Posts Tagged ‘ scarring ’

New Hope for Mesh Patients

Feb 19th, 2013 | By
New Hope for Mesh Patients

By David Spellberg, MD As a Urologist, I have read about horrible complications such as bleeding, abdominal pain, perforated organs, and sexual dysfunction associated with certain types of mesh products and some of the terrible suffering of mesh patients. The Food and Drug Administration issued two warnings, one in October of 2008 and another in
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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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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.