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premature failure 39 articles

Medical device makers offering guarantees to some hospitals

Medical device manufacturers, facing an uphill battle to win the confidence of patients and physicians, are making deals with hospitals to compensate them in the event a device fails to perform as expected. Device makers including Medtronic, Johnson & Johnson, and St. Jude Medical are among the first to offer guarantees on some of their devices. These promises include offers to share in the cost of follow-up treatments, and are a starting point of sorts for manufacturers to start taking responsibility – and more financial risk – for devices that are found to be subpar. Hospital officials aren’t easily wooed, however. ... Read More

Newer hip implants may not be better than older models

When Dr. Art Sedrakyan and fellow researchers published the first paper on premature failures of metal-on-metal hip replacement systems in 2011, several medical device manufacturers responded by withdrawing their all-metal hip implants. It turned out the failures were caused when the metal parts rubbed against each other, causing metal bits to inflame neighboring tissue and leech into the bloodstream poisoning the blood. “Back in 2011 when we published the first paper on metal-on-metal hips, hundreds of people contacted me and asked if they should be worried about hip replacement in general,” says Sedrakyan, of the Patient Centered Comparative Effectiveness Program ... Read More

Readers warn people with metal hip implants to have their blood checked for metal ions

“If you have a metal-on-metal (hip) replacement, it is imperative to have the metal ion test as soon as possible,” warned BJackson, in a comment on Missoulian’s Letters to the Editor. “My neighbor’s wife passed away a little over a year ago because of cobalt and chromium poisoning. .. she had the offending metal-on-metal (hip implant) removed and a new hip put in, (but) it was too late for her. They had spent three years telling her that she had ALS, but they were incorrect, and it was the metal-on-metal (hip implant) that killed her.” The comment was posted in ... Read More

Johnson and Johnson to pay Oregon $4 million for deceptively marketing metal hip implants

Johnson & Johnson will pay $4 million to settle a lawsuit with the State of Oregon over claims that the company failed to warn doctors and patients that its artificial hip had a high failure rate. The settlement is being called the first of its kind by the Oregon Department of Justice. The settlement involves Johnson & Johnson’s subsidiary DePuy Orthopaedics’ ASR metal-on-metal hip replacement system, which was recalled in 2010 after mounting reports of premature failure. Not only were the devices failing at a higher than expected rate, in some cases the metal devices were corroding inside the body, ... Read More

More government oversight credited for jump in medical device recalls

The number of medical device recalls has doubled in the past 10 years, according to a new report, a result of more government oversight and manufacturers doing a better job of halting sales of defective devices, officials say. Yearly recalls jumped from about 600 in 2003 to 1,200 in 2012, according to the report, which was prompted in 2011 by the Government Accountability Office (GAO). The largest rise was due to radiological devices, such as MRI and CT scanners, which have been found to register false positives and increase the risk of cancer. A fifth of the recalls in 2012 ... Read More

Fictional Dr. House character helps solve real-life medical mystery

Doctors were stumped by the symptoms exhibited by the 55-year-old man with severe heart failure. He had fever, swollen lymph nodes, hearing and vision loss when he arrived at the Center for Undiagnosed Diseases in Marburg, Germany. He also had a metal hip implant that replaced a previous ceramic one. The team of German doctors was no stranger to medical mysteries. They use a variety of resources to help pinpoint difficult-to-diagnose conditions. For this case, doctors recalled an episode of the then-recently-ended Fox TV series, House, a show in which the fictional character Dr. Gregory House solves some of the ... Read More

Researchers find metal ion concentration, device brand may predict hip implant failure

The amount of metal ions in the blood and the type of hip implant may predict premature failure of metal-on-metal hip replacements, according to a team of United Kingdom researchers. Researchers reviewed data from 299 resurfacing procedures in 278 patients with various brands of hip implants. The patients had reported complications that were likely related to high levels of metal in their blood. Patients were put through a blood metal ion screening protocol, ultrasound scanning, and joint aspiration to determine the level of cobalt concentration. Researchers found that blood-cobalt concentration and the type of device used were significant risk factors ... Read More

Biomet to pay $56 million to settle metal-on-metal hip implant lawsuits

Medical device company Biomet Inc. has agreed to pay at least $56 million to settle multidistrict litigation (MDL) in Indiana federal court claiming its metal-on-metal hip replacement devices were defective. MDLs are special federal legal procedures designed to speed up the process of handling complex cases, such as product liability lawsuits. Biomet disputes the fact that its devices caused people harm, however it agreed to set aside the money for MDL plaintiffs who qualify. The agreement resolves the MDL, which it has been fighting since October 2012. Plaintiffs in the MDL who received either the Biomet M2a-38 or M2a-Magnum hip ... Read More

3 medical devices that can harm you

Medical devices are vitally important to the industry. They vary in complexity and application, from tongue depressors and disposable gloves to implants and prostheses. Because they are used to diagnose, prevent or treat disease or other conditions, these items are regulated by the Food and Drug Administration (FDA) to ensure their safety and efficacy. However, this does not guarantee the devices don’t have hidden design flaws that can cause serious health risks. Here are three commonly used medical devices that were designed to help people, but ultimately caused more harm that good: 1. Transvaginal mesh – Also known as vaginal ... Read More

Johnson and Johnson settles metal hip lawsuit

Robert Ottman was ready for his day in court against consumer health care products giant Johnson & Johnson. Ottman underwent total hip replacement surgery in 2008 during which he was implanted with Johnson & Johnson’s DePuy ASR metal-on-metal artificial hip system. Ottman claims the device caused him so much pain and disability that in 2011 he was forced to undergo invasive revision surgery to remove and replace the defective device. In 2010, Johnson & Johnson pulled the hip implants due to an alarmingly high number of premature failures. Ottman’s lawsuit claims that Johnson & Johnson and its subsidiary DePuy Orthopaedics ... Read More