Archive for June 2012

FDA Panel – No Decision on Metal Hips

Jun 30th, 2012 | By
Sharee Winslow- Defective metal hip

  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 ~ A woman from Texas 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. She writes: “Please understand I am completely aware that women out there are relying on the information
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J&J Continued to Sell Vaginal Mesh Implant After FDA Ordered Halt

Jun 26th, 2012 | By

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
Dr. John Wei, U of Mi. Urology

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
Total Hip Replacement, FDA

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
Glenda Woods

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
Dr. Jeffrey Shuren, CDRH

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
Clock, WikiCommons

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
TVT Secur

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
FDA 202

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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