How to improve patient safety and quality of care in breast implant surgery? First outcomes from the Dutch Breast Implant Registry (2015–2017)

Spronk, P.E.R.; Becherer, Babette E.; Hommes, Juliëtte; Keuter, Xavier H. A.; Young-Afat, DA; Hoornweg, Marije J.; Wouters, Michel W. J. M.; Mureau, Marc A.M.; Rakhorst, Hinne

doi:10.1016/j.bjps.2019.06.023

Cited by 16 publications

(14 citation statements)

References 22 publications

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“…For this reason, the Dutch Breast Implant Registry (DBIR) was founded in 2015 as an initiative of the Dutch Society of Plastic Surgery, which aims to register and monitor the quality of care and implants. 35 For now, we intentionally chose to include women with all brands and types of breast implants and all reported systemic symptoms for a broader overview. Hopefully, for future studies, the DBIR will be the foundation for more detailed registration and documentation.…”

Section: Discussionmentioning

confidence: 99%

Patient-reported systemic symptoms in women with silicone breast implants: a descriptive cohort study

et al. 2022

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ObjectiveAn unknown portion of women with silicone breast implants (SBI) report development of systemic symptoms, recently named as ‘breast implant illness (BII)’. We aim to describe the symptoms and characteristics of women with SBI reporting these systemic symptoms and compare the clinical course of women who chose to keep their implants, to women who had their implants removed.DesignObservational cohort study.SettingSpecialised BII out-patient clinic at Amsterdam UMC, the Netherlands, from 2011 to 2020.ParticipantsAll women presenting to the BII clinic with SBI and systemic symptoms.Results467 women were included for baseline analyses and 398 women for follow-up. Most frequently reported systemic symptoms at baseline included fatigue (88%), arthralgia (71%), morning stiffness (59%), myalgia (48%), cognitive impairment (33%), peripheral neurological symptoms (30%) and lymphadenopathy (22%). Furthermore, 56% reported pre-existing allergies at baseline and positive antinuclear antibodies were observed in 23%. At follow-up with a median of 3.3 years (IQR 2–4), 152 women had their implants removed on clinical grounds. Symptoms improved significantly in 65 women (43%), improved moderately in 37 women (24%), did not change in 37 women (24%) and deteriorated in 13 women (9%). Women who underwent explantation showed more improvement of their systemic symptoms compared with women who did not (OR 2.9, 95% CI 1.3 to 6.2). Additionally, women who underwent explantation within 10 years after implantation improved significantly better than women who got the implants removed after 10 years (p=0.007). Lastly, local symptoms decreased from 75% to 34% after implant removal (p<0.0001).ConclusionMost women with SBI who developed systemic symptoms experienced improvement after explantation, especially when removed within 10 years after implantation. Early recognition of the pattern of systemic symptoms in women with SBI is important and implant removal should be considered.

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Section: Discussionmentioning

confidence: 99%

Patient-reported systemic symptoms in women with silicone breast implants: a descriptive cohort study

et al. 2022

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“…Overall, in 2018, the data capture rate was >90%. Registry output included indications for breast implant surgery, laterality, age, smoking, body mass index (BMI), intraoperative techniques (timing of reconstruction, incision site, plane, mastopexy, capsulectomy, autologous flap cover, fat grafting, drains, mesh/acellular dermal matrix use), infection control measures, revision surgery, and device characteristics (shape, texture, coating, fill, volume) [ 13 , 20 ]. With 2 full registration years, the data completeness of DBIR still needs to improve [ 21 ].…”

Section: Resultsmentioning

confidence: 99%

A Systematic Review of the National Breast Implant Registry for Application in Korea: Can We Predict “Unpredictable” Complications?

et al. 2020

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Background and Objectives: Since silicone breast implants were introduced to the market several decades ago, the safety of breast implants has remained controversial. Recently, several studies have explored breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) and breast implant illness (BII). Several countries have developed national breast implant registries to improve the safety and quality of breast implant surgery. We performed a systematic review of the current status of national breast implant registries and propose a pilot form of an appropriate breast implant registry model for Korea. Materials and Methods: The systematic review was conducted in accordance with the “preferred reporting items for systematic reviews and meta-analyses (PRISMA) pro forma”. PubMed and Google Scholar databases were searched to identify all articles containing information on national breast implant registries. We limited the search to articles written in the English language from 2010 to 2020. Articles were reviewed by two independent authors. Results: A total of 63 articles related to national breast implant registries, registry principles and national breast implant registry annual reports were identified. After reviewing the literature, 25 national breast implant registry-related articles were included in the full-text synthesis. Currently, four countries, The Netherlands, Australia, Sweden, and the UK, have breast implant registries with well-formed sources for big data. Overall, similarities in data points were detected for three categories: implant-related complications, operation details, and device information. However, there were differences for each registry in terms of governance, funding, and capture rate. Conclusion: After reviewing other countries’ experiences, tentative datasets for the Korean Breast Implant Registry (K-BIR) were developed. The K-BIR can improve the quality of breast implant surgery in Korea by providing datasets on overall processes and outcome measures with quality indicators and risk adjustment factors. This approach will register characteristics of patients and monitor breast implants, complications, and surgical procedures to improve the outcomes of breast implant surgery in Korea. In addition, it can be used as a track-and-trace system with automated notifications to patients in the event of a product recall or other safety concerns related to a specific type of implant.

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“…Furthermore different infection control measures were analysed. The results emphazise the benefit of further developments regarding national data base and ultimately breast implant surgery (2).…”

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confidence: 87%

“…The introduction of different means of complication control, for example those evaluated by the Dutch Breast Implant Registry (DBIR) such as implant immersion in antiseptic solution or administration of intravenous antibiotic or the placement of drainages (2) have led to significant changes in surgical practices and thus furthered the evolution of breast implant surgery. Spronk et al (2) have analysed the DBIR, first established in 2015 and have found high participation rates for hospitals and private clinics. The DBIR enabled a minimum estimate of implant incidence rate for Dutch women, an understanding for indication, as well as for patient, device and surgery characteristics.…”

mentioning

confidence: 99%

“Without standards, there can be no improvement”—Taiichi Ohno

2019

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How to improve patient safety and quality of care in breast implant surgery? First outcomes from the Dutch Breast Implant Registry (2015–2017)

Cited by 16 publications

References 22 publications

Patient-reported systemic symptoms in women with silicone breast implants: a descriptive cohort study

Patient-reported systemic symptoms in women with silicone breast implants: a descriptive cohort study

A Systematic Review of the National Breast Implant Registry for Application in Korea: Can We Predict “Unpredictable” Complications?

“Without standards, there can be no improvement”—Taiichi Ohno

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