Tag Archives: MAUDE
Mesh Medical Device News Desk, May 17, 2017 ~ Does MAUDE work? MAUDE is the FDA’s central database that’s supposed to identify problems with medical devices that are on the market. Washington University did a review and found it was inadequate. Printed on the website of Society of American Gastrointestsinal and Endoscopic Surgeons (SAGES),is [continue reading…]
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 is a stainless steel needle attached generally to a plastic handle that resemble hooks. A [continue reading…]
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) [continue reading…]
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 [continue reading…]
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?
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 [continue reading…]