Posts Tagged ‘
MAUDE ’
Mar 31st, 2013 |
By Jane Akre
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
[continue reading...]
Posted in Feature |
17 comments
Tags: Adverse events, AE, AUGS President, FDA, informed consent, MAUDE, Mesh medical Device News Desk, pelvic organ prolapse, POP, prolapse repair, Q&A: Dr. Anthony Visco, Stress urinary incontinence, SUI, transabdominal mesh, urogynecology, vaginal mesh, Visco
Mar 21st, 2012 |
By Jane Akre
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
[continue reading...]
Posted in Media Reports |
1 Comment »
Tags: 510(k), Bloomberg, defective product, DePuy, FDA, Gary Pruden, Gynecare Prolift, illegal marketing, Johnson & Johnson, lawsuits, MAUDE, MDND, mesh, nonabsorbable polymer, Prolift M, Sheri S. McCoy
Nov 14th, 2011 |
By Jane Akre
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? Share this:
Posted in Your Turn |
14 comments
Tags: Adverse Event, complications, FDA, MAUDE
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
[continue reading...]
Posted in Media Reports |
No Comments »
Tags: Benefit, Class II, Class III, high-risk, Incontinence, MAUDE, mesh, pelvic floor problems, POP, Risk, SUI