Archive for August 2012
Aug 31st, 2012 |
By Jane Akre
“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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Posted in Your Turn |
1 Comment »
Tags: America Now, David Sawyer, gold standard, Incontinence, MDND, Mesh medical Device News Desk, Prolapse, Teresa Sawyer, Toledo News Now, transvaginal mesh, TVTNO, YouTube
Aug 31st, 2012 |
By Jane Akre
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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Posted in Op-Ed |
No Comments »
Aug 31st, 2012 |
By Jane Akre
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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Posted in Mesh Reading Room Resource |
9 comments
Tags: Abdominal mesh, American Medical Systems, Bard, Covidien, DePuy, Dr. Donald Ostergard, Endo Pharmaceutical, Ethicon, GAO, gynecare, Institute of Medicine, Johnson & Johnson, kugel mesh, Markey, Mentor, metal-on-metal, not inert, Ob Tape, POP, ProteGen, Sound Devices Act, SUI, transvaginal mesh
Aug 30th, 2012 |
By Jane Akre
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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Posted in Feature |
2 comments
Tags: Avaulta Plus, C.R.Bard, Mesh Gone Wrong, pelvic organ prolapse, transvaginal mesh, urinary incontinence, vaginal mesh
Aug 30th, 2012 |
By Jane Akre
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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Posted in Legal News |
1 Comment »
Tags: American Medical Systems, Avaulta, Avaulta Plus Biosynthetic Support System vaginal implant, Axis, Bard, Boston Scientific, Coloplast, Ethicon, Exair, JPML, Mentor Ob Tape, Multidistrict Litigation, Novasilk, Suspend
Aug 19th, 2012 |
By Jane Akre
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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Posted in Patient Profiles |
21 comments
Tags: Bard, Bard Composix Kugel Mesh Hernia Repair Patch., C.R.Bard, Composix Kugel Mesh Patch, Davol, FDA, hernia repair, Kugel Hernia Patch, Kugel mesh litigation, Kugel mesh ring, Kugel settlement, Medicare, ring break, Social Security
Aug 9th, 2012 |
By Jane Akre
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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Posted in Op-Ed |
4 comments
Tags: Christine Scott, chronic pain, dyspaurenia, erosion, Ethicon, Gynecare TVT, Johnson & Johnson, MDL, MDND, mesh contraction, Mesh medical Device News Desk, Mesh slings, Multidistrict Litigation, New England Journal of Medicine, OPUS Trial, Organ perforation, POP, profound morbidity, SUI, TVT Secur, urinary incontinence
Aug 9th, 2012 |
By Jane Akre
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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Posted in Legal News |
7 comments
Tags: Adverse events, Deborah Smith, defective product, end user, Ethicon, failure to warn, Johnson & Johnson, learned intermediary, mersilene, product liability, sacroplexy
Aug 7th, 2012 |
By Jane Akre
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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Posted in FDA |
1 Comment »
Tags: Center for Devices and RAdiological Health, FDA, Hamburg, MassDevice, Pharmalot, Sebelius, Shuren, whistleblowers, William Maisel
Aug 7th, 2012 |
By Jane Akre
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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Posted in FDA |
No Comments »
Tags: Consumers Union, MDUFA, Medical Device user Fee, nion, ProteGen vaginal mesh, Rep. Edward Markey, Safe Patient Project, Sound Devices Act, UDI, Unique Device identification System