I talked to the FDA today and they say that it could take many months for individuals within the FDA to read all of the comments made to a Petition to reclassify pelvic mesh as High Risk! Some of you may have posted that you wanted to be private so you might not see your comment on the FDA site. Also if a group submitted, such as Mesh Survivors, that shows up as one comment.
Apparently there was an unusually high number of comments registered.
I asked if there is any disadvantage to not being considered individually and the docket guy said no.... it is the content that is important. It actually becomes cumbersome to count each letter rather than to go through a letter with many signatures.
I'm very grateful to Corporate Action Network and their support of the easy to register form which they then gathered and got to the FDA before the deadline. Making it so easy meant people didn't have to be intimidated finding the right words to express their outrage. Their heart and their technology is brilliant and I'm so thankful to them for their support on this issue!
CAN worked on the J&JHurtsWomen campaign and is in this for the right reasons- to speak back to corporate abuses!! I know I'm grateful for all they provided at no cost and with no agenda other than a grassroots campaign to make change happen. Thank you CAN!
So according to regulations - First- there was an expert panel, gathered September 8,9, 2011 (here) as well as a White Paper (here) authored by those inside the FDA; then this Petition, then the comment gathering period. When that concludes, the FDA with decide to reclassify or not to reclassify.
The process works much too slowly however there are likely people within the agency who would like to fast-track this. That White Paper is a great piece of work.
Yes... 488 of you signed onto the reclassification petition here in addition to the others who added their voices directly to the FDA Petition to reclassify mesh to high risk! Thank you,,, thank you...