Posts Tagged ‘ FDA ’

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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Batiste v. Ethicon trial: An unexpected emotional rollercoaster in Texas

Mar 25th, 2014 | By
Batiste v. Ethicon trial: An unexpected emotional rollercoaster in Texas

by Aaron Leigh Horton  Aaron Leigh Horton arrived in the Dallas courtroom this morning, Monda,y March 24, to continue witnessing the trial of Linda Batiste v. Ethicon, now in its second week. Aaron, The Mesh Warrior, reports she had to leave the courtroom during some of the morning testimony because of the emotional toll it
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Endo/ American Medical Systems Under Investigation for Transvaginal Mesh

Mar 5th, 2014 | By
Endo/ American Medical Systems Under Investigation for Transvaginal Mesh

Endo Health Solutions took over American Medical Systems (AMS) in 2011 for $2.9 billion and in doing do inherited roughly 22,000 transvaginal mesh lawsuits. That may have been a mistake. In its annual report released by the Securities and Exchange Commission Monday, Endo says it has received subpoenas from several states investigating its pelvic mesh
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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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J&J Systematically Destroyed Evidence in Upcoming Mesh Trials, Pl Lawyers Call it ”Severe” Destruction of Evidence

Dec 8th, 2013 | By
J&J Systematically Destroyed Evidence in Upcoming Mesh Trials, Pl Lawyers Call it ”Severe” Destruction of Evidence

Ethicon Pelvic Repair System Products Liability Litigation, 12-MD-02327, In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation Joseph R. Goodwin, presiding Date filed: 02/07/2012 Date of last filing: 12/03/2013 PART ONE     (Continues in Part 2) According to a 30-page document filed in federal court in West Virginia December 2, officials at Johnson & Johnson
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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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Suffering in New Zealand: Jacqui Scott Wants Mesh Removed in States

Nov 20th, 2013 | By
Suffering in New Zealand: Jacqui Scott Wants Mesh Removed in States

Jacqui Scott is making headlines in New Zealand. The Napier resident has been the subject of a column by Kerre McIvor of the New Zealand Herald, as well as a feature article in New Zealand Women’s Weekly. The November 3 Herald article, entitled “Rape victim may yet get justice,” reports that Scott’s ordeal began in
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Scotland’s Health Secretary Calls for More Regulation and Informed Consent over Mesh

Nov 13th, 2013 | By
Scotland’s Health Secretary Calls for More Regulation and Informed Consent over Mesh

The Daily Record- the newspaper of Scotland – reports that due to front page headline reports by its sister publication, The Sunday Mail, the country’s Health Secretary, Alex Neil, is calling for tougher regulations concerning transvaginal mesh and more informed consent. The Sunday Mail, and reporter Marion Scott, have done a series of hard-hitting exposes
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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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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.