Archive for September 2011

Suffering in Silence: Amy Gezon Tells FDA Panel Boston Scientific Mesh Sling Devastated Her with Pain

Sep 29th, 2011 | By
Amy Gezon

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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The Next Medical Device Controversy: Vaginal Mesh, Business Week, September 15, 2011

Sep 26th, 2011 | By

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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Dr. Susan Lark: Undoing Urinary Incontinence

Sep 26th, 2011 | By
Dr. Lark Image 260 wide

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.



Two Studies on Mesh Offer Questionable Outcomes of Success

Sep 20th, 2011 | By
Prolene Mesh

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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Wall Street Journal- Venture Capital Dispatch, Sept. 15, 2011

Sep 16th, 2011 | By

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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Suffering in Silence: Diane Maassen Tells FDA Panel About Her Nightmare with Pelvic Mesh Sling

Sep 16th, 2011 | By
Jerry and Diane Maassen

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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Boston Scientific Hires Former J & J Exec Involved with Defective Recalled Hip Device, Mass Device, CBS News, September 14

Sep 15th, 2011 | By
Michael Mahoney 150 boston scientific

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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Former FDA Director Joins Consulting Company as President, Market Watch, September 14

Sep 14th, 2011 | By

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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FDA Panel Wants More Data on Mesh Tx for Incontinence, MedPage Today, September 9

Sep 13th, 2011 | By

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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J & J–Led Vaginal Mesh Group Says FDA Should Require More Studies, Bloomberg, Sept 8, 2011

Sep 13th, 2011 | By
Medical concept -  stethoscope over the dollar bills

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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