Food and Drug Administration

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Bruce Rosenberg Column: Hernia Mesh Help Here

Mesh Medical Device News Desk,  August 23, 2018 ~ As many readers already know, polypropylene (PP) is the plastic polymer component that goes into making up most meshes, whether used in the pelvic region for prolapse and incontinence or used to make hernia mesh.  With one million hernia mesh repairs [...]

By |2018-09-12T01:17:10-04:00August 23rd, 2018|Medical News|24 Comments

FDA’s 510(k) Clearance Does NOT Lead to Safer Gyn Medical Devices

Mesh Medical Device News Desk, April 11, 2018 ~ The Food and Drug Administration's 510(k) clearance process for medical devices has been called a fast-track to market clearance process. This study reveals it does not lead to safer gynecologic medical devices. FDA Approval of Gynecologic Medical Devices Image: Desara mesh by [...]

By |2018-06-05T11:11:01-04:00April 11th, 2018|FDA News|0 Comments

FDA Covers for Device Makers, Keeps Injuries Under Wraps

FDA Office of the Commissioner, Silver Spring, MD Medical Device News Desk, October 20, 2016 ~ The system is supposed to be transparent.   Medical device makers are required to alert the U.S. Food and Drug Administration (FDA) when their products injure consumers or malfunction.  The FDA then theoretically alerts [...]

By |2016-10-20T13:33:06-04:00October 20th, 2016|FDA News|4 Comments

FDA Funding: Medical Device Makers and Lap Dog Watchdogs

Consumers Union Safe Patient Project Mesh Medical Device News Desk, August 29, 2016 ~ The medical device industry and the U.S. Food and Drug Administration (FDA) have reached tentative agreement on $1 billion in funding from the very industry it regulates. The Medical Device User Fee Agreement IV [...]

By |2016-08-29T13:50:55-04:00August 29th, 2016|FDA News|15 Comments

Report: Deaths Caused by the FDA

Mesh Medical Device News Desk, July 5, 2016 ~ Deaths Caused by the FDA That is the title of a campaign by the Alliance for Natural Health, USA.  Digging into the Food and Drug Administrations (FDA) database, the consumer group, that promotes sustainable natural health, counts 750,659 deaths caused by [...]

By |2016-07-05T09:49:54-04:00July 5th, 2016|FDA News|6 Comments

FDA to Consider Reclassifying Trocars Used to Place Surgical Pelvic Mesh

Capio, retropubic sling instrument, transobturator sling instrumentation, from FDA Mesh News Desk, March 14, 2016 ~ When mesh kits were first developed and marketed in the U.S. in the mid 2000’s, they came complete with precut mesh and what’s known as a trocar. What are trocars? A trocar [...]

By |2017-01-16T12:47:25-05:00March 14th, 2016|FDA News|11 Comments

Mesh Survivor on the FDA’s Oversight of Chinese Boston Scientific Mesh Controversy

Plastics recycling in Guandong Province Mesh News Desk, February 26, 2016 ~Written by an anonymous woman in response to the story about Chinese mesh smuggled in by Boston Scientific from China. Judge Goodwin has asked the Food and Drug Administration (FDA) to weigh in as to whether the [...]

By |2016-02-26T13:59:34-05:00February 26th, 2016|FDA News|11 Comments

Biomedical Expert on Regulatory Parellels of Pelvic Mesh to Breast Implants, Federal Preemption and There’s No Medical Grade Mesh

William A. Hyman Biomedical expert MND, January 13, 2016 ~ Dr.William A. Hyman, a Biomedical expert has been brought in as a consultant in some pelvic mesh cases.  Dr. Hyman compares FDA's reclassification of POP (pelvic organ prolapse) mesh to class III as a parallel to breast implant reclassification.  [...]

By |2016-01-13T17:02:04-05:00January 13th, 2016|News|14 Comments

Have You Filed Your FDA Adverse Event Report Concerning Surgical Mesh?

MND, November 17, 2015 ~ This woman did one year ago. She found the MAUDE database inside the FDA.  Here is the URL for her anonymous report she made after receiving the Gynecare (J&J) Prolift mesh kit.  See it  here.   You can also go to MedWatch and report your [...]

By |2018-07-08T16:51:37-04:00November 17th, 2015|FDA News, Take Action|4 Comments