Using a Digital Implant Catalog Improves Data Quality and Reduces Administrative Burden in the Dutch Breast Implant Registry.

BACKGROUND Correct registration of implant characteristics is essential to monitor the safety of implants within implant registries. Currently, in the nationwide Dutch Breast Implant Registry (DBIR) these characteristics are being registered manually by plastic surgeons, resulting in administrative burden and potentially incorrect data entry. OBJECTIVES This study evaluated the accuracy of manually registered implant data, possible consequences of incorrect data, and the potential of a Digital Implant Catalog (DIC) on increasing data quality and reducing the administrative burden. METHODS Manually entered implant characteristics (fill, shape, coating, texture) of newly inserted breast implants in DBIR, from 2015 to 2019, were compared with the corresponding implant characteristics in the DIC. Reference numbers were used to match characteristics between the two databases. The DIC was based on manufacturers' product catalogs and was set as the gold standard. RESULTS 57,361 DBIR records could be matched with the DIC. Accuracy of implant characteristics varied from 70.6 to 98.0 percent, depending on the implant characteristic. The largest discrepancy was observed for 'texture', the smallest for 'coating'. All manually registered implant characteristics resulted in different conclusions about implant performance when compared to the DIC (P<0.01). Implementation of the DIC reduced the administrative burden from 14 to 7 variables (50 percent). CONCLUSIONS Implementation of a Digital Implant Catalog increases data quality in DBIR and reduces the administrative burden. However, correct registration of reference numbers in the registry by plastic surgeons remains key for adequate matching. Furthermore, all implant manufacturers should be involved and regular updates of the DIC are required.