FDA > CDRH > Breast Implants > Consumer Information > FDA Breast Implant Consumer Handbook - 2004

FDA Breast Implant Consumer Handbook - 2004

INTRODUCTION

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).

Personal Financial Costs - Breast implant surgery and treatment of complications may not be covered by your health insurance. Typically, insurance companies will not cover breast augmentation or any reoperations and additional doctor visits following augmentation. However, most insurance companies cover the first breast reconstruction operation. Insurance coverage for reoperation procedures or additional doctor visits following reconstruction may not be covered, depending on your insurance policy.

Aside from insurance coverage specific to your surgery, you need to find out about how breast surgery will affect your health insurance, as a whole. For some women, companies may increase premiums, drop coverage, or deny future coverage following breast implant surgery or following complications from the breast implants or surgery. Policies on coverage may also change from year to year.

Before surgery, be sure to get, in writing, answers from your insurance company to the following questions, at a minimum:

• Does my policy cover the costs of the implant surgery, the implant, the anesthesia, and other related hospital costs? To what extent?

• Does it cover removal and replacement of the implants if this becomes necessary? To what extent?

• Does it cover the cost of detecting or treating a complication as a result of either the implant or the reconstruction? To what extent?

• Will there be an increase in my insurance premium? To what extent?

• Will future coverage be affected? To what extent?

In addition to collecting information from your insurance company, you should also ask your doctor to provide cost information such as:

• What are the costs of getting breast implants (the implants, the anesthesia, the surgery, etc.)?

• What are the costs for follow-up visits?

• What are the costs for detecting or treating a complication, especially treatment that involves a reoperation, such as implant removal with or without replacement?

• What is the specific manufacturer warranty for the implants that you are gathering information on?

Realistic Expectations: Your decision whether or not to get breast implants should be also based on realistic expectations of the outcome. There is no guarantee that your results will match those of other women. Your results will depend on many individual factors, such as your overall health (including age), chest structure, breast/nipple shape and position, skin texture, healing capabilities (which may be slowed by radiation and chemotherapy treatment, smoking, alcohol, and various medications), tendency to bleed, prior breast surgery(ies), surgical team's skill and experience, type of surgical procedure, and type and size of implant.

¹Patient labeling is the general term used for the patient information provided for approved breast implants. An informed consent document, on the other hand, is the format for providing patient information to all investigational (not approved) breast implants under clinical studies. Refer to the Status/Availability section for more details.

Updated June 8, 2004