To the patient considering breast implants filled with saline or silicone gel intended for breast augmentation or breast reconstruction:
The review and understanding of this document is a critical step in making the decision whether you should choose breast implant surgery. You should learn about breast implants and then carefully consider the benefits and risks associated with breast implants and breast implant surgery before you make that decision. This form lists important risks, including those known or reported to be associated with the use of the device based on information from clinical trials, scientific literature, and reports from patients who have undergone device placement.
This Patient Decision Checklist is intended to supplement the additional patient information documents that should be provided to you by your physician. You should receive patient information documents that include important information about your specific breast implant, as well as a boxed warning and Patient Decision Checklist. After reviewing the information in the patient information documents for the specific implant that will be used, please read and discuss the items in this checklist carefully in consultation with your physician. You should place your initials in the location provided next to each item to indicate that you have read and understood the item. Your full signature at the end of this document confirms that you have read the materials and that your physician has answered all questions to your satisfaction.