AeroForm Tissue Expanders for Breast Reconstructions
If you are about to have a mastectomy due to breast cancer, your doctor will talk to you about options to rebuild your breasts. Breast reconstruction may take place during, soon after, or much later after mastectomy or lumpectomy. During the reconstruction, your plastic surgeon will work to recreate a breast shape using an artificial implant, or tissue flap obtained from another area of your body. Specifically for patients needing to undergo radiation, a temporary expander will be inserted to hold the shape of the breast and stretch the skin and tissues to create room for a permanent implant or tissue flap later on. Because radiation would kill the tissue flaps, the expander will need to be placed until treatment is completed.
The purpose of tissue expanders in breast reconstruction
A tissue expander is an inflatable implant that’s designed to stretch your breast’s muscle and skin to create room or ‘hold room’ for a future, more permanent tissue flap or implant. Tissue expanders are indeed temporary devices that make way for the permanent changes in your breast reconstruction. Think of it like a balloon where increasing amounts of liquid are added over time till the skin is stretched enough to accommodate the implant.
Before the emergence of AeroForm Expanders, Dr. Theunissen would insert a traditional tissue expander beneath your breast skin and muscle during the initial mastectomy and reconstruction. About 3-4 weeks later, the patients would come into the office to have the expander filled with a saline solution. This is then done periodically through a tiny valve on the expander to help with the gradual expansion of the skin and tissue in the breast.
What is the new AeroForm tissue expander system?
AeroForm tissue expander technology is the newest (and most advanced) option for women undergoing implant breast reconstruction. Having been cleared by the FDA in December 2016, AeroForm Tissue Expander is the first-ever patient controlled expander available today. It has two main mechanisms: a hygienic implant made with a silicone shell and known as the expander, and a hand-held wireless device known as the controller that communicates with the expander.
The AeroForm expander is either implanted during the mastectomy, or at a later time. Unlike traditional expanders that use saline solutions, this new approach allows patients more control of their expansion process. Women can easily use a remote dose controller to blow up (fill up) their expander and thus avoid those regular trips to the office. The AeroForm technology is developed and mass-produced by AirXpanders, a company based in Palo Alto, California.
How it works
AeroForm tissue expansion is made up of two components – a gas-storage silicone tissue expander that is inserted in your breast, and a remote dosage controller to control the expansion process. With the press of a button, the dosage controller will sync with the tissue expander and fill it with a single dosage of 10 cc carbon dioxide. This allows the expander to expand gradually. This process should be repeated up to 3 times a day, allowing the patient to insert a total of 30cc of carbon dioxide gas into their expander. A major pro is that the patient can do this from home, and there’s no need to visit the doctor’s office. What’s more, a visual and audible signal on the remote (dosage controller) provides key information on current expander fill level.
Your doctor keeps the master key
Your doctor has a master key that will be used to control the expander during scheduled visits (which are less because most of the work is done by the patient at home). The master key will be inserted in your dosage controller allowing the doctor to activate your expander in flexible ways. It enables the doctor to inflate the expander up to a desired level, and adjust the gas (CO2) volume as needed during office visits. The AeroForm master key is only be used by the doctor, and never the patient.
Why the AeroForm tissue expander system
AeroForm is a revolutionary and much necessary innovation for breast reconstruction. Rather than using needles and salt-water to expand your breast tissue after a mastectomy, the surgeon will insert a carbon dioxide cartridge and a Bluetooth remote for remote/wireless inflation.
This technology has clear advantages over traditional expanders.
- Reduced visits to the office –by bringing wireless technology to traditional two-stage breast reconstruction, AeroForm makes it possible for breast reconstruction patients to minimize expansion office visits.
- More convenient since it be operated by the patient at home – the AeroForm technology is more patient friendly in that women can operate this device from home, on vacation, or wherever they are without feeling constrained to make regular visits to their plastic surgeon.
- Painless expander filling – with saline expanders, a nurse uses a needle to insert the saline solution into the expander. Since AeroForm expanders can be inflated wirelessly, there are no needle pricks involved, and this process more painless.
- Reduced expansion time – with AeroForm, the expansion time is significantly reduced as compared to traditional tissue expanders. AeroForm expanders are known to work within just weeks, whereas traditional expanders need months before permanent implants can be inserted.
- Less discomfort compared to traditional (saline) expanders – AeroForm expanders are generally more comfortable than saline expanders. This is not to say, however, that they are discomfort free. There might be a little pressure and mild discomfort involved due to the stretching of the chest muscle. Nonetheless, most women who have used this technology will not describe it as ‘too uncomfortable’.
AeroForm tissue expanders are truly a cutting edge technology, and a lot of plastic surgeons are recommending them as the best option for patients.
AeroForm Technology is FDA approved
The AeroForm tissue expander technology was approved by the U.S Food and Drug Administration (FDA) in December 2016. The FDA describes AeroForm as a tissue expander device that is based on carbon dioxide gas. It is used for tissue expansion in breast reconstruction after a mastectomy. It may also be used to treat underdeveloped breasts and soft tissue breast deformities. Keep in mind that the tissue expander technology is only intended for temporary use and should not stay under the skin for more than 6 months.
According to the FDA, the AeroForm may be used for women who are preparing for a breast reconstruction after a mastectomy – or patients who have underdeveloped breasts or soft tissue deformities. Surgeons must evaluate each patient’s circumstances and decide whether they are a good fit for the AeroForm tissue expander option.
Situations where AeroForm tissue expander systems must NOT be used
Since AeroForm tissue expanders are considered to be MR unsafe, Magnetic Resonance Imaging (MRI) tests cannot be done with the AeroForm tissue expander implanted. If this rule is not observed, Magnetic Resonance Imaging can trigger movement of the tissue expander leading to displacement or injury.
Tissue expanders should also not be used if the expansion site is deemed unsuitable by a surgeon. Infection, history of compromised wound healing, scar deformity, compromised vascularity, radiation damage and ulceration are some of the things that may make tissue unsuitable for this kind of reconstruction technology.
Expanders must not be used where the patient has any other electronic implantation (including neurostimulators and pacemakers), or when there’s residual gross tumor at the intended expansion site.
Are breast reconstruction expanders covered by insurance?
Under the U.S. Women’s Health and Cancer Act of 1998, insurance firms that already cover mastectomy must also cover breast reconstruction. This includes the cost of the AeroForm expander system, and other reconstruction costs. If you have any specific questions regarding your procedure being covered by insurance, it’s best to contact your insurer first.
Call our office to understand the best options for you
Breast reconstruction usually works fine when you spend enough time consulting and doing your research before the procedure. You’ll feel more comfortable and confident about the whole operation after you talk to your board certified plastic surgeon. The goal is to communicate any concerns you might have, and discuss options available to you. Every decision about the reconstruction should be made thoughtfully by both you and your surgeon, putting into consideration your needs, and whatever options are available out there. Contact our Baton Rouge office today to find out more on AeroForm Tissue Expanders or return to the Homepage