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Tag Archives: MAUDE

Trocars

FDA to Consider Reclassifying Trocars Used to Place Surgical Pelvic Mesh

By Mesh Medical Device Newsdesk |

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…]

Dr. Anthony Visco, AUGS

Q&A: Dr. Anthony Visco, AUGS President

By Mesh Medical Device Newsdesk |

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…]

Gynecare Prolift package, from website, West Coast Medical Resources

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

By Mesh Medical Device Newsdesk |

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…]

Jane Akre, Editor

To Whom Have You Reported Your 'Adverse Event' ?

By Mesh Medical Device Newsdesk |

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

By Mesh Medical Device Newsdesk |

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…]

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