FDA Orders Surveillance of Hip Implants

Image via Wikipedia

Hip replacements are utilized through the workers' compensation medical delivery system in an effort to cure and relieve medical conditions arising out of employment injuries and exposures. The US Food and Drug Administration (FDA) has recently announced that it is widening its roll in monitoring the hip implants. This follows a recent recall of defective hip implants.

"The FDA is continuing to gather and review all available information about currently marketed metal-on-metal hip systems, including information related to adverse events that may be associated with increase levels of cobalt and chromium in the bloodstream. To that end, on May 6, 2011 the FDA issued orders for postmarket surveillance studies to manufacturers of metal-on-metal hip systems. The FDA sent 145 orders to 21 manufacturers. Manufacturers will be required to submit a research protocol to the FDA that addresses specific safety issues related to these devices. Data from the studies conducted will enable the agency to better understand these devices and their safety profiles.

Related articles

• Defective Artificial Hips Maybe a Costly Problem for Workers' Compensation (workers-compensation_blogstop.com)
• GAO renews critique of FDA medical device system (sfgate.com)
• J&J, Hip Makers Asked by FDA for Data on Metal in Patients (businessweek.com)
• Hip replacement worries spark FDA inquiry (cbsnews.com)
• Studies Ordered for Makers of Artificial Hips (nytimes.com)

Defective Artificial Hips Maybe a Costly problem for Workers' Compensation

The workers' compensation insurance system is about to be the initial payor for joint replacement surgery and for the complications of defective artificial hip joint damage that were said to be inadequately tested because of a loophole in FDA's rules. With an estimated 93,000 DePuy recalled artificial hips implanted worldwide, the workers' compensation benefit system will probably be paying for a vast amount of the remediation and treatment costs, and then having its hand out through direct and indirect subrogation efforts to seek reimbursement from the manufacturer, Johnson and Johnson.

Called "one of the most troubled orthopedic implants of the past decade," recently recalled Johnson & Johnson artificial hips, DePuy Orthopedics, have drawn recent attention for being sold and promoted without adequate testing. The concern has been focused on devices known as A.S.R., Artificial Surface Replacement hip joints. The device was first introduced in the US in 2005 and was recalled from the market in August 2008.

The New York Times reported that, "Current rules do not require device producers to notify the F.D.A. when they bundle together components from approved and unapproved devices, Mark Melkerson, an agency official, acknowledged. New iterations of device designs already used on patients typically receive scant scrutiny from the F.D.A. before going to market."

It further reported that, "... back in 2005, the F.D.A. allowed DePuy to start selling the other version of the A.S.R., a modified standard hip replacement that used the same A.S.R. cup found in the company’s unapproved resurfacing device." 

As a result of hip joint pain following surgery, and many adverse reports, and surgical implant failures, further investigation have resulted in the recall of DePuy Orthopedics, ASR artificial hips,  Some individuals may suffer damage to bones, muscles and nerves following implant. Lawsuits have been filed against DePuy.

Related articles

• Hospitals Are Not For Sick People (workers-compensation.blogspot.com)
• Hip Implants Recalled Due to Failure
• Preventing Joint Replacement Surgery in Workers' Compensation Claims
• DePuy Hip Replacement Claims

Hip Implants Recalled Due to Failure

Johnson and Johnson has recalled 2 Hip Implants because of failure. The two implants were made by the DePuy Orthopaedics unit of Johnson and Johnson. The decision to withdrawn the products was based upon the fact that many patients require a second hip replacement because of product failure.

DePuy release a statement today that they two products being recalled were: the ASR XL Acetabular System, a hip socket used in traditional hip replacement, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur, a method intended to preserve more bone. There about 93,000 of the defective appliances that have been implanted worldwide.

For over two years the US Food and Drug Administration (FDA) has been besieged with complaints about the failure of the devices and painful surgery to replace them.

The office of Jon L. Gelman has advocated for consumer rights and has helped those who have unfortunately received defective medical devices. Please call 1-973-696-7900 or e-mail for further information.

Workers' Compensation and Joint Replacement

• Preventing Joint Replacement Surgery in Workers' Compensation Claims 

Related articles

• J and J unit recalls hip replacement products (usatoday.com)
• J and J recalls 2 hip replacement systems for problems (sfgate.com)
• J and J Recalls 2 Hip Replacement Systems for Problems (abcnews.go.com)
• Johnson and Johnson Recalls Hip Implants (nytimes.com)