Posts Tagged ‘ complications ’

Find Your Mesh in the 510(k) Process

Nov 21st, 2013 | By

For those readers who want to know more about the mesh they may have had implanted for pelvic organ prolapse, stress urinary incontinence or hernia, the process is made easier if you have the Medical Device approval number from the FDA. Below is a handy list of 510(k) approvals which you must look up under
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Dr. Twiss Part II: On the Basics of Medicine and Biocompatible Materials for Transvaginal Mesh

Oct 30th, 2013 | By
Dr. Twiss Part II: On the Basics of Medicine and Biocompatible Materials for Transvaginal Mesh

Christian Twiss, MD  is a surgeon at the University of Arizona’s Department of Surgery, division of urology. He is a Board Certified urologist by training with a subspecialty and certification in female pelvic medicine and reconstructive surgery (FPMRS). Dr. Twiss studied with Dr. Shlomo Raz at the University of California Los Angeles (UCLA) between 2006-2008.
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Teapapers: Doctors Knew About Mesh Infections in 2005

Jun 17th, 2013 | By
Teapapers: Doctors Knew About Mesh Infections in 2005

June 17, 2013~ Once again Teapapers hits it out of the park. (Teapapers is a blog written by a mesh-injured survivor). Linda found a 2005 study from Australia (Royal Women’s, Mater and Wesley Hospitals, Brisbane, AU; Charite University Hospital, Berlin, Germany; and Cantonal Hospital Lucerne, Switzerland) the object of the study was to describe the
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FDA Asks Consumers to Report Product Failures

Jun 10th, 2013 | By
FDA Asks Consumers to Report Product Failures

June 10, 2013 ~ New and Improved? The U.S. Food and Drug Administration (FDA) is celebrating 20 years of the MedWatch program by providing consumers with a new form that should encourage consumers and medical professionals to report adverse events, complications and bad outcomes with drugs and medical devices, cosmetics, medical equipment, food or supplements.
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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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Carpenter v. American Medical Systems Trial Delayed

May 8th, 2013 | By
Carpenter v. American Medical Systems Trial Delayed

May 8, 2013 ~ The trial of Marion Carpenter v. American Medical Systems which was scheduled to begin in San Bernardino California, May 13th, has been delayed until January or February of 2014. Attorney Stewart Albertson tells MDND that decision was made by both sides appearing before Judge Bryan F. Foster, in the San Bernardino
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The Links Between Surgical Mesh Complications and the Development of Autoimmune Diseases

May 7th, 2013 | By
The Links Between Surgical Mesh Complications and the Development of Autoimmune Diseases

Greetings from Nonie Wideman, a survivor of medical complications from Foreign Body Response (FBR) to synthetic medical mesh. I have spent over 15 years advocating for children and families, over twelve of them as a specialized care provider teaching coping and life skills.  I had to put into practice myself what I taught after a
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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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Day 20 Linda Gross v. Ethicon: Medical Director Mesh Exposure 15%

Feb 9th, 2013 | By
Day 20 Linda Gross v. Ethicon:  Medical Director Mesh Exposure 15%

February 8, 2013 ~ In presenting her case,  Christy Jones, the attorney representing Ethicon,  had to refute on this Day 20 what has been presented so far. That is why she re-called Dr. Piet Hinoul, the former Medical Director of Gynecare Women’s Health and Urology, now with Wound Care at Ethicon. His job as Medical
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Day 17 Linda Gross v. Ethicon: Complication Rate Was Known and Acceptable says Medical Director

Feb 5th, 2013 | By
Day 17 Linda Gross v. Ethicon:  Complication Rate Was Known and Acceptable says Medical Director

Thanks go out to Courtroom View Network for access to this trial. February 5, 2013 ~ On this Day 17 as the Linda Gross v. Ethicon trial plaintiff presentation wraps up, the  former Medical Director for Ethicon Women’s Health and Urology (Gynecare) was brought to the stand via his videotaped presentation. David Robinson was involved
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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.