A retrospective audit of Novagold 'hydrogel' breast implants.

Abstract

Novagold breast implants were withdrawn from use in the UK in December 2000 due to concerns about the metabolic fate of the implant filler material, the hydrogels polyvinylpyrrolidine (PVP) and guar gum. A total of 250 women in the UK had these implants, 66 of which were performed in our unit. A total of 44% of cases needed further surgery for complications. Capsular contracture requiring surgical intervention occurred in 32%. Symptomatic ruptures occurred in 10.5%. Infection was recorded in 1.5%. From comparison with published data, the incidence of capsular contracture is comparable, but the occurrence of rupture is almost twice that of saline-filled implants. It is hypothesised that an osmotic gradient occurs due to the hydrogel filler causing the implants to swell and weaken the elastomer shell. When the PVP/guar gum filler is released into the subcutis, a vigorous tissue reaction occurs causing pain and swelling. These results show that this composition of implant poses potential risks, which should be considered by manufacturers in the future. We advise removal of symptomatic implants, as rupture is likely to have occurred.