Archive for August 2011

How to Post an Adverse Event with the FDA

Aug 30th, 2011 | By
How to Post an Adverse Event with the FDA

When you have a new car that develops a “safety” issue i.e. braking, steering, airbags, wiring, engine cooling, unintended acceleration etc, the auto dealer reports the problems to the manufacturer, who by law, must report the issue to the National Highway Traffic Safety Administration within five days. But when a patient has a problem with
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Gateway FDA: The New 510 (k) Guidance: A Product Liability Perspective, Gateway FDA, August 26, 2011

Aug 26th, 2011 | By

This August 26, 2011 blog on Gateway FDA is written for the medical device industry and its lawyers. The FDA recently issued new draft guidelines so manufacturers understand how to comply with the controversial 510(k) fast-track approval for marketing of their medical device. The new guidelines replace the 1997 guidelines for 510(k) submission. Included is
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Pelvic Surgeon Dr. M. Tom Margolis on ‘Getting the Mesh Out’

Aug 26th, 2011 | By
Pelvic Surgeon Dr. M. Tom Margolis on ‘Getting the Mesh Out’

  As a Pelvic Surgeon/Urogynecologist, Dr. Margolis helps women suffering from incontinence, pelvic organ prolapse and a variety of surgical problems involving the female pelvis. He has done mesh removal surgery from his office, Bay Area Pelvic Surgery, in the San Francisco Bay area. Share this:



Public Citizen: Recall Synthetic Surgical Mesh

Aug 25th, 2011 | By
Public Citizen: Recall Synthetic Surgical Mesh

AUGUST 25, 2011 – Synthetic surgical mesh is implanted into women for the treatment of pelvic organ prolapse and incontinence and now Public Citizen is calling for a ban citing the needless exposure of patients to serious, life-altering complications. Synthetic mesh used for pelvic surgeries, and hernia repair in men, is made of a petroleum-based
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Study Halted Due to Mesh Complications

Aug 21st, 2011 | By
Study Halted Due to Mesh Complications

This study, Vaginal Mesh for Prolapse: A Randomized Controlled Trial, was published in the August 2010 issue of the journal, Obstetrics & Gynecology. A three month double-blind trial recruited 65 women from three academic sites – Washington Hospital Center, (Washington, D.C.) Stanford University and Yale University. All of the women suffered from pelvic organ prolapse
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Suffering in Silence: Jim Shull from Synthetic Bard Hernia Mesh

Aug 17th, 2011 | By
Suffering in Silence: Jim Shull from Synthetic Bard Hernia Mesh

Jim Shull’s story started in September 2005. He had passed a kidney stone and went to see a urologist who ordered a CT scan to see if there were any more stones. The urologist looked at the X-ray and told Jim he had a hernia. “I don’t have a hernia I feel fine, I know
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Brevard Women Sue Over Mesh Devices, Florida Today, August 9, 2011

Aug 15th, 2011 | By
Brevard Women Sue Over Mesh Devices, Florida Today, August 9, 2011

Florida Today reports that while the FDA considers tougher regulations over medical devices, that decision will come too late for four women from Brevard County, Florida. The four say they were damaged by mesh device implants to treat pelvic floor problems. “For six weeks, I was walking around with the equivalent of barbed wire inside
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Changes Are Afoot in U.S. Medical Device Regulations, Morningstar, August 15, 2011

Aug 15th, 2011 | By

This excellent article by Morningstar reminds us that the Food and Drug Administration (FDA) has been reviewing the regulatory process that allows most medical devices to make their way into the marketplace and the agency plans to have new changes in place by October. This is sparked by the July release of the Institute of
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U.S. Advisers Call for New Medical Device Regime, Reuters July 29, 2011

Aug 14th, 2011 | By
U.S. Advisers Call for New Medical Device Regime, Reuters July 29, 2011

The FDA is pushing back on an Institute of Medicine recommendation that the fast-track approval process for medical devices is fatally flawed and should be replaced, reports Reuters. FDA’s Jeffrey Shuren, director of the Center for Devices and Radiological Health, which oversees devices, said the 510(k) process should not be eliminated, but “we are open
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Study of Medical Device Rules Is Attacked, Unseen, New York Times, July 27, 2011

Aug 14th, 2011 | By

Allies of the medical device industry criticized an Institute of Medicine report, to be released July 29, that says the approval process for a wide range of medical devices such as hip implants, hospital pumps, surgical mesh and external heart defibrillators is deeply flawed, is injuring patients and causing numerous injuries, reports the New York
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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.