Posts Tagged ‘ Food and Drug Administration ’

Have You Filed Your FDA Adverse Event Report Concerning Surgical Mesh?

Nov 17th, 2015 | By
maude report nov 2014

MND, November 17, 2015 ~ This woman did one year ago. She found the MAUDE database inside the FDA.  Here is the URL for her anonymous report she made after receiving the Gynecare (J&J) Prolift mesh kit.  See it  here.   You can also go to MedWatch and report your adverse event. ADVERSE EVENT What
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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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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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POWER MORCELLATION and the Risk of Uterine Sarcoma Dissemination

Aug 15th, 2014 | By
Anonymous woman 200

By Dan Bolton, Keller, Fishback & Jackson LLP An estimated 50,000 women a year in the United States undergo a hysterectomy (removal of the uterus) or myomectomy (removal of uterine fibroids) with the use of a medical device known as a power morcellator. Power morcellators typically use a rapidly rotating blade to cut (or “morcellate”)
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ProteGen Mesh ~ The Grandmother of them All

Jul 13th, 2014 | By

Fantastic researcher and friend, Suzanne McClain has always been the most competent person in digging through the U.S. Food and Drug Administration records (FDA), tedious work which involves a lot of patience. Here she has prepared a spreadsheet that shows the Johnson & Johnson meshes, and predicate devices used in order to clear them through
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Women’s Words Speak Truth About Mesh

Jul 1st, 2014 | By
Anonymous woman, WikiCommons

Remember the Stories of Anger series from a couple of years ago? Read it here. Women were speaking out and expressing their frustration with the medical system, their anger at the Food and Drug Administration and of course, their disgust with pelvic mesh manufacturers. The following are some of their quotes. I am now looking
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When Doctors Speak……Should We Always Listen?

Apr 28th, 2014 | By
doctors why we trust them

A Mesh News Desk thoughtful reader has this to say about the Position Statement from the American Urogynecology Society  (AUGS). See background story here. You may recall they feel the use of pelvic mesh is justified and still a “tool” they want to have in their toolbox. That may be a fallback position but as
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Bard Faces Plaintiff After Mistrial in First Federal Case Against Transvaginal Mesh

Jul 29th, 2013 | By
Donna Cisson Facebook page

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
Dr. Lennox Hoyte

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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Op-Ed: Dr. Shezad Malik on Doctors and Transvaginal Mesh

Jul 2nd, 2013 | By
Dr. Malik

Op-Ed: Dr Shezad Malik Law Firm Dr. Malik is a cardiologist and now an attorney in Dallas who heads his own law firm. He is board certified in internal medicine and was a practicing cardiologist for 10 years. In 2003 he decided to go to law school and has been practicing personal injury law
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