FDA

Home/Tag: FDA

The Lancet on Makers Told to Stop Selling POP Mesh

Mesh Medical Device News Desk, April 22, 2019 ~ The Lancet is one of the oldest medical journals in the world. Ed Holt writes for The Lancet about last month's FDA decision to halt the sales of any POP mesh due to concerns about safety and efficacy.  It is the [...]

By |2019-05-22T15:25:39-04:00May 22nd, 2019|Media Reports|0 Comments

Pelvic Mesh Remains on the Market Despite FDA Decision!

Mesh Medical Device News Desk ~ Mesh News Desk is trying to clear up some of the confusion concerning the 2019  FDA decision about POP mesh applications to market denied!   There is a lot of confusion about the Tuesday announcement by the FDA to stop the sale of the remaining [...]

By |2020-05-21T12:06:04-04:00April 17th, 2019|FDA News|11 Comments

Conflicts of Interest in FDA Expert Panels

Mesh Medical Device News Desk, November 6, 2018 ~ Expert Panels often decide to approve drugs and devices, but how objective are the panelists and do conflicts make a difference?  A report in Science Magazine (here) has peeled back to revelations of the conflict of interests that exist among experts who advise [...]

By |2018-11-07T10:53:19-05:00November 6th, 2018|FDA News|4 Comments

Mary Dickson Reports on her Depo with J&J

Mary Dickson after depo Mesh Medical Device News Desk, October 3, 2018 ~ Mary Dickson claims her mother died from the complications of her two Johnson & Johnson mesh implants. She is taking her case forward Pro Se, without an attorney after she parted ways with two firms. [...]

By |2018-10-11T21:46:16-04:00October 3rd, 2018|News|7 Comments

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

Variety Reports Bayer Blasting The Bleeding Edge Producers

Mesh Medical Device News Desk, August 7, 2018 ~ The entertainment industry news source, Variety, reports on the controversy surrounding the documentary, The Bleeding Edge. The Bleeding Edge, a documentary just released on Netflix, is being attacked by the companies it profiles. Bayer, maker of the Essure birth control device, [...]

By |2018-08-07T14:24:21-04:00August 7th, 2018|Media Reports|0 Comments

30 Months is Up! POP Mesh is Officially High Risk, Too Late for Many

Prolift for POP repair Mesh Medical Device News Desk, July 10, 2018 ~ Pelvic Organ Prolapse (POP) polypropylene mesh, that has injured so many, has just suffered another blow. After an initial announcement and a 30 month waiting period, finally this month, the FDA has officially reclassified POP [...]

By |2018-10-22T17:32:39-04:00July 10th, 2018|FDA News|13 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 Pilot Program Helps Manufacturers Streamline Approval of Medical Devices

Mesh Medical Device News Desk, September 18, 2017 ~ The FDA spends much of its resources working with device and drug manufacturers to help ease their way to market. Here is another example of a newly announced pilot program that will help do just that.  Unlike drugs, high-risk medical devices, [...]

By |2017-09-18T00:24:03-04:00September 18th, 2017|FDA News|5 Comments