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metal on metal 195 articles

Court documents show DePuy knew nearly 40 percent of its hip implants failed within 5 years

Documents unsealed ahead of the first faulty hip implant lawsuit against Johnson & Johnson and DePuy Orthopedics to go to trial show that company executives knew in 2011 that its ASR metal hip implants would fail in nearly 40 percent of patients within five years, but withheld that information. DePuy, a division of medical giant Johnson & Johnson, recalled its ASR XL Acetabular and ASR Hip Resurfacing Systems in August 2010 as evidence mounted that the hip devices, which consisted of a metal ball and metal cup, failed at unusually high rates. At the time of the recall, the devices ... Read More

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

FDA proposes requiring makers of metal hips to submit premarket approval applications

The Food and Drug Administration (FDA) is proposing requiring manufacturers of metal-on-metal total hip replacement systems to submit premarket approval applications in order to assess risks associated with the devices. The proposed order was announced Thursday along with updated safety information and recommendations for patients and health care providers about illnesses and injuries associated with the devices. Metal-on-metal hip replacement and resurfacing systems, unlike traditional hip systems made with ceramic or plastic parts, have a metal ball that moves within a metal socket. This movement can cause bits of metal debris to release into the joint space, causing soft tissue damage ... Read More

FDA warns doctors, patients about risks associated with metal-on-metal hip implants

The Food and Drug Administration (FDA) released updated safety information to patients and health care providers about risks associated with metal-on-metal hip replacement systems and metal-on-metal hip resurfacing systems based on the agency’s current assessment of the implant and results from the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting. The safety announcement advises health care providers to consider the benefit-risk profile of using metal-on-metal hip implants as opposed to an alternative hip system made with ceramic or plastic parts, to inform patients about the risks associated with the all-metal implants, and be aware of risk factors in the ... Read More

Companies should avoid covering up issues related to product recalls

When companies are required to recall their products due to problems or reports of injury, the worst thing they can do is try to cover up the mistake, says Kevin Erb, a public relations and social media director. “It’s not the crime, it’s the cover-up,” that can tarnish a company’s public image, Erb told the Journal Gazette. Thus, companies should be prepared for product issues and recalls to arise and have a plan in place. Doing so, Erb said, sets the tone for media coverage and public reaction. Erb’s sage advice should be noted by pharmaceutical companies and medical device ... Read More

Ceramic-on-ceramic hip implants are best for children with juvenile arthritis

Ceramic-on-ceramic artificial hips are a good option for children who suffer from juvenile arthritis, a new study shows. Juvenile arthritis is any form of arthritis or arthritis-related condition that develops in children or teenagers who are younger than 18 years of age. It is one of the most common childhood diseases in the United States, and can lead to joint deformity and impaired use of the joint. Some children with the condition may require joint replacement surgery. Hip replacement in children can be challenging. First, their bones are smaller and it is often difficult to find hip implant parts that ... 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

New consortium aims to improve safety of medical devices

The Food and Drug Administration (FDA) has caught much flack in the past couple years over its medical device approval process, with critics arguing that not enough effort is made to ensure the safety and efficacy of devices before they hit the market. In response, a new consortium of leaders from industry, academia and government agencies was formed to help guide the advancement of medical device regulatory science. The Medical Device Innovation Consortium (MDIC), is a public-private partnership with the FDA’s Center for Devices and Radiological Health (CDRH). FDA Commissioner Dr. Margaret Hamburg called the formation of the consortium a ... 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