Depuy ASR Implant Failure — Continued Pain for Patients
Published by Brenda Fulmer in Defective Design, Mass Torts, Product DefectIt has now been more than a year since the DePuy ASR implant was recalled due to an alarmingly high rate of failure of the device, which was first documented in Australia and Europe years ago, at a time when the hip implants enjoyed continued strong sales in the United States.
For tens of thousands of patients, the past 15 months or so have been ones filled with extreme anxiety, pain, and frustration because of the following:
- Receiving countless empty promises, significant delays, and the proverbial “run around” from the Broadspire “claims program,” which has been far more kind to surgeons and healthcare providers with unpaid bills than to injured patients.
- Experiencing significant fear and apprehension over blood tests showing elevated levels of cobalt and chromium in their bloodstream, without any clear answers as to what harm this might cause them over time and what can be done about it.
- Enduring yet another painful hip implant revision surgery. In some cases, within mere months of their original surgery (at which time, they were promised by DePuy that they would not have to undergo this ordeal for 15 years or more due to the alleged proven performance and superiority of the DePuy ASR and other metal-on-metal hip implant products over traditional ceramic and plastic liners).
Thousands of patients have suffered significant complications and have had less than favorable outcomes due to the trauma of extra procedures, complications stemming from metallosis and inflammatory reactions to the metal-on-metal surfaces, pseudotumor formation, infections, and other serious side effects.
Thankfully, scientists are working to answer questions that DePuy should have answered long before their first DePuy metal-on-metal device was implanted in patients. Several studies have been recently published that help to expand the understanding of the systemic reaction that is triggered by metal-on-metal implants in patients as well as why these devices are failing at alarmingly high rates. The recent most findings by scientists are:
- Cobalt and Chromium Ions Reduce Human Osteoblast-Like Cell Activity In Vitro, Reduce the OPG to RANKL Ratio, and Induce Oxidative Stress, published in the Journal of Orthopaedic Research, on October 24, 2011 – This study focused on how elevated levels of cobalt and chromium in the blood reduce the number of osteoblast-like cells and essentially impair the body’s ability to normally regenerate and maintain healthy bone. Ultimately, the authors concluded that patients with elevated levels of chromium and cobalt in the blood are at risk for impaired bone health and that consideration should be given to removal of their metal-on-metal hip implants, even when x-rays and other evidence indicate that the DePuy ASR or other metal-on-metal implants are properly positioned without solid evidence of loosening.
- Corrosion Fatigue of Biomedical Metallic Alloys: Mechanisms and Mitigation, published in the Acta Biomaterialia, in 2011 – This highly complex medical article from Brazil includes a review of the professional literature that has been published around the world on the scientific explanation for the widespread premature mechanical failure of metal-on-metal hip devices due to corrosion. The study focuses on a number of different metals and alloys including titanium, surgical-grade stainless steel, cobalt, chromium, and magnesium. The study also focuses on wear patterns, development of fatigue cracks, pitting corrosion, and formation of crevices at the taper junction, which allow infiltration and pooling of bodily fluids that induce corrosion and cause the release of metallic ions. The processes of corrosion and metal fatigue combine to lead to premature failure of the devices, which necessitated the recall of the DePuy ASR implants, but, so far, has not resulted in the recall of a number of other metal-on-metal devices manufactured by DePuy (including some models in the popular Pinnacle family) as well as similar MOM products manufactured by Zimmer, Stryker, Biomet, Smith & Nephew, and other medical device companies.
- Pseudotumor from a Metal-on-Metal Hip, published in The Journal of Rheumatology, in 2011 – This publication from physicians in Tokyo includes a graphic, intra-operative photograph of a revision surgery where the synovial tissue has been stained due to the metallosis process. This same staining as well as the presence of abnormal appearing inflammatory fluid and even metal shavings have been noted in other patients, including some of my clients, who have undergone revision surgeries following the DePuy ASR recall. In the Japanese patient featured in this medical report, the surgeons noted the presence of pseudotumors in the patient’s pelvis, thigh, and gluteal region, which were triggered by a breakdown in the chemical properties of the metallic surfaces of the patient’s hip implant. This patient’s pseudotumors and obvious inflammatory reaction occurred about three years after being implanted with an Encore Medical metal-on-metal hip implant, a product that is now sold by DJO Surgical of Austin, Texas.
While the steady stream of new scientific reports are helpful to patients pursuing lawsuits against DePuy and other manufacturers, it is little comfort to those duped into implanting themselves with a toxic, defective product and are now faced with scary prospects with regard to their medical and surgical future. While the Food & Drug Administration (“FDA”) has noted that it has been looking into safety issues for the past 15 months, the FDA’s slow pace in issuing stronger safety alerts and/or recalling defective metal-on-metal implants has resulted in tens of thousands of patients not being properly monitored for toxicity due to a lack of awareness by surgeons, patients, and the public. I hope that the flood of new information will be disturbing enough for the FDA to act more definitively.














