Archive for August 2012

David Sawyer Taking his Message to YouTube

Aug 31st, 2012 | By
David Sawyer Taking his Message to YouTube

“I’m not shutting up until they stop murdering women,” says David Sawyer. Sawyer along with his wife Teresa have just formed the nonprofit group TVTNo.org to help women who are suffering financial losses due to the disabling injuries associated with transvaginal mesh. Part of the group’s mission statement is to bring more attention to the
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Blog: Hope for Those in Pain

Aug 31st, 2012 | By
Blog: Hope for Those in Pain

Because so many women have discovered Dr. Shlomo Raz at UCLA, who is perhaps the best at mesh removal surgery in the world, he is backed up for six months. Many women simply cannot wait. Teapapers blog talks to these women almost every day and write on her blog about those conversations. “Yesterday morning as
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Reporters Resource on Covering Mesh Issues

Aug 31st, 2012 | By
Reporters Resource on Covering Mesh Issues

Mesh 101: The Basics For reporters looking for a way to get started on the transvaginal mesh story, here are some highlights to shortcut your research. This is not a lawyer-generated story!  There are real women suffering devastating injuries from the use of plastic mesh and it continues today!   “We were very shocked and
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Mesh Lawsuit Victor, Christine Scott Establishes ‘Mesh Gone Wrong’ Website

Aug 30th, 2012 | By
Mesh Lawsuit Victor, Christine Scott Establishes ‘Mesh Gone Wrong’ Website

She is the first woman to have successfully sued a surgical mesh manufacturer. Last month, Christine Scott, 53, and her husband were awarded $5.5 million by a Bakersfield, California jury for the injuries she suffered after being implanted with a synthetic vaginal mesh. The manufacturer, C.R. Bard announced immediately it would sue. The jury determined
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Coloplast: Sixth MDL to Represent Women Injured by Transvaginal Mesh

Aug 30th, 2012 | By
Coloplast: Sixth MDL to Represent Women Injured by Transvaginal Mesh

It is one of the lesser known transvaginal meshes. On August 6, the Judicial Panel on Multidistrict Litigation (JPML) ordered at least 24 Coloplast federal lawsuits to be consolidated into one court forming MDL No. 2387. Here is the transfer order. At least 13 of the cases have common questions of fact and they will
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Trudy Thomas: Suffering in Silence and Financially after Kugel Mesh Settlement

Aug 19th, 2012 | By
Trudy Thomas:  Suffering in Silence and Financially after Kugel Mesh Settlement

Trudy Thomas is 53-years-old and the song, “If it wasn’t for bad luck, I wouldn’t have no luck at all,” might be her anthem. Thomas lives in Cascade, Colorado near Colorado Springs and halfway through our profile interview, she had to flee her mountain cabin. Flames invaded the canyons around her home where she lives
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Shortcomings of Vaginal Mesh Do Not Add Up – Are Docs Paying Attention?

Aug 9th, 2012 | By
Shortcomings of Vaginal Mesh Do Not Add Up – Are Docs Paying Attention?

August 9, 2012, by Amy Gezon ~ In the weeks preceding the first landmark settlement against the manufacturers of surgical mesh implants used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the New England Journal of Medicine (NEJM) (here) published an article promoting the prophylactic use of mesh slings at
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Mississippi Court Upholds Ethicon Win in Mesh Warning Lawsuit

Aug 9th, 2012 | By
Mississippi Court Upholds Ethicon Win in Mesh Warning Lawsuit

August 8, 2012 ~ An appeals court ruling in Mississippi has upheld a lower court dismissal of a $10 million vaginal mesh case against Johnson & Johnson’s Ethicon division. The United States Court of Appeals Fifth Circuit filed the decision August 2, 2012 in the case against Ethicon by Deborah and Michael Smith. Deborah Smith
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Personal Troubles for FDA’s Dr. Maisel

Aug 7th, 2012 | By
Personal Troubles for FDA’s Dr. Maisel

August 7, 2012 ~ This item  apparently bypassed the desk of MDND. Last month, Deputy Director of the FDA’s Center for Devices and Radiological Health, Dr. William Maisel, was reportedly arrested in a prostitution sting operation in Maryland, according to MassDevice (here). According to the case report here , Dr. Maisel, 46,  was arrested on
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MDUFA for Another Five Years

Aug 7th, 2012 | By
MDUFA  for Another Five Years

August 6, 2012 ~ The U.S. Food and Drug Administration (FDA) has a renewed source of funding for the review of medical devices, at least for the next five years. On October 1, 2012 the Medical Device User Fee Amendments of 2012 or MDUFA III will go into effect. It will expire October 1, 2017.
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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.