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A medical device recall is when the manufacturer either removes a device or takes corrective action to address a problem with a device that is in violation of the FDA laws, such as when the device is defective and/or a risk to health.
These are some basic FAQs and resources to help you understand medical device recalls.
Surgical mesh has been used to treat hernias since the 1950s. In the 1970s, gynecologists began using it for abdominal repair of pelvic organ prolapse (POP) and in the 1990s for the transvaginal repair of POP.
March 8, 2019. In an article published by Kaiser Health News, we learned that some medical device manufacturers have been using a secret reporting mechanism to let the FDA know of problems with their devices.
The problem? The data is hidden so that neither the public nor doctors are aware of any problems reported.
In 2018, the medical device industry and the FDA came under fire from:
December 20, 2018. FDA Commissioner, Scott Gottlieb, issued a statement on the new steps the FDA will take to strengthen the long-term safety oversight of Essure. In his statement, Gottlieb said the FDA will continue to evaluate the product’s long-term safety profile even after it has been discontinued in the US market.
“Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety and effectiveness of medical devices.”
On Monday, November 26, 2018, the Food and Drug Administration announced that it plans to modernize its current process, the 510(k) clearance pathway, which is how a majority of the medical devices are reviewed and approved by the FDA today.
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.