Reclaim Your Curves recently spoke to Western Australia’s Dr Tony Connell, the world’s most experienced surgeon using the new AeroForm tissue expansion technology to understand his role in making this new reconstruction option available for women.
RYC: Dr Connell, I understand that you led the clinical trials into the AirXpanders device, AeroForm, and have performed the most implants to date worldwide using this technology. How did you first get involved with AirXpanders?
I was initially contacted by a marketing company back in 2008 and was asked if I would be interested in hearing about a new tissue expansion device that had been developed by US Plastic Surgeon Dr Dan Jacobs. This device offered a needle-free, patient-controlled expansion technology. As someone who has specialised in breast reconstruction surgery for the past 15 years, with around one third of my work solely focussed on breast reconstruction, I was intrigued to hear more about the technology and how it might benefit my patients.
I met with Dr Jacobs and representatives of AirXpanders who were looking to establish a clinical trial of the first 10 implants in the world, and were seeking Surgeons to collaborate with in Australia. Their interest in trialling the device in Australia was due to a number of factors; firstly the regulatory barriers are less onerous here than in the United States, secondly, we have a well regarded medical research sector and, finally, Australia’s breast cancer experience and incidence rates reflect the general picture in developed countries worldwide.
After hearing about the device and the potential benefits for my reconstruction patients, I offered to be involved in the very first trial of the device - the Patient Activated Controlled Expansion (PACE I ) study. This trial involved implanting 7 of my patients here in Western Australia with the first 10 AeroForm devices in the world. The study involved a diverse group of women of different ages, from various locations across the State (including some rural and remote areas), with varying treatment histories. The device worked well with no adverse effects and successful expansion in all cases. But most importantly, the women who trialled the device were really happy with it. They loved the fact that they could control the process from the comfort of their own homes and that the expansion process was much quicker.
After that initial trial I became the Principal Investigator in two further clinical trials – PACE II and ASPIRE - to test the safety and effectiveness of the device in a larger number of patients, with an even broader range of breast cancer histories.
The results of these studies, which brought the overall number of AeroForm devices implanted to around 100, demonstrated that the device was safe, worked well, provided a more comfortable expansion process for patients and had a lower complication rate than for traditional saline implant reconstruction. The data in the PACE II study also showed that the women using the AirXpander device were able to complete their expansion in 17 days on average, as opposed to several months with the standard device. The outcome of these studies led to the Therapeutic Goods Administration (TGA) approving the technology for use in Australia in November 2013, and has paved the way for a larger US trial which is showing similarly successful results.
In 2014 the device was listed under the Australian Government Prostheses List Arrangement which means that the AeroForm is now covered by private health insurance and there are now a growing number of other plastic surgeons across Australia offering their patients this new technology.
RYC: What are the main benefits you believe this technology offers women seeking implant reconstruction?
TC: This technology offers women greater choice and flexibility with the main benefits being:
RYC: What feedback have you had to date from your patients about this product?
TC: They love it! I offer my patients the option of using either the AeroForm or a traditional implant and, without exception, every woman has chosen to go with the AeroForm and, more importantly, has been extremely happy with their choice.
RYC: Who are the most suitable candidates for this surgery?
TC: Anyone who needs tissue expansion is a suitable candidate.
RYC: Is it safe for women to fly with the expander in?
TC: This is one of the questions I looked at as part of the ASPIRE study into the device. Those patients that have flown with the device at altitudes above 1,000 meters did report a slight filling sensation upon ascent, which then normalised on descent. Based on those results I recommend that it is safe for patients to fly with the expanders implanted, but dosing of the AeroForm should be discontinued for 2 weeks before flying and resumed once the patient has returned home.
RYC: How suitable is the AeroForm for women who have had radiation therapy? What are the risks?
TC: The studies I have done to date show that the AeroForm expander doesn’t interfere with the delivery of radiotherapy, so patients can have this form of treatment with the expander in place. My studies also confirm that typical radiotherapy doses do not affect, or interfere with the expander mechanism and I have had multiple patients that have had radiotherapy and successfully used the device.
RYC: Do you see AeroForm replacing traditional needle filled expanders in the future?
TC: Absolutely! This technology is much less invasive and the flexibility it offers women to control the expansion process in their own home, and at their own pace, makes it an extremely attractive option. Sadly, the breast reconstruction rates are very low in this country in comparison to the rates in the US and the UK, and one of the main barriers is the need for weekly surgery visits to fill the expander. With the AeroForm this becomes a non-issue and many more women, even in very remote locations, will now be able to consider having reconstruction which will hopefully help them to move forward in their recovery from breast cancer, which is something I’m very passionate about.
Interview by Jane Goodwin-Moore
Jane Goodwin-Moore is a writer and consumer. She interviews Australian health professionals about their role and thoughts on breast reconstruction in Australia