Neal Handel1, M Emily Garcia, Roger Wixtrom. 1. Santa Barbara, Calif.; and Springfield, Va. From the Division of Plastic Surgery, David Geffen School of Medicine at the University of California, Los Angeles; Mentor Worldwide LLC; and LSCI.
Abstract
BACKGROUND: Rupture has long been considered one of the key complications of silicone-gel breast implants. The incidence of rupture has been correlated with implant generation, and extensive data on current-generation breast implants, including prospective multicenter clinical trials, are now available from numerous sources. METHODS: Device-retrieval data from breast implant manufacturers were reviewed to identify common factors that likely contribute to rupture. The cumulative incidence of rupture from a prospective clinical study was estimated in multiple ways using the Kaplan-Meier method to demonstrate the need for a uniform calculation methodology. RESULTS: The complexity of identifying, analyzing, and understanding rupture is addressed, and the clinical management of rupture in older generation breast implants lacking highly cohesive gels and barrier layers is reviewed. The data suggest that iatrogenic damage is the most frequent cause of rupture. Data from one manufacturer's prospective breast implant core study are presented to address the complexity of rupture-rate calculations-a single-time-point rupture rate varies from 9.0 to 12.2 percent, depending on which statistical parameters are used. CONCLUSIONS: The significant contribution of iatrogenic damage to overall rupture rate suggests that rupture may be more often operator-related than device-dependent. In addition, there is a critical need to implement uniform statistical methodology using follow-up data only through the patient's last magnetic resonance imaging scan, as rupture rates can vary greatly depending on the statistical methodology selected. Adoption of a uniform standard for rupture rate calculations would enable both patients and surgeons to base clinical decisions on more accurate and consistent information. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.
BACKGROUND:Rupture has long been considered one of the key complications of silicone-gel breast implants. The incidence of rupture has been correlated with implant generation, and extensive data on current-generation breast implants, including prospective multicenter clinical trials, are now available from numerous sources. METHODS: Device-retrieval data from breast implant manufacturers were reviewed to identify common factors that likely contribute to rupture. The cumulative incidence of rupture from a prospective clinical study was estimated in multiple ways using the Kaplan-Meier method to demonstrate the need for a uniform calculation methodology. RESULTS: The complexity of identifying, analyzing, and understanding rupture is addressed, and the clinical management of rupture in older generation breast implants lacking highly cohesive gels and barrier layers is reviewed. The data suggest that iatrogenic damage is the most frequent cause of rupture. Data from one manufacturer's prospective breast implant core study are presented to address the complexity of rupture-rate calculations-a single-time-point rupture rate varies from 9.0 to 12.2 percent, depending on which statistical parameters are used. CONCLUSIONS: The significant contribution of iatrogenic damage to overall rupture rate suggests that rupture may be more often operator-related than device-dependent. In addition, there is a critical need to implement uniform statistical methodology using follow-up data only through the patient's last magnetic resonance imaging scan, as rupture rates can vary greatly depending on the statistical methodology selected. Adoption of a uniform standard for rupture rate calculations would enable both patients and surgeons to base clinical decisions on more accurate and consistent information. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.
Authors: Todor I Todorov; Erik de Bakker; Diane Smith; Lisette C Langenberg; Linda A Murakata; Mark H H Kramer; Jose A Centeno; Prabath W B Nanayakkara Journal: Int J Environ Res Public Health Date: 2021-04-24 Impact factor: 3.390