FDA OKs tissue expander device for breast reconstruction

The Food and Drug Administration on Thursday gave marketing clearance for the AeroForm tissue expander system.

The device, developed by Palo Alto, Calif.-based AirXpanders, is used to stretch out breast tissue in preparation for a two-stage breast reconstruction following a mastectomy. AeroForm can also be used to treat underdeveloped breasts and soft tissue deformities, according to a news release from the agency.

AeroForm is a balloon-like device that is implanted into a woman's breast and filled with saline or air. When the device expands, it gradually stretches out breast tissue and muscle to create space for a breast implant.

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