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heavy metals 21 articles

FDA provides guidance to help medical device manufacturers gain faster marketing approval

The Food and Drug Administration (FDA) is providing manufacturers with information to help them win faster approval for medical devices deemed “substantially equivalent” to other devices, even if the technology of the new device is different or carries different risks. The guidance is designed to prevent defective medical devices from passing through the agency’s abbreviated 510(k) approval process, which allows faster clearance to moderate risk devices if they are similar to other devices currently on the market. The FDA has been revamping the 510(k) process since it was revealed four years ago that the faulty Johnson & Johnson DePuy ASR ... Read More

Family says defective metal-on-metal hip implant caused mother’s brain cancer

A woman who had filed a lawsuit against Johnson & Johnson for its defective metal-on-metal hip implant has died of an aggressive brain cancer, a disease her family believes was caused by blood poisoning from her corroding artificial hip. Bharucha had broken a hip when she suffered a fall and in 2007 was fitted with Johnson & Johnson’s DePuy ASR hip replacement system. The surgery did not relieve her pain or help her regain her mobility. In fact, she grew increasingly worse. By 2011, a year after the device was recalled due to premature failures, Bharucha had revision surgery to ... Read More

Judge finds TVA liable for December 2008 coal ash spill

The Tennessee Valley Authority (TVA) did not build its holding ponds according to plan, did not train its inspectors to ensure the stability of the dikes, and did not properly maintain its Kingston, Tenn., facility in order to prevent one of the worst environmental disasters in U.S. history, a U.S. District judge ruled Thursday. TVA will be held liable for the December 2008 coal ash spill that dumped more than a billion gallons of toxic sludge onto a neighboring community. The ruling allows the hundreds of plaintiffs who filed lawsuits against the TVA to move one step closer to recovering for ... 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

Researchers hope to reduce failure rate of artificial hips

A team of researchers at the University of Limerick is working to find innovative ways to improve the lifespan of artificial hips and other orthopaedic implants. The team’s goal is timely. Approximately 750,000 orthopaedic implants are performed each year in the United States. That number is expected to jump to a staggering 4.5 million in the next 20 years. Most implants, such as artificial hips, can be expected to last 20 years or more before they begin to fail and need replacing. But some implants have shown a higher than expected failure rate at five years or less. Researchers hope ... Read More

Study aims to find better, safer materials for hip implants

Researchers at the University of Limerick are gathering preliminary data on artificial joints in hopes of improving the lifespan of orthopaedic devices including artificial hips. About 750,000 surgeries to implant orthopaedic joints are performed each year in the United States, and that number is expected to climb to 4.5 million by 2030. Artificial hips are valuable devices for improving mobility and easing pain and discomfort for patients with hip joints damaged by osteoarthritis, rheumatoid arthritis, injury or other conditions. Typically, hip implants can last up to 20 years or more with about 13 percent failing prematurely. These traditional hip implants ... Read More

FDA increases fees in hopes of improving medical device approval process

Medical device manufacturers will have to double the fees they pay to the Food and Drug Administration (FDA) in order to have their products reviewed over the next five years as part of a plan to provide faster, more thorough evaluations. The increase would allow the FDA to hire 200 new full-time employees within five years to assist with medical device evaluations. As part of the approval process, evaluators would be required to meet with device applicants midway through the review process in order to address concerns. Medical device makers are in favor of a plan that would allow for ... 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

DePuy artificial hip patients may be victim of faulty design

Stephen Ellis, 57, of the United Kingdom, was furious when he learned that black liquid drained from his right hip joint during revision surgery to replace his two-year-old metal hip implant which had started poisoning his blood. Ellis suffers from rheumatoid arthritis, and is among thousands of Liverpudlians who have had to undergo revision surgery to replace their faulty hip implant. All told, about 93,000 people worldwide, including in the United States, are affected by a recall of one brand of metal-on-metal hip implant, the ASR made by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. While the medical device ... Read More

More problems with metal-on-metal hip implants expected

Patients who have metal-on-metal hip implants should have regular checkups to ensure their device is working properly and that it isn’t poisoning their blood with heavy metals. The warning comes after a recent English study found metal-on-metal hip implants were failing at three times the rate of more traditional metal-on-plastic or metal-on-ceramic devices. Over the past decade, materials used to make hip resurfacing and total hip replacement systems have expanded to include metal-on-metal parts, meaning that both the ball and socket that fit into and move against each other are made of metal. The design was intended to be more ... Read More