Long-term implant integrity and complications after risk-reducing mastectomy with immediate implant reconstruction: a retrospective cohort study with prospective ultrasound follow-up at a Swedish university hospital

Abstract

Abstract Introduction Implant-based breast reconstruction is widely performed following bilateral risk-reducing mastectomy in women at increased genetic risk of breast cancer. Although breast implants are not considered lifetime devices, there is limited evidence regarding long-term implant integrity and implant-related complications beyond 10 years after reconstruction. Current recommendations regarding long-term surveillance vary internationally, and data describing asymptomatic implant rupture and other implant-related complications in this patient population remain scarce. The aim of this study is therefore to investigate the prevalence of long-term implant-related complications in women who underwent bilateral risk-reducing mastectomy with immediate implant-based breast reconstruction. Methods and analysis This is a retrospective cohort study with prospective clinical and ultrasound follow-up. Women who underwent bilateral risk-reducing mastectomy with immediate implant-based reconstruction at Karolinska University Hospital between 1995 and 2015 will be identified through medical records. Eligible participants are women with implants that have remained in situ for at least 10 consecutive years at the time of study inclusion. Participants will undergo a clinical examination and standardised ultrasound assessment of implant integrity and implant-related complications. Clinical, surgical and follow-up data will be extracted from medical records. The primary outcome is the prevalence of ultrasound-detected implant rupture among women with implants in situ for more than 10 years. Secondary outcomes include capsular contracture (Baker grade III–IV), implant rotation and seroma. Patient-reported outcomes will be assessed using the BREAST-Q questionnaire. Data will be analysed using descriptive statistics, comparative analyses and multivariable logistic regression where appropriate. Ethics and dissemination The study was approved by the Swedish Ethical Review Authority (Dnr 2026–02857-01). Participation is voluntary and requires written informed consent. Ultrasound examinations involve no ionising radiation and are associated with minimal risk. Clinically relevant findings will be managed through routine healthcare pathways. Results will be disseminated through peer-reviewed publications, conference presentations and summaries available to participants upon request.