Posts Tagged ‘ transvaginal ’

FDA Approves New American Medical System Transvaginal Mesh Sling

Dec 9th, 2013 | By
FDA Approves New American Medical System Transvaginal Mesh Sling

American Medical Systems (AMS) has just received FDA clearance to market a new incontinence sling, according to a press release that appears in the Wall Street Journal. The RetroArc Retropubic Sling System received the Food the Drug Administration’s 510(k) clearance, a standard that does not require any clinical trials but relies on naming a similar 
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Bard Opening Arguments in Federal Transvaginal Mesh Case

Jul 9th, 2013 | By
Bard Opening Arguments in Federal Transvaginal Mesh Case

July 9, 2013 ~“Our job together is to figure out the facts. Trust is a sacred and powerful thing. Although a corporation may be doing good work, if you find they failed in warning, making and manufacturing this device, you must hold them accountable.” That was the opening statement from attorney Henry Garrard who represents
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Survey: Transvaginal Mesh Advertising Frightens Patients

May 28th, 2013 | By
Survey: Transvaginal Mesh Advertising Frightens Patients

May 28, 2013 ~ Medscape Medical News reports that all of those ads you see on television warning about the complications from transvaginal mesh are worrying women and raising a red flag about whether it is a viable option, but not scaring them away.  Story is here. Women from two urology and urogynecolocy clinics were
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Day 24: Linda Gross v. Ethicon J&J Case Goes to Jury in First Vaginal Mesh Trial

Feb 19th, 2013 | By

February 19, 2013 ~  In this first lawsuit to go to trial over whether the Ethicon unit of Johnson & Johnson properly designed the Prolift vaginal mesh implant, nine jurors received instructions this morning from Judge Carol Higbee in the Atlantic City, New Jersey courtroom. Jurors are required to accept the ‘The Charge’ of Judge
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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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America Now: Routine Surgery Dangerous for Women

May 14th, 2012 | By
America Now: Routine Surgery Dangerous for Women

May 14, 2012 ~ The syndicated show, America Now, ran a story last week on Teresa Sawyer of TVTNo.org and also the subject of a Patient Profile in MDND. Here is our story that ran last August. In the video story, Routine Surgery Dangerous for Women, Sawyer told reporter Craig Thomas (from WTOL)  they they
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The Future of Mesh Sales is Rosy Says Market Research Group

Apr 26th, 2012 | By
The Future of Mesh Sales is Rosy Says Market Research Group

April 24, 2012 ~ Even though the number of lawsuits against synthetic mesh manufacturers is growing by the day, surgical mesh products are expected to surge in sales in 2012, according to the Millennium Research Group (MRG). The group interviewed 181 U.S. surgeons (gynecologists, urologists and urogynecologists) in November and December of last year. Among
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Kathleen: Questions to Ask Before Mesh Removal

Apr 2nd, 2012 | By
Kathleen: Questions to Ask Before Mesh Removal

‘Kathleen‘ (not her real name which she doesn’t want to use because of litigation)  is a regular reader of MDND and has some suggestions on the questions to ask of doctors before a mesh removal procedure.  She has had her mesh removed and met with many doctors before choosing one. Since there are so few
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Sick of Suffering in Silence

Mar 19th, 2012 | By

MARCH 19, 2012 ~ By Jane Akre    A story before I tell this story.  I was commissioned to write a 2,100 word piece for the Chicago-based magazine “In These Times.”  I had pitched the long-time editor and he said they were very interested. Great I thought. The money wasn’t much but the exposure for an
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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.