The U.S. Food and Drug Administration today permitted to market a new tissue expander gadget for soft tissue enlargement in two-stage breast rebuilding following mastectomy and in the treatment of immature breasts and soft tissue distortions. A patient uses a dose controller to self-sufficiently to blow up the expander.

A tissue expander is a balloon-like trick that has a soft, expandable polymer shell and is steadily filled with air. Tissue expanders are naturally used prior to breast reconstruction to cause breast tissue and muscle that are stretched over time, which creates a space in between (called a "pocket") for the breast transplant.

The Tissue Expander Help Patients To Reconstruct Skin Tissue From Surgery Or Accident

"This tissue expander may result in fewer office visits for patients by allowing a patient to partially control their breast tissue expansion," said Binita Ashar, M.D., director of the Division of Surgical Devices at the FDA's Center for Devices and Radiological Health. "Patients need to speak with their surgeons about what type of tissue expander is appropriate for them and the benefits and risks of using an expander following their mastectomy."

The AeroForm, a tissue expander system has two main mechanisms: a hygienic implant with an outer shell made of silicone (called the "expander") and a remote dosage controller. The expander holds a basin of compressed carbon dioxide. The controller is a hand-held wireless device that interconnects with receiver antenna and electronics located in the expander.

The most mutual adverse trials seen in the study were necrosis, seroma, post-operative wound infection, and procedural pain. The FDA studied the data for the AeroForm system through the de novo premarket review pathway, a controlling pathway for some moderate-risk medical gadget that are novel and for which there is no legally advertised predicate device to which to claim significant correspondence. AeroForm is mass-produced by AirXpanders of Palo Alto, California.