Tagged Articles

metal poisoning 42 articles

UK regulators issue warning about DePuy’s MITCH TRH all-metal hip implants

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety warning for MITCH TRH acetabular cups and MITCH TRH modular heads – a metal-on-metal hip implant system manufactured by U.K.-based Finsbury Orthopaedics, a division of DePuy Orthopaedics. Both companies are owned by healthcare giant Johnson & Johnson. The MITCH TRH System is a metal-on-metal hip replacement system consisting of components that can be used in different combinations to carry out either hip resurfacing arthroplasty or total hip replacement. In the new Medical Device Alert, MHRA regulators warn that a higher-than-expected number of DePUY MITCH hip devices ... Read More

Some DePuy ASR hip implant lawsuits heading to trial this year

The first lawsuits filed against health care giant Johnson & Johnson and its subsidiary DePuy Orthopaedics by plaintiffs alleging injuries caused by DePuy’s metal-on-metal ASR hip devices will go to court this year. About 4,200 lawsuits have been filed against the companies in federal court, with another 2,000 filed in state courts. The first state lawsuits are slated to go to trial in Las Vegas, Nevada, in mid-December 2012, with another trial scheduled for January 2012 in a Maryland state court. Federal lawsuits, which will be tried in U.S. District Court in West Virginia, will probably be heard in March ... Read More

FDA plans 2-day metal hip device review

Responding to growing concerns over complications associated with metal-on-metal hip implant devices, the U.S. Food and Drug Administration (FDA) said it has planned a two-day review of the devices in June that could result in tougher regulations. A global recall of two different all-metal hip implants made by DePuy Orthopaedics in 2010 compounded fears that such devices could fail prematurely and harm recipients, sometimes in serious, debilitating ways. A number of other companies manufacture metal-on-metal hip implants, but most complaints center around DePuy’s ASR XL Acetabular and Hip Resurfacing systems. “We are asking outside scientific and medical experts to discuss ... Read More

FDA to scrutinize metal-on-metal hips in June

Signaling more trouble for metal-on-metal hip devices and their manufacturers, the U.S. Food & Drug Administration (FDA) announced it has planned a 2-day review of the controversial medical devices, which have become the subject of thousands of personal injury lawsuits around the world. “We are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations,” Dr. William Maisel, deputy director of science at FDA’s Center for Devices and Radiological Health, said in a statement. Hip replacement systems made with all metal components were first conceived about ... Read More

Metal hip implant debris can cause chain reaction of damage to body

No matter what they’re made of, all hip implant devices release debris into the body through normal wear. Traditional hip implants made of metal and plastic composites typically last about 15 years in the average patient and, while particles of plastic can cause bone damage and lead to loosening of the device, the problems are relatively less aggressive. Ironically, all-metal hip devices, which were designed to last even longer and packed a lot of appeal for younger, more active patients, often fail prematurely in just a few years’ time, leaving some patients in chronic pain and permanently damaged in the ... Read More

New Zealanders cannot sue over defective hip implant

New Zealander Mark Grennell was in his 40s when he had hip replacement surgery to repair an injury sustained in a car accident when he was a child. The surgery gave him relief from pain, but the success was short-lived. Soon Grennell’s pain returned with vengeance and he became homebound. He had to give up his job, which required heavy lifting, and packed on nearly 200 pounds, exasperating his situation. It wasn’t until Grennell read an article in the New Zealand Herald that he realized that a metal-on-metal hip implant made by DePuy Orthopaedics, a subsidiary of Johnson & Johnson, ... Read More

San Diego man sues DePuy, alleging hip implant poisoned him

A San Diego man who underwent revision surgery to replace the DePuy hip implant he originally received described the experience to San Diego’s 10News as “a nightmare.” The 62-year-old man said he also feels angry because he feels DePuy rushed the medical device to market without adequately testing it for safety. He is now joining dozens of other San Diego-area residents who seek damages from DePuy for the pain, illness, and other hardships they allege their DePuy hip implants caused. DePuy Orthopaedics recalled its ASR hip devices a year ago after clinical trials found a high rate of failure for ... Read More

IOM to make recommendations on FDA medical device approval process

The Institute of Medicine (IOM) this week is expected to offer advice on the Food and Drug Administration’s fast-track process by which medical devices are approved for use in patients in hopes of cutting down on injuries and recalls. The accelerated approval process, known as 510(k) is widely used by the agency to get much-needed medical devices on the market. It is allowed on devices that are considered “substantially equivalent” to existing products. About 3,000 products are approved by the FDA through this process each year. Critics say this accelerated approval process puts medical devices on the market before they ... Read More

Injured by bomb then by DePuy hip implant: one Iraq veteran’s struggle

Articles about the faulty metal-on-metal hip implants manufactured by DePuy Orthopaedics often mention that the devices have been surgically implanted in 93,000 people, including 37,000 in the Unites States. But seldom do these reports show the human face of the problem so poignantly as a report published in Bloomberg about DePuy parent company Johnson & Johnson’s quality crisis. The article opens with the story of Marine Lance Corporal Cody Perkins, who was riding in his unit’s Humvee just outside of Haditha, Iraq, in November 2005 when a roadside bomb exploded, throwing Perkins in the air and killing his commanding officer. ... Read More

Five Chicago hip implant patients file lawsuits against DePuy

An ABC affiliate in Chicago reports that five Chicago area residents are filing lawsuits against DePuy Orthopedics, a Johnson & Johnson subsidiary, over their defective hip implant devices. According to ABC 7 Chicago, the DePuy hip implant recipients accuse the manufacturer of ignoring evidence that the hip implant devices were defective and then acting too slowly to recall them. The implants contain large metal-on-metal components which with friction release potentially toxic heavy metals into the bloodstream and surrounding tissue. DePuy artificial hip recipients across the United States have reported symptoms associated with metalosis or metal poisoning because of the faulty ... Read More