By Kamakshi R. Zeidler, MD
As it stands, the pre-breast-reconstruction tissue-expansion process is time-consuming and arduous. While effective, saline-based tissue expansion does prevent breast cancer survivors from moving past their diagnosis by delaying the time it takes to complete breast reconstruction.
Current techniques for tissue expansion involve a surgeon placing a temporary saline tissue expander under the skin and chest muscle. During weekly office visits, the surgeon inserts a needle through the breast skin into a valve on the tissue expander, and injects saline to fill the expander. As the device expands, the skin and tissue covering the expander stretches until there is enough room to accommodate a permanent implant.This can take several months. Most surgeons will then wait up to
2 months before performing the second operation to exchange the expander for a permanent implant.
There were not any other options until now.
Today, women are electing to enroll in a clinical trial of a new expansion option. The XPAND study will compare the AirXpanders (Palo Alto, Calif) investigational expander to standard saline tissue expanders to see if the process can be accomplished in a more comfortable and less time-consuming manner. The plan is to enroll 138 women. So far, there are 115 participants, and I have enrolled 30 of them. Results should be available by March 2014.
AirXpanders’ AeroForm™ tissue expander system eliminates the need for saline injections with needles by using compressed CO2 that is gradually released through a small internal valve into the expander. Following a standard implant procedure, the patient uses the handheld remote at home to fully complete the expansion process according to her surgeon’s instructions.
As the expander gradually fills with carbon dioxide, the skin and tissue covering the expander will stretch. Once the tissue is expanded, the patient will return to her surgeon to have the expander exchanged for a permanent implant.
NEW EXPANDER SHOWS PROMISE
Early results from clinical trials show that the process may be faster and less painful than traditional saline expansion. Specifically, data from the Australian PACE and US-based XPAND trials show that women expanded in 17 days with the AeroForm, on average, versus 52 days with the traditional saline expander.
Patient reaction has been positive thus far. “From beginning to end with the AeroForm, my experience has been nothing less than stellar,” says Joan Greffrath, 57, of Worcester, Massachusetts. “I had minimal pain and truly very little discomfort, and didn’t have to use excessive pain medication. One of the greatest aspects of the AeroForm is I have been in charge of my own expansion. When you become a cancer patient, a great deal of what you control is taken away. Therefore, it is refreshing to gain access to some control again.”
If the new expander gets federal Food and Drug Administration approval, it may make breast reconstruction a more palatable option for women with breast cancer.
Kamakshi R. Zeidler, MD, practices aesthetic and reconstructive plastic surgery in the Los Gatos, San Jose, and greater South Bay Area. She is an investigator on the EXPAND trial. Zeidler can be reached at [email protected]