Are patients most satisfied with a synthetic or a biological mesh in dual-plane immediate breast reconstruction after 5 years? A randomized controlled trial comparing the two meshes in the same patient.

Biological or synthetic meshes are commonly used in implant-based immediate breast reconstruction (IBR). The aim of this study was to compare patient-reported outcome measurements (PROMs) after IBR with a synthetic mesh and a biological mesh, in a single-blinded randomized controlled trial, using the compared materials in the same patient, thereby eliminating patient-related confounders. Twenty-four patients were recruited, and all patients had a prophylactic bilateral mastectomy and a dual-plane reconstruction using anatomical breast implants. The patients' two breasts were randomized preoperatively to a biological or a synthetic mesh, using a simple approach with a parallel design. PROMs were measured with BREAST-Q. Twenty-one patients answered (88%). Most participants were equally satisfied/dissatisfied with the synthetic and the biological mesh sides regarding size of bra, softness, feel to touch, natural part of body, appearance compared with preoperatively, and palpable wrinkles, and about half of the patients regarding shape of bra, natural appearance, and visible wrinkles. The frequency of capsular contracture rate was zero in both groups at 5 years. One mesh type was not clearly superior to the other regarding PROMs, but biological and synthetic meshes seem to give rise to different types of reconstructed breasts, and more studies are needed regarding whether knowledge about the effects of different meshes can be used to tailor breast reconstructions to individual patients' wishes. The rate of complications and corrections in the biological mesh breasts was higher, and this must be considered when the type of mesh is chosen. Trial registration number: ClinicalTrials.Gov identifier NCT02985073.