FDA Calls For Assembly On Metal-On-Metal Hip Replacement Device Safety

by | June 25th, 2012

June 25, 2012

The U.S. Food and Drug Administration (FDA) has scheduled an assembly later this week to examine the safety of metal-on-metal hip replacement implants. According to Bloomberg News, the assembly is being organized in response to the growing concern of safety following several warnings and recalls of the products because of reports of early failure rates and a link to poisoning from metal fragments.

In all, 16,800 adverse event reports have been filed for various metal-on-metal hip implant systems and have resulted in roughly 14,000 revision surgeries and 8,700 reports of patient post-operative pain. These reports have resulted in a growing amount of defective medical device lawsuits from individuals claiming that the manufacturers were negligent in putting these faulty devices on the market. Johnson and Johnson faces 6,000 lawsuits for their faulty hip implants. Recipients of the recalled Biomet Hip Implants are also seeking damages.

Experts say it may be impossible to determine if the devices had an early failure rate. The lifetime of the device is expected to be approximately 15 years; however, the FDA can only order a Post Market Study for three years.

The Norfolk Personal Injury Lawyers with Lowell “The Hammer” Stanley are hopeful that the assembly will be an opportunity for experts and officials to re-examine the overall safety of metal-on-metal hip replacement devices and find a solution to the growing number of patients suffering because of them.