Posts Tagged ‘ MAUDE Database ’

FDA Workshop on Health of Women

Apr 9th, 2013 | By

April 9, 2013 ~ According to a new page on the FDA’s website (here), a public workshop will be held on HoW to Improve the Health of Women (HoW).  The purpose is to delve into how some medical devices work differently in women than men. It’s been noted that some hip implants have an early
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Day 8: Linda Gross v Ethicon, Prolift Launched Under FDA Radar

Jan 22nd, 2013 | By
Day 8: Linda Gross v Ethicon, Prolift Launched Under FDA Radar

January 22, 2013 ~ Much thanks to Courtroom View Network for access to the live court proceedings and graphics shown to the jury. The Prolift surgical mesh did not undergo any FDA approval before it was marketed in March 2005. Last June Ethicon, a division of Johnson & Johnson announced it was removing Prolift and
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Hernia Mesh Complications- Is the FDA Watching? Part II

Nov 28th, 2012 | By
Hernia Mesh Complications- Is the FDA Watching?  Part II

November 28, 2012 ~ Continuation from Part I, According to hernia mesh removal surgeon, Dr. Kevin Petersen, in a certain percentage of patients, the body will detect hernia mesh as a foreign material and will reject it. Symptoms may include scar tissue that leads to chronic pain and causes mesh to shrink and shrivel up,
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Dollars and Sense? Saving Money on Hernia Mesh

Sep 17th, 2012 | By
Dollars and Sense? Saving Money on Hernia Mesh

  “Application of Evidence-Based Value Analysis: Standardization of Surgical Mesh Products” In this White Paper, Winifred Hayes, a medical efficiency analyst, known as, “Your Outsourced Research Partner,” tells hospitals how to save money buying hernia mesh by being more efficient. Problem: In the case of hernia mesh, hospitals buy mesh from a limited number of
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Consumers Union on Improving the Safety of Medical Devices

Feb 8th, 2012 | By

  Improve the safety of medical devices An overview of Consumers Union’s Safe Patient Project Initiative Medical devices, like eyeglasses and contact lenses, are a part of our everyday lives and are a growing part of the health care we receive. Complex devices like artificial hip joints, surgical mesh, and cardiovascular stents, are permanently implanted
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How to Post an Adverse Event with the FDA

Aug 30th, 2011 | By
How to Post an Adverse Event with the FDA

When you have a new car that develops a “safety” issue i.e. braking, steering, airbags, wiring, engine cooling, unintended acceleration etc, the auto dealer reports the problems to the manufacturer, who by law, must report the issue to the National Highway Traffic Safety Administration within five days. But when a patient has a problem with
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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.