After a mastectomy, there exist two options when it comes to breast reconstruction: autologous reconstruction
or reconstruction with an implant. While the end result?reconstructed breasts?is the same, that's about where the similarities between the options end. The former procedures use the patient's own tissue to reconstruct a breast, and often do not require the use of medical devices in the reconstruction. The latter, however, use not only the breast implants themselves, but also use tissue expanders in the process.
Tissue expanders are exactly what they sound like. Because a mastectomy removes most of the breast tissue, the little tissue left behind is compromised and fragile. This skin must be stretched?or expanded?in order to create enough space to place the permanent breast implant. Until recently, there has been only one kind of tissue expander available. A traditional tissue expander is a deflated silicone sac that is surgically inserted into the breast and then slowly filled with saline, gradually stretching the breast. The process, by all accounts, is both painfully slow and outright painful for the woman, as the expansion occurs over several months, and requires multiple doctors? visits. Despite this, there has been very little innovation in the realm of tissue expanders until recently.
Enter the AirXpander
. This product has completely revolutionized the tissue expansion process. This new type of tissue expander addresses the pitfalls of the traditional expander outlined above. It is a patient-controlled device that uses CO2
to fill the expander, and, what's more, the expansion can be completed in as little as a few weeks. When I wrote about AirXpanders in the US and European Markets for Breast Implant Devices 2012, they had not yet been approved by any major regulatory body. I am happy to report that, in October 2012, AirXpanders gained CE approval
, enabling their distribution in Europe and other select countries. The reason that I am so excited about these new tissue expanders is because, compared to a traditional tissue expander, they can help a woman feel in control of the process, by allowing her to choose the frequency and volume of the expansion, but also by reducing the number of doctors? visits she has to endure. The new tissue expanders can effectively shorten the entire reconstruction process considerably, which would allow a woman to get back to her normal, cancer-free life that much sooner. I can only hope that these tissue expanders will be granted FDA approval?which is known to be a bit more arduous
process than obtaining CE approval?once their clinical trial
[Editor's note: Read about the many, many other medtech industries affected by the delays between device approvals in the US versus Europe here.]