This feasibility study represents the first report of a new carbon dioxide-based tissue expander designed to allow gradual controlled expansion and to eliminate the need for percutaneous injections. Seven patients underwent implantation with a total of 10 (three bilateral) tissue expanders. After intraoperative filling by the surgeon and wound healing, small doses of carbon dioxide were administered on a daily basis by the patient by means of a hand-held dosage controller leading to gradual, incremental expansion. Rapid expansion during the active dosing phase and flexibility to meet individual patient needs during expansion were demonstrated with all subjects. These patients achieved full expansion in an average of 15 days. All seven patients were able to use the device safely and with ease at home, leading to successful tissue expansion and permanent breast reconstruction.
Clinical question/level of evidence: Therapeutic, IV.
Trial registration: ClinicalTrials.gov NCT01009008.