The U.S. Food and Drug Administration’s (FDA) December approval of AeroForm® tissue expanders clears the way for long overdue innovation, providing mastectomy patients with a new reconsructive alternative.
Although a small percentage of women who have breast reconstruction are able to have breast implants placed immediately after mastectomy, most such reconstruction involves the use of tissue expanders—temporary implants that are placed in the chest during the initial surgery. In a few weeks, when the patient’s incision has healed sufficiently, she then visits her plastic surgeon’s office every week to 10 days, where saline is injected into the expanders. The expanders gradually “grow” and stretch the muscle as more saline is added, until enough "pocket" space is created under the muscle to accomodate the full-sized breast implant. The process typically takes at least 6 to 8 weeks—some plastic surgeons poceed more conservatively (administering smaller and/or less frequent fills) or more aggressively (administering larger and/or more frequent fills).
The new AeroForm expanders introduce a kind of do-it-yourself expansion. When the 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 of 10cc each per day in their own home (or office) and at their own pace. Because no saline injections are needed, patients can forego the frequent office visits and the injections during the expansion process.
AeroForm expanders produce similar results in a shorter timeframe with less discomfort, and offer three big differences over traditional saline expanders:
- They are anatomically-shaped (traditional expanders are round).
- The patient controls when, where and how much she is expanded, without needles or office visits.
- They significantly shorten the overall expansion timeframe. During the clinical trial, women who used AeroForm expanders completed expansion in an average of 18.2 days, compared to 57.4 days on average among women who used traditional saline expanders.
According to the FDA, no serious adverse events occurred in the 99 patients who used the AeroForm device during the trial. (Fifty-two women used traditional saline expanders.) Among the entire group, 96% of the AeroForm users achieved successful expansion and were exchanged to a breast implant, compared to almost 99% of those who used saline expanders. The most common adverse events were necrosis, seroma, postoperative wound infection, and procedural pain.
Plastic surgeons can now choose whether they will offer tissue expansion with traditional saline expanders or the new AeroForm devices. Some surgeons may offer one or the other, while many will likely offer both, depending on which best fits individual patients. Women who have residual tumors at the expansion site, require magnetic resonance imaging (MRI) during expansion, or have other electronic implants (e.g. defibrillator, pacemaker or neurostimulator device) are not eligible for treatment with the AeroForm tissue expander.