Is TUBA FDA approved?
The job of the U.S. Food and Drug Administration (FDA) is to approve drugs and medical devices such as breast implants for use in the United States. It does not approve or evaluate surgical techniques. When breast implants were pulled off of the market for a period of time, the FDA required implant makers to submit data on their products based on transaxillary, periareolar, and inframammary insertions. At the time, few surgeons used the transumbilical breast augmentation technique and no data on it was submitted. But the FDA was only looking at the safety of the breast implants, not of routes of insertion. However, the 2004 edition of the FDA Breast Implant Consumer Handbook notes that the transumbilical incision site is not recommended by implant makers. This is true. Neither Mentor nor Allergan, the two makers of FDA-approved breast implants officially recommend a transumbilical insertion for any of their products. That said, once the FDA approves an implant, a surgeon can use any in
