Does the Evolution Toward More Cohesive Gels Reduce Silicone Leakage in Breast Implants?

Michel Alain Danino, MD PHD FRCSC1,2, Melvin Dziubek, md3, Christophe sammouR., md4, Jacqueline Dalfen, md5, Socorro Ortiz, md phd4 and louiS. Gaboury, md6, (1)Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, QC, Canada, (2)University Hospital of Montreal, Montreal, QC, Canada, (3)Centre Hospitalier Universitaire Brugmann, membre du réseau IRIS et du CHU de Bruxelles,, bruxelles, Belgium, (4)universite libre bruxelle, bruxelle, Belgium, (5)mc gill university, westmount, QC, Canada, (6)montreal university, westmount, QC, Canada
Goals/Purpose: Since the 1960s, breast implant development has included adjustments in gel cohesiveness to enhance shape stability and reduce silicone leakage. This study compares silicone leakage across different implant brands based on gel cohesiveness.

Methods/Technique: This multicenter retrospective study analyzed 51 periprosthetic capsules collected during implant removal or exchange. Each sample was evaluated for silicone particle count and size, using a validated method. Implants were categorized by gel cohesiveness levels (I, II, III) based on manufacturer catalogs. Particle densities and average sizes were compared among groups for each brand.

Results/Complications

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Among the analyzed capsules, 25 were from Allergan® implants, 21 from Mentor®, and 5 from Motiva®. Capsules from Allergan® and Mentor® implants contained over 2 million particles regardless of gel generation, whereas Motiva® implants contained approximately 100,000 particles.

For Allergan® implants, Cohesiveness I had 30 particles/mm³ (mean size: 32.37 μm), Cohesiveness II: 74 particles/mm³ (mean size: 32.58 μm), and Cohesiveness III: 43 particles/mm³ (mean size: 42.94 μm). Mentor® implants with Cohesiveness I had 131 particles/mm³ (mean size: 25.05 μm) and Cohesiveness II: 27 particles/mm³ (mean size: 25.98 μm). For Motiva® implants, Cohesiveness I had 1 particle/mm³ (mean size: 35.8 μm) and Cohesiveness II: 5 particles/mm³ (mean size: 21.54 μm).

Conclusion: Gel cohesiveness does not uniformly affect silicone leakage across implant brands. In Allergan® implants, leaks were influenced more by Biocell texture than by gel cohesiveness. Higher gel cohesiveness did not reduce leakage in Allergan® and Motiva® implants, whereas Mentor® implants showed a reduction. Motiva® implants exhibited lower silicone leakage overall, unrelated to gel generation used.