Archive for February 2012

Jim Shull- Observations on How Lawmakers View Medical Device Regulation

Feb 22nd, 2012 | By
Jim Shull- Observations on How Lawmakers View Medical Device Regulation

February 22, 2012 ~ Jim Shull was a member of a patient advocacy group when in October of 2008, the Food and Drug Administration, largely at the group’s urging, issued its first public health notification (PHN) about transvaginal mesh (here). Thousands of women were coming forward with injuries attributed to use of synthetic surgical mesh
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Hernia Mesh Injured Patient Jim Shull Testifies on FDA’s Lax Oversite of Medical Devices

Feb 16th, 2012 | By
Hernia Mesh Injured Patient Jim Shull Testifies on FDA’s Lax Oversite of Medical Devices

February 15, 2012 ~ Testimony of James Shull U.S House Committee on Energy and Commerce/Subcommittee on Health My name is Jim Shull and I am from Browns Mills, New Jersey. I would like to thank you for allowing me the opportunity to speak here today. My story goes back to 2005 when I was told
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Metal Hip Device Implant Sold in EU After Rejected in U.S.

Feb 15th, 2012 | By
Metal Hip Device Implant Sold in EU After Rejected in U.S.

February 15, 2012 ~ Barry Meier of the New York Times reports that Johnson & Johnson’s DePuy division continued to sell a defective artificial hip overseas even after it was rejected for sale in the U.S. Two related versions of the metal-on-metal hip, DePuy ASR were implanted in about 93,000 patients worldwide with about one-third
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FDA: What is MDUFA? Hearings on $595 Million and What Industry Wants

Feb 14th, 2012 | By
FDA: What is MDUFA? Hearings on $595 Million and What Industry Wants

February 14, 2012 ~ What is MDUFA? The Medical Device User Fee and Modernization Act shortened from MDUFMA. Enacted in 2002 and again in 2007 it authorized the FDA to collect a user fee from industry to review medical devices before they go on sale. MDUFA in 2010 funded about 20 percent of the medical
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Where Are the Postmarket Surveillance Plans for POP, SUI Mesh?

Feb 14th, 2012 | By
Where Are the Postmarket Surveillance Plans for POP, SUI Mesh?

February 14, 2012 ~ Where’s the Plan? On January 3, 2012, the FDA sent out copies of a 522 order to 33 manufacturers of synthetic surgical mesh for pelvic organ prolapse and 7 manufacturers of mesh for stress urinary incontinence. Here is the background story on MDND. The request says, “Within 30 days of receipt
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Lorraine Evans Highlights Global Problem of Mesh Mess

Feb 13th, 2012 | By
Lorraine Evans Highlights Global Problem of Mesh Mess

Press Release For Immediate Release: Monday, February 13, 2012 End our ‘human guinea pig’ hell A TIRELESS campaigner (from the UK) is calling on surgeons to stop treating incontinent women as medical guinea pigs. Currently, medics aim to cure stress urinary incontinence (SUI) by inserting a device known as trans-vaginal tension free tape (TVT), or
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Must Watch Live Feed: Hearings on Mesh, Medical Device Budget Pits Patient Safety v. Industry

Feb 13th, 2012 | By
Must Watch Live Feed: Hearings on Mesh, Medical Device Budget Pits Patient Safety v. Industry

A must watch show How to Watch:  Go to www.energycommerce.house.gov  (link will show up when gavel begins hearing, live feed)  Hearing: “Reauthorization of MDUFA: What It Means for Jobs, Innovation and Patients” When: The Subcommittee on Health has scheduled a hearing on Wednesday, February 15, 2012, at 10:00 a.m. in room 2322 of the Rayburn
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Call to Action – House Energy & Commerce Committee Hearings on Mesh

Feb 12th, 2012 | By
Call to Action – House Energy & Commerce Committee Hearings on Mesh

  House Democrats are asking Republicans for a hearing on Johnson & Johnson synthetic surgical transvaginal mesh used to treat pelvic organ prolapse, and the Allergan Lap-Band for weight reduction because of a growing number of patient injuries and a fear that device makers and the U. S. Food and Drug Administration (FDA) may not
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Call to Action This Week!

Feb 12th, 2012 | By
Call to Action This Week!

Call to Action The stories in Patient Profiles show something within the FDA is clearly broken, and needs to be fixed. Most blame the 510(k) process which is sort of an ‘honor system’ allowing medical device makers to market their products, while the FDA and consumers hope the devices are safe and effective. We know
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Industry Says EU Medical Device Sales Healthy, Silicone Scandal May Change That

Feb 10th, 2012 | By
Industry Says EU Medical Device Sales Healthy, Silicone Scandal May Change That

February 10, 2012 ~ A survey by a medical device consultant, Emergo Group, released Friday, (news release here) February 10, finds that overseas sales of medical devices outpaced domestic business in 2011. Surveying more than 2,600 medical device makers, 53 percent reported a rosy sales picture last year. Compare that to 42 percent reporting positively
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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.