Archive for November 2011

Important Links, Resources, Support

Nov 28th, 2011 | By
Reading research logo

THE READING ROOM This is a great place to get started if you are new to the issues and experiencing complications which you can’t explain following mesh implantation surgery. Mesh Medical Device News Desk (MND)

More Media on Medical Devices, Money and Prison Time

Nov 28th, 2011 | By
Vertebral Fractures, iStockphoto

Three medical device executives are going to prison for the death of three patients who were subjected to an experimental bone cement they produced. Three former executives of West Chester, Pa-based Synthes, North American president Michael Huggins, 54, and former executive VP Thomas Higgins, 55, each received a nine month sentence in federal prison. They
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What Do You Want?

Nov 28th, 2011 | By
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
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Merck’s Blockbuster Vioxx Settlement

Nov 23rd, 2011 | By
Dorothy Hamill in Vioxx ad

NOVEMBER 22, 2011-When a defective product has harmed so many people and cost so many lives, the settlement numbers are huge too. Now the U.S. Justice Department says it has settled its civil case with Merck, the pharmaceutical giant that aggressively marketed Vioxx (Rofecoxib) making it a blockbuster drug.

X-Rated, Misbranded Medical Device Winner a Loser

Nov 23rd, 2011 | By
DOJ logo 200 2

This true story will help you enjoy your holiday. Not to have a laugh at someone else’s expense, but when they are so wrong, why not? In this case a Mr. Gary Winner (his real name), 49, from Buffalo Grove, Illinois, owned a company called Planned Eldercare which allegedly supplied durable medical equipment to the
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Suffering in Silence: Hal Samples’ Years of Pain Following Mesh Hernia Repair

Nov 21st, 2011 | By
Hal Samples and friends

Dallas photographer and artist, Hal Samples’ name is synonymous with the trendy, downtown Dallas art district. His gallery was named Best Art Gallery in Dallas in 2009 and his photographs, film work, and documentaries have taken him around the world and provided an income most artists hope to achieve.

Mesh-Injured Patient Reserches ProteGen Mesh Predicate

Nov 18th, 2011 | By
Suzanne McClain

Editors Note* – I first interviewed Suzanne McClain, 45,  in March 2009 and she became part of the series of reports for . 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.

Can the FDA Promote Innovation and Protect Patients?

Nov 17th, 2011 | By
Jeff Shuren MD

CDRH Shuren Defending FDA Against Harsh Industry Critics Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), was on the hot seat

Want to Reclassify a Medical Device? The FDA is all Ears

Nov 15th, 2011 | By
FDA logo green background

The Food and Drug Administration on Monday, November 14, announced it will receive public comment on whether or not a medical device should be reclassified to require more or less regulatory oversight.

To Whom Have You Reported Your ‘Adverse Event’ ?

Nov 14th, 2011 | By
Jane Akre, Editor

I have a question – Assuming you’ve had a problem with synthetic surgical mesh, who have you reported your complications to?   The manufacturer, the FDA?