Posts Tagged ‘ POP ’

FDA Loosens its Leash on Medical Device Makers

Oct 21st, 2014 | By
FDA Loosens its Leash on Medical Device Makers

The Food and Drug Administration (FDA) is making it a little easier on medical device manufacturers to “tweak” their product without having the burden of reapplying for permission to market. Last week, the FDA announced it would not require manufacturers to alert the agency when changes are made to a device unless the change poses
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Speak to the FDA Now!

Jul 28th, 2014 | By
Speak to the FDA Now!

  Midnight Wednesday July 30, the opportunity ends to weigh into the FDA concerning the reclassification of POP mesh to class III or a high-risk device which it certainly is. Mesh will never survive that scrutiny. Mesh News Desk and Corporate Action Network, a consumer group, are asking you to share the link below with
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Boston Scientific Opening Arguments in Mass. Court

Jul 9th, 2014 | By
Boston Scientific Opening Arguments in Mass. Court

Today was Day One for opening arguments in the trial of Diane Albright v. Boston Scientific being heard in Middlesex Co. Superior Court in Woburn, Massachusetts.  It appears to be the first product liability trial against Boston Scientific, maker of transvaginal mesh.  The case is being heard before Judge Diane M. Kottmyer and could take
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Women’s Open Letter to Doctors – The Truth About Pelvic Mesh

Jul 3rd, 2014 | By
Women’s Open Letter to Doctors – The Truth About Pelvic Mesh

The letter below is from Noni Wideman, researcher extraordinaire! and long time contributor to Mesh News Desk and her own Links on Mesh, a Facebook page. Here. This is a letter you may want to share with your medical practitioners or anyone who needs an update on the current crisis in women’s healthcare. Thank you. 
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#Not One More Campaign

Jun 26th, 2014 | By
#Not One More Campaign

The #NotOneMore campaign is a Public Service Announcement sponsored by the Mesh Warrior foundation for the Injured. Its mission is to raise awareness abuot the dangers of polypropylene mes used to treat pelvic organ prolapse, stress urinary incontinence and for hernia repair.  It was never tested on humans. These women add their voices to the
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Scotland Becomes First Country to Suspend Sales of Transvaginal Mesh!

Jun 17th, 2014 | By
Scotland Becomes First Country to Suspend Sales of Transvaginal Mesh!

  One day after one of the country’s health boards voted to ban the use of transvaginal mesh use in that country, Scotland’s Health Secretary Alex Neil has requested the use of mesh implants stop in Scotland until an investigation into mesh complications is conducted. About 1,500 women undergo transvaginal mesh implants in Scotland every
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Mesh Injuries Front Page News as Scottish Mesh Petitioners Meet With Parliament

Jun 3rd, 2014 | By
Mesh Injuries Front Page News as Scottish Mesh Petitioners Meet With Parliament

Today’s story from the BBC shows women in Scotland implanted with pelvic mesh are making front page news and making headway in their fight to raise awareness of pelvic mesh injuries. See the BBC story here. Tuesday, several mesh implant survivors gave “heartbreaking” evidence to the Scottish Parliament Committee. The Scottish Mesh Survivors campaign has
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Open Letter to Doctors – A Serious Concern as Doctors Divide

Jun 3rd, 2014 | By
Open Letter to Doctors – A Serious Concern as Doctors Divide

Editorial- Jane Akre, MND – In July 2011 the U.S. Food and Drug Administration (FDA) issued a Safety Communication that surgical mesh used to treat pelvic organ prolapse (POP) carried more risks than benefits and was “of serious concern.”  See the notice here. Mesh erosion can “require multiple surgeries to repair and can be debilitating
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UK Woman Notes Changes to J&J Website

May 8th, 2014 | By

Seems a bit strange if you visit these websites  particularly Ethicon and you try to access SUI and POP products, you get an  access denied message.  Hernia lighter meshes are accessible. If they have nothing to hide why are they hiding  products that previously were vigorously marketed and easily  accessed? Type TVT-O of Gynecare in the
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Endo Offers $830 Million to Settle 20K AMS Pelvic Mesh Lawsuits

Apr 30th, 2014 | By
Endo Offers $830 Million to Settle 20K AMS Pelvic Mesh Lawsuits

*This Just In* Late this afternoon, Endo Health Solutions announced it had reached an agreement with several law firms to settle in principle about 20,000 defective pelvic mesh lawsuits sold by its subsidiary American Medical Systems. Here is Endo’s news release.   Here is Exhibit A: Resolution Framework: http://www.motleyrice.com/files/medical-devices/exhibit_a.pdf MR press release about the settlement
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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.