Clinical outcome and patient satisfaction with the use of bovine-derived acellular dermal matrix (SurgiMend™) in implant based immediate reconstruction following skin sparing mastectomy: A prospective observational study in a single centre.
BACKGROUND
The advent of acellular dermal matrix devices (ADMs) has enhanced both the scope of implant-based immediate breast reconstruction (IBR) following skin sparing mastectomy (SSM) for the treatment or risk reduction of breast cancer. Currently, there are a wide range of options available for the use of ADMs.


METHODS
This is a prospective observational single institution study of 118 consecutive patients undergoing a total of 164 SSM and IBR procedures either for treatment for breast cancer or for risk reduction, between 2012 and 2014. IBR was performed using an implant and bovine-derived ADM (SurgiMend™). Nipple sparing mastectomy (NSM) accounted for 103 procedures. IBR was performed as a single stage procedure in 23% of patients. The primary endpoint of this prospective study was the explantation rate and secondary endpoints included quality of life, patient satisfaction, aesthetic outcome assessed objectively, surgical complications, overall and disease free survival.


RESULTS
Forty-six patients (39%) had a bilateral and 72 underwent a unilateral SSM. Of those who underwent a unilateral SSM, 25 had a contralateral adjustment procedure. Out of 164 procedures, 117 (71%) were for the treatment of breast cancer. Sixty-one patients received chemotherapy (52%) and 32 (27%) had radiotherapy. In this study 27 patients underwent post-mastectomy radiotherapy. At a mean follow of 21 months, the explantation rate was 1.2%, 4% (6 patients) developed wound complications. The patient satisfaction with the procedure was found to be very high. The mean Breast Q Score was 85 and the mean overall patient satisfaction rating 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. There were two 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.


CONCLUSIONS
SurgiMend™ is an effective adjunct to implant based IBR following SSM. It is associated with a very low rate of implant loss and a high level of patient satisfaction and is associated with a very low incidence of inflammatory reaction. Neither prior radiotherapy nor post-mastectomy radiotherapy (PMRT) represents a contraindication to its use.
The London Breast Institute, The Princess Grace Hospital, 42-52 Nottingham Place, London W1U 5NY, United Kingdom.
Hannah
H
Headon
The London Breast Institute, The Princess Grace Hospital, 42-52 Nottingham Place, London W1U 5NY, United Kingdom.
Abdul
A
Kasem
The London Breast Institute, The Princess Grace Hospital, 42-52 Nottingham Place, London W1U 5NY, United Kingdom.
Aisling
A
Manson
The London Breast Institute, The Princess Grace Hospital, 42-52 Nottingham Place, London W1U 5NY, United Kingdom.
Christina
C
Choy
The London Breast Institute, The Princess Grace Hospital, 42-52 Nottingham Place, London W1U 5NY, United Kingdom.
Amtul R
AR
Carmichael
The London Breast Institute, The Princess Grace Hospital, 42-52 Nottingham Place, London W1U 5NY, United Kingdom. Electronic address: kefahmokbel@hotmail.com.
Kefah
K
Mokbel
D000818:Animals; D002417:Cattle; D005260:Female; D006801:Humans; D008875:Middle Aged; D062088:Acellular Dermis; D001943:Breast Neoplasms / Q000473:pathology / Q000601:surgery; D018270:Carcinoma, Ductal, Breast / Q000473:pathology / Q000601:surgery; D002285:Carcinoma, Intraductal, Noninfiltrating / Q000473:pathology / Q000601:surgery; D005500:Follow-Up Studies; D016462:Mammaplasty; D008408:Mastectomy; D009364:Neoplasm Recurrence, Local / Q000473:pathology / Q000601:surgery; D009367:Neoplasm Staging; D059351:Organ Sparing Treatments; D017060:Patient Satisfaction; D011379:Prognosis; D011446:Prospective Studies; D011788:Quality of Life
Acellular dermal matrix; Breast cancer; Reconstructive surgery