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:
Traditional breast expanders
-filled with saline
-requires period saline injections
by plastic surgeon
-filled with carbon dioxide
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).