- The study addressed the lack of rigorous comparisons between synthetic and biologic products for prepectoral direct-to-implant breast reconstruction.
- Researchers conducted a retrospective cohort study comparing 170 breasts with ADM alone to 168 breasts with ADM plus GalaFLEX™.
- Patients receiving ADM plus GalaFLEX™ experienced significantly lower implant malposition rates (1.8% vs 7.1%, p=0.031).
- The authors concluded that ADM plus GalaFLEX™ for complete implant coverage reduced malposition and operating room costs.
- This suggests that ADM plus GalaFLEX™ may offer a more cost-effective approach with improved implant stability.
Optimizing Support in Prepectoral Breast Reconstruction
Implant-based breast reconstruction remains a cornerstone of post-mastectomy care, with prepectoral direct-to-implant (DTI) techniques gaining favor for their muscle-sparing advantages [1, 2]. However, achieving long-term implant stability and preventing complications like malposition, infection, and capsular contracture is a persistent clinical challenge [3, 4, 5]. To enhance soft-tissue support, surgeons frequently use adjuncts such as acellular dermal matrices (ADMs), which are scaffolds derived from processed biologic tissue, to reinforce the implant pocket and potentially mitigate adverse events [6, 5, 7]. More recently, fully resorbable synthetic meshes like poly-4-hydroxybutyrate (P4HB) scaffolds (GalaFLEX™) have been introduced, raising questions about the optimal combination of these support materials [8, 9, 10, 11]. A recent study provides a direct comparison of two such strategies, offering data to guide surgical decision-making in prepectoral DTI reconstruction.
Comparing Implant Support Strategies
To clarify the relative benefits of different support materials, investigators performed a retrospective cohort study comparing two common approaches in immediate prepectoral DTI breast reconstruction. The study aimed to evaluate both clinical outcomes and surgical costs. The first group involved using an acellular dermal matrix (ADM) alone to provide total anterior coverage of the implant. The second group utilized a combination strategy: an ADM paired with a resorbable synthetic mesh (GalaFLEX™) to achieve complete implant coverage. The analysis included patients who underwent reconstruction between 2019 and 2024, all of whom received smooth, round, silicone implants to maintain consistency. The primary clinical endpoint was implant malposition, with all outcomes assessed at 6 months postoperatively.
Reduced Malposition with Combined Support
The investigation revealed a significant advantage for the combined-support strategy in preventing implant displacement. The study included 170 breasts reconstructed with ADM alone and 168 breasts with the ADM plus GalaFLEX™ combination. At the 6-month follow-up, the rate of implant malposition was nearly four times lower in the combination group. Specifically, the malposition rate was 1.8% for ADM plus GalaFLEX™ versus 7.1% for ADM alone, a statistically significant difference (p=0.031). A survival analysis further quantified this risk, finding that the probability of implant malposition was 7.7 times higher in the cohort receiving only ADM. This finding suggests the dual-product approach provides a more robust scaffold for maintaining proper implant position. Interestingly, despite the clear difference in malposition rates, the study found that the frequency of revision surgery was not significantly different between the groups. This may indicate that not all instances of malposition were severe enough to warrant reoperation within the initial 6-month period, or that other factors besides malposition contributed to revision procedures.
Cost Implications of Support Strategies
In addition to clinical outcomes, the study evaluated the economic impact of each approach. The analysis showed that index operating room costs were significantly less in the ADM plus GalaFLEX™ cohort compared to the group receiving ADM alone. This finding is notable, as it suggests that the strategy associated with a better clinical outcome in terms of implant stability is also more cost-effective at the time of the initial surgery. For clinicians and healthcare systems, this dual benefit is highly relevant. The authors concluded that for immediate prepectoral DTI breast reconstruction, using a combination of ADM and GalaFLEX™ for complete implant coverage is associated with both a lower incidence of implant malposition and reduced initial surgical costs when compared to using ADM for only anterior coverage. These results provide compelling evidence to support consideration of a combined biologic and synthetic mesh strategy for optimizing both clinical and economic outcomes in this patient population.
References
1. Nolan IT, Farajzadeh M, Bekisz JM, Boyd CJ, Gibson EG, Salibian AA. Prepectoral versus Subpectoral Breast Reconstruction after Nipple-sparing Mastectomy: A Systematic Review and Meta-Analysis. Plastic & Reconstructive Surgery Global Open. 2024. doi:10.1097/gox.0000000000005808
2. Zhong T, Fletcher GG, Brackstone M, et al. Postmastectomy Breast Reconstruction in Patients with Non-Metastatic Breast Cancer: An Ontario Health (Cancer Care Ontario) Clinical Practice Guideline. Current Oncology. 2025. doi:10.3390/curroncol32060357
3. Ogita M, Sawayanagi S, Jinnouchi H, et al. Postmastectomy radiation therapy for implant-based breast reconstruction: a systematic review and meta-analysis for the 2022 Japanese Breast Cancer Society Clinical Practice Guideline. Breast Cancer. 2025. doi:10.1007/s12282-025-01788-2
4. Tanas Y, Gasper G, Tanas J, Swed S, Velasquez GDS. Comparative outcomes of human acellular dermal matrices in breast reconstruction: a systematic review and meta-analysis framework.. Systematic reviews. 2025. doi:10.1186/s13643-025-02915-y
5. Ellsworth WA, Hammer J, Luo L, Schumacher A. Acellular Dermal Matrices in Breast Reconstruction: CARE Trial 5-Year Outcomes Data for More Than 9500 Patients. Plastic & Reconstructive Surgery Global Open. 2022. doi:10.1097/gox.0000000000004258
6. Marra C, Cuomo R, Ceccaroni A, Pentangelo P, Alfano C. Acellular dermal matrix in breast augmentation surgery: A systematic review. JPRAS Open. 2024. doi:10.1016/j.jpra.2024.02.004
7. Ellsworth WA, Hammer J, Luo L, Schumacher A. Acellular Dermal Matrices in Breast Reconstruction: CARE Trial 5-Year Outcomes Data for More Than 9500 Patients.. Plastic and reconstructive surgery. Global open. 2022. doi:10.1097/GOX.0000000000004258
8. Vernice NA, Boyd C, Amro C, et al. Systematic Review of Poly-4-Hydroxybutyrate: A Swiss Army Knife in Modern Breast Surgery. Aesthetic Surgery Journal Open Forum. 2025. doi:10.1093/asjof/ojaf018.003
9. Milani-Reis A, Oliveira JA, Eskandar K, et al. The Use of Poly-4-Hydroxybutyrate (P4HB) Scaffold in Cosmetic Breast Surgery: A Systematic Review and Meta-Analysis.. Aesthetic plastic surgery. 2026. doi:10.1007/s00266-025-05306-9
10. Vernice NA, Boyd CJ, Hemal K, et al. Systematic Review of Poly-4-Hydroxybutyrate in Modern Breast Surgery.. Aesthetic surgery journal. 2025. doi:10.1093/asj/sjaf099
11. Palmesano M, Storti G, Lisa A, et al. Poly-4-hydroxybutyrate mesh (GalaFlex®) in aesthetic breast surgery: A comprehensive systematic review. JPRAS Open. 2025. doi:10.1016/j.jpra.2025.09.029