Posts Tagged ‘ surgical mesh ’

FDA Must Reclassify Synthetic Mesh Now!

Oct 1st, 2014 | By

October 2, 2014   Margaret A. Hamburg, M.D. Commissioner, Food and Drug Administration Department of Health and Human Services   Jeffrey E. Shuren, M.D., J.D. Director, Center for Devices and Radiologic Health Food and Drug Administration Department of Health and Human Services   Dear Drs. Hamburg and Shuren, We, the supporters and members of the
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Open Letter to Doctors – A Serious Concern as Doctors Divide

Jun 3rd, 2014 | By
Open Letter to Doctors – A Serious Concern as Doctors Divide

Editorial- Jane Akre, MND – In July 2011 the U.S. Food and Drug Administration (FDA) issued a Safety Communication that surgical mesh used to treat pelvic organ prolapse (POP) carried more risks than benefits and was “of serious concern.”  See the notice here. Mesh erosion can “require multiple surgeries to repair and can be debilitating
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June – Watching and Waiting for News of Mesh Settlements, Reclassification

Jun 2nd, 2014 | By

Tensions are beginning to get strained over the extremely long wait for justice for the mesh- injured. Welcome to Mesh News Desk aka MMDND your source for all news mesh-related. Much is happening at this time but much of it is behind the scenes.   Take for example, the recent announcement that Endo/AMS had decided to
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Harvard Researchers Take FDA’s Device Approvals to Task

Apr 2nd, 2014 | By
Harvard Researchers Take FDA’s Device Approvals to Task

Using documents that recently came to light, Harvard researchers have traced a troubling approval process within the Food and Drug Administration that allows medical devices to be sold with little oversight. Essentially the supplemental application resembles the agency’s 510(k) process that allows medical devices to be marketed without clinical trials. The paper is reported in
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Number of Websites Addressing Mesh Pain & Info Explodes Globally

Mar 31st, 2014 | By

It doesn’t seem like it was that long ago when the issue of polypropylene mesh used for surgery was known by a few people. Truth in Medicine was probably the first website devoted to mesh injuries. Mesh Medical Device News Desk (Mesh News Desk) came along in the summer of 2011. Today there has been
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Your Turn: How One Woman Told Her Friends

May 29th, 2013 | By

May 29, 2013 ~ This woman wants to remain anonymous, but she tells MDND she sent out an email to about 60 friends and family members to let them know about her mesh situation.  Surprisingly, she heard back from three people who are also experiencing complications from surgical mesh.     Here is her email: 
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Suffering in Silence: Thousands of Canadian Women and Cherie Storozinski

May 3rd, 2013 | By
Suffering in Silence: Thousands of Canadian Women and Cherie Storozinski

May 3, 2013~  “My name is Cherie Storozinski. I am 50 years old and live in Dauphin, Manitoba, Canada. I am a victim of transvagnial mesh.” That’s how Cherie started her email to MDND. Cherie, 50, had a wonderful life in rural Manitoba, Canada. She and her husband, Curt, live on 20 acres and run
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Dear Doctor, Dear Doctor, Lend Me You Ear

Apr 19th, 2013 | By

April 19, 2013~ This essay is written by contributor, Nonie Wideman of British Columbia, who has suffered with mesh injuries for years. As a research and writer, Wideman has been a voice of the community of mesh-injured women. MDND supports more open communication between doctors and their patients who are suffering mesh complications.  Thank you
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Dr. Robert Bendavid: Women May Not Always be Candidates for Surgical Mesh for Hernias

Apr 9th, 2013 | By
Dr. Robert Bendavid: Women May Not Always be Candidates for Surgical Mesh for Hernias

April 9, 2013 ~ Dr. Robert Bendavid  is a well-known hernia surgeon who in this editorial for the Africa Middle East  Hernia Society discusses surgical mesh. Past president and a founding father of the American Hernia Society, Dr. Bendavid has performed thousands of procedures and is presently associated with the Shouldice Hospital in Toronto where the natural tissue, mesh-free,
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FDA Workshop on Health of Women

Apr 9th, 2013 | By

April 9, 2013 ~ According to a new page on the FDA’s website (here), a public workshop will be held on HoW to Improve the Health of Women (HoW).  The purpose is to delve into how some medical devices work differently in women than men. It’s been noted that some hip implants have an early
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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.