepared by the National Toxicology Program (NTP) is a federal program which operates with the goal of safeguarding the public by identifying substances that may affect human health. It can be found here:
If you or a loved one suffered from elevated metal ion levels and onset metallosis, please call us for an immediate consultation.
High Failure Rates Often Require Revision Surgery
DePuy ASR Hip Implants Recall Update
DePuy Orthopaedics Inc., a unit of Johnson & Johnson, recalled its ASR XL Acetabular System and DePuy ASR Hip Resurfacing System, Aug. 26, 2010, due to early system failures. The Associated Press reports this is the 11th Johnson & Johnson recall since last September.
The most recent recall is based on early failures. According to reports, about 13 percent of people who had a ASR total hip replacement have needed to undergo replacement surgery within five years. And, some 12 percent of people who received the ASR resurfacing device (outside of the U.S.) needed to have the device removed within five years.
The FDA says it has received about 400 patient complaints regarding these metal-on-metal hip implants since 2008. Some patients claim their implants failed within three years. Hip implants should last approximately 15 years.
Symptoms of hip implant failure can include pain, swelling and difficulty moving or walking. These signs may indicate that the hip implant is loose, a fracture has occurred in the bone around the implant, or that the implant’s ball and socket dislocated.
According to a DePuy spokeswoman, some 93,000 metal-on-metal hip implants are included in the latest hip implant recall.
Early Failures in ASR Hip Implants
DePuy Orthopaedics, the orthopedic arm of Johnson & Johnson, announced that it is withdrawing its ASR hip implant from the market after increasing reports of the device failing soon after implantation. The ARS device is one of several models sold by DePuy and is known as a “metal-on-metal” implant. While hip implants typically last 15 years or more, doctors have been reporting that the ASR implant has been failing soon after implantation in many patients; often within two years.
A group of Australian researchers led by Stephen Graves, MD, has discovered that patients with the ASR implant require revision surgery significantly sooner than patients implanted with similar devices. In December 2009, DePuy took ASR off the market in Australia. Later that year, it announced that it would phase out sales of ASR worldwide due to declining sales. Then, on March 6, the company stated that it had reviewed the Australian data and concluded, “This is new and important information surgeons who continue to use ASR should have to inform their clinical decision making.”
About Hip Replacement Surgery
Hip replacement surgery, also known as total hip arthroplasty, is the process by which a diseased hip joint is removed and replaced with an artificial joint (prosthesis). Hip prostheses consist of a ball made of metal or ceramic and a socket lined with plastic, ceramic or metal. Hip implants are biocompatible, which means that they are designed to be accepted by the body.
Most people undergo hip replacement as a result of joint damage due to arthritis or injury. After recovery and rehabilitation from surgery, many hip replacement patients experience a reduction in pain and an increased range of motion in their hip joint.
An alternative to total hip replacement is hip resurfacing, in which much of the patient’s bone is retained, but covered with surface material.
ASR is used in both total hip replacement and hip resurfacing. Although the ASR resurfacing system has not been approved by the FDA for use in the United States, it has been used abroad for years. In addition, the FDA approved use of ASR components in traditional, total hip replacements in 2005. Since then, many U.S. patients have received ASR hip components.
Problems with ASR Implants
Since the start of 2008, the FDA has received about 300 complaints regarding the ASR implant, most involving patients who had the implant removed soon after receiving it.
Orthopedic surgeons believe there may be a couple reasons for failures in ASR.
Because the ASR is a metal-on-metal device, experts believe it may generate an excessive amount of metallic debris as it wears. This debris can cause a severe inflammation response, leading to damage in muscles and other soft tissue.
There are also concerns that the socket component may be particularly difficult to implant properly. Some surgeons believe that the reason for the poor outcomes is that the ASR cup is shallower than that of similar devices.
DePuy ASR Lawsuits
Many doctors report that DePuy was informed of the problems with the ASR two years ago, but did not act to inform patients or address the health problems resulting from its product. If you believe that you or someone you love has been harmed by a DePuy implant, please consult an experienced defective medical devices attorney at AWKO Law by calling (844) 794-7402.