MAUDE

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FDA to Consider Reclassifying Trocars Used to Place Surgical Pelvic Mesh

Capio, retropubic sling instrument, transobturator sling instrumentation, from FDA Mesh News Desk, March 14, 2016 ~ When mesh kits were first developed and marketed in the U.S. in the mid 2000’s, they came complete with precut mesh and what’s known as a trocar. What are trocars? A trocar Read more

By | 2017-01-16T12:47:25+00:00 March 14th, 2016|FDA News|11 Comments

Q&A: Dr. Anthony Visco, AUGS President

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 Read more

By | 2016-09-25T17:18:23+00:00 March 31st, 2013|Featured|22 Comments

Breaking News ~ J & J Sold Vaginal Mesh Implant Without FDA Approval

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, Read more

By | 2012-03-21T14:53:04+00:00 March 21st, 2012|Media Reports|1 Comment

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

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 Read more

By | 2011-09-13T01:50:01+00:00 September 13th, 2011|Media Reports|0 Comments