Breast reconstruction is a frequent consequence resulting from a fight with breast cancer. Women trying to become whole again have to undergo an implantation of a saline bag followed by regular, sometimes painful injections that gradually expand the size of the bag. There is another option, cleared by the FDA last year and in Europe back in 2012, that avoids injections altogether and allows women to choose when, where, and how much to expand the implant.
We spoke with Scott Dodson, President & CEO of AirXpanders, the makers of the innovative AeroForm system, to learn more about the technology from patients’ and physicians’ perspectives.
Medgadget: AeroForm devices have been designed to overcome the downsides of saline injections. What are these downsides and how does AeroForm solve them?
Scott Dodson: For over 40 years, patients have had to undergo saline-based tissue expansion in preparation for breast reconstruction following mastectomy. This procedure involves the insertion of a temporary balloon that is gradually enlarged with injections of saline to stretch the skin and muscle in and around the chest wall. This traditional method can be very time consuming, requiring regular visits to the doctor and also placing patients under the unnecessary stress of receiving needle injections in a doctor’s office each week following an already difficult and traumatic treatment process. Furthermore, saline injections can cause significant pain to the patient due to the injections, filling sensation, and also the heavy weight of the device once it is filled. This process can take months to achieve a formed pocket that a permanent implant can then reside.
The AeroForm System represents the first major change in the breast tissue expansion space offering a needle-free alternative for women. AeroForm is inserted underneath or in front of the chest muscle and the patient uses a wireless controller to release small amounts of carbon dioxide into the expander, gradually stretching the tissue of the chest wall to make room for a permanent implant. With the simple push of a button on a palm-sized remote control, the programmed amount of carbon dioxide is delivered in seconds, allowing the patient to utilize the device from the comfort and convenience of home. The device itself is lightweight and minimizes discomfort for the patient. There is less need for weekly visits to their surgeon’s office and they can administer when they choose, how they choose and from wherever they choose to do so. This also provides great convenience for the physician and removes the possibility of infection that can result from needle injections.
Medgadget: Who will most benefit from AeroForm?
Dodson: Each year, more than 100,000 women in the United States have surgery to remove a cancerous breast, with 40 percent opting for reconstructive surgery with an implant. As part of this process, women must undergo tissue expansion to prepare a space for breast implants. The AeroForm System is the first and only FDA-cleared, needle-free, patient-controlled, wireless, tissue expander for women who choose to have reconstructive surgery following a mastectomy. AeroForm offers an alternative to these women, allowing them to forgo the traditional, time-consuming method of saline injections, which must be administered by their physician.
Medgadget: Does implantation differ from traditional saline bag implantations?
Dodson: While the process of the implantation remains unchanged, the experience and outcome for patients differs vastly. AeroForm gives women a sense of security by allowing them to control the rate of the expansion from the comfort and convenience of their own home or place of work. When the device was originally created, we underestimated the psychological benefit women would feel when leaving the surgeon’s office with a remote control in their hands. Most people wouldn’t think to associate the word “positive” with their reconstruction process, but patients are defining their experience with AeroFrom as “empowering” and “positive.”
Medgadget: How heavy are these? What does a woman feel after implantation?
Dodson: AeroForm is lightweight and available to patients in 3 different sizes, small, medium and large, depending on their individual anatomy. The small device weighs 150g, the medium is 165g, and the large weighs 190g. Because the AeroForm devices are filled with CO2, they weigh the same amount fully expanded. Patients should expect to feel the same post-operative soreness that is common with any surgery. More importantly, a fully expanded AeroForm device weighs ten times less than a fully inflated saline device which puts less stress on the incisions that have been made during the mastectomy.
Medgadget: Is it common to have them taken out early?
Dodson: It is not common to have these devices taken out early. There can be wound healing issues that are associated with all surgical procedures that could cause early removal and in the case of a deep-seated infection, it may be necessary to remove the devices and clean out the pocket, but this too is not very common.
Medgadget: What has been the response from physicians and how are they adopting the technology?
Dodson: Physician and patient response has been very strong. AeroForm is currently available in over 160 hospitals and used by over 135 plastic surgeons across the United States. Many women aren’t aware of their breast reconstruction options and that technology has advanced as much as it has. We are working with the entire breast cancer care team, including oncologists, breast surgeons, radiation oncologists and plastic surgeons to bring more awareness to the benefits of our system and the significant impact it can have on women’s lives after cancer. The greatest testament to this advancement recently occurred when one of our physician advocates was diagnosed with the BRCA gene and opted for AeroForm Tissue Expander over saline for her own reconstruction.
Medgadget: What is the future for AirXpanders? Do you plan on further studies and are you developing new technologies?
Dodson: We anticipate significant growth and increased use of the AeroForm system in 2018 due to a number of factors. We are planning to introduce new sizes, which will allow women of most breast sizes the option to choose AeroForm in their reconstruction journey. We are also working to better understand and reach the entire breast cancer care team, as they all play a vital role in helping a patient decide on the best option for her care. Later this year, we also look forward to presenting new quality of life data related to the use of our device.
Link: AirXpanders AeroForm…
Flashbacks: AeroForm Tissue Expander System for Breast Reconstruction Cleared by FDA…; AirXpanders AeroForm Tissue Expander for Breast Reconstruction CE Marked…; AeroForm Breast Tissue Expanders Now Being Implanted in IDE Trial…; Tissue Expansion System for Breast Reconstruction Receives FDA Investigational Device Exemption…
