Researchers randomized 135 women who planned to undergo mastectomy followed by immediate implant-based breast reconstruction to have the procedure with the addition of acellular dermal matrix or to join a control group that didn't have acellular dermal matrix. The primary endpoint of the trial was reoperations at two years, and healthcare-related quality of life was a secondary endpoint.
Among the 129 patients with data at two years, 44 of 64 (69%) women who had acellular dermal matrix underwent at least one surgery related to their implants, compared with 43 of 65 (66%) in the group without acellular dermal matrix. This difference wasn't statistically significant.
"The disadvantage of a direct-to-implant procedure is that it does not entail an opportunity for secondary adjustments, while tissue expanders as two-stage surgeries permit alterations for symmetry during the second surgery," said lead study author Dr. Fredrik Lohmander of the Karolinska Institute in Stockholm, Sweden.
The majority of secondary procedures in this trial were done for the purpose of symmetry, commonly with a contralateral mammoplasty, as well as releasing a capsular contracture on the ipsilateral side in conjunction with an implant exchange, Dr. Lohmander said by email.
"In a setting of bilateral procedures, without a setting of breast cancer treatment, acellular dermal matrix might have had an effect on the overall number of procedures," Dr. Lohmander added.
Among women who did have acellular dermal matrix, 31 patients (48%) had at least one reoperation on the ipsilateral side, and there were a total of 42 reoperations during follow-up. In the control group, 35 patients (54%) had at least one reoperation on the ipsilateral side, with a total of 43 reoperations.
At two years, 9 patients (14%) in the acellular dermal matrix group and 7 patients (11%) in the control group had the implant removed, the study found.
There were no significant differences between the groups in postoperative health-related quality of life, perceptions of body image, or satisfaction with the cosmetic appearance of the breasts, according to the report in JAMA Network Open.
One limitation of the study is that it was completed before the subcutaneous implant position, known as a prepectoral method, became more widely adapted among breast reconstruction surgeons. As a result, results from the trial might not reflect current patient outcomes.
Even so, the results underscore the importance of informed consent and shared decision making, Dr. Lohmander said.
"Women with breast cancer considering immediate implant-based breast reconstruction should anticipate several reoperations," Dr. Lohmander said. "Clinics should also inform patients about the limited evidence of the benefit of acellular dermal matrix-assisted breast reconstruction."
SOURCE: https://bit.ly/3nRO8ks JAMA Network Open, online October 1, 2021.
By Lisa Rapaport
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