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Implant risks uncertain


When the Food and Drug Administration convened a special panel in February to consider potential health risks of silicone breast implants, there was more confusion than clarification. In fact, the FDA reported receiving nearly 2,000 calls a day from women who wanted more information on the panel's findings.

The debate was healthy, but it is difficult to know if accurate information reached the millions of women who have silicone implants or who are considering them. Of particular concern was the possible connection between the escaped silicone and connective tissue or immune-related disorders such as lupus and rheumatoid arthritis.

Q: What did the panel decide?

A: The panel acknowledged that:

* The rupture rate of silicone implants is not certain, but it probably is higher than originally believed.

* The devices do not last a lifetime.

* Rupture can be undetected in some women.

* Implants "bleed" silicone, but the significance of the bleed is uncertain.

Q: What are the signs of a rupture of a gel-filled implant?

L A: Symptoms include redness, pain and new lumps of hardness.

Q: Did the panel members establish a direct relationship between gel-filled implants and immune or connective tissue disorders"

A: No, it concluded there is not enough evidence to establish any relationship. It recommended, however, that if women with implants have symptoms of those disorders they should see their doctors.

Q: What should women do if they already have gel-filled implants?

A: The panel recommended that those women be checked regularly by their physician or plastic surgeon, if symptoms of problems are not apparent. Women with gel-filled implants who have muscle and joint pain should see their physicians.

Q: What if an implant ruptures?

A: The general rule is that if an implant ruptures, it should be removed.

Q: What if you're not sure of what brand you have and whether it's saline or silicone?

A: Each woman's medical record has that information. She shouldcontact the hospital where the surgery was performed or the physician in charge of the procedure.

Q: What else can women do to detect complications from their implants?

A: They should examine their breasts monthly so they become familiar with the normal feel and can sense any changes. The best time is two or three days after menstruation. Women who do not have their periods should pick a day of the month and make the exam a routine each month on the same date.

Q: What are other options besides gel-filled implants?

A: Saline implants are one option. Another is a more extensive surgical procedure in which natural tissue is formed into new breasts. These procedures should be discussed with the physician on an individual basis.

Q: How can women report problems with implants?

A: Call the FDA at (800) 638-6725 to report specific problems only. It is not an information hot line. Include, if known, the manufacturer's name; product brand name; style, size and lot number; date of surgery; date of problem; nature of problem; name and address of surgeon and facility where surgery was performed; and, if you wish, your name, address and telephone number.

For general information on gel-filled breast implants, call the Food and Drug Administration information line at (800) 532-4440.

Dr. Matanoski is a physician and professor of epidemiology at the Johns Hopkins School of Public Health.

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