FDA Breast Implant Consumer Handbook - 2004
The three basic types of breast implants are saline-filled, silicone gel-filled, and alternative (e.g., soybean oil) implants. Breast implants are designed for treatment of augmentation, reconstruction, and revision patients. While many women believe breast implants cause illnesses, such as autoimmune disease, this is not proven at this time. However, most women with breast implants will experience local complications, such as pain, capsular contracture, and rupture/deflation. You may need to have nonsurgical treatments or reoperations to treat local complications. Breast implants do NOT last a lifetime. You should be prepared for long-term follow-up, reoperations to treat complications, and personal financial costs.
Before you make your decision whether or not to get breast implants, it is very important that you:
- read the information in this handbook
- read the patient labeling for the approved saline-filled breast implants at FDA's website (http://www.fda.gov/cdrh/breastimplants/) to learn about the types and rates of complications seen with breast implants
- read the specific patient labeling or informed consent documents for the breast implants for which you are gathering information1
- collect specific information from your insurance company and your doctor to estimate personal financial costs (see below)
- have a realistic expectation of the outcome (see below).