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Pelvic Mesh Remains on the Market Despite FDA Decision!

Mesh Medical Device News Desk, April 17, 2019 ~ Mesh News Desk is trying to clear up some of the confusion concerning Tuesday's 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 [...]

By |2019-06-01T17:52:23-04:00April 17th, 2019|FDA News|9 Comments

* Latest News * FDA Orders Mesh Makers to Stop Selling Prolapse Pelvic Mesh!

Mesh Medical Device News Desk, April 16, 2019~ Even though the Food and Drug Administration began taking in mesh-related complaints in the early 2000's and noted problems with pelvic organ prolapse (POP) mesh, it has taken until today to finally remove it from the market! The U.S. Food and Drug [...]

By |2019-05-15T12:25:42-04:00April 16th, 2019|FDA News|23 Comments

The Road to FDA Approval for Pelvic Organ Mesh

Mesh Medical Device News Desk, February 13, 2019 ~ The panel agreed more information is needed of a long-term nature before outstanding questions are answered about the safety of mesh used for pelvic organ support. Meanwhile, three POP meshes remain on the market with manufacturers hoping to clear this regulatory [...]

By |2019-02-25T11:22:24-04:00February 13th, 2019|FDA News|9 Comments

FDA Meets on POP Pelvic Mesh, Final Day to Submit Comments

Mesh Medical Device News Desk, February 11, 2019 ~ Today, February 11th, is the last day to submit comments to the Federal Register as the FDA convenes its Obstetrics and Gynecology Devices panel Tuesday to decide the future of transvaginal pelvic mesh used to treat pelvic organ prolapse (POP).  Industry and the [...]

By |2019-02-22T15:08:19-04:00February 11th, 2019|FDA News|5 Comments

FDA Convenes Panel on POP Mesh in February 2019

Mesh Medical Device News Desk, November 22, 2018 ~ The FDA continues to explore what went wrong with mesh for pelvic organ prolapse and will rely on the public and experts to weigh in on February 12, 2019.  The U.S. Food and Drug Administration has slowly reacted to events concerning [...]

By |2019-02-11T13:40:40-04:00November 22nd, 2018|FDA News, News|4 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 |2018-11-07T10:53:19-04:00November 6th, 2018|FDA News|4 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|7 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 Finds No Prob with Boston Sci Chinese Counterfeit Mesh

Marlex from China Mesh Medical Device News Desk, November 7, 2017 ~ It's been more than a year since it was notified, but now the U.S. Food and Drug Administration (FDA) says there are no worries with the pelvic mesh made from raw polypropylene sourced under questionable circumstances [...]

By |2017-12-31T18:20:12-04:00November 7th, 2017|FDA News|22 Comments