Silicone Breast Implants ; Part 2

by Food and Drug Administration (FDA)

(Page 3 of 3)

If You Have Implants ...

Most women with silicone gel-filled breast implants do not experience serious problems. If you are not having problems, there is no need to have your implants removed. But you should have regular checkups by a physician or plastic surgeon. If you have any breast discomfort, changes in size or shape of your breast, or any symptoms you think may be related to your implants, see your doctor.

Regarding specific concerns, the agency advises the following:

You should be checked periodically by your physician for as long as you have implants.

Implants can last from a very short time to many years, depending on the patient and the implant. In any case, they should not be expected to last a lifetime.

A ruptured implant should be removed. The percentage of implants that rupture is not certain. An FDA advisory panel concluded that the rupture rate may be higher than previously thought. Manufacturers' reports suggest a range between 0.2 and 1.1 percent; the medical literature contains figures ranging between 0 and 25 percent; and individual doctors have said the implants fail in as many as 32 percent of their patients.

The panel also noted that rupture may go undetected in some patients. In some undetected ruptures, the gel may be contained within the fibrous tissue that forms around the implant. Also, the implants "bleed," or leak, silicone, but the significance of the leakage is uncertain.

Routine mammograms are not recommended to detect such "silent" ruptures. Other methods of detection, such as ultrasound, computed axial tomography (CAT) scans, and magnetic resonance imaging (MRI), are being studied, but are not now recommended on a routine basis.

The chance for rupture may increase the longer the implant is in the body. Injury to the breast may also increase the chance of rupture, as may capsular contracture (shrinking of scar tissue around the implant that makes the breast feel hard). Closed capsulotomy — a nonsurgical technique sometimes used to reduce the contracture — may also increase the likelihood of rupture.

The value of tests to detect silicone in blood and urine is uncertain.

Since small amounts of silicone "bleed" even from intact implants, these tests cannot tell whether your implant has ruptured. Also, silicone is found in many products, including commonly used medicines and cosmetics, so the source of silicone detected may not be clear.

If you have symptoms of connective tissue or immune-related disorders, see your doctor.

It is not known whether implants can cause or contribute to the development of connective tissue and immune-related disorders. But you should be aware of symptoms that can occur with these disorders. They include:

• joint pain and swelling
• skin tightness, redness or swelling
• swollen glands or lymph nodes
• unusual and unexplained fatigue
• swollen hands and feet
• unusual hair loss

People who have immune-related disorders generally have a combination of these and other symptoms. These symptoms can also occur with a variety of other health problems, however, and a doctor's evaluation can rule out other possible causes.

Although the possibility cannot be ruled out, there is currently no evidence that silicone gel-filled implants increase the risk of cancer in humans. Studies now under way should shed more light on this matter in the next few years.

About 10 percent of women have silicone gel-filled implants coated with polyurethane foam, intended to reduce the risk of capsular contracture. These implants have not been used since April 1991, because studies showed the polyurethane coating could break down to release very small amounts of TDA, a substance that can cause cancer in animals. It is not known whether women with this type of implant have an increased risk of cancer. However, based on current evidence, FDA does not recommend removing polyurethane-coated implants because of cancer concerns. The agency is requiring the manufacturer of these implants to conduct studies analyzing blood, urine, and breast milk for TDA.

It is not known whether the silicone that "bleeds" from an implant gets into breast milk and, if so, whether it could affect a nursing child.

Research is being planned to resolve these concerns.

As is recommended for all women, you should have regular breast examinations by a trained health professional, and you should do monthly self-exams.

To examine your breasts, 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, with your right arm raised above your head, use the flat surface of your fingertips on your left hand to feel for any unusual lump, swelling, or mass under the skin of the right breast. Also feel for swollen glands or lumps in the armpit. Using your right hand, follow the same procedure to examine the left breast. Repeat the procedure lying down.

Pay particular attention to changes in the firmness, size or shape of the breasts. Also, note pain, tenderness or color changes in the breast area, or any discharge or unusual sensation around the nipple. Report them, or any other concerns about your breasts, to your doctor.

You should have screening mammography at the same intervals recommended for all women in your age group. Good quality mammograms are essential to detect cancer in any woman — with or without breast implants. (If you have had breast cancer surgery, ask your doctor whether mammograms are still necessary.) Mammography is not recommended to detect implant rupture. The radiation exposure to younger women is not justified for this purpose.

Mammographic examination of women with breast implants requires special expertise, however, because implants can often obscure breast tissue, impairing the ability to detect cancer. By taking extra views of the breast and pushing the implant backward and breast tissue forward, visibility is improved. Be sure the mammography facility you go to has personnel trained and experienced in the special techniques needed for women with implants.

Tell the radiologist and the technician that you have implants before they take the mammograms so they know to use special techniques and can take extra care when compressing the breasts to avoid rupturing the implant.

Facilities accredited by the American College of Radiology (ACR) are likely to have appropriately trained staff. For names and locations of ACR-accredited facilities, call the Cancer Information Service (toll-free 1-800-4-CANCER) or your local American Cancer Society chapter. Then double-check with the facility to make sure it can perform the needed techniques.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.