Posts Tagged ‘ FDA ’

POWER MORCELLATION and the Risk of Uterine Sarcoma Dissemination

Aug 15th, 2014 | By
POWER MORCELLATION and the Risk of Uterine Sarcoma Dissemination

By Dan Bolton, Keller, Fishback & Jackson LLP., Sponsored Content An estimated 50,000 women a year in the United States undergo a hysterectomy (removal of the uterus) or myomectomy (removal of uterine fibroids) with the use of a medical device known as a power morcellator. Power morcellators typically use a rapidly rotating blade to cut
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Thank You All for Telling the FDA to Reclassify!!

Jul 31st, 2014 | By
Thank You All for Telling the FDA to Reclassify!!

Thank you,,, thank you…. thank you! I talked to the FDA today  and they say that it could take many months for individuals within the FDA to read all of the comments made to a Petition to reclassify pelvic mesh as High Risk!    Some of you may have posted that you wanted to be private
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Huskey V. Ethicon- Case Survives Summary Judgment

Jul 24th, 2014 | By
Huskey V. Ethicon- Case Survives Summary Judgment

Jury selection August 22. Pelvic mesh trial to start August 25. The case of Huskey v. Ethicon (Johnson & Johnson) has survived a summary judgment motion and will continue to federal court in Charleston, West Virginia. Jo Huskey is a 54-year-old woman who was implanted with a TVT-O pelvic mesh device in February, 2011 to
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ProteGen Mesh ~ The Grandmother of them All

Jul 13th, 2014 | By
ProteGen Mesh  ~ The Grandmother of them All

Fantastic researcher and friend, Suzanne McClain has always been the most competent person in digging through the U.S. Food and Drug Administration records (FDA), tedious work which involves a lot of patience. Here she has prepared a spreadsheet that shows the Johnson & Johnson meshes, and predicate devices used in order to clear them through
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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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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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FDA: *IMPORTANT* How To Weigh in on Reclassifying Pelvic Mesh To High-Risk!

Apr 29th, 2014 | By
FDA: *IMPORTANT* How To Weigh in on Reclassifying Pelvic Mesh To High-Risk!

*NEW*  Readers of Mesh News Desk understand that the Food and Drug Administration has allowed  the polypropylene-based material onto the market to treat pelvic organ prolapse and incontinence with very little scrutiny.  In fact, the 510(k) approval process is an approval to sell, and does not require safety and efficacy assurances. Now the agency is
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When Doctors Speak……Should We Always Listen?

Apr 28th, 2014 | By
When Doctors Speak……Should We Always Listen?

A Mesh News Desk thoughtful reader has this to say about the Position Statement from the American Urogynecology Society  (AUGS). See background story here. You may recall they feel the use of pelvic mesh is justified and still a “tool” they want to have in their toolbox. That may be a fallback position but as
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Harvard Researchers Take FDA’s Device Approvals to Task

Apr 2nd, 2014 | By
Harvard Researchers Take FDA’s Device Approvals to Task

Using documents that recently came to light, Harvard researchers have traced a troubling approval process within the Food and Drug Administration that allows medical devices to be sold with little oversight. Essentially the supplemental application resembles the agency’s 510(k) process that allows medical devices to be marketed without clinical trials. The paper is reported in
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Batiste v. Ethicon trial: An unexpected emotional rollercoaster in Texas

Mar 25th, 2014 | By
Batiste v. Ethicon trial: An unexpected emotional rollercoaster in Texas

by Aaron Leigh Horton  Aaron Leigh Horton arrived in the Dallas courtroom this morning, Monda,y March 24, to continue witnessing the trial of Linda Batiste v. Ethicon, now in its second week. Aaron, The Mesh Warrior, reports she had to leave the courtroom during some of the morning testimony because of the emotional toll it
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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.