Recent reports involving the DePuy ASR hip replacement implants have been cause for concern in the orthopedic community as patients have experienced serious complications resulting from the device. These reports involving the ASR hip replacement, the purpose of which is meant to help patients recover and increase mobility, have instead in some cases, caused serious injuries requiring revision surgery.
The metal-on-metal implants were designed to have a lifespan of about 15 years, but have been discovered to have an alarmingly high failure rate with an ever-growing number of cases.
United Kingdom Registry Data
The DePuy ASR hip replacement has been at the center of medical controversy for the past few years including a recall in August 2010 initiated by Johnson & Johnson (J&J). The U.S. Food and Drug Administration (FDA) voluntary DePuy ASR hip replacement recall was on the heels of troubling statistics after reviewing data revealed by the United Kingdom (UK). More than 90,000 devices were included in the recall. DePuy Orthopaedics is a subsidiary of pharmaceutical giant Johnson & Johnson.
The UK joint registry revealed that 13 percent of ASR hip replacement patients had to undergo revision surgery due to debilitating injuries allegedly caused by the all-metal hip implant. According to the UK registry, the injuries reported concerning the DePuy ASR hip replacement included from severe pain to life-threatening complications such as metal poisoning (metallosis).
Metal poisoning occurs when toxic levels of metal build up in the body. This can cause damage to tissue, bone, and the nervous system. Symptoms of metallosis may vary, but one of the most common symptoms is tissue or bone death, called necrosis.
Most of the complications associated with metal-on-metal hip implants stem from the ball and socket components of the device. The components of the metal-on-metal hips are made of cobalt and chromium alloy. These components may shed metal ions into the blood stream causing dangerous levels exacerbated by simple everyday actions such as walking.
Product liability attorneys at Parker Waichman are actively reviewing potential lawsuits regarding medical devices including DePuy ARS hip replacement implants.
DePuy ASR Background
The DePuy ASR hip replacement is a metal-on-metal hip implant, which is implanted into patients who have a damaged hip joint and have thereby lost some mobility. Upon the first release of metal-on-metal hip implants in the United States, they were believed to be superior to their ceramic and plastic counterparts.
These newer, all-metal hip implants were promoted as being longer lasting than other hip implant choices, as well as being customized to patients. In addition, metal-on-metal hip implants were considered a better choice for younger patients, as they could tolerate more strenuous physical movements such as running or other types of exercise.
Despite all of these clearly attractive benefits ensuring the initial popularity of the metal-on-metal hip implants, unfortunately for their patients, injury reports began to mount directed to their manufacturing companies as well as to the FDA.
FDA Fast-Track Approval
Many of the metal-on-metal hip implants were approved by the FDA through the 510(k) fast-track program. This allows for new products to be released into the market in a streamlined process provided the newer product is “substantially equivalent” to a similar product or device previously approved by the FDA. This means the newer product can forego the thorough, premarket testing and evaluation and be made available to the public faster.
Although Johnson & Johnson and other manufacturing companies have reportedly been aware of the potential complication the metal hip implants posed to their recipients, the companies have allegedly neglected to warn the public.
Prior Lawsuits Involving DePuy and J&J
The plaintiff in the first trial following the 2010 recall was a former professional dancer who received two artificial hips. She claimed that the DePuy’s hip J&J manufacturer, did not warn her about the potential risks of the implant. According to the complaint, the plaintiff sought at least $15 million in damages.
In 2010, J&J recalled its 93,000 ASR hips worldwide, which included 37,000 hip implants in the U.S. The recall came after the discovery that over 12 percent of them failed within five years of being implanted.
Have You Been Injured by a Metal-on-Metal Hip Implant?
If you or someone you know has sustained injury associated with a metal-on-metal hip implant, you may be eligible for valuable compensation. Parker Waichman personal injury law firm has handled many cases involving a broad spectrum of devices, including DePuy ASR hip replacement implants. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).