Posts Tagged ‘ Polypropylene 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
[continue reading...]



Groups Calls for DOJ to Investigate J&J for Document Destruction, Launches Website

Mar 26th, 2014 | By
Groups Calls for DOJ to Investigate J&J for Document Destruction, Launches Website

Today, March 26th, a consumer group, Corporate Action Network (CAN) called on the Department of Justice (DOJ)  to investigate Johnson & Johnson for document destruction. A copy of the letter the group sent to Attorney General Eric Holder is here. CAN also announced the launch of the website  www.JohnsonAndJohnsonHurtsWomen.org in Response to Pattern of Defective
[continue reading...]



MND Interviews Dr. Veronikis: On Transvaginal Mesh, Injuries and Explants

Dec 19th, 2013 | By
MND Interviews Dr. Veronikis: On Transvaginal Mesh, Injuries and Explants

The name of Dr. Dionysios Veronikis St. Louis is one that is increasingly heard among mesh-injured women.  Dr. Veronikis tells Mesh News Desk (MND) he now spends half of his time doing mesh removal surgeries, also known as explants, and although he still uses synthetic mesh on rare occasions, his surgical skills allow him to
[continue reading...]



The Faces of Mesh – One Woman’s Baffling Battle

Oct 16th, 2013 | By
The Faces of Mesh – One Woman’s Baffling Battle

The Faces of Mesh – One Woman’s Baffling Battle October 4, 2013 By Aaron Leigh Horton *Editors Note- Vance is at UCLA at this writing and planning surgery with Dr. Raz on Friday, October 18,2013! Navigating through a violent Texas rainstorm in August was not how I pictured the moments leading up to my very
[continue reading...]



In C.R. Bard Transvaginal Mesh Federal Trial Tempers Flare

Aug 1st, 2013 | By

With more than 27,000 cases naming six transvaginal mesh makers consolidated in a Charleston, West Virginia federal courtroom, the Donna Cisson v. C.R. Bard is the first to go to trial. The first Cisson trial, which began July 8, ended in a mistrial two days later. Drugwatch reports on the second day of testimony in
[continue reading...]



When Family Members Suffer – Watching a Loved One Hurt by Transvaginal Mesh

Jul 25th, 2013 | By
When Family Members Suffer  – Watching a Loved One Hurt by Transvaginal Mesh

Your Call to be a Mesh Warrior July 21, 2013,   by Aaron Leigh Horton,   themeshwarrior@gmail.com For many of us, family members of those implanted with transvaginal mesh, life is now largely about watching someone we love writhe in unendurable pain for days on end, staying up nights kissing foreheads, caressing locks of hair, whispering prayers
[continue reading...]



Mesh Fails 25 Percent of Time in Vaginal Prolapse Repair

May 15th, 2013 | By
Mesh Fails 25 Percent of Time in Vaginal Prolapse Repair

  May 15, 2013 ~ Bloomberg (here) reports surgery to treat pelvic organ prolapse failed about 25 percent of the time within seven years. Reported in the May 15th Journal of the American Medical Association (JAMA) this is the longest look ever to determine how those who undergo pelvic organ prolapse (POP) repair fared in
[continue reading...]



Ethicon Trial Opening Statements Thursday

Jan 8th, 2013 | By
Ethicon Trial Opening Statements Thursday

January 8, 2013 ~ Jurors are being selected today for the first of 1,974 lawsuits to be heard in a New Jersey state court against Johnson & Johnson, maker of the Gynecare Prolift Pelvic Floor Repair System (here) transvaginal mesh. Plaintiff Linda Gross from Watertown, South Dakota and her lawyers argue that Ethicon, a division
[continue reading...]



Teresa Hughes: Demanding Answers and Raising the Profile of Vaginal Mesh Injuries in the UK

Nov 5th, 2012 | By
Teresa Hughes: Demanding Answers and Raising the Profile of Vaginal Mesh Injuries in the UK

Teresa Hughes, 61, a resident of Liverpool, England, and mother of two, has made so much noise about defective vaginal mesh that last year she was profiled in the UK paper, The Daily Mail. It started: “Thousands of women have been left severely damaged as a result of an implantable ‘sling’ operation to treat problems
[continue reading...]



A Nonsurgical Way to Correct Incontinence?

Oct 30th, 2012 | By
A Nonsurgical Way to Correct Incontinence?

October 30, 2012 ~ KING5.com, a Television station in Seattle, reports on a new, non-surgical method to treat urinary incontinence. (here) About 13 million American women suffer incontinence and many who turned to surgery are featured in the Patient Profiles on MDND. Often the choice of a polypropylene mesh to hold up the bladder or
[continue reading...]



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.