Breast Reconstruction with Implants Following Mastectomy: An International Observational Study on Outcomes and Quality of Life (I-PREPARE)

Breast cancer is a disease in which cells in the mammary gland multiply uncontrollably; in some cases, removal of the breast (mastectomy) is medically advisable. In prepectoral reconstruction, the implant is placed above the pectoral muscle (musculus pectoralis, hence “prepectoral”). The goal is a natural appearance and a faster recovery, since the muscle does not need to be detached from the rib cage. Standard care following a mastectomy includes, depending on the situation, reconstruction using an implant or the patient’s own tissue. The appropriate option is determined on an individual basis in consultation with the treatment team.

The aim of this I-PREPARE observational study is to systematically assess the surgical, aesthetic, and oncological outcomes, as well as the patients’ quality of life following surgery (postoperatively). In this international, prospective observational study (no new form of therapy or medication is being investigated), a total of 1,236 women are expected to be followed “in real life.” The most important criterion is the frequency of implant loss (unplanned removal, e.g., due to infection) during the first three months. Additional objectives include infections (with or without hospitalization), readmissions or repeat surgeries, early complications such as seromas (accumulation of bodily fluid in the breast after surgery), hematomas (bruising), skin or nipple necrosis (tissue death), wound healing disorders, or implant malposition, as well as late complications such as capsular contracture, wrinkling, or visible implant contours at 6, 12, and 24 months. Quality of life and satisfaction will be assessed using the BREAST-Q questionnaire at several time points (before surgery and 6, 12, and 24 months afterward).

Women aged 18 and older who are scheduled to undergo unilateral or bilateral therapeutic mastectomy followed by prepectoral implant or expander reconstruction (with or without mesh) are eligible to participate in the study. Those who cannot participate include, among others, men, individuals who are not suitable for surgery, and women scheduled for subpectoral reconstruction or reconstruction using only autologous tissue.