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.
Subject(s)
Breast Implantation/standards , Breast Implants , Patient Safety/statistics & numerical data , Quality of Health Care , Registries , Adult , Breast Implantation/trends , Esthetics , Female , Humans , Male , Mammaplasty/standards , Mammaplasty/trends , Middle Aged , Netherlands , Prosthesis Design , Prosthesis Failure , Retrospective Studies , Risk Assessment , Silicone Gels/therapeutic useABSTRACT
BACKGROUND: Initiation of adjuvant chemotherapy within 6-12 weeks after mastectomy is recommended by guidelines. The aim of this population-based study was to investigate whether immediate breast reconstruction (IBR) after mastectomy reduces the likelihood of timely initiation of adjuvant chemotherapy. METHODS: All patients with breast cancer who had undergone mastectomy and adjuvant chemotherapy between 2012 and 2016 in the Netherlands were identified. Time from surgery to adjuvant chemotherapy was categorized as within 6 weeks or after more than 6 weeks, within 9 weeks or after more than 9 weeks, and within 12 weeks or after more than 12 weeks. The impact of IBR on the initiation of adjuvant chemotherapy for these three scenarios was estimated using propensity score matching to adjust for treatment by indication bias. RESULTS: A total of 6300 patients had undergone primary mastectomy and adjuvant chemotherapy, of whom 1700 (27·0 per cent) had received IBR. Multivariable analysis revealed that IBR reduced the likelihood of receiving adjuvant chemotherapy within 6 weeks (odds ratio (OR) 0·76, 95 per cent c.i. 0·66 to 0·87) and 9 weeks (0·69, 0·54 to 0·87), but not within 12 weeks (OR 0·75, 0·48 to 1·17). Following propensity score matching, IBR only reduced the likelihood of receiving adjuvant chemotherapy within 6 weeks (OR 0·95, 0·90 to 0·99), but not within 9 weeks (OR 0·97, 0·95 to 1·00) or 12 weeks (OR 1·00, 0·99 to 1·01). CONCLUSION: Postmastectomy IBR marginally reduced the likelihood of receiving adjuvant chemotherapy within 6 weeks, but not within 9 or 12 weeks. Thus, IBR is not contraindicated in patients who need adjuvant chemotherapy after mastectomy.
ANTECEDENTES: Las guías clínicas recomiendan iniciar la quimioterapia adyuvante entre las 6 y las 12 semanas después de la mastectomía. El objetivo de este estudio de base poblacional fue investigar si la reconstrucción inmediata de la mama (immediate breast reconstruction, IBR) tras mastectomía reduce la posibilidad de iniciar la quimioterapia adyuvante en el momento adecuado. MÉTODOS: Se identificaron todas las pacientes con cáncer de mama a las que se había realizado mastectomía y quimioterapia adyuvante entre el 2012 y el 2016 en los Países Bajos. El tiempo transcurrido entre la cirugía y la quimioterapia adyuvante se clasificó en tres grupos: ≤ 6 versus > 6 semanas, ≤ 9 versus > 9 semanas y ≤ 12 versus > 12 semanas. El impacto de la IBR en el inicio de la quimioterapia adyuvante en estos tres escenarios se estimó mediante un análisis de emparejamiento por puntaje de propensión para ajustar el tratamiento por sesgo de indicación. RESULTADOS: Se realizó una mastectomía primaria y quimioterapia adyuvante en 6.300 pacientes, de las que a 1.700 (27%) se hizo una IBR. El análisis multivariable demostró que la IBR redujo la probabilidad de recibir quimioterapia adyuvante dentro de las 6 y 9 semanas (razón de oportunidades, odds ratio, OR 0,76; i.c. del 95% 0,66-0,87 y OR 0,69; i.c. del 95% 0,54-0,87, respectivamente), pero no dentro de las 12 semanas (OR 0,75, i.c. del 95% 0,48-1,17). Al emparejar mediante el análisis de puntaje de propensión, la IBR solo redujo la probabilidad de recibir quimioterapia adyuvante dentro de las 6 semanas (OR 0,95; i.c. del 95%: 0,90 a 0,99), pero no dentro de las 9 ó 12 semanas (OR 0,97; i.c. del 95%: 0,95 a 1,00 y OR 1,00, i.c. del 95% 0,99-1,01). CONCLUSIÓN: La IBR postmastectomía disminuyó marginalmente la probabilidad de recibir quimioterapia adyuvante dentro de las 6 semanas, pero no más allá de las 9 ó 12 semanas. Por lo tanto, la IBR postmastectomía no está contraindicada en pacientes que necesitan tratamiento con quimioterapia adyuvante.
