Posts Tagged ‘
Adverse events ’
Mar 31st, 2013 |
By Jane Akre
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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Posted in Feature |
15 comments
Tags: Adverse events, AE, AUGS President, FDA, informed consent, MAUDE, Mesh medical Device News Desk, pelvic organ prolapse, POP, prolapse repair, Q&A: Dr. Anthony Visco, Stress urinary incontinence, SUI, transabdominal mesh, urogynecology, vaginal mesh, Visco
Feb 11th, 2013 |
By Jane Akre
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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Posted in Legal News |
13 comments
Tags: Adam Slater, Adverse events, Christy Jones, complications, Courtroom View Network, Day 21 Linda Gross v. Ethicon, Dr. Elizabeth Kavaler, Dr. Shlomo Raz, Gynemesh PS, Mesh medical Device News Desk, miles murphy, Prolift, rectovaginal, sean O'bryan, transvaginal, Urogynecologist, vincent lucente
Jan 31st, 2013 |
By Jane Akre
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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Posted in Welcome- Why We're Here |
4 comments
Tags: Adverse events, Faces of adverse events, FDA, Hernia Mesh, MDND, Mesh medical Device News Desk, petroleum-based, polypropylene, registry, transvaginal, transvaginal placement
Jan 26th, 2013 |
By Jane Akre
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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Posted in Legal News |
7 comments
Tags: Adverse events, complications, Dr. Charlotte Owens, dyspareunia, gynecare, Gynemesh PS, inflammation, Johnson & Johnson, mesh contraction, pelvic pain, Prolapse, Prolift, retraction, sean O'bryan, shrinkage, worldwide medical director
Nov 8th, 2012 |
By Jane Akre
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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Posted in Legal News |
No Comments »
Tags: 2, 500 product liability lawsuits, Adverse events, Attorney General Kamala Harris, Avaulta Plus, Boston Scientific, breach of warranty, Christine Scott, defective design and manufacturing, failure to warn, False Claims Acts, fraud, fraudulant bills, loss of consortium, off label promotions, product liability litigation, Securities and Exchange Commission, synthetic transvaginal mesh, transvaginal mesh, transvaginal surgical mesh implants, urology/ women's health, violations of state consumer protection laws
Nov 7th, 2012 |
By Jane Akre
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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Posted in Your Turn |
19 comments
Tags: Adverse events, bleeding, entrapment, implanted mesh, inert, infections, injury, shrink
Sep 17th, 2012 |
By Jane Akre
“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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Posted in Feature |
1 Comment »
Tags: Adverse events, biologic mesh, clinical data, hematoma, Hernia Mesh, infection, MAUDE Database, MDND, polyethylene, postoperative pain, PTFE, recurrence, seroma, surgical mesh
Aug 9th, 2012 |
By Jane Akre
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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Posted in Legal News |
7 comments
Tags: Adverse events, Deborah Smith, defective product, end user, Ethicon, failure to warn, Johnson & Johnson, learned intermediary, mersilene, product liability, sacroplexy
Apr 30th, 2012 |
By Jane Akre
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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Posted in Op-Ed |
58 comments
Tags: 10 Downing Street, Adverse events, medical device, Meshies United Group, meshiesunitedgroup, MHRA, Parliament, Teresa Hughes, TOT, transobturator, transvaginal mesh, TVT, United Kingdom, vaginal mesh tapes
Mar 6th, 2012 |
By Jane Akre
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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Posted in FDA |
No Comments »
Tags: Adverse events, clinical trials, FDA, medical device, regulation