The advent of acellular dermal matrix devices (ADMs) has facilitated immediate breast reconstruction (IBR) with mammary implants following skin sparing mastectomy (SSM) for breast cancer treatment or risk reduction.

This is a prospective observational single institution study of 118 consecutive patients undergoing a total of 164 SSM and IBR procedures using an implant and bovine-derived ADM (SurgiMend) for breast cancer or risk reduction purposes during 2012-2014. The primary endpoint was the explantation rate and secondary endpoints included patient quality of life, patient satisfaction, objective assessment of aesthetic outcome, surgical complications, recurrence and mortality.

The mean age of the patients was 50.1 years (median age of 48, range of 27-78). Median follow up time was 21 months (mean of 21.4 months, range of 2-40 months). 46 patients had a bilateral SSM and IBR, 5 of whom had bilateral breast cancer and 3 for risk reduction due to a significant genetic mutation. The remaining 37 patients had unilateral breast cancer and a contralateral risk reducing mastectomy. 27 (37.5%) of the 72 patients who had unilateral SSM underwent contralateral adjustment procedures to optimise symmetry, including 9 augmentation mammoplasty, 12 mastopexy and 4 reduction mammaplasty procedures and 2 combined augmentation-mastopexies. 61 patients (51.7%) received chemotherapy, 5 of whom had primary systemic therapy prior to surgery. 32 (27.1%) patients received radiotherapy (10 patients had prior radiotherapy and 22 patients had post mastectomy radiation: PMR). Those with ER positive disease received hormonal therapy. Those with Her2 positivity received Herceptin +/- Pertuzumab.

Over the study period, 2 implants had to be removed resulting in an explantation rate of 1.2%. Overall, wound complications were observed in 6 (3.7%) cases. There were 2 cases of local recurrence (1.7%), one distant recurrence (0.8%) and one patient died of metastatic breast cancer (0.8%). Overall survival was 99.2% and locoregional disease free survival (LRFS) was 98.3%. One patient (0.8%) developed a mild inflammatory reaction secondary to the underlying mesh. Wound complications were observed in 3 other patients (2 haematomas and wound dehiscence/persistent seroma requiring implant replacement).

Patient satisfaction with the procedure was very high. The mean Breast Q Score was 85 and mean overall patient satisfaction was 9 out of a possible 10. The mean objective assessment score was 8.9 out of a possible 10 and the mean subjective capsular contracture severity score was 2.9 out of 10.

In patients undergoing reoperations, the incorporation rate of the mesh was found to be very high almost approaching 95%.

SurgiMendTM is an effective adjunct to IBR using implants following SSM for breast cancer or risk reduction, with a very low rate of implant loss and a high level of patient satisfaction. Furthermore, this ADM seems to incorporate readily and is associated with a very low incidence of inflammatory reactions. Neither prior radiotherapy nor PMR radiation represents a contraindication to its use.

Citation Format: Wazir U, Kasem A, Headon H, Choy C, Manson A, Heeney J, Mead O, Mokbel K. Clinical outcome and patient satisfaction with the use of bovine-derived acellular dermal matrix (SurgiMendTM) in implant-based immediate reconstruction following skin sparing mastectomy: A prospective observational study. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P2-13-04.