Patient-Reported Outcomes 3 and 18 Months After Mastectomy and Immediate Prepectoral Implant-Based Breast Reconstruction in the UK PRE-BRA Prospective Multicentre Cohort Study

Obstetrics and Gynecology Medicine Oncology
breast reconstruction patient-reported outcomes prepectoral implant multicentre study mastectomy

Mastectomy is a common surgical procedure in the treatment of breast cancer, with approximately 55,000 women diagnosed with breast cancer each year in the UK, of whom up to 40% undergo mastectomy. Mastectomy has a profound impact on women’s physical and mental health, and the UK National Institute for Health and Care Excellence (NICE) recommends that breast reconstruction surgery should be routinely offered to improve quality of life. Implant-based breast reconstruction is the most commonly used reconstruction technique worldwide, but its technology has evolved rapidly over the past decade, with a lack of high-quality evidence to support best practices.

Traditional implant-based breast reconstruction typically involves two stages: first, a tissue expander is placed under the pectoralis muscle, followed by a second surgery to implant a fixed-volume prosthesis. In recent years, the use of biological and synthetic meshes has allowed for the creation of a larger subpectoral pocket during the initial surgery, enabling the implantation of a fixed-volume prosthesis in a single procedure. However, despite the rapid adoption of subpectoral mesh-assisted reconstruction as the standard of care, its benefits lack high-quality evidence.

The latest technological advancement involves placing the implant in the prepectoral position rather than under the pectoralis muscle. This technique avoids “implant animation,” the upward movement of the implant when the chest wall muscles contract. Theoretically, prepectoral implant reconstruction has less impact on chest wall function and may offer better cosmetic outcomes compared to subpectoral techniques. However, since subcutaneous implant reconstruction was abandoned in the past due to high complication rates, high-quality evidence is needed to demonstrate the safety of prepectoral implant reconstruction and its improvement in patient-reported outcomes (PROs).

Source of the Paper

This paper was authored by Kate L. Harvey, Leigh Johnson, Parisa Sinai, Nicola Mills, Paul White, Christopher Holcombe, and Shelley Potter, affiliated with the University Hospitals Bristol, Bristol Medical School, the Applied Statistics Group at the University of the West of England, the Royal Liverpool University Hospital, and the Bristol Breast Care Centre at North Bristol NHS Trust. The paper was published in 2025 in the British Journal of Surgery (BJS), with the DOI 10.1093/bjs/znaf032.

Research Process

Study Design and Participants

This study was a single-arm, multicenter, prospective observational cohort study aimed at evaluating the impact of prepectoral implant-based breast reconstruction (PPBR) on patient-reported outcomes. Ethical approval was obtained (NRES Oxford-B South Central Committee ref:19/SC/0129, IRAS ID: 255421), and the study was prospectively registered (ISRCTN11898000) before participant recruitment began.

The study recruited women who underwent mastectomy and chose immediate prepectoral implant reconstruction at 40 centers in the UK between July 2019 and December 2020. Participants were required to complete the Breast-Q questionnaire preoperatively, at 3 months, and at 18 months post-surgery, and to assess overall satisfaction with the reconstruction outcome at 18 months. A total of 338 women were included, with 343 planned for prepectoral reconstruction, and 4 converted to subpectoral reconstruction due to intraoperative skin flap viability issues.

Data Collection and Analysis

Participants completed the Breast-Q questionnaire electronically or on paper, which included four main domains: “Satisfaction with Breasts,” “Physical Well-being: Chest,” “Sexual Well-being,” and “Psychosocial Well-being.” Additionally, two domains particularly relevant to prepectoral reconstruction were evaluated: “Satisfaction with Implants” and “Animation Deformity.” Questionnaire scores were calculated according to the developers’ instructions, and unadjusted scores at 3 and 18 months were compared with baseline values. Linear regression analysis was used to explore factors affecting patient-reported outcomes.

Research Findings

  1. Changes in Patient-Reported Outcomes: Compared to baseline, women reported statistically significant and clinically meaningful decreases in “Physical Well-being: Chest” and “Sexual Well-being” scores at 3 and 18 months post-surgery. After adjusting for baseline, at 18 months, women who experienced implant loss or underwent surgery for malignancy reported lower scores across all Breast-Q domains.

  2. Implant Satisfaction: At 3 months post-surgery, approximately 34.8% of women expressed dissatisfaction with the wrinkles/ripples in their reconstructed breast, a proportion that significantly increased to 45.6% by 18 months.

  3. Overall Satisfaction: At 18 months, two-thirds of women (66.5%) rated their reconstruction outcome as “excellent” or “very good.” Women who experienced major complications, implant loss, or dissatisfaction with wrinkles/ripples in the reconstructed breast reported lower overall satisfaction.

Conclusions and Significance

This study shows that although prepectoral implant reconstruction avoids disturbance of the pectoralis muscle, women still report significant decreases in “Physical Well-being: Chest” scores at 3 and 18 months post-surgery. Women who experienced implant loss reported significantly lower scores across all Breast-Q domains, and the implant loss rate may be higher than previously reported. Additionally, women’s dissatisfaction with wrinkles/ripples in the reconstructed breast significantly increased by 18 months, affecting overall satisfaction.

Research Highlights

  1. First Multicenter Prospective Study: This study is the first multicenter prospective study to evaluate the longitudinal impact of prepectoral implant reconstruction on patient-reported outcomes using a validated questionnaire.

  2. Implant Loss Rate: The study suggests that the implant loss rate may be higher than previously reported, and women who experienced implant loss were less likely to complete follow-up questionnaires, raising further concerns about the safety of the technique.

  3. Changes in Patient-Reported Outcomes: The study found that prepectoral implant reconstruction did not significantly improve patient-reported outcomes, with outcomes similar to those of subpectoral reconstruction.

Application Value

This study provides important information for women considering breast reconstruction surgery, helping them make informed decisions based on realistic expectations of surgical outcomes. The findings underscore the need for further large-scale studies to explore the long-term clinical and patient-reported outcomes of prepectoral implant reconstruction, particularly regarding late (>3 months) implant loss and the impact of chest wall radiotherapy on these outcomes.

Additional Valuable Information

The study also found that although prepectoral implant reconstruction avoids disturbance of the pectoralis muscle, women may still experience tightness and discomfort from surgical scars, affecting their physical well-being scores. Additionally, the study recommends that future research should explore more factors influencing patient-reported outcomes and provide longer-term follow-up data to comprehensively evaluate the effectiveness of prepectoral implant reconstruction.

Through this study, the authors have provided valuable insights into the field of breast reconstruction, emphasizing the importance of high-quality evidence amid rapid technological advancements. The findings not only guide clinical practice but also offer direction for future research.