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# FDA OKs Breast Reconstruction Tissue Expander
- URL: https://www.fdaweb.com/fda-oks-breast-reconstruction-tissue-expander/
- Published: 2017-01-03T12:00:00.000Z
- Updated: 2026-09-14T21:57:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137602

FDA has allowed for marketing AirXpanders’ AeroForm tissue expander system for soft tissue expansion in two-stage breast reconstruction following mastectomy and in treating underdeveloped breasts and soft tissue deformities. An FDA media [release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm534192.htm?ref=fdaweb.com) says that patients use a controller to independently inflate the expander, a balloon-like device that has a soft, expandable polymer shell and is gradually filled with air.

The agency says the AeroForm product differs from available saline-filled tissue expanders that are expanded by the surgeon and use a needle to pierce the skin and inject saline into the expander through a port or injection area. Since the AeroForm is filled with air, the release says, there is no need for a needle and the patient has some control over slowly expanding the device at home.

Results of a clinical trial of 99 patients using the AeroForm and 52 patient using a saline expander were reviewed by FDA. Some 96.1% of AeroForm patients and 98.8% of patients using saline expanders could have their breast tissue successfully expanded and exchanged to a breast implant, according to the release. The most common adverse events in the study were necrosis, seroma, post-operative wound infection, and procedural pain. Patients using the AeroForm did not report any serious adverse events.

FDA reviewed the data for the AeroForm system through the *de novo* premarket review pathway.