Archive for June 2012

FDA Panel – No Decision on Metal Hips

Jun 30th, 2012 | By
FDA Panel – No Decision on Metal Hips

  June 30, 2012 ~The U.S. Food and Drug Administration (FDA) convened an 18-member expert panel to look at the large number of complications arising from metal-on-metal (MoM) hip replacements in patients. Dr. William Rohr opened the proceedings on June 27 saying they were not there to discuss reclassification of the hip, and the experts
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A Trip to See Dr. Raz at UCLA

Jun 30th, 2012 | By

June 30, 2012 ~ Linda K. has just returned from a trip to UCLA to have an initial consultation with Dr. Raz, the surgeon who is helping so many from around the world with mesh complications. Her Teapapers Blog is read by many, here is an excerpt. “Please understand I am completely aware that women
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J&J Continued to Sell Vaginal Mesh Implant After FDA Ordered Halt

Jun 26th, 2012 | By
J&J Continued to Sell Vaginal Mesh Implant After FDA Ordered Halt

June 26, 2012 ~ Johnson & Johnson, the global healthcare company, has once again found itself in the spotlight for failing to follow the rules. J & J was ordered to stop selling a controversial vaginal mesh product, the Gynecare Prolift,  but kept selling it even after being warned by the U.S. Food and Drug
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Using Vaginal Mesh as a Preventative? Study Says it’s Okay

Jun 21st, 2012 | By
Using Vaginal Mesh as a Preventative? Study Says it’s Okay

June 20, 2012 ~ With all of the bad news about vaginal mesh (see Patient Profiles) and the thousands of lawsuits that have been filed by women who claim life-altering complications,  a story like this is a glaring departure and deserves a closer look. Bloomberg reports on a newly published study that says the Johnson
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Coming Up: FDA Expert Panel Weighs in on Metal Hips

Jun 20th, 2012 | By
Coming Up: FDA Expert Panel Weighs in on Metal Hips

Next Wednesday, June 27 and Thursday, June 28, the U.S. Food and Drug Administration (FDA) will convene one of its expert panels – this one on patient complications after a metal-on-metal hip implant. It is a gathering called by the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee within the FDA. The
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Consumer Alert- Walks Like News, Quacks Like News- Must be News? Wrong

Jun 19th, 2012 | By
Consumer Alert- Walks Like News, Quacks Like News- Must be News? Wrong

Op-Ed – June 19, 2012 ~ Editors Note- * -As someone who worked in the mainstream news for 25 years I know how it used to work. That was before the 500 channel universe and all eyeballs abandoned newspapers to go online. But the profitable business models for news – both print and broadcast –
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FDA’s Shuren Tells Industry Medical Device Reviews are Faster, More Efficient

Jun 14th, 2012 | By
FDA’s Shuren Tells Industry Medical Device Reviews are Faster, More Efficient

If you ask the public, most say they want safer medical devices, not more of them.  If you ask the patients profiled in Mesh Device News Desk (MDND) they’d say they wished they’d known that the medical devices they received had come with a prominent warning that would have told them what they were in
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What is a Statute of Limitations?

Jun 14th, 2012 | By
What is a Statute of Limitations?

If you are considering filing a legal action, you’ve probably heard the term “Statute of Limitations.” A “statute” is the common law that sets the time frame within which you have to file a lawsuit. A filing outside of that time frame may mean it is too late to prosecute the person or company responsible
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Will the FDA Grant J&J’s Request to Stop the Studies?

Jun 9th, 2012 | By
Will the FDA Grant J&J’s Request to Stop the Studies?

A few folks have asked whether or not the Food and Drug Administration (FDA) has granted Ethicon’s request to place a hold on a three-year study on the complications with transvaginal mesh? The short answer is, not yet. No doubt Ethicon, a division of Johnson & Johnson (J&J), was not looking forward to spending in
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Will Ethicon Skirt the 522 Request?

Jun 8th, 2012 | By
Will Ethicon Skirt the 522 Request?

In the Ethicon June 4, announcement to two courts that it was taking four synthetic vaginal meshes off the market, Ethicon, a division of Johnson & Johnson, asked that the Food and Drug Administration’s (FDA) January order to conduct postmarket studies be “placed on hold.” There were about 75,000 women implanted with synthetic mesh to
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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.