INDUSTRIAL-GRADE SILICONE IN BREAST IMPLANTS- EVALUATING COST IMPLICATIONS OF DIFFERENT EXPLANTATION STRATEGIES

Author(s)

Montouchet C1, Hart P21Medaxial Group, London, United Kingdom, 2Medaxial Group, London, London, United Kingdom

OBJECTIVES: In December 2011, French health authorities agreed to reimburse the explantation of defective Poly Implant Prothèse (PIP) breast implants, triggering responses from  other national policy makers. Spurred by public concern and media coverage, the UK health secretary announced that the National Healthcare Service (NHS) would remove and replace the defective devices it had installed. Using the UK as a case study, we evaluated three PIP-related policy scenarios that have been instituted internationally. A cost comparision model was developed to assess the cost implications of different explantation scenarios and to identify key cost drivers from the perspective of the NHS. METHODS:  The model explored the following scenarios: (a) immediate removal of all PIP breast implants; (b) targeted removal of ruptured implants; (c) symptom surveillance, with no extraordinary removal of implants. Complication (e.g. rupture, silicone leakage) rates were taken from the medical literature.  Event management and screening costs were drawn from NHS Reference Costs (2009-2010). Sensitivity analyses were conducted using a range of costs, complication rates and patient numbers. RESULTS: Regardless of observed rupture rates, reimbursing all explantations was the costliest option, followed by screening and targeted removal of ruptured implants. Given the apparently low rate of complications, the least costly option was a policy of symptom surveillance, where explantation stemmed from presentation of rupture-related symptoms. CONCLUSIONS: The dearth of implant-related complication data makes analysis of the current crisis challenging. Until reliable data about the clinical implications of the faulty implants are gathered, policy makers will struggle to accurately assess the relative budget impact of their recommendations. Even then, heterogeneity among the devices exported to different countries may confound predictions.  More broadly, the lack of complication data highlighted by this study indicates a need for improved regulation and monitoring of medical devices to ensure future policy decisions are better informed.

Conference/Value in Health Info

2012-06, ISPOR 2012, Washington, D.C., USA

Value in Health, Vol. 15, No. 4 (June 2012)

Code

PMD21

Topic

Economic Evaluation

Topic Subcategory

Cost-comparison, Effectiveness, Utility, Benefit Analysis

Disease

Reproductive and Sexual Health

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