Posts Tagged ‘ ProteGen ’

Welcome to MDND

May 30th, 2013 | By

June 1, 2013 ~ Welcome.  I’m Jane Akre, the Editor of MDND. We are now entering our second year of publishing and unfortunately the mesh-injured community is only growing.  At last count there were nearly 22,000 cases consolidated in one federal court in West Virginia and that does not take into account the hundreds if
[continue reading...]



Reporters Resource on Covering Mesh Issues

Aug 31st, 2012 | By
Reporters Resource on Covering Mesh Issues

Mesh 101: The Basics For reporters looking for a way to get started on the transvaginal mesh story, here are some highlights to shortcut your research. This is not a lawyer-generated story!  There are real women suffering devastating injuries from the use of plastic mesh and it continues today!   “We were very shocked and
[continue reading...]



Family Tree of Meshes from The Female Patient, April 2009

May 28th, 2012 | By
Family Tree of Meshes from The Female Patient, April 2009

If you find it difficult to understand all of the different types of synthetic transvaginal mesh, this graphic from The Female Patient, April 2009 may help. Share this:



Sound Medical Devices Act- Dems Want FDA to Block Approvals When Similar Device is Recalled

Feb 2nd, 2012 | By
Sound Medical Devices Act- Dems Want FDA to Block Approvals When Similar Device is Recalled

  February 1, 2012 ~ Bloomberg reports on a bill  introduced this week that would put the brakes on the approval of a medical device that claims to be similar to another approved device that’s been recalled or found to be defective. The bill was introduced by Democratic lawmakers including Rep. Edward Markey (D-MA) on
[continue reading...]



FDA Orders Manufacturers to Study Mesh Complications

Jan 5th, 2012 | By
FDA Orders Manufacturers to Study Mesh Complications

JANUARY 4, 2012 ~ Bloomberg reports that the Food and Drug Administration’s division that oversees medical devices has ordered surgical mesh manufacturers to study how often synthetic mesh harms women by causing infection and organ damage. (story is here) The order follows an FDA report last summer of a five-fold jump in the number of
[continue reading...]



Mesh-Injured Patient Reserches ProteGen Mesh Predicate

Nov 18th, 2011 | By
Mesh-Injured Patient Reserches ProteGen Mesh Predicate

Editors Note* – I first interviewed Suzanne McClain, 45,  in March 2009 and she became part of the series of reports for Injuryboard.com . She is not just a mesh-injured woman but  has spent hours digging into the FDA’s files to research the predicates for the devices currently on the market. Share this:



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.