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The documentary, The Bleeding Edge, has focused some much-needed attention on the medical device industry and the process to bring these devices to market.
The film documents the following four medical devices, raising the question as to how well our system is working in regulating medical devices.
Medical devices, many of which save lives every day or give us a better quality of life, are everywhere.
Over the past 10 years, nearly 70 million Americans have been implanted with medical devices.
– Jeanne Lenzer, The Danger Within Us [quote from The Bleeding Edge]
Have you heard of the documentary, The Bleeding Edge? It chronicles the unnecessary pain and suffering of patients caused by complications of medical devices that received little or no testing.
Available on Netflix, this documentary is extremely powerful. It is worth taking the time to watch and share with everyone you know especially if you will be undergoing an expensive or risky medical procedure.
FDA Letter to Health Care Providers
Posted by the FDA on April 25, 2018.
The Issue: FDA is providing preliminary information concerning magnetic resonance (MR) thermometry reliability with magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) devices.
Permanent birth control is one of the most widely used methods of contraception today. It can be highly effective, doesn’t require a surgical procedure and women no longer have to remember to take a daily pill. So why has the FDA restricted the sale and distribution of the Essure device and required boxed warnings?
It is the responsibility of manufacturers to ensure the products they bring to market are safe for public use. While the US FDA reviews the products before going to market, what do medical device manufacturers do to gain market approval?
A new study, published in the scientific journal, JAMA Surgical on September 28, 2016, suggests that IVC filters may not help people who are at risk of dangerous blood clots to improve their chances of survival.
More and more people turn to hip replacement surgeries to give them back their mobility and to relieve the pain caused by diseases such as osteoarthritis.
The Bair Hugger forced air warming blanket system is used in thousands of hospitals across the country. The system was designed to keep patients warm during surgery, reduce the risk of infections and improve recovery times. However, many lawsuits filed allege that the device is flawed and may contribute to post-operative deep joint infections.
A little more than a year ago, NBC News aired a 2-part series investigating the safety of IVC filters, alleging that some have high failure and breakage rates causing devastating results.
IVC filters are a small, cage-like device implanted in patients who have an increased risk of developing blood clots and cannot be successfully treated by other methods, such as blood thinners. Unfortunately, these devices have been linked to complications such as migration and perforation of other organs.