Archive for November 2011
Nov 28th, 2011 |
By Jane Akre
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. Share this:
Posted in Mesh Reading Room Resource |
2 comments
Tags: Adverse events, complications, FDFA, Incontinence, POP, Prolapse, SUI
Nov 28th, 2011 |
By Jane Akre
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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Posted in Media Reports |
1 Comment »
Tags: bone cement, Drug and Cosmetic Act, FDA, FDCA, Federal Food, Johnson & Johnson, Synthes, The Park Doctrine
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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Posted in Your Turn |
No Comments »
Tags: approval, FDA, medical device, synthetic mesh
Nov 23rd, 2011 |
By Jane Akre
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. Share this:
Posted in Media Reports |
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Tags: blockbuster, Cox-2 inhibitor, Defective drug, Dr. David Graham, FDA, heart attack, illegal promotion, Medicaid, Merck & Co., Overseas manufacturers, rheumatoid arthritis, settlements, stroke, Vioxx
Nov 23rd, 2011 |
By Jane Akre
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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Posted in Legal News |
No Comments »
Tags: arthritis, diabetes, DOJ, elderly, fraud, health care fraud, medical device, prostate
Nov 21st, 2011 |
By Jane Akre
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. Share this:
Posted in Patient Profiles |
7 comments
Tags: Baylor Surgical School, Bruce Rosenberg, Dr. Kevin Petersen, Hal Samples, hernia, homeless, infection, Johnson & Johnson, mesh, meshoma, narcotics, Prolene 3D patch, repair, voodoo, WFAA
Nov 18th, 2011 |
By Jane Akre
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:
Posted in Op-Ed |
2 comments
Tags: Class II medical device, Ethicon, FDA, In-sling, medical device, mesh, ProteGen, surgical mesh, urinary incontinence, vaginal erosion
Nov 17th, 2011 |
By Jane Akre
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 Share this:
Posted in FDA |
2 comments
Tags: 510(k), FDA, industry, Institute of Medicine, Medical Device user Fee, Medical devices, Shuren, venture capitalists
Nov 15th, 2011 |
By Jane Akre
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. Share this:
Posted in FDA |
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Tags: FDA, medical device, reclassification
Nov 14th, 2011 |
By Jane Akre
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? Share this:
Posted in Your Turn |
14 comments
Tags: Adverse Event, complications, FDA, MAUDE