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.

Background: The majority of postmastectomy breast reconstructions (PMBRs) are currently performed in two stages using a tissue expander (TE). However, complications during the expansion phase occur regularly, leading to unplanned reoperations and/or reconstruction failure. This study aimed to identify risk factors for unplanned reoperation after TE placement, assessed the time until unplanned and planned reoperation, and investigated indications for unplanned reoperation. Methods: Patient and surgery-related characteristics of patients who underwent two-stage PMBR between 2017 and 2021 were collected from the Dutch Breast Implant Registry (DBIR). Unplanned reoperation was defined as TE explantation followed by either no replacement or replacement with the same or a different TE. Co-variate adjusted characteristics associated with unplanned reoperation were determined using backward stepwise selection and multivariable logistic regression analyses. Results: In total, 2529 patients (mean age, 50.2 years) were included. Unplanned reoperation occurred in 19.4 percent of all registered TEs (n=3190). Independent factors associated with unplanned reoperation were BMI≥25 kg/m 2 (adjusted Odds Ratio [aOR]=1.63;99% Confidence Interval [99%CI]=1.20-2.57 for BMI 25-29.9 kg/m2, aOR=2.57;99%CI=1.74-3.78 for BMI≥30 kg/m 2), low institutional volume (aOR=1.51;99%CI=1.06-2.18), no drains (aOR=2.06;99%CI=1.15-3.60), subcutaneous TE placement (aOR=5.71;99%CI=3.59-9.10), and partial pectoralis major muscle coverage (aOR=1.35;99%CI=1.02-1.79). Age<40 years (aOR=0.49;99%CI=0.32-0.74) and delayed PMBR (aOR=0.35;99%CI=0.19-0.60) reduced the risk of unplanned reoperation. Median time until reoperation was 97 days for unplanned and 213 days for planned reoperation. Deep wound infections were most often registered as indication for unplanned reoperation (34.4 percent). Conclusion: This study identified several risk factors for unplanned reoperation which may be used to reduce complications in expander-based PMBR.

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