FDA Panel Says Metal-on-Metal Hip Implants Offer Few Good Reasons for Use

December 31, 1969

According to a US Food and Drug Administration panel of health experts, there are very few reasons for why patients should continue to use metal-on-metal hip implants , especially considering that there is growing evidence to indicate that these medical devices are prone to breaking down too soon. This is important to know, considering that approximately 400,000 Americans undergo hip replacement procedures each year.

"Our Orange County, California hip implant defect law firm represents patients that have suffered unwanted complications and earlier failure related to their medical device," said Anaheim defective medical device lawyer Vincent Howard.

Many hip implant patients are elderly seniors or younger people who were injured or suffering from arthritis and are seeking to restore better motion to their hip area. However, in the wake of a number of high profile recalls, in 2010 metal hip devices were only used in 27% of hip implant procedures compared to 40% in 2008. Apparently, doctors have been more hesitant to recommend the all-metal devices in the wake of all the reported complications and risks.

Already, over 500,000 patients in the US have been implanted with metal-on-metal hip replacement devices, which about a decade ago were starting to be marketed as longer lasting than hip implant devices made out of plastic or ceramic. However, the recent hip implant recalls in the few years and data from the registries of foreign countries now indicate that these metal devices are the ones that are more likely to fail early and/or deteriorate, the latter outcome placing patients at risk of exposure to high levels of metals, including chromium and cobalt. Meantime, the FDA has received close to 17,000 reports of problems involving the all-metal hip implants between 1992 and 2011. 12,000 of these were submitted in 2010, with 9,000 of them involving the DePuy ASR hip implants that were recalled the year before. Among the complaints (in addition to early failure), is the need for additional surgery to remedy resulting complications, including hip replacement, infection, and dislocation.

Regarding concerns that the device's metal particles may enter the joint, causing bone and tissue damage, some studies are linking these elevated levels of metal in the bloodstream to heart issues and neurological problems. According to one European investigation, cobalt and chromium from metals can spread to the spleen, lymph nodes, kidneys, and liver. There is even concern that the ions could cause genetic changes by impacting the chromosomes.

The FDA panel experts are recommending that patients experiencing hip implant failure symptoms should get their blood tested for metal levels and get X-rays regularly. Meantime, the regulator has asked all-metal hip implant makers, including Zimmer Holdings Inc. and Johnson & Johnson to conduct their own, long-term studies of the implant devices to get more information.

Undergoing a hip implant procedure can be challenging enough the first time. To have to undergo another hip replacement surgery can take a toll--especially for elderly patients who have weakened immune systems and may have already experienced some challenges from the initial procedure.

"It is unacceptable for a hip replacement device to be designed in a manner that the chance of early failure is likely," said Orange County, California hip defect attorney Vincent Howard.

Metal-on-metal hip implants, FDA

FDA panel finds little use for metal-on-metal hip implants, CBS News, June 29, 2012

FDA probes safety issues with metal hip implants
, Fox News, June 25, 2012


More Blog Posts:

FDA Wants Transvaginal Mesh Device Makers to Study Related Health Complications, California Injury Lawyers, January 11, 2012

California Products Liability: Defective Hip Implant Devices Continue Causing Injuries, California Injury Lawyers, December 30, 2011

California Defective Medical Device Cases: Lawsuits Filed by Patients Injured by Recalled DePuy ASR Hip Replacement Systems, California Injury Lawyers, August 22, 2011

Howard Law, PC represents clients throughout Orange County, Riverside County, Los Angeles County, and San Bernardino County. Your first case evaluation with LA hip defect attorney Vincent Howard is free.