A newer, quicker method of breast reconstruction with implants moved one step closer to reality last week, as AirExpanders released its interim results of the XPAND trial using AeroForm patient-controlled tissue expanders at the 2015 American Society of Plastic Surgeons (ASPS) Meeting.
Traditional implant reconstruction uses temporary expanders to gradually form a pocket behind the pectoralis muscle to eventually hold the breast implant. The entire tissue expansion process typically takes several weeks, depending on how much and how often more saline is added to the tissue expander.
AeroForm devices appear to represent a greatly improved tissue expansion process, allowing patients to self-inflate the expander at home. Like traditional tissue expansion, using AeroForm still requires a tissue expander be placed behind the muscle, but offers three significant differences:
The XPAND trial showed that compared to traditional tissue expansion, this new do-it-yourself concept produces similar results in a shorter timeframe, with less discomfort, and allows the patient to control when, where and how much she is expanded, without injections or office visits. Patients use a wireless remote control to release up to 30 cc per day (three doses of 10 cc each) from a small reservoir within the expander, in their own home and at their own pace.
Both traditional saline expanders and AeroForm were found to be safe and effective during the trial, culminating in exchange surgery to remove the expander and position the breast implant in the behind-the-muscle pocket. The 138 women who used AeroForm, however, reached their targeted expander volume in an average of 18.2 days, compared to an average of 57.4 days for women who randomly received traditional saline expanders. Ninety-eight percent of the AeroForm patients said the device was convenient and easy to use.
AeroForm expanders are already available in Europe and Australia.
FDA approval for use in the U.S. is expected in 2015.
Read earlier blogs about the AeroForm trial (scroll down the page).