Posts Tagged ‘ MAUDE ’

Q&A: Dr. Anthony Visco, AUGS President

Mar 31st, 2013 | By
Dr. Anthony Visco, AUGS

April 3, 2013 ~ Dr. Anthony Visco is Chief of Urogynecology at Duke Univ. Medical Center and President of AUGS.  The American Urogynecologic Society (AUGS) was founded in 1979 and is a professional organization of 1,400 physicians and allied health professionals who care for women with pelvic floor disorders, specifically pelvic organ prolapse (POP) and
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Breaking News ~ J & J Sold Vaginal Mesh Implant Without FDA Approval

Mar 21st, 2012 | By
Gynecare Prolift package, from website, West Coast Medical Resources

March 21 ~ Bloomberg is reporting (here) that major medical device maker Johnson & Johnson (J&J) sold the Gynecare Prolift surgical mesh for three years before it was approved by the U.S. Food and Drug Administration (FDA). The mesh is now the subject of more than 550 lawsuits, reports Bloomberg. Prolift is a pre-cut mesh
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To Whom Have You Reported Your ‘Adverse Event’ ?

Nov 14th, 2011 | By
Jane Akre, Editor

I have a question – Assuming you’ve had a problem with synthetic surgical mesh, who have you reported your complications to?   The manufacturer, the FDA? 



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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