Tagged Articles

chromium 102 articles

FDA proposes new rules for metal-on-metal hip implant approval

The U.S. Food and Drug Administration (FDA) has proposed new regulatory rules that, if passed, will require orthopedic device manufacturers to test their all-metal hip replacement and resurfacing systems for safety and efficacy before approval. The proposed measures come in response to alarmingly high rates of failure and injury associated with metal-on-metal hip devices, such as the ASR XL Acetabular and Hip Resurfacing Systems made by DePuy Orthopedics, which were recalled for safety concerns in August 2010 after being implanted in about 93,000 patients worldwide, including approximately 40,000 Americans. The FDA’s proposed order would require manufacturers to file a premarket ... Read More

UK health regulator warns of problems with metal-on-metal hip implants

The risk from metal-on-metal hip replacement systems is greater than previously thought, with even greater failure rates, U.K. health regulator the Medicines and Healthcare Products Regulatory Agency (MHRA) reported. Artificial hips are traditionally made with ceramic or plastic parts, but over the past decade medical device manufacturers began making hip implants with all metal parts. The idea was that the new design would make the hips more durable over time. Traditional hip implants can last 20 years or more before they need replacing. However, shortly after the metal-on-metal hips hit markets around the world, reports of premature failures began pouring ... Read More

New study underscores dangers posed by metal-on-metal hip implants

Just over a decade ago, when orthopedic device manufacturers began making hip implants with all metal parts, some researchers warned that the metal-on-metal designs could pose a health threat. They knew that all artificial hip implants, whether made of ceramic, plastic, metal, or a combination of materials, shed particles into the blood and tissue through normal wear and tear. But, according to a New York Times report, “those warnings were not heeded, and now doctors and patients face a growing public health problem as one of the country’s biggest medical device failures unfolds.” At the same time, there has been ... Read More

People still suffering from defective metal-on-metal hip implants

Eighteen months after receiving an all-metal artificial hip, Sally Gration’s pain started. Soon after, she began walking with a limp. But it wasn’t until five years after her surgery that doctors tested her blood and confirmed that the problems she was experiencing with her hip implant were because the metal device was corroding inside her body. “I discovered that I had high levels of chromium cobalt in my body and the implant needed to come out,” Sally told The Telegraph. “But when they removed it, they couldn’t put a new one in because it had affected my body so badly… ... Read More

First hip-injury lawsuit against DePuy gets green light in Ireland

An Irish woman who had both of her hips replaced with DePuy hip implants filed what is expected to be the first of many lawsuits against the orthopedic device maker in Ireland. Irene Pierson alleges in her lawsuit that the DePuy hip implants were “not of merchantable quality, and have both commenced to malfunction,” Ireland’s Kildare Nationalist reported. Ms. Pierson had her right hip replaced with a DePuy implant in March 2007. She was fitted with a DePuy implant in her left hip in September 2008. Ireland’s High Court granted Ms. Pierson approval to serve the defendants she names in ... Read More

Patients with metal hips should be checked by doctor annually

People who have received metal-on-metal hip replacement systems should be checked by a doctor every year for as long as they have the implant to ensure the implant isn’t failing or poisoning their blood, says the UK regulator of medical devices. Metal-on-metal hip implants were introduced a decade ago as a more durable artificial hip. Traditional hip implants are made with plastic or ceramic parts, but several manufacturers began offering all-metal versions. The design turned out to be a major flaw. Most hip implants can last 20 years or more, but the newer metal-on-metal devices were beginning to fail at a ... Read More

Man files lawsuit against makers of recalled metal hip implant

“It started to feel a bit clunky and was grinding and then it started to squeak very loudly – loud enough for people in the street to be startled and stare at me,” Chris Monk told the Evening News of his artificial hip. “I was in so much pain and could barely walk a few yards when it was at its worst.” Monk had scans that showed his all-metal hip implant was defective and had damaged his flesh. It had also dropped bits of metal debris inside his body that seeped into his bloodstream causing a type of blood poisoning ... Read More

Dozens of UK citizens sue DePuy, others for failed metal hips

Dozens of metal-on-metal hip replacement patients in South Yorkshire, Great Britain, are seeking damages from the manufacturers of the hip devices, alleging injuries ranging from device failure to toxic metal poisoning. According to The Star, 34 patients in South Yorkshire are suing DePuy Orthopaedics, maker of the ASR XL Acetabular and Hip Resurfacing systems, which the company recalled in August 2010 after medical data indicated a staggering number of the devices failed prematurely. Since then, patients have reported myriad problems, including intense pain, dislocation, immobility, bone fracture, muscle and tissue decay, nausea, and other severe complications linked to hip devices ... Read More

Metal-on-metal hip devices recalled due to corrosion risk

Last week, orthopaedic device maker Stryker issued a recall of two modular-neck hip stems because of a potential for fretting and corrosion that may result in tissue damage and blood poisoning. The recall involved specific lots of the Rejuvenate Modular and the ABG II modular-neck hip stems. Hip stems are not full hip replacement systems but attachments for artificial hips that allow the device to fit a patient better. The hip stems were made with metal parts that were eroding in some patients, dropping bits of metal into surrounding tissue, causing pain and swelling, and in some cases, seeping into ... Read More

Patient with recalled metal hips worries about his health

Steve Lorenz has always been active, but the 52-year-old foreman’s life changed after he had both his hips replaced. The surgery was intended to restore his active lifestyle, but it ended up causing him more discomfort and poisoning his blood. Steve was one of an estimated 93,000 people worldwide who received the ASR XL Acetabular hip replacement system made by Johnson & Johnson subsidiary, DePuy Orthopaedics. Unlike traditional hip implants which are made of plastic or ceramic parts, the DePuy device was made with all metal parts. Designed to be more durable, the implant proved to fail at a higher ... Read More