I wanted to ask Dr. Brown a question.
In order to obtain the silicone gel-filled breast implants, physicians are required to seek authorization through special access. Special access is defined as “access to a medical device for emergency use, or if conventional therapies have failed, are unavailable, or are unsuitable”.
With respect to the silicone gel breast implants, could you explain the meaning of “emergency use” and “conventional therapies”? Further, do you apply for special access for breast implants? Could you provide the committee with some estimate of how often your special access requests are for replacement of a failed implant, for reconstruction, or for cosmetic augmentation?