Posts Tagged ‘ MDND ’

Next Trial – May 13: Carpenter v. AMS

May 8th, 2013 | By
Next Trial – May 13: Carpenter v. AMS

May 7, 2013 ~ The Marion Carpenter v American Medical Systems product liability trial is set to begin in San Bernardino County California on May 13. Carpenter has filed a medical malpractice action against her doctors and a products liability action against American Medical System. She is represented by Stewart Albertson of Albertson & Davidson
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Tort Reform and You

Apr 16th, 2013 | By
Tort Reform and You

April 16, 2013 ~ We generally don’t discuss politics on MDND because the community of medical device-injured patients is united by the common denominator of pain and a sense of injustice. Everything else is secondary. But I’d like to share some thoughts about the movements underway in the country as I just returned from Mass
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FDA: Stress Urinary Incontinence (SUI) Surgical Mesh Reports up 36 Percent

Mar 29th, 2013 | By
FDA: Stress Urinary Incontinence (SUI) Surgical Mesh Reports up 36 Percent

March 29, 2013 ~ In September 2011, the U.S. Food and Drug Administration convened a panel of experts to try and get a handle on the concerning number of complications the agency was receiving about surgical mesh used to treat pelvic organ prolapse (POP)  and stress urinary incontinence (SUI).  The experts  suggested that because of the
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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 One: Linda Gross v. Ethicon over Transvaginal Mesh

Jan 10th, 2013 | By
Day One: Linda Gross v. Ethicon over Transvaginal Mesh

January 10, 2013 ~ Johnson & Johnson was on the defense this afternoon in the trial of a South Dakota woman who claims she is in perpetual pain due to defective transvaginal mesh (TVM). Linda Gross, 47, from Watertown, South Dakota is represented by New Jersey-based attorney Adam Slater in the first of more than
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Hope for the New Year

Dec 27th, 2012 | By
Hope for the New Year

December 27, 2012 ~ Our Patient Advocate Linda K.  – always at the keyboard even during the busy holiday season- wishes you all the best this time of year. She warns mesh doctors and sales reps are not going away and neither are your mesh symptoms of pain, erosion,  nerve damage, painful sex, infection, limited
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Hernia Mesh Complications- Is the FDA Watching? Part II

Nov 28th, 2012 | By
Hernia Mesh Complications- Is the FDA Watching?  Part II

November 28, 2012 ~ Continuation from Part I, According to hernia mesh removal surgeon, Dr. Kevin Petersen, in a certain percentage of patients, the body will detect hernia mesh as a foreign material and will reject it. Symptoms may include scar tissue that leads to chronic pain and causes mesh to shrink and shrivel up,
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FDA Whistleblower Case Moving Ahead

Nov 13th, 2012 | By
FDA Whistleblower Case Moving Ahead

November 13, 2012 ~Round one in the FDA whistleblower scandal goes to the U.S. Food and Drug Administration. Regulatory Focus (here) reports the FDA had a minor victory November 9, in its case against the National Whistleblower Center (NWC) which is representing five both current and former employees of the FDA who claim they were
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Disease and Profits: Plastic Use Expected to Rise in Medical Devices

Oct 31st, 2012 | By
Disease and Profits: Plastic Use Expected to Rise in Medical Devices

October 31 ~  As the baby boomer population increases in the U.S., expect the use of polypropylene plastic to grow for use in medical devices. That according to an obscure website called plastemart.com (here) says it “covers the entire spectrum of the plastics supply chain” from the raw material to manufacturers. The company is based
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The Scandal of Defective Medical Device Approval in UK

Oct 29th, 2012 | By
The Scandal of Defective Medical Device Approval in UK

October 28, 2012 ~ Working with undercover reporters from The Daily Telegraph in the UK, the British Medical Journal’s (BMJ) Deborah Cohen has exposed, “a fragmented, poorly regulated, market driven system, with financial incentives to prioritize manufacturers’ interests over those of patients, and with no requirement for clinical evaluation of a device’s safety or effectiveness,”
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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.