For the first time in 40 years, patients who are considering reconstructive surgery after a mastectomy because of breast cancer have a new option for tissue expansion—a process that is often necessary to create a “pocket” for the insertion of breast implants.
Tissue expanders work like balloons to expand breast tissue, muscle, and skin until reconstructive implants can be placed.
Traditionally, expanders are gradually filled through weekly injections of saline over the course of 6 to 8 weeks. Once the expander reaches a size agreed on between the patient and the surgeon, the expanders are removed and a permanent saline implant is inserted.
In December 2016, the FDA approved AeroForm Tissue Expander System (from AirXpanders), which relies on the same principle of tissue expansion as traditional saline expanders, but with a few important changes.
Instead of relying on saline or silicone injections, a canister of carbon dioxide that is inside the AeroForm expander is slowly released to expand the woman’s breast tissue. This is the fi rst tissue expander that is needle-free, and the process takes only about 21 days to reach full expansion. Most important, AeroForm allows patients to control their own tissue expansion using a wireless, handheld controller in the comfort of their home, and on their own time frame.
Potential Advantage of Aeroform
According to Mark Payne, Senior Director of Research and Development at AirXpanders, carbon dioxide is the perfect medium to replace saline in tissue expanders.
“Carbon dioxide has the virtue of being compressed and can therefore be placed in a very small space,” Mr Payne said. “In addition, it’s a natural product of respiration and your body knows how to handle it.” In the recent past, some women have complained of serious problems related to their silicone-based implants. The new needle-free and patient-guided device may offer women more control of the process in the comfort of their home.
The AeroForm Tissue Expander can be placed when the mastectomy is done, or later (for those opting to delay reconstruction). Using smart-wave technology that syncs with a wireless dose controller, carbon dioxide is gradually released into the inner liner of the tissue expander device. AeroForm limits how much, and how often, carbon dioxide can be released each day.
You Are In Control
Michael Denk, MD, a plastic surgeon in Virginia Beach, VA, has been guiding patients using AeroForm and believes that the emotional benefi ts for women may be even more important than the technical benefi ts of the new expander.
“The biggest advantage of the expander is that it catches women when they are in a situation when they are told that they have breast cancer and things are out of their control,” Dr. Denk said. “To have something put back in their control, it just gives them more security, more peace of mind, and ultimately more control over the process.” Dr. Denk explains that the tissue expansion process is still fully monitored by a physician, and that patients will be informed of the system’s safety issues. For example, although patients should avoid having an MRI while using expanders, radiation therapy has been shown to be safe with the AeroForm expander in place.1
“AeroForm requires that patients pass a patient training session with a nurse and a doctor. We also typically have them do the first expansion in front of us so that we can make sure they feel good about it,” Dr. Denk said. “We then saw our patient back every 2 weeks. We also want to make sure the tissue is still closed and doing well and that the skin that you are stressing still has good blood supply and is still healthy.”
Dr. Denk cautions that AeroForm is not for everyone, noting that patients need to consider whether they will be comfortable taking control of their own tissue expansion.
“With the treatment of breast cancer, there’s a lot of information for these women and their team to absorb. Trying to deal with the technology of this device can be daunting for some people,” Dr. Denk said. “But any plastic surgeon using this device will be there for the entire process to help the patient out. It’s defi nitely not for every patient, and it just depends on the patient’s comfort,” he emphasized.
There are currently 3.1 million breast cancer survivors in the United States, according to the American Society of Plastic Surgeons. Because fewer than 20% of the women elect to undergo immediate reconstruction after mastectomy, many survivors are candidates for delayed breast reconstruction.
Dr. Denk points out that, in general, any woman who is a candidate for tissue expander reconstruction, whether immediate or delayed, is a candidate for the AeroForm Tissue Expander. According to the maker of AeroForm, the new device became available in the United States this fall.
- Rembert JL, Heitz R, Hoffman A. Radiation testing of the AeroForm CO2- based breast tissue expander implant. Radiation Oncology. 2013;8:235.