EACTS 2014, page-44

the FDA changed or is still in the middle of changing the rules to the pelvic floor patches/reconstructions as a few companies like J&J had some major problems and a lot had to be recalled. We had a trial that was pulled as we do not know what the outcome is for them (and us) until the results are known, with what will be asked of all companies to better understand what went wrong with infections, most will do what we are doing and that is little to nothing.
Some are going ahead but the rules for the FDA could make what they do worthless as no one knows what they want at this stage, to get a new approval through.
It could end up being a complete waste of time, money and resources until the FDA tells all companies what they want the new results to look like, (but this was what I learnt awhile ago & and this may not be the case now)