Archive for June 2012
Jun 30th, 2012 |
By Jane Akre
June 30, 2012 ~The U.S. Food and Drug Administration (FDA) convened an 18-member expert panel to look at the large number of complications arising from metal-on-metal (MoM) hip replacements in patients. Dr. William Rohr opened the proceedings on June 27 saying they were not there to discuss reclassification of the hip, and the experts
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Posted in FDA |
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Tags: 510(k), ASR, chromium, cobalt, DePuy Orthopaedics, Johnson & Johnson, metal-on-metal, MOM hips, necrosis, orthopaedic, Smith & Nephew
Jun 30th, 2012 |
By Jane Akre
June 30, 2012 ~ Linda K. has just returned from a trip to UCLA to have an initial consultation with Dr. Raz, the surgeon who is helping so many from around the world with mesh complications. Her Teapapers Blog is read by many, here is an excerpt. “Please understand I am completely aware that women
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Posted in Op-Ed |
4 comments
Jun 26th, 2012 |
By Jane Akre
June 26, 2012 ~ Johnson & Johnson, the global healthcare company, has once again found itself in the spotlight for failing to follow the rules. J & J was ordered to stop selling a controversial vaginal mesh product, the Gynecare Prolift, but kept selling it even after being warned by the U.S. Food and Drug
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Posted in Media Reports |
4 comments
Tags: Ethicon, FDA, Food and Drug Administration, J&J, Johnson & Johnson, Organ perforation, prolapsed tissue, Prolift, vagiinal mesh
Jun 21st, 2012 |
By Jane Akre
June 20, 2012 ~ With all of the bad news about vaginal mesh (see Patient Profiles) and the thousands of lawsuits that have been filed by women who claim life-altering complications, a story like this is a glaring departure and deserves a closer look. Bloomberg reports on a newly published study that says the Johnson
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Posted in Medical News |
6 comments
Tags: ., American Urogynecologic Society, AUGS, bladder perforations, bleeding, Bloomberg, cheryl iglesia, Dr Wei, Ethicon, Gynecare TVT sling, incomplete bladder emptying, Incontinence, Johnson & Johnson, New England Journal of Medicine, tension-free tape, TVT, vascular complications
Jun 20th, 2012 |
By Jane Akre
Next Wednesday, June 27 and Thursday, June 28, the U.S. Food and Drug Administration (FDA) will convene one of its expert panels – this one on patient complications after a metal-on-metal hip implant. It is a gathering called by the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee within the FDA. The
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Posted in FDA |
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Tags: 510(k), A.S.R, acetabular component, advisory panel, Ann Morrison, BBC, birmingham Hip Resurfacing, British Medical Journal, chromium, Class II, Class III, cobalt, DePuy, FDA, Howard Sadwin, Johnson & Johnson, Medtronic, metal ions, metal-on-metal hips, MoM, recall, resurfacing system, Smight & Nephew, total hip replacements, transvaginal mesh
Jun 19th, 2012 |
By Jane Akre
Op-Ed – June 19, 2012 ~ Editors Note- * -As someone who worked in the mainstream news for 25 years I know how it used to work. That was before the 500 channel universe and all eyeballs abandoned newspapers to go online. But the profitable business models for news – both print and broadcast –
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Posted in Op-Ed |
1 Comment »
Tags: Bladder, electrical stimulation therapy, gold standard, Incontinence, kegals, leakage, Polypropylene Mesh, stress incontinence, synthetic surgical mesh, transvaginal mesh, Urethra, urodynamic testing
Jun 14th, 2012 |
By Jane Akre
If you ask the public, most say they want safer medical devices, not more of them. If you ask the patients profiled in Mesh Device News Desk (MDND) they’d say they wished they’d known that the medical devices they received had come with a prominent warning that would have told them what they were in
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Posted in FDA |
1 Comment »
Tags: CDRH, Consumers Union, Markey, MDND, MDUFA, medical device, Shuren, Sound Devices Act
Jun 14th, 2012 |
By Jane Akre
If you are considering filing a legal action, you’ve probably heard the term “Statute of Limitations.” A “statute” is the common law that sets the time frame within which you have to file a lawsuit. A filing outside of that time frame may mean it is too late to prosecute the person or company responsible
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Posted in Legal News |
No Comments »
Tags: civil law, cornell law, defective product, lawsuit, legal action, nolo press, product liability, Statute of Limitations
Jun 9th, 2012 |
By Jane Akre
A few folks have asked whether or not the Food and Drug Administration (FDA) has granted Ethicon’s request to place a hold on a three-year study on the complications with transvaginal mesh? The short answer is, not yet. No doubt Ethicon, a division of Johnson & Johnson (J&J), was not looking forward to spending in
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Posted in Your Turn |
2 comments
Tags: 522 study, Division of Small Manufacturers, DSMICA, dyspareunia, Ethicon, FDA, fistula, gynecare, incontnence, International and Consumer Assistance, Johnson & Johnson, Office of Women's Health, pelvic organ prolape, pelvic pain, Prolift, Prolift M, Prosima, scarring, transvaginal mesh, TVT Secur, vaginal shortening
Jun 8th, 2012 |
By Jane Akre
In the Ethicon June 4, announcement to two courts that it was taking four synthetic vaginal meshes off the market, Ethicon, a division of Johnson & Johnson, asked that the Food and Drug Administration’s (FDA) January order to conduct postmarket studies be “placed on hold.” There were about 75,000 women implanted with synthetic mesh to
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Posted in Legal News |
No Comments »
Tags: 522, complications, Ethicon, Johnson & Johnson, pelvic organ prolapse, PO, Stress urinary incontinence, SUI