Posts Tagged ‘ 510(k) ’

LEGAL THOUGHTS ON THE AMS TRANSVAGINAL MESH SETTLEMENT

May 22nd, 2014 | By
LEGAL THOUGHTS ON THE AMS TRANSVAGINAL MESH SETTLEMENT

SPONSORED CONTENT By Dan C. Bolton, Of Counsel, Keller, Fishback & Jackson LLP                 Recently, Endo Pharmaceuticals announced that it had reached a settlement in principle with four law firms representing plaintiffs in the transvaginal mesh litigation pending before Judge Goodwin in federal district court in West Virginia (MDL 2325).  The Press Release issued by
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Harvard Researchers Take FDA’s Device Approvals to Task

Apr 2nd, 2014 | By
Harvard Researchers Take FDA’s Device Approvals to Task

Using documents that recently came to light, Harvard researchers have traced a troubling approval process within the Food and Drug Administration that allows medical devices to be sold with little oversight. Essentially the supplemental application resembles the agency’s 510(k) process that allows medical devices to be marketed without clinical trials. The paper is reported in
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The 510(k) Process – Safety Forgotten

Jan 23rd, 2014 | By
The 510(k) Process – Safety Forgotten

Sponsored Content THE 510(k) PROCESS – SAFETY FORGOTTEN By Dan C. Bolton, Of Counsel, Keller, Fishback & Jackson LLP The 510(k) process is relied upon by the medical device industry, including pelvic mesh manufacturers, such as Ethicon/Johnson & Johnson, Atrium Medical Corporation, and Davol/Bard, to quickly get devices marketed in the United States.  (The term
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FDA Approves New American Medical System Transvaginal Mesh Sling

Dec 9th, 2013 | By
FDA Approves New American Medical System Transvaginal Mesh Sling

American Medical Systems (AMS) has just received FDA clearance to market a new incontinence sling, according to a press release that appears in the Wall Street Journal. The RetroArc Retropubic Sling System received the Food the Drug Administration’s 510(k) clearance, a standard that does not require any clinical trials but relies on naming a similar 
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Find Your Mesh in the 510(k) Process

Nov 21st, 2013 | By

For those readers who want to know more about the mesh they may have had implanted for pelvic organ prolapse, stress urinary incontinence or hernia, the process is made easier if you have the Medical Device approval number from the FDA. Below is a handy list of 510(k) approvals which you must look up under
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Vaginal Mesh and English Law

Nov 11th, 2013 | By
Vaginal Mesh and English Law

by Oliver Thorne, Michelmores law firm UK http://www.michelmores.com/ Vaginal Mesh and English Law There is a storm brewing over the Atlantic. With multi-million pound settlements and awards being secured in U.S. mesh claims, a picture is beginning to emerge of the global spread of these defective products, and their impact on women around the world.
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Law Professor Thomas A. Eaton on Tort Reform

Aug 29th, 2013 | By
Law Professor Thomas A. Eaton on Tort Reform

Earlier this month, the jury in the federal Donna Cisson transvaginal mesh case awarded Mrs. Cisson $1.75 million in punitive damages in addition to the $250,000 in compensatory damages. The Cisson case established the Bard Avaulta mesh she received as a treatment for pelvic organ prolapse was defective. Yet readers learned something startling about any
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Bard Faces Plaintiff After Mistrial in First Federal Case Against Transvaginal Mesh

Jul 29th, 2013 | By
Bard Faces Plaintiff After Mistrial in First Federal Case Against Transvaginal Mesh

The case of Donna Cisson v. C.R. Bard began for a second time in a federal court in Charleston, West Virginia today. Cisson, 55, was implanted with a Bard Avaulta Plus Posterior mesh on May 8, 2009 in Toccoa, Georgia. The initial product liability trial began July 8, but two days later, a statement by
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Mistrial Declared in First Federal Transvaginal Mesh Trial

Jul 10th, 2013 | By
Mistrial Declared in First Federal Transvaginal Mesh Trial

July 10, 2013~  Saying it was the first time in his 20 years on the bench he had declared a mistrial, federal Judge Joseph R. Goodwin ended the first federal trial involving one of six transvaginal mesh manufacturers, C.R. Bard, after just two days of testimony. More than 25,000 cases have been consolidated in the
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FDA Considers Revising 510(k), Industry Balks

Jun 13th, 2013 | By
FDA Considers Revising 510(k), Industry Balks

June 13, 2013~ “External stakeholders.” That is what the FDA calls medical device manufacturers who also  have a decisive role in shaping the regulations they fall under. Thursday, June 13, the FDA met with stakeholders to discuss modifying the 510(k) approval process. (here) About 90 percent of the 4,000 medical devices approved by the FDA
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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.