Pilot study of a breast expanding device and fat grafting for breast reconstruction after cancer
Many women with breast cancer or high risk of breast cancer require removal of the breast (mastectomy). This operation can lead to loss of self-esteem and reduced well-being. Reconstruction of the lost breast has been found to be valuable but many options for reconstruction involve lengthy and invasive surgeries, which can also add to time off work and family whilst recovery takes place.
Our team is investigating a new method of breast reconstruction which relies on the woman herself using an external suction cup to stretch up the skin around the mastectomy scar over a period of 4 weeks and then a much shorter less invasive procedure which can be done as a day case. This procedure is called "autologous fat grafting" and involves sucking some fat out of the tummy or thighs with a special suction instrument and carefully injecting in strands into the area where the breast was removed. Sometimes repeat procedures are required, but patients seem to find recovery is quick and there are no long scars after the surgery.
We are testing whether this type of reconstruction genuinely helps these women, in terms of their well-being and self-esteem and whether the fat that we inject persists long-term or whether it "melts away" again over time. We are also testing how acceptable this type of treatment is for women with this problem.
What we aim to achieve
If this research is successful, we will go on to perform a larger study which we hope will establish the best way to use these new treatments of external tissue expansion (BRAVA device) and autologous fat grafting. We already know that breast reconstruction provides a very important improvement to the lives of women who have suffered breast cancer, but if we can prove that this new technique is valuable it may allow many more women to have breast reconstruction, and also allow them to have reconstruction without the trauma of very major surgery. This will enable them to get out of hospital more quickly, returning them to their normal family or work life.
The research could also allow more reconstructive options for those who have had part of the breast removed and are suffering from the consequences of feeling "imbalance" as a result. Returning women who have reduced self-esteem and psychological and physical well-being to better health also has a positive effect on the community. It helps their children, partners and work colleagues and hence society in general.
Our next steps and milestones
The data yielded from the pilot study has already illustrated to us that a randomised controlled trial (RCT) on different combinations of external expansion device and autologous fat grafting would be feasible and valuable. We have now designed this RCT and it has been conditionally passed by our Ethics Committee. We have also discussed with our consumer research forum how this RCT would work and sought their feedback on it. We have applied for funding for this RCT and hope, if it is funded that this could commence in October 2014. The full dataset from the pilot study should be available 10 months from now and at this stage it will be written up for peer-reviewed publication and presented.
What motivates me
I am in the fortunate position of being both a clinician and a researcher. I therefore see the immediate beneficial effect that the reconstruction of breast cancer defects has on women's lives and also have the opportunity to constantly be seeking new ways to do this with less pain and suffering. I find this combination of research and treatment of individuals very satisfying. The constant interaction with patients allows me to always make sure that my research ideas are focussed and relevant.
My message to supporters
Research into breast reconstruction requires meticulous data collection, specialised equipment and compensation of patients' travel expenses. The money we have received from Cancer Council SA donors has already directly benefited some study patients who were not suitable for other types of reconstruction and has made this study possible.
We felt it was very important not to seek funding from the manufacturers of the external expander device that we use as this would have created a conflict of interest. Cancer Council SA has therefore facilitated a world-class unbiased study, which will be very valuable to researchers, patients and clinicians. We are very grateful to have received this funding which we know has been generated through tireless efforts of many individuals.