Posts Tagged ‘ FDA ’

How to Post an Adverse Event with the FDA

Aug 30th, 2015 | By
Pacemaker, Courtesy WikiCommons, Steven Fruitsmaak

MND, August 30, 2015 ~When you have a new car that develops a “safety” issue i.e. braking, steering, airbags, wiring, engine cooling, unintended acceleration etc, the auto dealer reports the problems to the manufacturer, who by law, must report the issue to the National Highway Traffic Safety Administration within five days. But when a patient
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FDA Expert Panel Meets Sept. 24 Over Controversial Essure Birth Control Device

Jul 23rd, 2015 | By
Essure, ABC, Tampa

MND, July, 23, 2015 ~ The following is from the FDA’s website.  The issue of the controversial Essure birth control implant has made the headlines. Women claim they have been injured by the implant which is made by Bayer HealthCare.  The implant is placed through the vagina and into the fallopian tube to prevent pregnancy.
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*New* Power Morcellator Controversy Spurs FDA Proposal – But Does it Go Far Enough?

Jul 13th, 2015 | By
Power morcellator graphic, WSJ

The Wall Street Journal (WSJ) reports on Friday the House passed a bill that would improve the safety monitoring of medical devices. It was inspired by a gynecological device – the power morcellator. The morcellator is a tool that is used to grind up growths in the uterus, however a woman has a one in
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Hello May- Doctor Duh!

Apr 30th, 2015 | By
Jane Akre, editor Mesh News Desk

This story was originally submitted to the New York Times as an Op-Ed. It was not picked up. So far mainstream media has a blackout on this type of news, likely because of the potential advertisers who make these medical devices. I thought I would post it here for May because lately I’m hearing from
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Faulty design and cleaning procedures in widely used endoscope may have caused superbug outbreak

Apr 8th, 2015 | By
CRE bacteria, Source: CDC

By Farid Zakaria, Keller, Fishback & Jackson LLP  An outbreak of a drug-resistant strain of bacteria at a major southern California hospital last February has been linked to a medical device used in the treatment of cancers, gallstones, and other ailments of the digestive system. On February 18, the Los Angeles Times reported that nearly
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FAVORABLE JURY VERDICTS CONTINUE IN TRANSVAGINAL MESH (TVM) LITIGATION—IS AMS WATCHING?

Dec 11th, 2014 | By

By Dan C. Bolton, Of Counsel, Keller, Fishback & Jackson LLP                 In recent months, Endo Pharmaceuticals made several announcements concerning global settlements in the transvaginal mesh litigation against American Medical Systems (AMS) pending before Judge Goodwin in federal district court in West Virginia (MDL 2325).  Based on the numbers of women participating, the AMS
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FDA – What Are We Waiting For?

Oct 28th, 2014 | By
red flag waving

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

Oct 10th, 2014 | By

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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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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Scottish Medical Officer Says Docs Can Continue to Implant Mesh Despite Mesh Suspension

Sep 28th, 2014 | By
Marion Scott, reporter Sunday Mail

Marion Scott, the reporter who has passionately reported on the pelvic mesh issue for the Daily Record and Sunday Mail newspaper in Scotland, reports a top medical adviser to the Scottish government suggests doctors may continue to perform mesh implants even though the Health Secretary has advised use of pelvic mesh be suspended. Dr. Frances
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