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metal 42 articles

Consumer Reports chief protests medical device approval process

“It’s a nightmare scenario,” Consumer Reports President Jim Guest wrote in an email blast to one million Americans earlier this year. He was warning consumers that medical devices they assume are safe may not be fully vetted before being approved by the Food and Drug Administration (FDA), and that the federal government needed to change this process that is putting the lives of millions of people at risk. Guest was speaking out against a long-used practice of the FDA in which so-called moderate risk medical devices are approved quickly without testing to prove they are safe and effective if similar ... Read More

Memo reveals DePuy knew its hip implants were defective but continued to sell them

Top executives for Johnson & Johnson subsidiary DePuy Orthopaedics had evidence that one of the company’s all-metal artificial hip devices was failing prematurely in patients a year before the device was recalled, but withheld this information and continued to market the device. The evidence is found in an August 2009 email sent to three top executives at DePuy from a vice president at the company regarding another hip device. The company had sought approval from the Food and Drug Administration (FDA) for its ASR hip implant used for a relatively new hip replacement procedure called resurfacing. Typically, the vast majority ... Read More

Seniors at greater risk of complications from hip implant defect

Seniors are at greater risk of suffering from complications from faulty medical devices that were approved before they were thoroughly tested, says the Consumers Union (CU), a nonprofit organization that works for a safe marketplace. The group also publishes Consumer Reports magazine and ConsumerReports.org. At issue is the current practice of medical device approvals by the Food and Drug Administration (FDA). Medical devices deemed “moderate-risk” can soar through the agency’s accelerated approval process without clinical testing to determine safety and efficacy if they are similar to ones already on the market. About 90 percent of all medical devices are approved ... Read More

Hip implant lawsuits mount in Canada and US

Class action lawsuits against the makers of hip replacement systems are mounting in Canada as well as the United States. Different hip implant manufacturers are named in the lawsuits, and some of the plaintiffs allege that their hip replacement surgery made them feel worse, not better. At least four class action lawsuits have been filed against various artificial hip manufacturers in Canada and several others have been filed in the United States, all alleging the hip implants are defective and require revision surgery to remove and replace the devices. Most lawsuits are focused on a newer version of implants that ... Read More

Study raises more concerns about metal-on-metal hip implants

Patients who received metal-on-metal hip replacements are more likely to experience problems requiring revision surgery to have their implants replaced than patients who have more traditional plastic or ceramic hip implants, according to a study recently published in the British Medical Journal. Each year in the United States, about 270,000 hip replacements are performed. Metal artificial hips were introduced in the mid 2000s with a goal of being more durable and better able to withstand wear and tear than traditional implants. But when the implants began failing at a higher than expected rate, doctors were baffled. It didn’t seem right ... Read More

Alabama man files lawsuit against maker of recalled artificial hip

When a Gaylesville, Ala., man received a hip implant in January 2007, he fully expected to keep his artificial hip for the next 15 years or more. But two years later, his device failed, leaving him in severe pain. The man received the ASR XL Acetabulator hip replacement system, manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. The hip implant was recalled in July 2010 after mounting reports of premature failure. The man turned down DePuy and Johnson & Johnson’s offer to pay for revision surgeries to replace the defective artificial hip, opting instead to seek compensation for ... Read More

Body realignment could eliminate need for hip replacement surgery

More than a half a million hip and knee replacements are performed in the United States each year, and the numbers are growing. One doctor suggests many surgeries could have been avoided if peoples’ bodies were better aligned. Osteoarthritis is the most prevalent form of arthritis and now the No. 1 cause of pain and disability in the United States. Treatment is often hip or knee replacement surgery. But many of the prostheses used to repair damaged joints need to be replaced in 10 to 15 years. Some fail just months after implantation. Currently, the Food and Drug Administration is reviewing ... Read More

Patients with metal hip implants may experience problems

Patients who have received metal-on-metal hip replacement systems should be aware of potential problems caused by the implants even if they have not experienced any symptoms, such as pain. The devices have come under review by the Food and Drug Administration (FDA) because or reports of joint space inflammation and blood poisoning caused by bits of metal that flake off the device when its metal parts rub together. The inflammation is being blamed on the accelerated failure of the devices, causing them to loosen, dislocate or fracture. The blood poisoning has been linked to various symptoms such as fatigue and ... Read More

Safety of medical devices is questioned

What do artificial hips and surgical mesh have in common? They are both considered moderate-risk medical devices and can be approved by the Food and Drug Administration (FDA) without rigorous testing through an expedited approval process known as 510(k). Many of these devices also have allegedly caused patients serious and sometimes permanent disability. This has led critics to question the safety of approving devices for use before they have been fully tested. For example, Johnson & Johnson subsidiary DePuy Orthopaedic received FDA approval through the 510(k) process in 2006 for its ASR metal-on-metal hip replacement system. The device manufacturer was ... Read More

Artificial hip recall leads to FDA review of metal-on-metal hip implants

Michael Stieler’s hip replacement surgery brought him relief from the pain he suffered when the cartilage in his right hip had worn down. But a year after surgery, Michael’s pain returned, with a vengeance. “It hurt. I couldn’t even walk on it,” he told the Sacramento Bee. It wasn’t until two years later that Michael learned that the problem with his metal-on-metal hip implant was not uncommon. The company that made his artificial hip, DePuy Orthopaedics, notified Michael last September that it was recalling the implants because of early failure rates and the potential for leaching of high levels of ... Read More