A new tissue expander for use in breast reconstruction has been okayed for marketing by the US Food and Drug Administration (FDA).
The AeroForm device, which can also be used to treat soft tissue deformities and underdeveloped breasts, allows patients to partially control the expansion process.
Tissue expansion is a common breast reconstruction technique. An enlargement of breast skin and muscle is accomplished using a temporary implant. After the implant is removed, patients receive either a permanent breast implant, or microvascular flap reconstruction.
The AeroForm expansion implant has a silicone outer shell that contains a reservoir of compressed carbon dioxide. The device is preprogrammed to release a small amount of the carbon dioxide once every three hours, up to a maximum of three times daily. Once the implant is in place, patients use a hand-held dosage controller to signal it, allowing patients to expand at their own pace.
While the expansion process can take four to six months with traditional saline-filled expanders, the AeroForm expansion takes approximately 17 days, and because it uses a built-in supply of air, injections are unnecessary.
“AeroForm has the potential to significantly improve the experience of women as they take control of their tissue expansion following a mastectomy,” notes the company on their website. “Time to completed expansion is faster...and the process is more empowering for patients...”
Approval for the new device followed the FDA’s review of a clinical trial where 99 patients had AeroForm expanders, and 52 patients used saline expanders. The FDA reported 96.1 percent of AeroForm users, and 98.8 percent of those with saline expanders had “their breast tissue successfully expanded and exchanged to a breast implant.”
A patient’s suitability for AeroForm use must be determined by a surgeon. Those with residual tumor at the expansion site, or with another electronic implant (e.g., pacemaker, defibrillator) are ineligible. Patients cannot undergo an MRI (magnetic resonance imaging) with an AeroForm implant in place.
Sources: Medscape; Hopkins Medicine
Photo credit: Simon Blackley