What Do You Want?

Nov 28th, 2011 | By | Category: Your Turn

Jane Akre

I’ve been working with a very smart 29-year old web person (who unfortunately has to try to teach this old dog new tricks), but she understands web content and conveying a presence and is amazingly clever in her delivery, in fact, I’m jealous of her youth and brains.

So she says what do you want your readers to do?  Well I thought I’d ask you’all the same questions.

Let’s have the Top Three Actions the FDA should take concerning surgical mesh?

The Top Ten Actions if you could wave a magic wand and change the way the FDA works where it concerns the approval of medical devices, specifically synthetic surgical mesh.

I’ll start – How about anything permanently implanted in the body undergoes PMA, premarket approval including clinical trials of some duration.

Doesn’t that sound reasonable?

BTW- this petition from Change.org (here) that came to my attention might have some ideas.




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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.