The micropolyurethane foam-coated Diagon/Gel4Two implant in aesthetic and reconstructive breast surgery – 3-year results of an ongoing study

Background: Breast implants are worldwide in use since 1962. Initially there were some problems with capsular contracture and the palpability of the rim of the implant. In 1968 this led to the introduction of the micropolyurethane foam-coating and then in 1970 to the first micropolyurethane foam-coated implant by F.A. Ashley. As a result of additional technical refinements in manufacturing this new implant design significantly reduced complications i.e. capsular contracture and implant rotation. Methods: This study reports a single surgeon’s experience with aesthetic and reconstructive breast surgery, in primary and secondary cases with the sole use of micropolyurethane foam-coated Diagon/gel4Two implants, partly in combination with the additional use of synthetic meshes, acellular dermal matrices and lipofilling. The trial is a prospective, single center cohort study designed to demonstrate the safety and effectiveness of the new implant design in primary and secondary aesthetic and reconstructive breast surgery. The reported data provide an interim report of the implantations performed from November 2010 to December 2013.Results: 90 patients were admitted to the study with 152 implants. The majority of the implants (n=95, 62.5%) were used in reoperative cases for either oncological (n=52, 34.2%) or aesthetic reasons (n=43, 28.3%). The median age of the study cohort was 45 years; the median body mass index was 21; the median observation time is 41 months. There was a very low complication rate, both short term within 6 weeks after the implantation of the silicone gel implant and in the follow up in November 2015. There were no serious complications needing explantation, no capsular fibrosis or implant rotation or rupture so far. There were only 4 minor complications (1.97%). There was 1 local recurrence 4 years after skin and nipple sparing mastectomy.Conclusion: The micropolyurethane foam-coated Diagon/gel4Two implant is a very reliable silicone gel implant filled with two high cross-linked, cohesive and form stable gels. The study demonstrated a very high safety profile of the 4Two implant and its effectiveness in both primary and secondary reoperative aesthetic, oncological and reconstructive breast surgery. The study is ongoing, a longer follow-up will be needed to consolidate the data

A Retrospective Head-to-head Comparison Between TiLoop Bra/TiMesh (R) and Seragyn (R) in 320 Cases of Reconstructive Breast Surgery

Background/Aim: Clinical data concerning synthetic meshes in comparison to acellular dermal matrices (ADMs) in breast reconstruction are limited. Also, direct comparisons between titanium-coated polypropylene mesh and partially absorbable polypropylene mesh have not yet been reported. Materials and Methods: This analysis represents a retrospective, single-surgeon, multi-center study of 320 cases using either TiLoop Bra/TiMesh (R) (n=192) or Seragyn (R) (n=128) in breast reconstruction. Results were compared with ADM-based reconstructions (Epiflex (R) and SurgiMend (R)). Results: Major complication rates (i.e. revision surgery) occurred in 3.9% (Seragyn (R)) and 8.3% (TiLoop Bra/TiMesh (R)) of all cases. Minor complications occurred in 18% (Seragyn (R)) and 8.9% (TiLoop Bra/TiMesh (R)). Subgroup analysis showed red breast syndrome to occur more often in the Seragyn group (3.9% Seragyn (R) vs. 0.5% TiLoop Bra/TiMesh (R), p<0.05). Conclusion: TiLoop Bra/TiMesh (R) and Seragyn (R) do not differ significantly in complication rates. There was no difference in performance when compared to ADMs

A Head to Head Comparison Between SurgiMend((R)) - Fetal Bovine Acellular Dermal Matrix and Tutomesh((R)) - A Bovine Pericardium Collagen Membrane in Breast Reconstruction in 45 Cases

Background/Aim: The use of acellular dermal matrices (ADM) has become a widely used option in breast reconstruction. A great deal of literature is available, totaling over 3,200 ADM reconstructions. Head-to-head comparisons between SurgiMend (R) and Tutomesh (R) are not yet reported. These are the first comparative clinical data reported on the use of Tutomesh (R) in breast reconstruction. Postoperative complication rates and costs for these devices were evaluated. Patients and Methods: This is a retrospective analysis of a 2-year experience with both SurgiMend (R) - fetal bovine acellular dermal matrix and Tutomesh (R) - a bovine pericardium collagen membrane in breast reconstruction in 45 cases from 2014-2015. Results: Forty-five patients received a total of 45 implant-based reconstructions using SurgiMend (R) (18 cases; 40%) or Tutomesh (R) (27 cases; 60%). Gross complication rates were 27.8% for SurgiMend (R) and 37.0% for Tutomesh (R) including hematoma, postoperative skin irritation, infection, red breast syndrome and revision surgery. The most common complication was postoperative red breast syndrome. Severe complications requiring revision surgery did not differ significantly in patients treated with SurgiMend (R) (0 cases, 0%) compared to Tutomesh (R) (1 case, 3.7%). Conclusion: This retrospective analysis shows similar overall clinical complication rates for Tutomesh (R) and SurgiMend (R). Severe complication rates are comparable to those reported in literature for both products. Although the retrospective nature of this work limits its clinical impact, it is possible to opt for the cheaper alternative (Tutomesh (R))