Archive for December 2011

Netherlands Newspaper Investigates Mesh Mess

Dec 29th, 2011 | By
Netherlands Newspaper Investigates Mesh Mess

DECEMBER 29,  2011 ~ The Netherlands will begin a patient registry of synthetic gynecological mesh in early 2012 requiring gynecologists to report the growing number of complications emerging from use of the mesh.  The U.S. has yet to establish post-surgery patient tracking to determine the actual number of adverse events.  Investigative reporter, Ellen de Visser
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Op Ed: David Sawyer on Caring After a Medical Device Nightmare

Dec 25th, 2011 | By
Op Ed: David Sawyer on Caring After a Medical Device Nightmare

As I reflect back on the last year I feel it is in order to share many things with those of you who have cared and loved us. I sat today looking back on how it all has been and last December It all started with the engine blowing up in my van, a week
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Former FDA Director Joins Public Citizen in Device Recall Petition

Dec 23rd, 2011 | By
Former FDA Director Joins Public Citizen in Device Recall Petition

DECEMBER 23, 2011 ~ The consumer group Public Citizen frequently calls for the recall of dangerous drugs or medical devices including a petition last August calling for the recall of synthetic surgical mesh from the market because of the complication rate and a failure to show a benefit over risk (here).  Share this:



Plaintiffs Want Mesh Lawsuits Centralized

Dec 22nd, 2011 | By
Plaintiffs Want Mesh Lawsuits Centralized

DECEMBER 22, 2011 – The Athens Georgia law firm of Blasingame, Burch, Garrard & Ashley, P.C. has filed a motion to have various plaintiffs from around the country centralize their defective transvaginal surgical mesh litigation in one federal court – the Southern District of West Virginia. Share this:



Physician Confidence in Mesh Shaken, Sales Projected to Improve says Market Research Group

Dec 22nd, 2011 | By
Physician Confidence in Mesh Shaken, Sales Projected to Improve says Market Research Group

DECEMBER 22, 2011 – This projection by the Toronto-based Millennium Research Group (MRG) says some doctors report they lack confidence in the current urogynecologic surgical mesh products. Sales have been flat in 2011 partially due to patients speaking out about adverse events (see Patient Profiles here), two warnings  about complications from the Food and Drug
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No Easy Solution to Removing Mesh

Dec 20th, 2011 | By

The topic of removing mesh has become problematic.  Not only should Mesh News Desk not recommend any doctor to remove mesh, (we didn’t) but there has been some expression that even a mention here by others implies an endorsement to those desperate for a solution. Realistically, MND cannot vouch for the expertise of any doctor
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More Monitoring of Medical Device Implants After Market

Dec 18th, 2011 | By
More Monitoring of Medical Device Implants After Market

Artificial hips that fail, surgical mesh that injures – the New York Times reports (here) on December 14, 2011, that amid the growing number of problems with medical devices a bipartisan bill was introduced in the U.S. Senate that would require device makers follow the life of their products after they’re approved for sale. Share
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Medtronic Pays $23 Million to Settle Doctor Kickback Charges

Dec 18th, 2011 | By
Medtronic Pays $23 Million to Settle Doctor Kickback Charges

Medtronic is the world’s top maker of medical devices and it didn’t get that way without help. The U.S. Department of Justice accused the Minnesota-based company of having friends in high places – Share this:



Anonymous: While I’m Still Speaking Out

Dec 13th, 2011 | By

Why I do this One thing that is hurting women is the letter they get from Lawyers telling them to not speak.  It is written in a way that the whole world is out to get you and take away your chance of receiving compensation if you say one word.  Share this:



FDA and Med Device Makers Make it Official

Dec 8th, 2011 | By
FDA and Med Device Makers Make it Official

by Jane Akre// DECEMBER 7, 2011 //Shuren Signs Memo of Understanding// Minnesota loves its medical device industry. Even Senator Al Franken (D-MN) who used to parade on Saturday Night Live with a satellite dish on his head as a roving comedic newsman, has gotten pretty serious when it comes to promoting legislation to help Minnesota’s
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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.