Welcome to Mesh/ Medical Device News Desk (MDND)
Putting a Face on Adverse Events
I hope you find this a helpful resource. I’m National News Editor, Jane Akre and I 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 underreported in much of the coverage of permanently implanted surgical mesh. 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 as a result. I believe this is one of the most incredible public health issues of our day!
My Interest in FDA and Surgical Mesh
I first became acquainted with the issues in 2009 and produced a series for Injuryboard.com called, Suffering in Silence, Part 1-4 where I interviewed many men and women who are suffering the effects of synthetic mesh used for hernia repair and female pelvic floor reconstruction.
My Background – I have been a journalist for nearly 30 years working as a broadcaster, anchor and reporter at stations all around the country as well as CNN. I’ve won numerous awards including the Society of Professional Journalists Award for Ethics as well as the Goldman Prize, North America 2001 for environmental reporting. My husband and I challenged News Corp after it tried to suppress a story about synthetic bovine growth hormone used in much of the nation’s dairy supply.
Understanding the way the FDA approved rBGH is very similar to the way some medical devices slip through critical scrutiny by a federal regulatory system that sometimes feels more like the tail wagging the dog. Our story was told in the film, The Corporation, see a clip (here). My bio appears on Journalism Juice website (here).
FDA and Surgical Mesh
Under much pressure, the FDA is reconsidering how it approves medical devices for marketing as all the evidence points to the need. On July 13, 2011 the agency issued its second warning about the benefit v. risk of synthetic surgical mesh. In August, the Institute of Medicine said the 510(k) approval process was “fatally flawed” and we have thousands of injured people who are not being heard! This is a place to put a face on the “adverse events” as the agency calls it.
I own the content through my company Independent News Group LLC. Your email WILL NOT be shared with anyone unless I contact you first. Promise. I am not a lawyer or a medical professional so the information contained in this site is not intended to substitute for information from your lawyer or doctor. This is not a law firm referral site.
Aaron Horton, communications expert is lending a hand with all things involving marketing. She can be reached at email@example.com.
As the public receives occasional reports on mesh and medical devices, doctors and nurses often rely on medical societies with financial ties to device makers and their sales reps for information that they use to educate patients. We will provide balanced reports produced with the highest professional journalistic standards, talking to all sides of the issue, and investigate issues behind the headlines concerning medical devices and surgical mesh.
We feel patient stories are the most compelling part of the controversy about medical devices and we invite you to join us. This information is provided without charge, however donations are always appreciated as is sponsorship and advertising. Note* a firewall exists between sponsorship/ advertising and editorial. This policy is firm.
Please feel free to contact me at firstname.lastname@example.org with any questions about content or to discuss partnering opportunities. #