Summary
An estimated 1–3% of all women in the Netherlands carry breast implants. Since the
introduction five decades ago, problems with a variety of breast implants have emerged
with direct consequences for the patients' health. Plastic surgeons worldwide reacted
through campaigning for auditing on long-term implant quality, surgeon performance,
and institutional outcomes in implant registries. Especially, the PIP implant scandal
of 2010 demonstrated the paucity of epidemiological data and uncovered a weakness
in our ability to even ‘track and trace’ patients. In addition, a recent report of
the Dutch Institute of National Health showed a lack of compliance of 100% of breast
implant producers to CE requirements. These arguments stress the need for an independent
implant registry.
Insufficient capture rates or dependence from the implant producers made the variety
of national and international patient registries unreliable. The Dutch Breast Implant
Registry (DBIR) is unique because it is an opt-out registry without the need for informed
consent and thus a high capture rate. Furthermore, an estimated 95% of breast implants
are implanted by board-certified plastic surgeons. Funding was received from a non-governmental
organisation to increase the quality of health care in the Netherlands, and maintenance
is gathered by 25 euros per implant inserted.
This article describes the way the Dutch have set up their system, with special attention
to the well-known hurdles of starting a patient registry. Examples include: funding,
medical ethical issues, opt out system, benchmarking, quality assurance as well as
governance and collaboration. The Dutch consider their experience and data shareware
for others to be used globally to the benefit of patient safety and quality improvement.
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
- Evaluatie landelijk uniforme regeling siliconenprothese.LRCB; Dutch reference centre for screening, 2015
- Vision for quality & safety.Nederlande Orthopaedische Vereniging (NOV), 's Hertogenbosch2013
- A paradigm shift in U.S. breast reconstruction: increasing implant rates.Plast Reconstr Surg. 2013; 131: 15
- Long-term health outcomes in women with silicone gel breast implants: a systematic review.Ann Intern Med. 2016; 164: 164-175
- Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases.N Engl J Med. 2000; 342: 781-790
- MEDICAL DEVICES: guidance document, classification of medical devices.in: Consumer DHa 2010 (MEDDEV 2. 4/1 Rev.9 ed: European Commission, DG Health and Consumer, Directorate B, Unit B2 “Cosmetics and medical devices”)
- Conformity assessment of breast implants according to directive 93/42/EEC relating to medical devices. 1998
- Registries of implantable medical devices in Europe.Health Policy. 2013; 113: 20-37
- The safety of silicone gel-filled breast implants: a review of the epidemiologic evidence.Ann Plast Surg. 2007; 59: 569-580
- Situation update on checking procedures performed by the heatlh authorities on Poly Implant Prothèse Company.2011
- Silicone breast implants in the Netherlands: a market surveillance study.2016
- Anaplastic large-cell lymphoma in women with breast implants.J Am Med Assoc. 2008; 300: 2030-2035
- Opinion on the safety of Poly Implant Prothèse (PIP) silicone breast implants update of the opinion of February 2012.European Union, Luxembourg2014
- Poly Implant Prothèse (PIP) breast implants: final report of the Expert Group.Department of Health, NHS Medical Directorate, Leeds, the UK2012
- Registratie van implantaten in Nederland Inventarisatie en pilot.Rijksinstituut voor Volksgezondheid en Milieu, Bilthoven2014 (Contract No.: 2014-0089)
- Innovation and regulation in human implant technologies: developing comparative approaches.Soc Sci Med. 2001; 53: 895-913
- Medical specialty society–sponsored data registries: opportunities in plastic surgery.Plast Reconstr Surg. 2013; 132: 159e-167e
- International importance of robust breast device registries.Plast Reconstr Surg. 2015; 135: 330-336
TOPS registry (USA). http://www.plasticsurgery.org/for-medical-professionals/quality-and-health-policy/tops.html.
- The United Kingdom breast implant registry.Int J Risk Saf Med. 1996; 8: 79-83
- 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
- Breast implant registries: the problem with ambition.Aesthet Surg J. 2015; 36: 255-259
- Medical device registries for breast implants – where to?.Saf Health. 2015; 1: 1-4
- Breast implant registries: a confusion of identities.J Plast Reconstr Aesthet Surg. 2015; 68: 1772-1773
- Transforming Australia's breast implant registry.Med J Aust. 2012; 196: 232-234
ICOBRA. http://wwwplasticsurgeryorgau/protecting-patient-safety/icobra/.
- Registries for evaluating patient outcomes: a user's guide.2nd ed. Agency for Healthcare Research and Quality, Rockville, MD2010
- Together we make care count.2014 (Leiden)
- Progress toward value-based health care, lessons from 12 countries.2012
- Use of 13 disease registries in 5 cuntries demonstrates the potential to use outcome data to improve health care's value.Health Aff. 2012; 31: 220-227
- The role of consent and individual autonomy in the PIP breast implant scandal.Public Health Ethics. 2013; 6: 220-229
- Impracticability of informed consent in the registry of the Canadian Stroke Network.N Engl J Med. 2004; 350: 1412-1421
- More than 95% completeness of reported procedures in the population-based Dutch Arthroplasty Register.Acta Orthop. 2015; 86: 498-505
Article info
Publication history
Published online: May 12, 2017
Accepted:
April 14,
2017
Received:
March 26,
2016
Identification
Copyright
© 2017 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
ScienceDirect
Access this article on ScienceDirectLinked Article
- Commentary on “The New Opt-Out Dutch National Breast Implant Registry: Lessons learnt from the road to implementation”Journal of Plastic, Reconstructive & Aesthetic SurgeryVol. 70Issue 8
- PreviewAfter the PIP crisis in 2010, the Australian Breast Device Registry dataset was shared with countries including Austria, Australia, Canada, France, Germany, Ireland, Italy, Netherlands, New Zealand, South Africa, UK and USA via the newly formed ICOBRA (International Collaboration of Breast Registry Activities).1,2
- Full-Text
- Preview
- Commentary on “The new opt-out Dutch national breast implant registry – Lessons learnt from the road to implementation”Journal of Plastic, Reconstructive & Aesthetic SurgeryVol. 70Issue 10
- PreviewThe Dutch can be considered fortunate in, unlike many other countries, an estimated 95% of implants are used by a single craft group and funding for a breast implant registry is forthcoming.1 The authors point out that the variance between the quality and uptake around the world of different registry projects has detracted from the ability to extract useful information from these data bases in the past, and believe that an opt out system will improve the situation. ICOBRA was established to increase the homogeneity of the data set, but without universality of uptake as in the Dutch system, assemblage of these various sources is questionable.
- Full-Text
- Preview
