Home/Tag: 522

Will Ethicon Skirt the 522 Request?

In the Ethicon June 4, announcement to two courts that it was taking four synthetic vaginal meshes off the market, Ethicon, a division of Johnson & Johnson, asked that the Food and Drug Administration’s (FDA) January order to conduct postmarket studies be “placed on hold.” There were about 75,000 women [...]

By |2018-07-10T14:38:51-04:00June 8th, 2012|Legal News|0 Comments

Where Are the Postmarket Surveillance Plans for POP, SUI Mesh?

February 14, 2012 ~ Where's the Plan? On January 3, 2012, the FDA sent out copies of a 522 order to 33 manufacturers of synthetic surgical mesh for pelvic organ prolapse and 7 manufacturers of mesh for stress urinary incontinence. Here is the background story on MDND. The request says, [...]

By |2012-02-14T14:36:17-05:00February 14th, 2012|FDA News|2 Comments