The FDA is allowing marketing of a new tissue expander system for soft tissue expansion in 2-stage breast reconstruction following mastectomy and in the treatment of underdeveloped breasts and soft tissue deformities.
Indication: The AeroForm device (AirXpanders, Palo Alto, CA) is a wireless tissue expander for patients who choose to have reconstructive surgery following a mastectomy.
Dosage and administration: The AeroForm tissue expander has 2 main components: a sterile implant with an outer shell made of silicone and a remote dosage controller. The expander contains a reservoir of compressed carbon dioxide. The controller is a handheld device used to communicate to a valve in the reservoir to release carbon dioxide and gradually inflate the expander. It is preprogrammed to limit releasing a small amount of carbon dioxide once every 3 hours, up to a maximum of 3 times per day.
Safety and efficacy: The FDA reviewed results from a clinical trial of 99 patients using the AeroForm expander and 52 patients using the saline expander. The results showed that 96.1% of patients using AeroForm expanders and 98.8% of patients using saline expanders were able to have their breast tissue successfully expanded and exchanged to a breast implant.
Adverse reactions: The most common adverse events seen in the study were necrosis, seroma, post-operative wound infection and procedural pain. Patients using the AeroForm device in the clinical trials did not report any serious adverse events.
US Food and Drug Administration. FDA permits marketing of new tissue expander for women undergoing breast reconstruction following mastectomy. FDA Web site. December 21, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm534192.htm?.... Accessed December 28, 2016.