P E R Spronk1, B E Becherer2, J Hommes3, X H A Keuter4, D A Young-Afat5, M J Hoornweg6, M W J M Wouters7, M A M Mureau8, H A Rakhorst9. 1. Department of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, the Netherlands; Scientific bureau, Dutch Institute for Clinical Auditing (DICA), Leiden, the Netherlands. Electronic address: p.e.r.spronk@lumc.nl. 2. Scientific bureau, Dutch Institute for Clinical Auditing (DICA), Leiden, the Netherlands; Department of Plastic and Reconstructive Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands. 3. Department of Plastic, Reconstructive and Hand Surgery, Maastricht University Medical Center, Maastricht, the Netherlands. 4. Department of Plastic, Reconstructive and Hand Surgery, Maastricht University Medical Center, Maastricht, the Netherlands; Department of Plastic, Reconstructive and Hand Surgery, VieCuri Medical Center, Venray, the Netherlands. 5. Department of Plastic, Reconstructive and Hand Surgery, Amsterdam University Medical Center, location VU medical center, Amsterdam, the Netherlands. 6. Department of Plastic and Reconstructive Surgery, Antoni van Leeuwenhoek, Amsterdam, the Netherlands. 7. Scientific bureau, Dutch Institute for Clinical Auditing (DICA), Leiden, the Netherlands; Department of Surgical Oncology, Antoni van Leeuwenhoek, Amsterdam, the Netherlands. 8. Department of Plastic and Reconstructive Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands. 9. Department of Plastic, Reconstructive and Hand Surgery, Medisch Spectrum Twente, Enschede, the Netherlands.
Abstract
BACKGROUND: Although the use of breast implants is generally considered to be safe, breast implants are associated with short- and long-term complications. To evaluate and improve the quality of breast implant surgery, and increase our knowledge of implant performance, the national Dutch Breast Implant Registry (DBIR) was established in 2015. DBIR is one of the first up-and-running breast implant registries worldwide and follows an opt-out structure. OBJECTIVE: This article provides an overview of the first outcomes and experiences of the DBIR. METHODS: The national coverage of DBIR was studied using data from the Dutch Health and Youth Care Inspectorate. The incidence rate of breast implants was calculated for 2016 and 2017, and patient, device, and surgery characteristics were compared between cosmetic breast augmentations or reconstructive indications. Four infection control, measures were selected to demonstrate the variation in the Dutch clinical practice. RESULTS: In 2016, 95% of the hospitals and 78% of the private clinics participated in DBIR. Between 2015 and 2017, a total of 15,049 patients and 30,541 breast implants were included. A minimum breast implant incidence rate of 1 per 1,691 women could be determined for 2017. The majority of devices were inserted for a cosmetic indication (85.2%). In general, patient, device, and surgery characteristics differed per indication group. Substantial variation was seen in the use of infection control measures (range 0-100%). CONCLUSION: Preliminary results obtained from DBIR show high national participation rates and support further developments toward the improvement of breast implant surgery and patient safety.
BACKGROUND: Although the use of breast implants is generally considered to be safe, breast implants are associated with short- and long-term complications. To evaluate and improve the quality of breast implant surgery, and increase our knowledge of implant performance, the national Dutch Breast Implant Registry (DBIR) was established in 2015. DBIR is one of the first up-and-running breast implant registries worldwide and follows an opt-out structure. OBJECTIVE: This article provides an overview of the first outcomes and experiences of the DBIR. METHODS: The national coverage of DBIR was studied using data from the Dutch Health and Youth Care Inspectorate. The incidence rate of breast implants was calculated for 2016 and 2017, and patient, device, and surgery characteristics were compared between cosmetic breast augmentations or reconstructive indications. Four infection control, measures were selected to demonstrate the variation in the Dutch clinical practice. RESULTS: In 2016, 95% of the hospitals and 78% of the private clinics participated in DBIR. Between 2015 and 2017, a total of 15,049 patients and 30,541 breast implants were included. A minimum breast implant incidence rate of 1 per 1,691 women could be determined for 2017. The majority of devices were inserted for a cosmetic indication (85.2%). In general, patient, device, and surgery characteristics differed per indication group. Substantial variation was seen in the use of infection control measures (range 0-100%). CONCLUSION: Preliminary results obtained from DBIR show high national participation rates and support further developments toward the improvement of breast implant surgery and patient safety.
Authors: Karlinde Amber Spit; Miranda Scharff; Christel Jm de Blok; Frank B Niessen; Yara Bachour; Prabath W Nanayakkara Journal: BMJ Open Date: 2022-06-09 Impact factor: 3.006