Posts Tagged ‘ Adverse events ’

Q&A: Dr. Anthony Visco, AUGS President

Mar 31st, 2013 | By
Q&A: Dr. Anthony Visco, AUGS President

April 3, 2013 ~ Dr. Anthony Visco is Chief of Urogynecology at Duke Univ. Medical Center and President of AUGS.  The American Urogynecologic Society (AUGS) was founded in 1979 and is a professional organization of 1,400 physicians and allied health professionals who care for women with pelvic floor disorders, specifically pelvic organ prolapse (POP) and
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Day 21: Linda Gross v. Ethicon Expert Says Prolift Did Not Injure Gross

Feb 11th, 2013 | By
Day 21: Linda Gross v. Ethicon Expert Says Prolift Did Not Injure Gross

February 11, 2013 ~  The trial of Linda Gross v. Ethicon started late in the day around noon on Day 21 of the proceedings.  Apparently legal arguments were taking place off camera and out of the ear of the jury. The case has now gone to Ethicon to refute the evidence presented so far. Remember
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Why We Are Here ~ To Put a Face on Adverse Events

Jan 31st, 2013 | By
Why We Are Here ~ To Put a Face on Adverse Events

January 31, 2013 ~ Quite simply put the reason we are here at Mesh Medical Device News Desk (MDND) is to calculate the human toll of complications from the unregulated world of medical devices. Most Americans do not understand that the vast majority of medical devices 75-90% approved in the U.S. bypass any safety and
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Day 11: Linda Gross v Ethicon: Medical Director Signs off on Prolift

Jan 26th, 2013 | By
Day 11: Linda Gross v Ethicon: Medical Director Signs off on Prolift

January 26, 2013 ~ It was Day 11 in the Linda Gross v. Ethicon trial that brought Dr. Charlotte Owens, Worldwide Medical Affairs Director for Ethicon to the stand via videotaped deposition. Her story was remarkable for the safety and efficacy information that did not make it into the Clinical Expert Report. It was her
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Boston Scientific Under Investigation for Transvaginal Mesh Sales

Nov 8th, 2012 | By
Boston Scientific Under Investigation for Transvaginal Mesh Sales

November 8, 2012 ~  A required report by Boston Scientific reveals a number of states plan to initiate an investigation about how Boston Scientific sells mesh. The information is contained in the company’s quarterly regulatory filing with the Securities and Exchange Commission, (here), issued November 6. In the report, the Natick, Mass.-based medical device company admits
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Open Letter to Surgeons Who Have Implanted Mesh

Nov 7th, 2012 | By
Open Letter to Surgeons Who Have Implanted Mesh

November 7, 2012 ~ The following is an essay by a mesh survivor who does not want to be identified. Her Open Letter to Surgeons is an important reminder that doctors have a commitment to put their patient first! Each of you who blatantly disregarded your patient’s pain and suffering has broken the oath, “First,
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Dollars and Sense? Saving Money on Hernia Mesh

Sep 17th, 2012 | By
Dollars and Sense? Saving Money on Hernia Mesh

  “Application of Evidence-Based Value Analysis: Standardization of Surgical Mesh Products” In this White Paper, Winifred Hayes, a medical efficiency analyst, known as, “Your Outsourced Research Partner,” tells hospitals how to save money buying hernia mesh by being more efficient. Problem: In the case of hernia mesh, hospitals buy mesh from a limited number of
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Mississippi Court Upholds Ethicon Win in Mesh Warning Lawsuit

Aug 9th, 2012 | By
Mississippi Court Upholds Ethicon Win in Mesh Warning Lawsuit

August 8, 2012 ~ An appeals court ruling in Mississippi has upheld a lower court dismissal of a $10 million vaginal mesh case against Johnson & Johnson’s Ethicon division. The United States Court of Appeals Fifth Circuit filed the decision August 2, 2012 in the case against Ethicon by Deborah and Michael Smith. Deborah Smith
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History in the Making Petition by Meshies United UK Group

Apr 30th, 2012 | By
History in the Making Petition by Meshies United UK Group

 Petition Delivered to 10 Downing Street I would like to introduce myself. My name is Teresa Hughes The Owner and Founder of The Meshies United Group in the United Kingdom. I originate from Liverpool, Merseyside, England the home of The Beatles and Liverpool Football Club. I had an operation for stress incontinence and the mesh
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Australia’s Version of FDA Lax on Medical Device Safety

Mar 6th, 2012 | By
Australia’s Version of FDA Lax on Medical Device Safety

With the global news about the defective French breast implants called PIP filled with industrial silicone, the Canberra Times (here), published in the capital city of Australia, takes a look at how medical devices reach the market there. Australia’s version of the U.S. Food and Drug Administration (FDA) is called the Therapeutic Goods Administration (TGA)
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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.