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FDA Permits Marketing of New Tissue Expander

FDA news release; 2016 Dec 21

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.

Citation:

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.