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hip replacement 104 articles

Study confirms high impact activities are harder on artificial hips

People who return to high impact sports following hip replacement surgery enjoy a higher quality of life, but their device generally fails faster than less active patients due to wear and tear, according to a study published recently in the journal Clinical Orthopaedics and Related Research. A growing number of people who undergo hip replacement surgery want to get back to high impact activities such as jogging or soccer as soon as possible, and doctors often make recommendations to their patients about choosing lower impact activities. But no study has confirmed whether these activities affect the lifespan of hip implants. ... Read More

Researchers aim to develop safer artificial hip

For young, active patients in need of hip replacement surgery, the recommended hip implant used to be ones made of all-metal construction. These artificial hips involved a metal ball-and-socket interface – where the artificial head of the femur moves within the artificial socket of the pelvis. Because they were made of metal, they were thought to be more durable than traditional ceramic-and-metal or plastic-and-metal implants. But in the past decade since the all-metal hips were introduced, the construction appears to be flawed. The metal surfaces can wear against each other, causing premature failure and potential blood poisoning when bits of ... Read More

Pradaxa safety issues cause delay in new blood thinner approval

Safety issues following the October 2010 approval by the Food and Drug Administration (FDA) of the blood thinner Pradaxa are being blamed for the three-month delay in the decision on a new blood thinner. Apixaban (Eliquis), made by Pfizer and Bristol-Myers Squibb, was set for FDA review in March but regulators opted to extend the deadline. The FDA had previously granted the application of a six-month priority review, which would have resulted in a decision by March 28. The new decision date is June 28. Eliquis is an anticoagulant indicated for the prevention of stroke in patients with a type ... Read More

Consumers Union pressures Congress to strengthen medical device approval laws

Consumers Union, an advocacy group associated with Consumer Reports, is recommending that Congress strengthen laws to approve medical devices to better ensure public safety. The call-to-action is part of a push by Consumers Union to pressure Congress about weak federal oversight that has led to the approval of medical devices before they had been tested for safety and efficacy. The Food and Drug Administration (FDA) approval process for medical devices came under fire after DePuy Orthopaedics, a subsidiary of Johnson & Johnson, issued a worldwide recall of an all-metal artificial hip. The devices were failing at a higher than expected ... 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

New study advises surgeons, patients avoid all-metal hip implants

A new study funded by the National Joint Registry of England and Wales and published this month in the British medical journal The Lancet calls on surgeons to stop using metal-on-metal hip implants completely, saying that evidence shows patients who receive the implants are much more likely to need revision surgery to have the implants repaired or replaced. The study’s authors analyzed data from the National Joint Registry of more than 400,000 hip replacements made from 2003 to 2011. While the vast majority of those surgeries involved traditional implants made of plastic or ceramic, more than 31,000 patients received metal-on-metal ... Read More

DePuy ordered phase-out of defective hip implant after FDA inquiry

Johnson & Johnson decided to phase out one of the hip implants made by its subsidiary DePuy Orthopaedics and sell off its inventory shortly after receiving an inquiry from the Food and Drug Administration (FDA) that questioned the device’s safety and efficacy. The federal agency was asking the drug and medical device manufacturer for safety data on its metal-on-metal ASR XL Acetabulator hip replacement and hip resurfacing systems, and informed the company that blood tests in patients who had received the implants showed “high levels of metal ions.” The latest news adds more concern that DePuy and Johnson & Johnson ... Read More

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

Another victim of recalled DePuy hip implant speaks out

Terri Wagner-Morley’s artificial hip seemed like an answered prayer. In just one year, she regained mobility lost from chronic arthritis, and was able to exercise again. She shed more than 50 pounds and was enjoying life again. “It felt great,” she told the Star Tribune. But shortly thereafter problems began to surface. It started with a popping sensation in her right hip, then came the pain. Soon, Terri wasn’t moving around like she had been. The exercising stopped, and the weight came back. Terri’s artificial hip failed. She needed surgery to remove the defective device. An infection set in, which ... Read More