FDA approves marketing of tissue expander system
Patients use a dose controller for the new system to inflate the expander independently.
"This tissue expander may result in fewer office visits for patients by allowing a patient to partially control their breast tissue expansion," FDA Center for Devices and Radiological Health Division of Surgical Devices Director Dr. Binita Ashar said. "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."
A tissue expander is a device that inflates in the same manner as a balloon. It has a soft, expandable polymer shell and slowly fills with saline or air. They are normally used before breast reconstruction to help the breast tissue and the muscles stretch over time. This helps create a pocket for implants.
The wireless tissue expander, called AeroForm, is for patients who choose post-mastectomy reconstructive surgery.
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