Tagged Articles

metallosis 229 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

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

Surgeon: Metal hip implant failures led to ‘severe patient wreckage’

“I’d seen patients coming into the clinic complaining of groin pain. I saw it once and then again and then again and again,” Surgeon Antoni Nargol told Four Corners, an investigative news program for ABC News Australia. Nargol was referring to patients who had received ASR metal-on-metal hip replacement systems made by Johnson & Johnson subsidiary DePuy Orthopaedics. The devices were recalled in 2010 after mounting reports of premature failures and infections caused by heavy metal blood poisoning. New research shows that Johnson & Johnson knew the devices were defectively designed as early as 2006 – four years before the ... Read More

Metal hip manufacturer faces new lawsuits alleging defective design

At least five new lawsuits were filed against Stryker Corp., and its subsidiary Howmedica Osteonics Corp., claiming that the companies’ hip implant was defective, causing injuries and poisoning blood. The lawsuits involve the Accolade TMZF hip stem and LFIT anatomic V40 femoral head. Stryker already is facing more than 500 similar lawsuits over other artificial hip models, the Rejuvenate and ABG II modular-neck stems. According to the complaint, the titanium hip stem can corrode when it is used with the femoral heads, which are made from cobalt and chromium. When the metal corrodes inside the body, it can inflame tissue, ... 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

Social media campaign takes aim at Johnson & Johnson

An activist group has launched a social media campaign attacking Johnson & Johnson, alleging the company’s transvaginal mesh implants have “hurt women across the country,” and is asking current and former employees to become whistleblowers and investors to divest or not to buy the company’s stock. The Corporate Action Network (CAN), a project of the Action Network Fund founded to address the imbalance of power between corporations and people, launched the campaign in an effort to gather more information against the company to strengthen a complaint the organization filed with the Department of Justice against Johnson & Johnson and its top ... Read More

Consumer Reports group pushes for warranties on artificial hips

Nearly a half-million Americans each year undergo hip replacement surgery, an invasive operation that requires weeks of rehabilitation. Typical hip implants can last 20 years or more before being replaced, but some have been shown to fail at a faster than expected rate. Thus, the Safe Patient Project, organized by Consumer Reports, is pushing for all hip implants to come with warranties. “One, it tells people how long this implant’s going to last,” said Lisa McGiffert of the Safe Patient Project. “It gives them realistic expectations. And two, it gives them a clear process to follow if their implant should ... 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

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