FDA

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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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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New* Fridays with the FDA: One Lovely Lady’s Plea

Jun 27th, 2014 | By

A lovely woman called me this afternoon. Her suggestion for a Friday effort and beyond!! She can’t be identified but she says: “The FDA is giving us an opportunity to speak and get mesh reclassified so  more women will be less likely to innocently have it done to them. Doctors would be forced to give
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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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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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FDA Approves New American Medical System Transvaginal Mesh Sling

Dec 9th, 2013 | By
FDA Approves New American Medical System Transvaginal Mesh Sling

American Medical Systems (AMS) has just received FDA clearance to market a new incontinence sling, according to a press release that appears in the Wall Street Journal. The RetroArc Retropubic Sling System received the Food the Drug Administration’s 510(k) clearance, a standard that does not require any clinical trials but relies on naming a similar 
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FDA Steps Up Medical Device Monitoring – It’s About Time

Sep 24th, 2013 | By
FDA Steps Up Medical Device Monitoring – It’s About Time

Could the entire mesh mesh have been averted much sooner before perhaps one million women were implanted with controversial transvaginal mesh? Yes, if the U.S. tracked medical devices the way it’s done elsewhere. The Food and Drug Administration (FDA) is finally taking a step in that direction. The FDA has just announced a final rule
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Happy Anniversary Food and Drug Administration – Now What?

Jul 2nd, 2013 | By
Happy Anniversary Food and Drug Administration – Now What?

July 2, 2013 ~ Many of you may be aware that the entire pursuit of lawsuits against mesh manufacturers began two years ago this month with the issuance of a safety warning from the U.S. Food and Drug Administration concerning transvaginal mesh. FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical
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FDA Considers Revising 510(k), Industry Balks

Jun 13th, 2013 | By
FDA Considers Revising 510(k), Industry Balks

June 13, 2013~ “External stakeholders.” That is what the FDA calls medical device manufacturers who also  have a decisive role in shaping the regulations they fall under. Thursday, June 13, the FDA met with stakeholders to discuss modifying the 510(k) approval process. (here) About 90 percent of the 4,000 medical devices approved by the FDA
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FDA Asks Consumers to Report Product Failures

Jun 10th, 2013 | By
FDA Asks Consumers to Report Product Failures

June 10, 2013 ~ New and Improved? The U.S. Food and Drug Administration (FDA) is celebrating 20 years of the MedWatch program by providing consumers with a new form that should encourage consumers and medical professionals to report adverse events, complications and bad outcomes with drugs and medical devices, cosmetics, medical equipment, food or supplements.
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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.