Posts Tagged ‘ Mesh medical Device News Desk ’

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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Mesh Survivors UK- Contact Your GP, MP – Challenge the Information!

Oct 10th, 2014 | By
Mesh Survivors UK- Contact Your GP, MP – Challenge the Information!

A mesh survivor from the UK suggests survivors contact their GP and MP with their mesh survivor stories.  (GP is general practitioner and MP is Member of Parliament. The reason – no one ever gets a letter to confirm it has been reported. Finally, this writer got a report to confirm. It said:  this event
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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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Scotland: Industry Sponsored Docs on Mesh Safety Review Team

Oct 6th, 2014 | By
Scotland: Industry Sponsored Docs on Mesh Safety Review Team

Another story by Scottish reporter Marion Scott finds that a government probe into mesh implants is allegedly under the heavy influence of industry in this case Johnson & Johnson’s Ethicon division.  Two of the doctors placed on a government review team have been named –  Ash Monga and Karen Guerrero. Dr. Monga calls himself a
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October ~ Welcome to Mesh News Desk

Oct 5th, 2014 | By
October ~ Welcome to Mesh News Desk

Hello and Welcome October Readers to Mesh News Desk. How are you? If you are new to the Pelvic Mesh issue you are in the right place. We cover the medical, legal and regulatory issues concerning pelvic mesh. Fashioned from hernia mesh it has long been known to be associated with complications. Hernia mesh patients
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Isreali Lawyers Preparing Class Action Defective Product Suits Over Prolift Mesh

Oct 1st, 2014 | By
Isreali Lawyers Preparing Class Action Defective Product Suits Over Prolift Mesh

More news is coming into Mesh News Desk from around the world concerning mesh litigation. Johnson & Johnson is being sued in Israel over complications linked to its Prolift Vaginal Mesh kit used to treat pelvic organ prolapse.  You may recall that the Prolift was sold by Ethicon (Johnson & Jonson) before it ever received FDA approval.  See background story
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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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Report Finds Doctors Still Using Power Morcellator Despite the Risks

Sep 22nd, 2014 | By
Report Finds Doctors Still Using Power Morcellator Despite the Risks

Months after the U.S. Food and Drug Administration (FDA) warned a medical device could spread deadly uterine cancer, many doctors and hospitals are still using it. The power morcellator made by Johnson & Johnson (J&J) was removed from the market after the FDA warned it could spread undetected uterine cancers. A report in the Wall
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Court Watchers Wanted for Next Boston Scientific Trial

Sep 19th, 2014 | By
Court Watchers Wanted for Next Boston Scientific Trial

Are you able to travel to Dallas October 6 to observe the Figueroa trial against Boston Scientific in Dallas?  Judge Molberg will preside, the same judge who recently oversaw the $73.5 million verdict in favor of plaintiff Martha Salazar.  Mesh News Desk is looking for Court Watchers to continue to inform others about what is
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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.