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Spike in Metal-on-Metal Hip Implant Complaints May Point to Looming Disaster

Date Published: Wednesday, August 24th, 2011
Source; News Inferno

More and more recipients of metal-on-metal hip implants are complaining of painful complications, according to a report from The New York Times. Since January, the U.S. Food & Drug Administration (FDA) has received around 5,000 adverse event reports related to all-metal hip replacements, more than it received in the previous four years combined.

The Times’ review revealed that 75 percent of those complaints involved DePuy Orthopaedics’ ASR hip implant, which was recalled last August. Other all-metal devices that were the subject of complaints included Zimmer’s Durom cup, and the all-metal version of DePuy’s Pinnacle implant. Most of the complaints received by the FDA have come from people who have undergone, or will require, revision surgery because of complications they suffered just a few years after receiving their all-metal hip, the Times said. The devices are designed to last fifteen years.

According to the Times, some experts fear all-metal hip implants could become one of the biggest and most costly medical implant problems in recent history.

According to The New York Times, before they became the subject of safety concerns, metal-on-metal hip implants accounted for nearly one-third of the estimated 250,000 replacements performed each year. According to one estimate, some 500,000 patients have received an all-metal replacement hip.

Newsinferno has given extensive coverage to problems surrounding all metal hips. It is believed the devices can shed dangerous amounts of cobalt and chromium through wear, leading to tissue damage, premature device failure, the need for revision surgery, and even long-term health problems. Symptoms discussed in the Times’ article include pain, rashes, and inflammation. Unfortunately, many metal-hip implant recipients who sustain tissue damage have no symptoms, making it difficult to determine if their device should be removed.

According to the Times’ review, between 2007 and this June, the DePuy ASR hip implant was the subject of 7,500 complaints to the FDA. During the same period, about 1,600 complaints related to the Durom Cup were filed with the agency. The all-metal version of DePuy’s Pinnacle implant was the subject of 200 complaints, while another 400 noted metal-related problems in Pinnacle patients. It’s not clear how many of those were associated with all-metal devices, as the Pinnacle is sold in several versions, the Times said.

Unfortunately, the FDA doesn’t yet seem to have a handle on how big the problems surrounding all-metal hips might be. In May, the agency asked DePuy Orthopaedics and 20 other manufacturers of metal-on-metal hip implants to conduct safety studies aimed at determining if these devices are shedding dangerous amounts of metallic debris in patients. They have also been told to determine how often their metal-on-metal hip implants fail prematurely. Unfortunately, it could be a couple of years before these studies are completed.

Most of the all-metal hip implants currently on the market were approved by the FDA without human testing. And in most cases, there were no requirements that manufacturers track adverse events related to the implants. That lack of scrutiny has angered many metal hip implant victims.

“We will be the little crash test dummies here until they figure out the health ramifications for us down the road,” Ann Morrison, 50, a physical therapist from Newark, New Jersey, told the Times. Morrison, who is still struggling to recover after revision surgery for two DePuy ASR hip implants that caused her to suffer extension tissue damage, called the FDA’s order for new studies “a joke.”

NewsInferno.com disclaimer: This article: Spike in Metal-on-Metal Hip Implant Complaints May Point to Looming Disaster was posted on Wednesday, August 24th, 2011 at 5:56 am at NewsInferno.com and is filed under Defective Medical Devices, Depuy, Metal Hip Implants.