Mr. WEISS. Thank you, Ms. Meader.

Ms. Lehman.

STATEMENT OF LAURIE LEHMAN, PALO ALTO, CA

Ms. LEHMAN. Mr. Chairman, members of the committee, my name is Laurie Lehman, and I am here today to testify about my own experience with injectable silicone.

In 1964, at the age of 13, I had plastic surgery performed on my nose, and, upon the recommendation of the surgeon, a silicone sponge was implanted in my chin. During an office visit several days after the surgery, the doctor, with no prior discussion of the procedure, injected silicone on the sides of my chin in order to change its shape. He told me what he was injecting and why he was doing it while he made the injections, and he said he would need to inject additional silicone at my next visit.

Fortunately, the injections were painful enough that I refused to allow any additional ones. I believe that my illness would have been even more serious if I had been injected with twice the amount I received.

In 1964, and for many years afterward, I had no idea what the possible future consequences of silicone might be. In 1972, 8 years later, I began having health problems, which my physicians and I believe are a result of the silicone implant and injections. Since 1972, in varying degrees of intensity, I have suffered from painful arthritis in all my joints. I have been hospitalized, put in traction, had a cast on leg from ankle to hip, and many times have needed crutches in order to walk.

From a few to many times a year, for period of 10 days to 10 weeks, my face, over the injection sites, becomes painful and swollen. At the same time this occurs, I develop arthritis in both my arms from my fingertips to my shoulders. The only effective treatment to reduce the inflammation in my face is cortisone which has many serious side effects. When the inflammation in my face improves, so does the arthritis.

Additionally, for the past 10 years, I have had a condition called iritis, which causes inflammation of the tissue inside the eye. It is often seen in conjunction with autoimmune or connective tissue diseases. In my eyes, it has caused scarring, a reduction in my vision, and glaucoma. It can be very painful and can cause blind

ness.

Iritis is treated with cortisone or sometimes with drugs used in cancer chemotherapy. There have been times when I have needed to use up to seven oral and topical medications daily to control the symptoms in my eyes. When these drugs are not effective, my ophthalmologist injects cortisone directly into my eyes.

The iritis and daily use of cortisone eventually caused me to develop cataracts in both eyes, and in the past 3 years I have undergone three operations to remove the cataracts and restore my vision. Three operations were necessary because the most common type of cataract surgery today involves replacing the lens of the eye with a lens made of plastic, although the newest ones are made of silicone.

Because of my medical history, my ophthalmologist and I were reluctant to implant any lens. Instead, I used a contact lens, but because of the continuing inflammation and other problems which developed, my vision was poor. Eventually, we decided to risk implanting nonsilicone intraocular lenses so I could continue to work. Prior to my cataract operations, I also underwent surgery several times on my face in order to remove the silicone sponge and to remove as much residual silicone and scar tissue and possible in the areas where the silicone had been injected. Much of the silicone can never be removed, as it spreads to areas distant from the injection sites. The surgery on my face was performed through incisions inside my mouth to prevent external scars and left me with nerve damage. Removing some of the silicone did, however, reduce the frequency and extent of the swelling in my face.

At this time, compared to many of the women with whom I have spoken, I feel fortunate. I do fear what may happen to me in the future, what new health problems I may develop. I'm concerned not only about my health but about that of all the other women and men with problems similar to mine, who are sick, in pain and afraid, whose doctors do not know what is causing their illness, either because they are unaware that silicone can make people sick or because they are assured by its manufacturers that the women reporting such problems are simply hysterical.

One of the problems with silicone-related illness is the length of time it can take for symptoms to develop, often 5 to 10 years, or even longer. By the time the person becomes ill, neither she nor her physician is likely to consider silicone the culprit. Until quite recently, when articles describing risks associated with silicone appeared in the national press, consumers would have found medical journal articles to be their only source of information.

When I became ill, none of my physicians who treated me for the first few years knew what caused my illness. It wasn't until I realized the clear temporal association between the swelling in my face around the injection sites and my arthritis that I suspected the silicone. When I visited a medical school library and read about the effects of injecting or implanting silicone, I was shocked by the large number of articles on just this subject and the ongoing controversy among plastic surgeons.

The lack of controls over the manufacturers of silicone and doctors who use it is appalling, and I can't think of even one reason why its use should be allowed unless and until those selling it or using it are able to prove conclusively that it is safe. I urge you to act now to ensure that long-term, large-scale studies be required on silicone, and until the results of such studies become available, if they ever do, I urge that this product be removed from the market for cosmetic use and that severe penalties be imposed upon those who continue to use or sell it.

Thank you.

[The prepared statement of Ms. Lehman follows:]

My name is Laurie Lehman, and I am here today to testify about my own experience with injectable silicone. In 1964, at the age of thirteen, I had plastic surgery performed on my nose and, upon the recommendation of the surgeon, a silicone sponge was implanted in my chin. During an office visit several days after the surgery, the doctor, with no prior discussion of the procedure, injected silicone on the sides of my chin in order to change its shape. He told me what he was injecting and why he was doing it while he made the injections, and he said he would need to inject additional silicone at my next visit. Fortunately, the injections were painful enought that I refused to allow any additional ones at the next visit. I believe that my illness would have been even more serious if I had been injected with twice the amount I received.

In 1964, and for many years afterward, I had no idea what the possible future consequences of silicone might be, although I later learned that it was considered an experimental substance and that no long-term studies had been done on the possible dangers of its use in humans.

In 1972, eight years later, began having health problems which my physicians and I believe are a result of the silicone implant and injections. Since 1972, in varying degrees of intensity, I have suffered from painful arthritis in all my joints. I have been hospitalized, put in traction, had a cast on my leg from ankle to hip, and many times have needed crutches in order to walk. From a few, to many times a year, for periods of ten days to ten weeks, my face, over the injection sites, becomes swollen and painful. At the same time this occurs, I develop arthritis in both my arms, from my fingers to my shoulders. The only effective treatment to reduce the inflammation in my face is cortisone, which has many serious side effects. When the infiammation in my face improves, so does the arthritis. Repeated blood tests over the years for autoimmune diseases known to produce symptoms such as mine have always been normal.

Additionally, for the past ten years, I have had a condition called iritis, or iridocyclitis, which causes inflammation of tissue inside the eye. It is often seen in conjunction with autoimmune or connective tissue diseases. In my eyes, it has caused scarring, a reduction in my vision and glaucoma. It can be very painful and can cause blindness. Iritis is treated with cortisone, or sometimes with drugs used in cancer chemotherapy. There have been times when I have needed to use up to seven oral and topical medications daily to control the symptoms in my eyes. When these drugs are not effective, my opthalmologist injects cortisone directly into my eyes.

The iritis and daily use of cortisone eventually caused me to develop cataracts in both eyes, and in the past three years I have undergone three operations to remove the cataracts and restore my vision. Three operations were necessary because the most common type of cataract surgery today involves replacing the lens of the eye with a lens made of plastic, although the newest lenses are made of silicone. Because of my medical history, my opthalmologist and I were reluctant to implant any lens. Instead, I used a contact lens, but because of the continuing inflammation in my eye and other problems which developed, my vision was poor. Eventually, my doctor and I decided to risk implanting non-silicone intraocular lenses to allow me to continue to work.

Prior to my cataract operations, I also underwent surgery several times on my face in order to remove the silicone sponge implant in my chin and to remove as much residual silicone and scar tissue as possible in the areas where the silicone had been injected. Much of the silicone can never be removed as it spreads to areas distant, from the injection sites. The surgery on my face was performed through incisions inside my mouth to prevent external scars and unavoidably left me with nerve damage. Removing some of the silicone did, however, reduce the frequency and extent of the swelling in my face.

At this time, compared to many of the women with whom I have spoken, I feel fortunate in terms of my health. But I do fear what may happen to me in the future, what new health problems I may develop. As lens implants are relatively new and generally used in patients much older than I am, mine will quite likely need to be replaced one day, requiring additional surgery and possibly resulting in a less successful outcome. I am concerned not only about my own health, but about that of all the other women and men with problems similar to mine, who are sick, in pain, and afraid, whose doctors do not know what is causing their illness, either because they are unaware that silicone can make people sick or because they are ́assured by its manufacturers that the women reporting such problems are simply hysterical or out to make money.

One of the problems with silicone caused illness is the length of time it can take for the illness to develop, often five to ten years or even longer. By the time a person becomes ill, neither she nor her physician is likely to consider silicone the culprit. Until quite recently, when articles describing risks associated with silicone appeared in the national press, consumers would have found medical journal articles to be their only source of such information. When I became ill, none of the physicians who treated me for the first few years knew, what caused my illness. It wasn't until I realized that there was a clear temporal association between the swelling in my face around the injection sites and my arthritis

3

that I began to suspect the silicone. When I visited a medical school library and read about the effects of injecting or implanting silicone and other foreign substances in humans and animals, I was shocked by the large number of articles on just this subject. These journal articles clearly showed the ongoing controversy among plastic surgeons about the safety and long-term effects of silicone, but until recently these concerns have not been shared with the people the silicone has been used on. Instead, physicians, manufacturers and the F.D.A. have allowed human beings, most of whom are women, to become the long-term testing ground.

At one time I näively believed that I could trust government agencies such as the F.D.A. to protect me from drugs or products which might be dangerous to my health. I believed that proof of their safety for use in humans would be required prior to their sale. I have lived in other countries where drugs such as antibiotics and narcotics are routinely sold over-the-counter, and I believed that the fact that these same drugs required a prescription here was evidence of the F.D.A.'s concern that these products be used safely and thoughtfully, while a person was under the care of a physician. Clearly it must follow, I believed, that this same institution would not allow unsafe, untested products to be injected or implanted in people's bodies. Clearly, I was wrong.

The lack of controls over the manufacturers of silicone and the doctors who use it is appalling. This is not a product being used to treat life-threatening illness, where a relaxation of regulations may be completely appropriate. We are talking about the use of a product in the context of cosmetic treatment, and I cannot think of even one reason why its use should be allowed unless and until those selling it or using it are able to prove conclusively that it is safe. I urge you to act now to ensure that long-term and by this I mean a minimum of ten years, large-scale studies be required on silicone, and until the results of these studies become available if they ever become available, I urge that this product be removed from the market for cosmetic use and that severe penalties be imposed upon those who continue to sell or use it.