The use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) after mastectomy was associated with an increased rate of adverse events compared with a two-stage procedure, according to the results of a multicenter study published in Lancet Oncology.
“Far more early postoperative complications occurred after one-stage IBBR with ADM than after two-stage IBBR,” wrote Rieky E. G. Dikmans, MD, of the department of plastic, reconstructive, and hand surgery at VU University Medical Centre, Amsterdam, Netherlands, and colleagues. “The one-stage technique was associated with a marked increase in wound healing problems, such as wound dehiscence, skin necrosis, and wound infection, necessitating reoperation and, frequently, removal of the implant.”
According to the study, most women undergoing reconstruction chose to undergo IBBR, which can be achieved using either a one-stage procedure (direct-to-implant), or a two-stage procedure which involved the temporary implantation of a tissue expander. Two-stage procedures require a second operation, more health care visits, and cost to the patient. Use of ADMs allows for immediate implantation of a larger-volume implant or tissue expander and is associated with a more natural looking breast; however, the pros and cons of using ADMs are scarce.
Dikmans and colleagues conducted an open-label study at eight hospitals in the Netherlands to compare the safety of IBBR with an ADM immediately after mastectomy with a two-stage procedure. The study included 142 women aged 18 or older; 59 underwent a one-stage procedure with ADM and 62 underwent a two-stage procedure.
Women who underwent one-stage IBBR with ADM had an almost four times higher risk for surgical complications (crude odds ratio [OR], 3.81; 95% CI, 2.67–5.43; P < .001). Nearly one-half of women (46%) in the one-stage group had surgical complications compared with 18% of women in the two-stage group (P = .008). In addition, they were at three times the risk for reoperation (OR, 3.38; 95% CI, 2.10–5.45; P < .001), and at significantly increased risk for removal of the implant, ADM, or both (OR, 8.8; 95% CI, 8.24–9.40; P < .001) compared with women who underwent a two-stage operation.
“Although one-stage IBBR with ADM led to significantly worse safety outcomes than two-stage IBBR, the incidences of surgical complication and implant removal with the one-stage procedure were very similar to those reported in a prospective study of one-stage IBBR without ADM,” the researchers noted. “We suggest that the increased risk associated with one-stage IBBR is due to the increased pressure on the skin flaps and the possibility of misjudging the appropriate implant size without the possibility of adjusting implant volume.”
Almost one in three women who underwent IBBR with ADM had grade 3 or worse adverse events compared with only 5% of women in the two-stage IBBR groups. Most adverse events were related to wound healing.
“Because we compared two different techniques, we were unable to assess the independent effect of the ADM,” the researchers wrote. “However, we noted no indications of adverse reactions to the ADM as a material, but we can neither confirm nor exclude that the added complexity of the ADM-assisted procedure had a causative role in the increased incidence of complications.”