Summary
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.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Journal of Plastic, Reconstructive & Aesthetic SurgeryAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Different types of implants for reconstructive breast surgery.Cochrane Database Syst Rev. 2016; CD010895
- US fda breast implant postapproval studies: long-term outcomes in 99,993 patients.Ann Surg. 2018; 14
- Late haematoma and seroma in patients with silicone mammary prosthesis: our reports and literature review.J Plast Reconstr Aesthetic Surg. 2011; 64: 185-186
- Is late seroma a phenomenon related to textured implants? A report of rare complications and a literature review.Aesthetic Plast Surg. 2014; 38: 139-145
- Breast implants and the risk of analplastic large-cell lymphoma in the breast.JAMA Oncol. 2018; 4: 335-341
- Breast implant-associated anaplastic large cell lymphoma: a systematic review of the literature and mini-meta analysis.Curr Hematol Malig Rep. 2013; 8: 196-210
- Anaplastic large-cell lymphoma in women with breast implants.JAMA. 2008; 300: 2030-2035
- Self-reported breast implants and connective-tissue diseases in female health professionals. A retrospective cohort study.JAMA. 1996; 275: 616-621
- Silicone breast implants and the risk of connective-tissue diseases and symptoms.N Engl J Med. 1995; 332: 1666-1670
- Silicone breast implants and the risk of autoimmune / rheumatic disorders: a real-world analysis.Int J Epidermiol. 2018; : 1-9
- Long-Term health outcomes in women with silicone gel breast implants: a systematic review.Anne Intern Med. 2016; 164: 164-175
- US fda breast implant postapproval studies: long-term outcomes in 99,993 patients.Ann Surg. 2018; : 1-7
- Observational research, randomised trials, and two views of medical science.PLoSMed. 2008; 5: e67
- Editorial: us fda breast implant postapproval studies – long-term outcomes in 99,993 patients.Ann Surg. 2018; 6: 11-12
- International breast implant registry: a user report.Aesthetic Plast Surg. 2006; 30: 616-621
- The danish registry for plastic surgery of the breast: establishment of a nationwide registry for prospective follow-up, quality assessment, and investigation of breast surgery.Plast Reconstr Surg. 2003; 111: 2182-2189
- The uk breast implant registry-ten years on.Br J Plast Surg. 2005; 58: 283-285
- The austrian breast implant register: recent trends in implant-based breast surgery.Aesthetic Plast Surg. 2014; 38: 1109-1115
- Use of national surgical quality improvement program data as a catalyst for quality improvement.J Am Coll Surg. 2007; 204: 1293-1300
- Plastic surgery statistics in the US: evidence and implications.Aesthetic Plast Surg. 2016; 40: 293-300
- The new opt-out dutch national breast implant registry – lessons learnt from the road to implementation.J Plast Reconstr Aesthet Surg. 2017; 70: 1354-1360
https://nvpc.nl. Accessed September, 4th, 2018.
https://dica.nl/dbir/homeAccessed September, 4th, 2018. [annual rapport 2017 online soon]
https://mrdm.nl. Accessed September, 4th, 2018.
https://opendata.cbs.nl/statlineAccessed September, 4th, 2018.
- Evolving trends in textured implants use for cosmetic augmentation in the United States.Plast Reconstr Surg. 2018; 142: 1456-1461
- Discussion: evolving trends in textured implants use for cosmetic augmentation in the United States.Plast Reconstr Surg. 2018; 142: 1464-1466
- U.S. epidemiology of breast implant-associated anaplastic large cell lymphoma.Plast Reconstr Surg. 2017; 139: 1042-1050
- Breast implant associated anaplastic large cell lymphoma in Australia and New Zealand—high surface area textured implants are associated with increased risk.Plast Reconstr Surg. 2017; 140: 645-654
- The dutch breast implant registry (DBIR): registration of breast implant – associated anaplastic large cell lymphoma (BIA-ALCL), a proof of concept.Plast Reconstr Surg. 2019; 143: 1298-1306
- Evaluating national practice of preoperative Leersum Nj Van, Kolfschoten NE, klinkenbijl JH, et al. 'Clinical auditing', a novel tool for quality assesment in surgical oncology.Ned Tijdschr Geneesk. 2011; 155: A4136
- Auditing surgical outcome: ten years with the Swedish Vascular Registry – Swedvasc. the steering committee of Swedvasc.Eur J Surg Suppl. 1998; : 3-8
- Clinical auditing as an instrument for quality improvement in breast cancer care in the netherlands: The National Nabon Breast Cancer audit.J Surg Oncol. 2017; 115: 243-249
- Patient-Reported outcome measures for breast implant surgery: a pilot study.Aesthet Surg J. 2019; 39 ([Epub ahead of print]): NP314-NP321
Spronk P.E.R., Husna B., Vishwanath S., et al. From the icobra initiative: a globally agreed core set of minimum data for breast implant surgery. [minor revisions PRS].
Article info
Publication history
Published online: July 09, 2019
Accepted:
June 12,
2019
Received:
January 31,
2019
Identification
Copyright
© 2019 Published by Elsevier Ltd on behalf of British Association of Plastic, Reconstructive and Aesthetic Surgeons.
