Broadly Covers Transvaginal POP Mesh Issue with MND Input

//Broadly Covers Transvaginal POP Mesh Issue with MND Input

Broadly Covers Transvaginal POP Mesh Issue with MND Input

From VICE

From VICE

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.

 

By | 2016-01-07T17:30:24+00:00 January 7th, 2016|Media Reports|4 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

4 Comments

  1. anonymous January 7, 2016 at 5:53 pm - Reply

    They need to be told and report that any and all mesh is bad and the procedure in which mesh is placed is a dangerous procedure that can hurt nerves permanently

  2. Angela January 8, 2016 at 11:06 am - Reply

    Jane have you heard anything about the sherrer trial yet?

  3. Tammy (KY) January 11, 2016 at 5:46 pm - Reply

    Thank you Jane, awesome reporting Lady. You ROCK!! God bless you for all you do for us Mesh Injured….

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