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Published on: February 24, 2023
A retrospective audit of Novagold 'hydrogel' breast implants
J Hardwicke1, N R Gaze, J K G Laitung
1Department of Plastic & Reconstructive Surgery, Lancashire Teaching Hospitals NHS Trust, Royal Preston Hospital, Sharoe Green Lane, Fulwood, Preston PR2 9HT, UK. joe_1976@lycos.co.uk
Summary
Novagold breast implants containing polyvinylpyrrolidine (PVP) and guar gum had high complication rates, including rupture. Removal of symptomatic implants is advised due to potential risks.
Area of Science:
- Plastic Surgery
- Biomaterials Science
Background:
- Novagold breast implants, using polyvinylpyrrolidine (PVP) and guar gum hydrogels, were withdrawn in the UK in December 2000.
- Concerns existed regarding the metabolic fate of the hydrogel filler material.
Purpose of the Study:
- To evaluate the complication rates and outcomes of Novagold breast implants.
- To compare the incidence of complications with other breast implant types.
Main Methods:
- Retrospective analysis of 66 Novagold breast implant cases from a single unit.
- Comparison with published data on saline-filled implants.
Main Results:
- 44% of cases required further surgery for complications.
- Capsular contracture occurred in 32%, symptomatic rupture in 10.5%, and infection in 1.5%.
- Rupture rates were nearly double those of saline-filled implants.
Conclusions:
- Novagold implants exhibit a high complication rate, particularly rupture, potentially due to osmotic swelling and shell weakening.
- The hydrogel filler can cause adverse tissue reactions upon release.
- This implant composition poses risks that warrant consideration by manufacturers; symptomatic implants should be removed.