Patient-activated controlled expansion for breast reconstruction using controlled carbon dioxide inflation:...

Women with breast cancer or those at high risk of developing breast cancer because of familial history of the disease or genetic mutations are frequently indicated for therapeutic or prophylactic mastectomy. Prosthetic reconstruction of the breast with placement of tissue expanders followed by implants offers favorable aesthetic and psychological results while adding only minimal additional surgical intervention. This study describes the confirmatory phase of an earlier feasibility trial that involved seven women who successfully underwent patient-activated controlled expansion for breast reconstruction with 10 AeroForm patient-controlled tissue expanders.

A prospective, open-label, single-arm, single-surgeon confirmatory study in Perth, Australia, evaluated outcomes of two-stage breast reconstruction using the investigational device. Each subject administered a preset 10-cc dose of carbon dioxide gas using a remote dosage controller, three times each day, with a 3-hour lockout between doses until full expansion was achieved.

Thirty-three women with breast cancer, family history, or predisposition because of the BRCA1 or BRCA2 gene mutation underwent pedicled latissimus dorsi flap procedures with placement of 61 carbon dioxide-based tissue expanders. The mean number of days for subjects to achieve desired expansion was 17 ± 5. Operating the dosage controller was described by the surgeon as very easy in 94 percent of the cases and by 97 percent of the subjects. No serious adverse events were reported.

This study confirms that the AeroForm breast tissue expander has demonstrated the ability to provide, relative to saline expanders, a needle-free, patient-controlled, convenient, and time-saving method of tissue expansion.

Therapeutic, IV.