FDA Rejected Hip Replacement Makes Its Way To Foreign Markets

Following the removal of metal-on-metal articular surface replacement (ASR) devices from the U.S. market, an orthopedic division of Johnson & Johnson has become the subject of increasing criticism while simultaneously experiencing a decrease in sales. Subsequently, the recent introduction of an incriminating letter has threatened to tarnish the medical device manufacturer’s reputation even further. In the letter addressed to the manufacturer, the U.S. Food and Drug Administration (FDA) told Johnson & Johnson in August 2009 that company studies and clinical data submitted to gain approval in the United States to sell ASR devices overseas were inadequate to determine the implant’s safety and effectiveness. However, the company continued to market ASR devices in foreign markets after the FDA had already rejected further sales of the same devices in the United States.

Metal-on-metal hip replacement systems are comprised of a series of metallic components (cobalt and chromium) in order to promote longevity and dexterity. Unfortunately, recent evidence suggests that metallic components consisting of cobalt and chromium may coincide with catastrophic complications in defective hip replacements. More specifically, the wear and tear that ball and socket components generate may lead to significant deterioration over a seemingly short period of time. This degeneration has a propensity to create minute metal shavings that may cause significant damage to an individual. As a result, these metal pieces may lead to a concentration of hazardous shards in the fluid of the joint and surrounding muscles that can cause extreme pain and swelling when leached into the recipient.

According to a recent study, DePuy’s ASR acetabular hip component has been regarded as one of the most frequent hip replacement systems to display signs of high failure rates. The design of the ASR acetabular component utilizes between 148 and 160 degrees of a sphere. As a result, more of the ASR head is uncovered, regardless of where the cup is situated. This may lead to increased edge loading and wear of the ASR cup. Chromium and cobalt concentrations from the ASR prostheses are significantly increased due to the orientation of these components. Therefore, there is an increase in metal ions at inclinations that are greater than 45° with the ASR hip replacement device.

Complications such as these were responsible for the official removal of the metal-on-metal hip replacement devices from the U.S. market in 2010. The version of the ASR rejected by the agency was developed by DePuy for use in a hip replacement procedure known as resurfacing. 2003 witnessed DePuy pursue sales of ASR devices overseas. The hip replacement device was believed to have been used in approximately 93,000 patients worldwide before being removed from the U.S. market in 2010 for its affiliation with extremely high failure rates and severe complications.

However, J&J continued to market the artificial hip in Europe and elsewhere overseas after the products were recalled in America.

While foreign regulatory agencies are accepting of devices previously recalled by the FDA, the introduction of ASR products in other markets is not against the law. Regulatory standards in other countries, like those in Europe, are more accepting and less critical of medical devices than those in America. According to a spokeswoman from the Medicines and Healthcare Products Regulatory Agency, companies like Johnson & Johnson are not required to notify regulatory agencies when the FDA refused to approve a product that was used on patients in America.

While the FDA’s rejection has not prevented foreign regulatory agencies from doing the same, it may contribute to the legal problems already burdening J&J. Last month witnessed J&J set aside $3 billion in order to handle anticipated legal and medical expenses associated with the recall. Subsequently, approximately 5,000 lawsuits involving the recalled devices are pending. The majority of the lawsuits are claiming that excessively high failure rates have led to metal toxicity and revision surgeries due to the shavings produced by the metal components.

By keeping the current approval process confidential, the FDA may potentially affect the health and safety of patients. Subsequently, by not making their rejection letter public, the FDA failed to alert those looking to get a hip replacement, of the dangers associated with ASR devices. An agency spokesman, Morgan Liscinsky, declined to disclose the letter on the ASR, saying the agency had a policy of not releasing such notices because they might contain confidential business information.