Innovations in breast reconstruction are always welcome, but they tend to be few and far between. That’s why hopes are riding high that clinical trials of a promising next-generation tissue expander will show that the device is safe and effective.
Direct-to-implant is a faster method of reconstruction because it doesn't require expansion. But not all surgeons offer this procedure, and not all women are candidates (it requires nipple-sparing mastectomy and undamaged, healthy breast skin). Most implant reconstruction involves the use of temporary tissue expanders that gradually stretch the pectoralis muscle and breast skin to make enough room for an implant. The process typically takes several weeks (2 - 3 months), although some plastic surgeons proceed more conservatively (administering smaller and/or less frequent fills) or more aggressively (administering larger and/or more frequent fills).
AeroForm expanders introduce a kind of do-it-yourself expansion. They appear to produce similar results in a shorter timeframe, with less discomfort, and offer one big difference: the patient controls when, where and how much she is expanded, without needles or office visits.
Image: AirXpanders Inc.
When the anatomically-shaped AeroForm expander is in place under the muscle, patients use a wireless remote control to activate release of carbon dioxide from a small reservoir within the expander: up to three doses per day—each dose is 10cc--in their own home and at their own pace.
Women who used AeroForm expanders in clinical trials in the U.S. (The EXPAND trial) and Australia (The PACE trial) completed their expansion in an average of just 17 days, compared to control participants with traditional saline fills who completed expansion in an average of 51 days. All AeroForm participants said they were highly satisfied with the experience and convenience; 94% said they would recommend the new expanders to other women for breast reconstruction.
Trial locations include select hospitals in California, Florida, Kentucky, Massachussetts, North Carolina, New York and Texas. For more information or to participate in the clinical trial, visit www.clinicaltrials.gov and search "XPAND."