Posts Tagged ‘ surgical mesh ’

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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Deb C Suffering: Stress Incontinence Mesh Injuring Women Too

Oct 10th, 2012 | By
Deb C Suffering: Stress Incontinence Mesh Injuring Women Too

 February 3, 2012. That was the day that Deb Contestabile says her health took a downturn from which she has still not recovered. The 46-year-old mother of two boys led a predictable and comfortable life with her husband of almost 22 years who owns a machine shop. They have busy lives with the two boys
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What Do We Know About Polypropylene?

Sep 28th, 2012 | By
What Do We Know About Polypropylene?

September 28, 2012 ~ The following was sent from a consultancy group, Frost & Sullivan.  Chemical, Materials and Research Analyst, Tridisha Goswami, provided MDND information on the properties, however nothing on whether or not polypropylene is safe to use for a permanently implanted medical devices. The analyst says more research must be done to determine
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Study: Mesh Removal May Cause Injuries

Sep 25th, 2012 | By
Study: Mesh Removal May Cause Injuries

September 25, 2012 ~ Increasingly women are deciding that their synthetic surgical mesh placed to treat incontinence and prolapse is causing more complication than it’s cured and are opting to have it removed, but a new report says the removal procedure may cause a host of internal injuries, especially to the urethra, or the smooth
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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.