Mesh News Desk, January 7, 2015 ~ Your editor, Jane Akre was interviewed for this January 5th story in “Broadly” a unit of the HBO show VICE.
Read the story here.
Reporter Gabby Bess was seeking a comment on the new Food and Drug Administration rule that reclassifies mesh used for pelvic organ prolapse or POP to high risk. Currently it enjoys a “moderate risk” classification as class II. For the next 30 months, mesh manufacturers must submit to the FDA proof that their mesh in safe and effective.
Any new pelvic mesh introduced for POP repair will have to provide clinical trials or proof of safety. Without proof which was previously not required, the mesh will have to be removed from the market.
Many mesh manufacturers have already removed their POP mesh from the market. See the background story here.
Must used for stress urinary incontinence or SUI is a smaller piece of mesh but it will remain in class II and will not require the more stringent requirements of class III.