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Tag Archives: Adverse events

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Where is the FDA on Pelvic Mesh Today?

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, June 7, 2016 ~ The FDA has been slow to act and react to mesh complications.   Be sure to make your report to the agency so it has the ammunition it needs to act.   The first warning came from the U.S. Food and Drug Administration (FDA) in [continue reading…]

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…]

maude report nov 2014

Have You Filed Your FDA Adverse Event Report Concerning Surgical Mesh?

By Mesh Medical Device Newsdesk |

MND, November 17, 2015 ~ This woman did one year ago. She found the MAUDE database inside the FDA.  Here is the URL for her anonymous report she made after receiving the Gynecare (J&J) Prolift mesh kit.  See it  here.   You can also go to MedWatch and report your adverse event. ADVERSE EVENT [continue reading…]

Defense Wraps in Huskey V. Ethicon, Cross on Million$ of Company Friends

By Mesh Medical Device Newsdesk |

Dr. Christina Pramudji, MD was the witness called by Ethicon as the defense wraps up its case in the second week of this product liability case, Huskey v Ethicon. The Houston- based urogynecologist was chosen by Ethicon (Johnson & Johnson) to do a physical exam on plaintiff Jo Husky to determine her mesh-related injuries. [continue reading…]

Heirloom tomatoes, Florida

Hello July- A Long, Hot Summer of Waiting

By Mesh Medical Device Newsdesk |

Welcome to Mesh Medical Device News Desk, also known as Mesh News Desk (MND). It is a long hot summer and so far those many bellwether lawsuits the mesh community had been promised are rescheduled or off the schedule entirely.  While the heat is good for heirloom tomatoes, not so good for patience. What [continue reading…]

Bruce Rosenberg and '64 LeMans convertible

Suffering in Silence: Hernia Mesh Patient Bruce Rosenberg

By Mesh Medical Device Newsdesk |

MND, Jan. 6, 2014 ~ Transvaginal mesh has been used in women to shore up pelvic organs since the late 1990s but long before that, the same polypropylene mesh was used in the treatment of hernias. In fact, it was thought that pelvic organ prolapse (POP) where the bladder, vagina, uterus or colon fall [continue reading…]

Prolene mesh

Find Your Mesh in the 510(k) Process

By Mesh Medical Device Newsdesk |

For those readers who want to know more about the mesh they may have had implanted for pelvic organ prolapse, stress urinary incontinence or hernia, the process is made easier if you have the Medical Device approval number from the FDA. Below is a handy list of 510(k) approvals which you must look up [continue reading…]

FDA medwatch form 200

FDA Asks Consumers to Report Product Failures

By Mesh Medical Device Newsdesk |

June 10, 2013 ~ New and Improved? The U.S. Food and Drug Administration (FDA) is celebrating 20 years of the MedWatch program by providing consumers with a new form that should encourage consumers and medical professionals to report adverse events, complications and bad outcomes with drugs and medical devices, cosmetics, medical equipment, food or [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…]

Day 21: Linda Gross v. Ethicon Expert Says Prolift Did Not Injure Gross

By Mesh Medical Device Newsdesk |

February 11, 2013 ~  The trial of Linda Gross v. Ethicon started late in the day around noon on Day 21 of the proceedings.  Apparently legal arguments were taking place off camera and out of the ear of the jury. The case has now gone to Ethicon to refute the evidence presented so far. [continue reading…]

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