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 final nail in the coffin on the largest mesh implants used to treat prolapse.
Published in The Lancet, a weekly peer-reviewed medical journal, April 27, 2019, Ed Holt reports that the two companies must stop selling all remaining surgical mesh products for pelvic organ prolapse repair. Here is the article.
The three meshes are made by Boston Scientific and Coloplast. There are not enough assurances of safety and efficacy reported the FDA to support a favorable benefit-risk profile. The companies failed to show a transvaginal mesh repair was more effective and as safe as a native tissue repair at 36 months.
“Cathryn Glazener, an emeritus professor at University of Aberdeen, (Scotland) who co-authored a study published by The Lancet in 2016 that compared native tissue prolapse repair, use of a synthetic mesh, and biological grafts during prolapse surgery, told The Lancet: “This raises the question of why someone having a first repair would undergo such a procedure when there is now mounting evidence of extra problems with mesh products.” “
The president of the American Urogynecologic Society told Holt that he was surprised by the announcement and complained that a mesh option will no longer be available for patients who have unsuccessful previous native tissue repair.
Within AUGS there are opposing thoughts about mesh, he said, though the society has in the past painted a united picture as being overwhelmingly pro-mesh.
The Lancet, April 27, 2019 here
Mesh News Desk, FDA Orders Makers to Stop Selling POP Mesh, April 2019, here
FDA News Release April 16, 2019
MND, February 13, 2019, The Road to FDA Approval for Pelvic Organ Mesh
Mesh News Desk, Transvaginal & Hernia Mesh Settlements
MND, July 2018, The Wait is up! POP Mesh Officially High Risk
MND, January 9, 2012, Mesh Makers Who Received FDA Letter Requiring Post Market Surveillance