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CELIA ANDERSON LITIGATION

Celia Anderson had deep wrinkles in her face. She
Dr. Woolf

consulted Dr. Robert Woolf, a plastic surgeon.'

recommended injections of liquid silicone (in the face) as "the treatment of choice." Celia Anderson received several such injections circa 1978-1979.

Celia Anderson suffered serious side-effects from the liquid silicone injections. Specifically, she suffered an inflammatory reaction which led to ulcerations of the facial

tissue.

The only solution to the problem was radical surgery to excise the liquid silicone. Celia Anderson has had over twenty surgeries to correct the problem. She remains grossly deformed, and more operations may be required in the future.

Celia Anderson sued Dr. Woolf under various theories of medical negligence. She also sued both Dow Corning and the American Association of Plastic and Reconstructive Surgeons under various theories of negligence and products liability. All of these claims are pending in state court in Utah.

In addition to the state claims (above
also sued the Food & Drug Administration in Feder
Freedom of Information Act. The Federal cas
F.2d 936 (10th Cir. 1990).

Celia Anderson

court under the

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reported at 907

'Dr. Woolf had shortly prior to this time been appointed as an "investigator" for a clinical investigation using liquid silicone. The experiment was co-sponsored by Dow Corning Corporation and the American Society of Plastic and Reconstructive Surgeons.

Mr. WEISS. Since receiving the Dow Corning report last fall, what has FDA done to warn consumers about these kinds of risks?

Mr. SHERIDAN. If I could cover the history of this product just very briefly. Certainly, it was being used fairly widely in the late 1970's I mean, the late 1960's. It was often being used in fact for breast augmentation. We brought this device under control in the drug area by defining it as a drug. We saw its use diminish outside the investigational arena that we had with Dow, through the 1960's and basically through the early 1970's, although we were aware of Dr. Orentreich's activities in New York.

We believe that it is a fairly recent matter where this substance has been used-it is becoming more popular. And we share the committee's concern and wish to warn the public, as Dr. Kessler has today, of the safety concerns we have about this device, about this material used in the injectable form.

Mr. WEISS. This is the study which supposedly you were all monitoring very closely, limited to 130 women, and then the report came out which indicated this necrosis, the death of the skin. My question to you was, since receiving the Dow Corning report last fall, what has FDA done to warn consumers about these kinds of risks?

Mr. SHERIDAN. To my knowledge-I'm not in the education area—but, to my knowledge, I'm not aware of a general program warning the public, aside from Commissioner Kessler's warning today and your attempts, of course, on the part of the committee to provide such warnings.

Mr. WEISS. Mr. Arcarese, would you try to respond to that?

Mr. ARCARESE. Yes, Mr. Chairman. Since 1979, FDA has produced educational documents and publications for consumers about the risks associated with unapproved injections of liquid silicone, both to enlarge breasts-the problems with that are the formation of nodules, discoloration, infection, breast removal, and even death—and also to treat wrinkles, acne scars, and other minor facial aberrations-and the problems there are the formation of cysts, tumors, and granular masses.

Such educational pieces include a 1979 FDA

Mr. Weiss. I know. But since the report came out in the fall of 1990 about these terrible consequences, demonstrated by the study of facial deformities, what have you done to try to warn the public of it?

[The FDA Backgrounder on liquid silicone, issued in August 1991, does not include that information. It follows:]

FDA BACKGROUNDER

CURRENT & USEFUL INFORMATION FROM THE FOOD & DRUG ADMINISTRATION

Collagen and Liquid Silicone Injections

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4. What are the risks of collagen treatments?

About 3 percent of the population is allergic to collagen, and these people should not receive the treatments. (This includes individuals who have had allergic reactions to other collagen-containing products, such as surgical sutures and sponges.) Collagen injections should also not be given to people with severe allergies to numerous other substances.

People may be allergic to collagen and not know it. For this reason, all patients considering collagen injections must first be tested for collagen allergy. To do this, the doctor injects a small amount of collagen in the forearm and watches for a reaction for four weeks before beginning any treatment. Even the allergy test is not perfect-a small percentage of patients who do not react to the test have developed allergies during the course of treatment. Collagen allergies can take the form of rash, hives, joint and muscle pain, headache, and, in a few cases, severe reactions that include shock and difficulty breathing. Other adverse effects that have occurred after collagen injections, and which appear to have been related to the injections, include infections, abscesses, open sores, lumps, peeling of the skin, scarring, recurrence of herpes simplex, and partial blindness.

Patients with certain connective tissue diseases may have an

HFI-40

increased risk of severe allergic reactions to collagen injections. These connective tissue diseases include, but are not limited to, rheumatoid arthritis, scleroderma, and juvenile rheumatoid arthritis. They also include polymyositis and dermatomyositis ("PM/ DM"), which are chronic, progressive, sometimes fatal inflammatory disorders. Thus, collagen injections should be used with caution in people who have had these diseases. Some experts recommend that people who have had these diseases should either not be given collagen injections at all or should be given multiple skin tests before treatment.

Some physicians have reported that patients developed PM/ DM and other connective tissue diseases after receiving collagen injections even though they never had these diseases before. FDA is investigating whether there is a cause-and-effect relationship between having collagen treatments and later developing PM/DM or similar diseases.

Because collagen stays in the body and continues to be absorbed, the possible effects of collagen injections before or during pregnancy are unknown.

5. Should doctors administering collagen injections provide patients with information on possible side effects of this product? Yes. The manufacturers provide doctors with a patient brochure that explains the possible risks of collagen injections and identifies patients who should not receive this treatment. The package insert that doctors receive says that patients should be given a copy of this brochure before the initial allergy test for collagen is performed.

6. If a person is considering collagen injections, what should he or she discuss with the doctor?

In addition to reading the brochure carefully, patients should discuss with doctors the advantages and disadvantages of collagen injections, including how often treatments need to be repeated to maintain the effect. Patients should ask about the potential risks and tell the doctor about any history of allergies or connective tissue diseases such as rheumatoid arthritis or scleroderma.

Liquid Silicone Injections

1. Has liquid silicone been approved by FDA for injection?

No. FDA has not approved the marketing of liquid silicone for injection for any cosmetic purpose, including the treatment of facial defects or wrinkles, or enlarging the breasts. The adverse effects of liquid silicone injections have included movement of the silicone to other parts of the body, inflammation and discoloration of surrounding tissues, and the formation of granulomas (nodules of granulated, inflamed tissue).

2. Can FDA prohibit doctors from promoting the injection of liquid silicone, since its marketing has not been approved? Yes. FDA prohibits manufacturers or doctors from marketing or promoting unapproved products such as liquid silicone. This means that a doctor cannot legally advertise or sell this material.

August 1991 BG 91-5.1

Mr. ARCARESE. I'm sorry, Mr. Chairman, I was unaware of the report, and my office has not done anything since then.

Mr. WEISS. Who are the FDA scientists that have been working on silicone issues for the last few years?

Mr. SHERIDAN. Mr. Chairman, there are quite a number of FDA scientists who have been working on FDA silicone issues. Included among them are one of the scientists we have here today, Dr. Mishra; Mr. Paul Tilton; people like Dr. Kalyn Wynn. I could give you a long list of names, if you would like.

[The list is provided in app. 2, pp. 273 and 280.]

Mr. WEISS. And where are they now?

Mr. SHERIDAN. Most of these people still work for the agency.
Mr. WEISS. Thank you. But where?

Mr. SHERIDAN. Where?

Mr. WEISS. Yes.

Mr. SHERIDAN. Some of them work within my office. Some of them work within the Office of Science and Technology in the Center for Devices and Radiological Health. I am also sure that there are still probably some people in the Center for Drug Evaluation and Research who are familiar with silicone, even to this day. Mr. WEISS. But they are no longer working on silicone or collagen; is that correct?

Mr. SHERIDAN. No, sir. I believe they are.

Mr. WEISS. Where is My Do Luu working?

Mr. SHERIDAN. Dr. Luu is in the Office of Science and Technology and is one of the primary people conducting research into polyurethane coatings for silicone breast implants.

Mr. WEISS. And where is Dr. Mishra?

Mr. SHERIDAN. Dr. Mishra is still within the Division of Surgical and Rehabilitation Devices and is, while not working within the branch that is dealing with silicone breast implants, is clearly available to assist in the evaluation of breast implants.

Mr. WEISS. That's nice that he is available. It would be nicer if, on the basis of some of the responses I have been getting here all afternoon, if people who were familiar with what the agency has been doing were still in the process of doing some of that rather than "being available." I mean, I get the sense that some of these people have been moved out of direct involvement because there has been a defensive reaction on the part of the agency, which focused on them rather than on trying to treat the problem.

Mr. SHERIDAN. I regret if you have been left with that impression. It certainly was not our intent, and, as a matter of fact, I believe it not to be so. Not only are all of the scientists that have fairly recently been involved in these issues still available to us, we have added additional scientists, who, over many years, had moved away from the evaluation of silicone but now have moved back into it.

Scientists like Dr. Thomas Callahan, who was involved in silicone issues for many years and is now Associate Division Director, will be looking at that product when we receive PMA's. We will also be establishing a special task force to review the premarket approval applications for silicone breast implants when they are submitted on July 9. That task force will include Dr. Mishra and all of the other people that you are probably familiar with.

Mr. WEISS. Well, I can't tell you how frustrating it is to be faced with a panel of people whose general response is, "I don't know. I wasn't here. I'm not familiar with that." That's very difficult, and an agency should not put itself in that kind of position, if it can help it.

In October 1990, a senior Johnson & Johnson official, Peter Bewley, spoke at a symposium here in Washington, DC, urging the promotion of drugs for unapproved uses. He argued that the current FDA position that such promotion is illegal is unconstitutional and unethical, because it is the company's duty to make information available about the possible new uses of a drug in order to help the maximum number of potential patients.

Mr. Levitt, I would like to hear your reaction to that position with regard to the types of cosmetic drugs and devices we are discussing at today's hearing.

Mr. LEVITT. I would like to ask Ms. Witt to answer the question. MS. WITT. I think the agency has long acknowledged that there is a role for scientific exchange in the medical community. However, as Dr. Kessler said repeatedly, promotion by manufacturers of drugs for unapproved uses is illegal. To the extent that a drug manufacturer is behind a discussion of unapproved uses, I think we would consider that to be an act of promotion that would violate the law.

Mr. WEISS. Mr. Bewley's position on this issue suggests that Johnson & Johnson does not want to abide by the law restricting the promotion of drugs unless they are forced to do so. I know that the symposium where he spoke was attended by many FDA staff. How will FDA respond to companies that clearly question FDA authority on the issue of promotion for unapproved uses?

Ms. WITT. I am not sure we are under an obligation to respond directly to Mr. Bewley or others. I think the way we will respond is with appropriate enforcement actions when their companies violate what we perceive to be the law, not what they perceive to be the law.

Mr. WEISS. I am going to turn now to some questions on collagen. Injections of bovine collagen were first approved by FDA in 1981. The Collagen Corp. now estimates that 350,000 men and women have received these injections. We heard testimony this morning that the Texas Department of Health is conducting an investigation of the risk of a rare life-threatening illness called PM/DM associated with collagen injections.

According to a 1990 letter from the assistant surgeon general, the Centers for Disease Control has concerns that collagen might cause PM/DM. Is that correct?

[The letter and supporting documents is in app. 4, pp. 367-372.] Mr. LEVITT. I would turn to Mr. Sheridan for that.

Mr. SHERIDAN. Sir, the Center for Disease Control has informed us that they are concerned about the potential association between collagen and PM/DM and has urged that we closely monitor that situation. You are correct, sir.

Mr. WEISS. I understand that there are debates about the statistics involved, which have implications for the safety of collagen. I will submit technical questions in writing following today's hearing.

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