Posts Tagged ‘ Food and Drug Administration ’

POWER MORCELLATION and the Risk of Uterine Sarcoma Dissemination

Aug 15th, 2014 | By
POWER MORCELLATION and the Risk of Uterine Sarcoma Dissemination

By Dan Bolton, Keller, Fishback & Jackson LLP., Sponsored Content 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
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ProteGen Mesh ~ The Grandmother of them All

Jul 13th, 2014 | By
ProteGen Mesh  ~ The Grandmother of them All

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
Women’s Words Speak Truth About Mesh

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
When Doctors Speak……Should We Always Listen?

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
Bard Faces Plaintiff After Mistrial in First Federal Case Against Transvaginal Mesh

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
Mistrial Declared in First Federal Transvaginal Mesh Trial

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

Op-Ed: Dr Shezad Malik Law Firm http://www.shezadmalik.com/ 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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Happy Anniversary Food and Drug Administration – Now What?

Jul 2nd, 2013 | By
Happy Anniversary Food and Drug Administration – Now What?

July 2, 2013 ~ Many of you may be aware that the entire pursuit of lawsuits against mesh manufacturers began two years ago this month with the issuance of a safety warning from the U.S. Food and Drug Administration concerning transvaginal mesh. FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical
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MDND: Welcome July 2013

Jul 2nd, 2013 | By
MDND: Welcome July 2013

July 2, 2013 ~ Welcome.  I’m Jane Akre, the Editor of MDND. There is a lot of stuff brewing this month. C.R. Bard, a mesh maker, will face off against Donna and Don Cisson in a federal court in West Virginia. This is the first of four bellwether cases, as they are called, in this
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Bard Docs: Company Knew Hernia, Transvaginal Mesh Not Fit for Human Implants

Jun 26th, 2013 | By
Bard Docs: Company Knew Hernia, Transvaginal Mesh Not Fit for Human Implants

June 26, 2013 ~ Bloomberg is reporting on court documents revealed in advance of the July 8, C.R. Bard trial that the company had been warned the plastic used in its hernia and transvaginal mesh was unfit for human implantation. Read the story here. Unsealed court records shows that the Bard Davol unit received a
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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.