What information should I obtain for my records?
If you are going to be fitted with a breast implant, there are several important items of information you should have for your personal records prior to your surgery.
- Patient information sheet for women considering breast implants: You may obtain this from your doctor.
- Manufacturer's sticker: A copy of the sticker identifies the brand of the implant you will receive, its size and the manufacturer's lot number. This data should be part of your personal medical record. It will be useful if you should have problems following surgery or seek care from another health care provider.
- Package insert: You should also receive a copy of the manufacturer's package insert for the breast implant you will receive. Each package insert contains important information about the precautions to be taken and the risks associated with the specific brand of implant. You should use this insert as a basis for discussion about the surgery with your doctor, and keep it for future reference.
- Informed consent form: This must be signed prior to surgery. It is advisable well in advance of your surgery to obtain from your doctor a copy of the informed consent form so that you may better understand the risks involved and ask questions. This should be kept as part of your records.
- Insurance coverage: Some insurance companies reimburse breast cancer patients for the costs of breast reconstruction after mastectomy including the cost of breast implants. In general, insurance companies do not cover costs associated with breast augmentation. Many insurance companies do not cover explantation. Before surgery, be sure to get in writing answers from your insurance company to these questions:
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/or 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?
How can a woman find out what kind of implant she has?
This information should be in her medical records. She can contact the hospital or facility where she had the surgery, or ask her surgeon. Women with implants who want this information should seek it as soon as possible, because physicians and hospitals do not keep medical records indefinitely.
How long will my implants last?
Implants age over time and may need to be replaced. Although your implant may last for many years, you should not expect it to last indefinitely.
Should I tell other doctors in the future about my implants?
Yes. Whenever you give a medical history, be sure to inform the doctor that you have breast implants, just as you should tell him or her about other previous surgical procedures.
What is the proper way of examining my breasts?
Like all women, those with breast implants should perform regular breast self-examinations and have regular examinations by their health care provider trained in breast examination. For women with breast implants, these examinations take on added importance because they can help to reveal complications that might be due to the implants. Women with implants should examine their breasts each month so they can detect changes. For women who menstruate, the best time to examine the breasts is two or three days after the menstrual period ends, when the breasts are least likely to be tender or swollen. Women who no longer menstruate should examine their breasts at the same time each month.
To examine your breasts, first stand in front of a mirror and look for anything unusual, such as changes in the shape or appearance of your breasts or nipples. Then lie down on your back to allow for a better examination of tissue which flattens and spreads out for deeper palpation.
With your right arm raised above your head, use the flat surface of your fingertips of your left hand to feel your right breast. Move your fingers in one of three ways: in a circular motion in a clockwise fashion; in strips (like mowing the lawn); or in a radiant pattern. Feel around the breast to feel for any unusual lump, swelling, or mass under the skin of your right breast.
You should also feel for any swelling of glands or lumps in your armpit. Follow the same procedure for the left breast, (using the right hand to examine the left breast, with the left hand raised above the head).
Pay particular attention to changes in the firmness, size, or shape of your breasts. Be attentive to pain, tenderness, or color changes in the breast area, or any discharge or unusual sensation around the nipple. Any of these changes should be reported promptly to a physician, as should any other concerns about your breasts.
Do I need to get regular mammograms?
Women with breast implants who are in an age group where routine mammograms are recommended should be sure to have these examinations at the recommended intervals. (Those who have had breast cancer surgery on both breasts should ask their doctors whether mammograms are still necessary.) But women should be aware that breast implants may interfere with the detection of cancer and that mammograms do not detect implant ruptures or leakage.
Magnetic resonance imaging (MRI) has been approved by FDA for detecting rupture or leakage of an implant. FDA has not been presented with data showing the effectiveness of other methods, such as ultrasound or computed axial tomography (CAT) scans, when used to detect rupture or leakage. You should discuss the best method of detection of rupture or leakage with your doctor.
Is there a test to detect silicone in the body or to determine whether an individual is sensitive to silicone?
There is no FDA-approved, standardized test to detect silicone in the body. Determining that silicon or silicone is present in body fluids does not indicate whether a person is sensitive to these substances or at risk for any specific disease. (Silicon is an element that is one component of silicone and is one of the most abundant elements on the earth. Everyone is exposed to silicone.)
Some researchers reportedly have developed a test that can detect antibodies to silicone in blood. However, the validity of the test is controversial. Even if such antibodies were detected, the significance would be unclear. Antibodies to silicone would not necessarily indicate that silicone is harmful, or that a person would necessarily have an adverse reaction to it. Some researchers have also reportedly developed a test to detect if a woman's immune system is sensitive to silica, a constituent of silicone breast implants and reportedly a breakdown product of silicone gel. The validity of this test also has been questioned, and it is not clear at this time whether the results of this test have clinical significance. FDA has not approved for general marketing any tests to determine silicone in the body, or to determine whether a woman's immune system is sensitized to any constituent of silicone breast implants.
Even if simple techniques to detect silicone were available, they might not be useful in detecting a rupture, because small amounts of silicone ordinarily bleed even from intact implants. Further, since silicone is found in food and many other products, including commonly used medicines and cosmetics, the tests would not easily determine whether the silicone came from the implant or another source.
Some researchers have also reported that a test called the Anti-Polymer Antibody Assay may be used to distinguish among women with implants who have signs and symptoms of disease ranging from mild to severe. However, the biologic basis for the assay has not been established. The test remains to be validated by additional studies and, at this time, the clinical significance of the test results remains unclear.
Should a woman have her breast implants removed?
If a woman is experiencing symptoms that may be related to her implants, she should contact her physician or surgeon in order to discuss the best course of action. This discussion should include the recognition that the cosmetic results of explantation may be unsatisfactory to some women.
COPYRIGHT 1999 U.S. Food & Drug Administration