Ethicon’s legal representative has written to a federal judge in West Virginia stating it intends to stop selling four vaginal mesh implants after being sued by more than 600 women who say the products caused internal injuries.
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Transvaginal Mesh: Regulators Urged To Act More Decisively
A US consumer protection website is urging regulators to move more quickly and decisively in dealing with the thorny subject of transvaginally inserted organ prolapse meshes.
J&J Selling Vaginal Mesh Without FDA Clearance Might Make A Good Headline, But Doesn’t Change Much
Vaginal Mesh problems are going to land at someone’s door and J&J’s looking like a soft target. It transpires the company decided to launch “Prolift” in 2005 as an “insignificant change” to a previous device, so didn’t feel the need to tell FDA about it.
Uro/Gyne Surgical Mesh Implants: FDA Updates Position
FDA has announced a heightened degree of scrutiny regarding transvaginally inserted meshes and is considering reclassifying from Class II to Class III.