Posts Tagged ‘ fistula ’

Study: Safety of Trans Vaginal Mesh procedure: retrospective study of 684 patients.

Jan 27th, 2013 | By
Study: Safety of Trans Vaginal Mesh procedure: retrospective study of 684 patients.

Safety of Trans Vaginal Mesh procedure: retrospective study of 684 patients. This is the study by the French researchers known as the TVM group who were perfecting the Prolift technique, learning to develop tools or trocars to implant the mesh in a woman’s pelvic area.  Find it here. The study had an average follow-up rate
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What Happened to the FDA Request for Transvaginal Mesh Studies?

Sep 19th, 2012 | By
What Happened to the FDA Request for Transvaginal Mesh Studies?

September 19, 2012 ~ Last January, after a five-fold increase in complications was noted by the U.S. Food and Drug Administration (FDA) concerning synthetic mesh used in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the FDA ordered mesh makers to find out why. At the time, the unprecedented request was
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Will the FDA Grant J&J’s Request to Stop the Studies?

Jun 9th, 2012 | By
Will the FDA Grant J&J’s Request to Stop the Studies?

A few folks have asked whether or not the Food and Drug Administration (FDA) has granted Ethicon’s request to place a hold on a three-year study on the complications with transvaginal mesh? The short answer is, not yet. No doubt Ethicon, a division of Johnson & Johnson (J&J), was not looking forward to spending in
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Linda Dodson: Suffering in Silence no Longer after Mesh and Medical Mishaps

Dec 1st, 2011 | By
Linda Dodson: Suffering in Silence no Longer after Mesh and Medical Mishaps

Linda Dodson, a dark-haired, attractive Georgia peach with a long southern drawl to match decided to visit a new gynecologist near her home in Georgia, just south east of Atlanta. After about 30 minutes on the exercise bicycle she would experience a muscle spasm in the urethra area. Not a big deal, she thought. Share
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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.