FDA permits marketing of new tissue expander for women under
The U.S. Food and Drug Administration today allowed marketing of a new tissue expander system for soft tissue expansion in two-stage breast reconstruction following mastectomy and in the treatment of underdeveloped breasts and soft tissue deformities. A patient uses a dose controller to independently inflate the expander.
A tissue expander is a balloon-like device that has a soft, expandable polymer shell and is gradually filled with saline or air. Tissue expanders are typically used prior to breast reconstruction to cause breast tissue and muscle to stretch over time, which creates a space (called a “pocket”) for the breast implant.

The AeroForm device is a wireless tissue expander for patients who choose to have reconstructive surgery following a mastectomy. Most women who have mastectomies to treat or prevent breast cancer are eligible for breast reconstruction....

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm534192.htm
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