“…In vitro and in vivo studies investigated the cytotoxicity ( McCollister et al, 1965 ) and degradation ( Caulfield et al, 2002 ) of polyacrylamide, informing the choice of the 2.5% (w/v) polyacrylamide concentration that was confirmed via multiple long-term clinical studies to be suitable in the targeted application ( Lose et al, 2010 ; Pai and Al-Singary, 2015 ; Kasi et al, 2016 ). Although polyacrylamide was not previously approved for clinical use by the FDA, it had been in clinically used for breast augmentation in China since 1997 and years earlier in Ukraine ( Margolis et al, 2015 ), albeit with reports of multiple adverse complications such as lumps, breast pain and induration, and in certain cases a foreign body response which destroyed the structure of adjacent muscle and gland ( Qiao et al, 2005 ). The much smaller volume of gel required for Bulkamid injection (total of 2 ml in 3 to 4 locations) relative to breast injections (∼150 ml) and the structure of the urethra significantly suppresses this risk, even in the context of a non-degradable hydrogel like polyacrylamide.…”