Archive for September 2011
Sep 29th, 2011 |
By Jane Akre
Amy Gezon is a 43-year-old mother of 3 from Salt Lake City, Utah and the wife of an emergency room doctor at the VA medical center. She studied nursing in college, graduated with a degree in exercise sports science and is currently pursuing a masters degree in mental health counseling. Professionally she coordinated research studies
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Posted in Patient Profiles |
21 comments
Tags: Boston Scientific, cystocele, FDA Expert Panel, laparoscopically, mesh, mid-urethral, POP, pudendal, rectocele, retroopubic, Rolfing, sling, SUI
Sep 26th, 2011 |
By Jane Akre
Business Week reports on The Next Medical Device Controversy: Vaginal Mesh Marci Sutin Levin, a 65-year-old New York marketing executive says she can’t sleep, work, or have sex because of endless pain she’s experienced ever since she had surgical mesh implanted in 2007. Hers is one of 600 lawsuits that have been filed against mesh
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Posted in Media Reports |
No Comments »
Tags: AMS, Bard, Boston Scientific, complications, lawsuits, pelvic organ prolapse, urinary incontinence
Sep 26th, 2011 |
By Jane Akre
Dr. Susan Lark is author and women’s health specialist who combines clinical nutrition with preventive medicine and complementary therapies to enhance the well-being of women. Share this:
Posted in Feature, Medical News |
2 comments
Tags: BMI, BMI Ayurvedic, Dr. Susan Lark, Kegel, Self Help, SUI, Urge Urinary Incontinence, vaginal cones, Women's Wellness Today
Sep 20th, 2011 |
By Jane Akre
Two Published Studies – Consider Your Odds SEPTEMBER 20, 2011- Two studies on the use of synthetic mesh for female stress urinary incontinence treatment offer a couple of different outcomes. The first one in the Journal of Minimally Invasive Gynecology published August 19, 2011 comes out of Tel Aviv University’s Department of Obstetrics and Gynecology.
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Posted in Feature, Medical News |
2 comments
Tags: Incontinence, medicine, Pelvic Floor disorders network, Prolapse, Stress urinary incontinence, SUI, urge incontinence
Sep 16th, 2011 |
By Jane Akre
The Push from Venture Capital Investors Venture capital investors are keeping a close eye on the FDA, especially since the way it approves medical devices may be changing. Not only are they watching, they are involved in pushing for reforms. The Medical Innovation and Competitiveness Coalition (MedIC) is one of two organizations along with the
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Posted in Media Reports |
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Tags: entrepreneurs, innovation, Medical devices, venture capital
Sep 16th, 2011 |
By Jane Akre
SEPTEMBER 16, 2011 – Editors Note: I attended the Food and Drug Administration expert panel convened on September 8 & 9, 2011 to listen to patients and industry as well as surgeons who use pelvic mesh to treat incontinence and pelvic floor weakness in women and hernias in men. All of the injured patients were
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Posted in Patient Profiles |
5 comments
Tags: 510(k), American Medical Systems, AMS, Bladder, bladder surgery, bowel, cystocele, depression, FDA Expert Panel, Incontinence, kidney, minimally invasive, rectocele, S.P.A.R.C., sling, surgical mesh, urinary tract infection, urology
Sep 15th, 2011 |
By Jane Akre
Boston Scientific New President from J & J Boston Scientific Corporation of Natick, Mass. announced it will have a new president on October 17. He is 46-year-old Michael Mahoney. The young executive will be eased into the job reports CBS News and take over the CEO title in November 2012 under the tutelage of William
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Posted in Media Reports |
No Comments »
Tags: Boston Scientific, DePuy ASR XL, Johnson and Johnson, Michael Mahoney
Sep 14th, 2011 |
By Jane Akre
Is this the revolving door? Ron Johnson, former Director of the Office of Compliance within the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA), has taken a job as President of BECKER CONSULTING, according to a press release on Market Watch. According to the release, Mr. Johnson spent
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Posted in Media Reports |
2 comments
Tags: CDRH, FDA, Post Employment Restrictions
Sep 13th, 2011 |
By Jane Akre
MedPage Today (here) reports an FDA advisory panel meeting over synthetic mesh used to treat stress urinary incontinence (SUI) said it would like more scientific data on the newer generation of devices but recommended leaving in place the 510(k) approval process. FDA Panel Listens to Industry, Patients, Staff The Obstetrics and Gynecology Devices panel issued
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Posted in Media Reports |
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Tags: Benefit, Class II, Class III, high-risk, Incontinence, MAUDE, mesh, pelvic floor problems, POP, Risk, SUI
Sep 13th, 2011 |
By Jane Akre
This article in Business Week (here) reports that medical device makers attending a September 8 & 9 panel of experts convened by the Food and Drug Administration (FDA) over the use of synthetic mesh in women with pelvic and incontinence problems agreed on the need for more safety studies, however they proposed new versions of
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Posted in Media Reports |
No Comments »
Tags: C.R.Bard, clinical trials, Ethicon, mesh