Superiority of the Dutch Breast Implant Registry over electronic patient records in tracing breast implants: results of a test recall.

BACKGROUND

The Poly Implant Prothèse (PIP) scandal in 2010 led to the first-ever international recall, revealing shortcomings in electronic patient records (EPRs) to effectively trace patients with PIP implants. In response, the Dutch Breast Implant Registry (DBIR) was established. This study aimed to investigate the track-and-trace ability of DBIR in a test recall setting.

METHODS

All patients in DBIR who received a breast implant between 2015 and 2019 in one of the pilot hospitals were included. A test recall scenario was drafted and translated to implant specifications as stated in the DBIR dataset. A third trusted party extracted patients per pilot hospital whose implants fell within the recall scenario. Subsequently, DBIR-data were compared to EPR-data. The number of traced implants with solely EPR versus traced with EPR and data from DBIR were compared.

RESULTS

In total, 1113 implants (726 patients) matched the recall scenarios. Significantly more implants could be traced with additional DBIR-data than with EPRs alone (n=1011 [90.8%; 95% CI, 89.1%-92.5%] versus n=915 [80.9%; 95% CI, 78.6%-83.2%], respectively). Due to incorrectly registered patient identifiers or missing implant data in EPRs and DBIR, 102 implants were untraceable.

CONCLUSION

This first-ever test recall study proved that adding DBIR-data to EPRs allows for tracing more implants and patients. Our study emphasizes the importance of complete and correct data registration in implant registries, so that patients can be informed in a timely and reliable way in case of an actual recall.