Posts Tagged ‘ transvaginal mesh ’

FDA – What Are We Waiting For?

Oct 28th, 2014 | By
FDA – What Are We Waiting For?

FDA-What Are We Waiting For? It’s been months since the FDA said a word about mesh, and years since it’s known stronger action was needed. Meanwhile, more and more people are getting hurt. Sign our letter below to let them know how you feel. Tell the FDA: Stop hesitating. Reclassify all pelvic mesh as high-risk.
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Doctor Directory: Dr. Daniel Elliott- Urology Department, Mayo Clinic, Rochester, MN

Oct 27th, 2014 | By
Doctor Directory: Dr. Daniel Elliott- Urology Department, Mayo Clinic, Rochester, MN

As part of an ongoing series: Doctor Directory, Mesh News Desk  will bring you interviews with the leading doctors involved with the current transvaginal mesh issue. Most of the doctors interviewed have been chosen because they recognize mesh injuries as real and deserving of attention, however, those profiled here may have different attitudes toward treatment.
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FDA Loosens its Leash on Medical Device Makers

Oct 21st, 2014 | By
FDA Loosens its Leash on Medical Device Makers

The Food and Drug Administration (FDA) is making it a little easier on medical device manufacturers to “tweak” their product without having the burden of reapplying for permission to market. Last week, the FDA announced it would not require manufacturers to alert the agency when changes are made to a device unless the change poses
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Salazar $73 Million Transvaginal Mesh Award Slashed in Half Due to Tort Reform

Oct 19th, 2014 | By
Salazar $73 Million Transvaginal Mesh Award Slashed in Half Due to Tort Reform

At the time, it was the highest award ever given a woman injured by pelvic mesh. Now that it has been reduced in half, to $34.6 million, it remains the highest award ever in transvaginal mesh litigation. The Dallas trial of Martha Salazar resulted in an unprecedented $73.4 million jury award to Mrs. Salazar. The
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C.R. Bard May Settle 500 Cases for $21 Million

Oct 8th, 2014 | By
C.R. Bard May Settle 500 Cases for $21 Million

October 8, 2014 – Readers of Mesh News Desk have been wondering why there has been no news on the C.R. Bard front while other mesh manufacturers are quietly settling pelvic mesh-injury cases. Bloomberg reports an agreement has been reached between lawyers and C.R. Bard to resolve more than 500 product liability lawsuits with a
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FDA Must Reclassify Synthetic Mesh Now!

Oct 1st, 2014 | By

October 2, 2014   Margaret A. Hamburg, M.D. Commissioner, Food and Drug Administration Department of Health and Human Services   Jeffrey E. Shuren, M.D., J.D. Director, Center for Devices and Radiologic Health Food and Drug Administration Department of Health and Human Services   Dear Drs. Hamburg and Shuren, We, the supporters and members of the
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$1.6 Billion Master Settlement Reached to Resolve AMS Pelvic Mesh Claims

Sep 30th, 2014 | By
$1.6 Billion Master Settlement Reached to Resolve AMS Pelvic Mesh Claims

Breaking  News* This afternoon Endo International announced a master settlement has been reached that will resolve the lawsuits facing the vaginal mesh maker and its subsidiary AMS (American Medical Systems). The press release says the settlement in no way admits any liability or fault. In its most recent SEC report from July, AMS tells shareholders
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Dallas Trial, Salazar v Boston Scientific Covered by Dallas Observer

Sep 3rd, 2014 | By
Dallas Trial, Salazar v Boston Scientific Covered by Dallas Observer

The Dallas Observer and reporter Amy Silverstein offer this coverage of the Martha Salazar v. Boston Scientific trial underway in Dallas. She wrote  a May feature story, about the Batiste trial. She was awarded $1.2 million by a jury in her defective mesh case against Johnson & Johnson.  Jurors also found her TVT-O was defectively
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Transvaginal Mesh – Does it Degrade? Defense Day One Hinges on Science

Sep 2nd, 2014 | By
Transvaginal Mesh – Does it Degrade? Defense Day One Hinges on Science

This coverage is provided in conjunction with We Are Mesh Survivors, a coalition of synthetic vaginal mesh implant survivors united to demand justice for those who have suffered and to demand that existing products be pulled from the market until their safety can be demonstrated. This is the first day for the defense in Huskey v.
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Huskey v Ethicon Day 4- Huskey Takes the Stand

Aug 28th, 2014 | By
Huskey v Ethicon Day 4- Huskey Takes the Stand

This coverage is provided in conjunction with We Are Mesh Survivors, a coalition of synthetic vaginal mesh implant survivors united to demand justice for those who have suffered and to demand that existing products be pulled from the market until their safety can be demonstrated. Jo Huskey, 54 took the stand in this, Day 4 of
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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.