Pilot Data on Biosynthetic Mesh Breast Reconstruction
PILOT data suggest biosynthetic mesh breast reconstruction may offer acceptable outcomes for high-risk implant candidates. Immediate implant-based breast reconstruction supported by a biosynthetic mesh (GORE BIO-A) was evaluated in a retrospective pilot study of 13 high-risk patients undergoing surgery across 23 breasts. The investigators focused on complication rates, capsular contracture, aesthetic appearance, and patient reported quality of life in this selected group.
Patients had a mean age of 41.8 years, with ages ranging from 31 to 56 years. The mean follow up period was 15.6 months, from 3 to 44 months, and the mean implant volume was 383 mL, ranging from 330 to 490 mL. Early complications occurred in 6 reconstructed breasts and were managed conservatively without the need for more invasive intervention. Overall, the authors report an acceptable early complication profile in this high-risk cohort.
Complication Profile and Capsular Contracture Outcomes
The study also examined capsular contracture using the Baker classification. Eighteen breasts were graded as Baker I, indicating minimal or no capsular contracture around the implant. Radiotherapy emerged as an important factor for adverse capsular outcomes, with a statistically significant association between radiotherapy exposure and more severe capsular contracture, with a reported P value of 0.03. Among the 10 breasts that received radiotherapy, 4 developed Baker grade III capsular contracture, highlighting the need for careful counseling and follow up when radiotherapy is planned alongside implant-based reconstruction supported by biosynthetic mesh.
Patient Satisfaction, Quality of Life, And Next Steps
Cosmetic results were assessed using both the Harvard scale and BCCT.core tools. Aesthetic outcomes were rated good or excellent in 11 of 13 cases on the Harvard scale and in 12 of 13 cases according to BCCT.core. Patient reported outcomes, captured with the EORTC QLQ BREC23 questionnaire, showed high levels of satisfaction with the surgery, with reported satisfaction rates of 100.0% for the procedure itself, 77.8% for the breast, and 100.0% for nipple preservation. Few side effects were reported overall, suggesting that biosynthetic mesh assisted reconstruction can be well tolerated in appropriately selected high risk patients. The authors emphasize that these are early retrospective data from a small pilot series and that larger controlled studies with longer follow up are needed to clarify the role of biosynthetic mesh breast reconstruction in routine practice.
Reference: Cavalcante FP et al. Assisted Breast Reconstruction With Biosynthetic Mesh and Implants: A Pilot Study. Plastic & Reconstructive Surgery Global Open. 2025;13(12):e7328.
