The DePuy Articular Surface Replacement (ASR) XL Acetabular Hip System and the DePuy ASR Hip Resurfacing System, also known as revision surgery, are part of a class of large-diameter, metal-on-metal (cobalt ball and chrome socket) monoblock hip resurfacing and replacement medical devices.
The ASR XL hip system was created as an alternative to total hip arthroplasty, which means the surgical repair of a joint. The device was intended for replacement and resurfacing procedures, and in theory offered greater range of motion than previous products. The systems were primarily recommended by surgeons to treat younger, more active, patients. The primary benefit of DePuy devices to patients was supposed to be a more stable design, which would lessen the chance of dislocation and other complications.
In 2003, the DePuy ASR was approved by the U.S. Food and Drug Administration (FDA). The ASR XL model, which was based upon the previous design, was approved in 2005 by a method known as the 501(k) approval. This method, according to the New York Times, allows for certain medical implants to gain approval without undergoing the same series of clinical trials required of the earlier, similar device. Such approvals allow manufacturers to rapidly make small changes to a device to improve it. They also have created a loophole, experts told the Times, that allows for companies to sell a device with minimal testing and, in the case of the DePuy products, with disastrous results.
A February 6, 2012 review of the FDA database for medical device reports (known as “adverse events and product problems”) revealed several common side effects detected in a growing number of patients who underwent hip replacement procedures involving DePuy devices. The side effects included, but were not necessarily limited to:
The following adverse side effects have been reported by large number of patients who underwent hip replacement with metal-on-metal (DePuy) devices. They include:
Because the ASR device is a metal-on-metal device, many healthcare experts believe it may generate excessive amounts of metallic debris the longer it is used. This debris can cause a severe inflammation which, in-turn, can lead to muscle and other soft-tissue damage in immediate proximity to the device. Early failure of metal-on-metal hip devices is another serious concern as the muscle and tissue damage caused by the original defective device can pose further complications in revision surgery.
Furthermore, excessive levels of cobalt have been measured in patients with recalled DePuy devices. This can result in a variety of symptoms, including convulsions, headaches, tinnitus, vertigo, hearing loss, damage to the optic nerve, peripheral neuropathy, cardiomyopathy, and hypothyroidism. Excessive amounts of cobalt in a patient’s system poses particular health hazards for patients with impaired kidney function. Patients who have a recalled ASR device may be at risk for excessive levels of cobalt even if they have no hip pain or symptoms of a failing hip prosthesis.
The FDA database includes more than 16,000 medical device reports that were received regarding metal-on-metal hip replacements. More than 12,000 of the reports are dated 2011 or later. The DePuy ASR replacement system accounts for more than 9,000, (or nearly three-quarters) of the reports made during that same period. The FDA notes that this increase in events may be related to the voluntary recall of the device in 2010 and the ensuing lawsuits against the DePuy manufacturer and its parent corporation, Johnson & Johnson.
Data from an independent national study in the UK in 2010 indicated an increase in the number of patients with ASR Hip System implants who were forced to undergo revision surgery after suffering serious complications due to their DePuy replacement devices. At the same time, the FDA was compiling US complaints and reports of serious side effects and injuries linked to the devices. Under mounting pressure, DePuy issued a voluntary recall in August of 2010. Neither of the devices are sold or marketed at this time.
Since that time, Johnson & Johnson has announced it is prepared to pay a $4 billion settlement to thousands of patients enrolled in a settlement program with the drug manufacturing giant. To understand more about the settlement, and to get help finding DePuy hip recall attorney in Washington, DC.
