Silicone Gel Breast Implant Litigation
Chicago Tonight
January 16, 1992
7 P.M.
Whole show: 15:38 - 42:27
Ken: 21:56 - 42:27
John Callaway: Searching for the truth in the controversy of silicone breast implants. Top experts debate that issue next on Chicago Tonight.
David Kessler: We still do not know how often the implants leak and when they do, we do not know exactly what materials get into the body.
John Callaway: Good evening I'm John Callaway, and welcome to Chicago Tonight. The controversy over the safety of silicone gel breast implants is having an immediate economic impact on the leading manufacturer of those implants, and the psychological impact of many on the 2 million American women who have had implants and may be wondering now if they are safe. The Dow Corning Corporation announced earlier this week that it has shut two plants that make the silicone breast implants. That news followed Dow's strong reaffirmation of the safety of the silicone breast implants after the New York Times published articles claiming that scientists who had worked years for Dow Corning had written memos in which they urged the company to stop putting off safety studies of the implants. And all of this came on the heels of the Food and Drug Administrations request for a voluntary 45 day moratorium on the use of the silicone gel implants. In an editorial in the Chicago Tribune this week the issue was put so succinctly 'maybe the breast implant should be banned, maybe not, maybe women who have a silicone gel implants should have it removed, maybe not. What is most inexcusable in the whole sorry debacle about silicone gel breast implants is the lack of accurate trustworthy information' from the Tribune editorial. Well tonight we'll try to find out whether or not there is any trustworthy information about silicone gel breast implants and how to cope with or without reliable information. Beginning with this report from correspondent Elizabeth Brackett.
Dr. David Ross: OK. Tell her to bring me the 325s.
Elizabeth Brackett: Dr. David Ross had five breast implants surgeries scheduled last week. He had plan to use silicone gel implants in each case, that was before the surprise announcement by the Food and Drug Administration.
DK: I am requesting a moratorium on the further use of all silicone gel breast implants.
E: So Dr. Ross switched to implants filled with saline rather than silicon, but he was not happy about it. He says saline feels less natural and if a saline implant leaks the breast immediately deflates.
Dr. DR: We're totally convinced in the safety of the gel implants. We believe in the gel filled implants morally, ethically, medically and I would use it, and I intended obviously, to use it this week if they were available.
DK: The information we've acquired since the last panel meeting rather than dispelling doubts has increased our concerns about the safety of these products. For example, we recently received reports from rheumatologists that they are seeing an increasing number of auto- immune diseases among breast implant patients.
EB: Evie Finley has suffered the kinds of symptoms the FDA is concerned about, worried about her small breast, Finley opted for silicone gel implants as a boost to her self-esteem. But shortly after her first surgery eleven years ago, her breast hardened after two more surgeries she still felt burning sensations, joint pain and chronic fatigue. She finally had a fourth surgery replacing the silicone implants with saline ones after learning that her silicone implant had broken.
EF: One was ruptured I mean completely ruptured and the gel had leaked out and traveled up into my shoulder. The other one, after they took them both out, the other also was leaking.
EB: Do you feel better now with the saline implant?
EF: Well I feel better mentally because I know that they're out of there.
Sue Gold: At the moment we're still waiting for additional information to come forth from the FDA. We're as stymied by the moratorium as everybody else is.
EB: At the 'Y-Me' breast cancer hot-line, staff members were fielding panicky calls from women who had silicone implants for years.
SG: They're scared to death. Are these things gonna cause a problem somewhere down the line. I'm happy with them but should I have them taken out?
EB: Sue Gold's breast reconstruction after a mastectomy was done with the silicone gel implant three years ago. She has been pleased with her implant, and she, like many, does not think the FDA has enough hard scientific data to warrant the moratorium.
SG: I don't think the moratorium was necessary. I think study could have gone on while the implants remained on the market and viable.
EF: I don't understand why they would even leave them on the market when they have a viable option and I've had no problems with the saline and I think that they're fine.
EB: Dr. Ross says the problem is that his patients options have suddenly been cut in half. Before the moratorium, there were five major companies selling breast implants. Now there are only two. And Ross appears that FDA actions and the threat of litigation could cause all implants to disappear from the market.
Dr. R: This is something I've been doing for close to 20 years and I would never have dreamed that that I would not have implants available. I always felt it was the best operation really we had so many satisfied individuals following this operation was really what I considered so few problems that the thought of the implant might not be available I don't think crossed any of our minds.
E: So the questions says the Dr. Ross is whether the FDA moves protects women's health or limits women's choices. For Chicago Tonight I'm Elizabeth Brackett.
J: And now joining us are Kenneth Moll who's attorney with the law firm of Dow Corning limited which has some 50 law suits filed on behalf of women who have allegedly had serious side effects from silicone jell breast implants. Dr. Peter McKinney who is professor of plastic surgery at North Western University Medical School and attending position in plastic surgery in North Western University Memorial Hospital. Dr. McCany also served as an investigator for the food and drug administration examining the safety of injectable silicone. Dr. Linda Hugh who was chairman of the department of obstetrics and gynecology at Rush North Shore Medical Center and she is the author of a book of women on women's health Mid life health issues called 'Mid-life health' and because of the bad weather which delayed her flight from Cincinatti, via telephone, we have Nancy Lawson who is partner with the Cincinatti based law firm of Densmore and Shol which currently represents Dow Corning Wright in several product liability lawsuits, involving silicone gel implants. Dr. McKinney, let me begin by you and ask you what you're hearing following the, all of this controversy and all of this news following the moratorium by the FDA what are you hearing from your patients what are they telling you.
PM: Chronic fatigue syndrome, and I'm not being a wise guy, we've talked about silicone for over 30 years and I think there's only one message that I can get to your viewers which is extraordinarily important. I give you this from the perspective from someone who has studied this for 30 years, who has been an investigator with injectible silicone at the FDA and this is an absolutely safe material. Now that will bring howls of protests from a very small percentage of people. The FDA has done something that should never have been done by a government agency. And they have unduly alarmed thousands of people who've been reconstructed with breast cancer, on unfounded allegations. There's no science for this John
JC: You've joined a ? statement but I want to go back personally. Have you heard from many of your patients?
Yes, quite a few even the coolest.
JC: What do you hear?
PM: They're terribly upset, they're worried, they are reassured after they speak with me and I send them a scientific insert, information and explain it the same way to them that the science supports the safety of this material. Politics is another issue and that's what's happened.
JC: And have you heard from anybody who's had a problem who perhaps thought, well it's simply a health problem but who's now thinking wait a minute, doctor maybe it's related to the breast implants. How about those persons
PM: I haven't but I don't do a whole lot of these operations because I explain to the patient, they're going to have hassles the rest of their life and this is an example of the hassles they have.
JC: Now when you say they're going to have hassles, when you explain to patients, they're going to have hassles, do you, are you in effect saying don't even do this implant?
PM: I try to talk them out of it.
JC: Why do you do that?
PM: Because of this very situation. I know this is going to happen, it's gone on every five years for 30 years, there's always a new accusation and when tracked down it doesn't hold water. Let me just finish with one thing, cause this is very important so you understand my perspective. Science is very vulnerable to these sorts of attacks. Because, as a good scientist, I must always say 'hey, maybe, possibly, I gotta look into this' Everytime a new charge comes up, we look into it, we looked into it for the last 30 years, the last new charge didn't hold any water.
JC: But you know that nothing is perfectly safe. . .
PM: abosolutley
JC: so therefore you'll have anecdotive, anectodal evidence that says this case, this case, this case and this case . . .
PM: and I'll
JC: and have millions of cases
PM: And I'll look and I'll make darn sure that's it's not harmful.
JC: Now Dr. H , before we go to the policy issues on this you have had implants, have you not, I mean tell us about your own experience personally.
Dr. Well I developed breast cancer about 3 1/2 years ago and ran through all the various choices at that time. I had a family history, I had and mother and sister that had both had mastectomies with no reconstructive surgery and I think it was devastating for the psychologically. I knew if I had to go through that type of surgery I was going to want reconstructive surgery. The implants offered the simplest, quickest, safest method for me. I've been very pleased personally. I would do it again.
JC: So this is silicone
Dr: Yes
JC: Not saline
Dr.: No, I have silicone implants
JC: So you've not had a problem
Dr.: No, I have had no problems. Now that doesn't mean that they're not problematic. Now moving to the politics a little as a women's health activists from way back, I have some concerns about the fact that the implants were essentially grandfathered in without any safety data in the first place. And concerns that we simply don't have the information we need to be able to give women to tell them. In autoimmune diseases, chronic fatigue syndrome, joint problems are very common in women, they're much more common in women than men, and 2 million women, of reproductive and post-reproductive ages had implants, you would expect a fair number of women with implants are going to have chronic fatigue are going to have joint problems, the fact that one woman has had a great experience and another women is having problems doesn't tell you whether those problems are related to the implants or not. Now what we need is data, I mean, what we need is some studies.
JC: Now, I want to go to this, when you had the implants done, did your physician say to you 'this product will last you a lifetime?
f: my plastic surgeon practically scared me to death about the implants. I mean he walked through every step along the way all of the various potential problems, potential benefits and I can't claim, there are a lot of women claiming that they weren't informed of risks and benefits before they had implants put in, you can never . . .
M: but did he tell you the life, did he say 'this will last a lifetime, this will last 10 years, or did even discuss the issue of longevity?
F: Oh , we discussed the issue
M: and what did he say, or she
F: He said, some of them will last 20 years, some of them, they can start to leak, some of them can do this, they can do that . . .
M: so you knew they could leak going into this . . .
F: yes
M: . . . and other side affects that was clearly discussed
F: yes
M: and do you think it's discussed with most patients? Do you think there's that up front conversation. Dr. Hough saying, hey I tell them. Now Mr. Moll since this controversy erupted now you just to introduce you have brought some 50 law suits on behalf persons who said they had problems, how far back do those laws suits go?
M: back to the late 1960's early 1970's.
M: and how have, how many of those suits have been resolved one way or the other?
M: There's nothing resolved, the one that's going to be filed recently is the recent issue and you are going to find out allot of them.....
M: oh I see, all of them are filed recently, but some of them go back to problems in the 60's.
M: That's correct
M: ok
M: ah.. commenting on what the Dr. said today we have not filed a law suit against any of the plastic sergeants. Our faults are not with the plastic sergeants, our fault is with the manufacturers. We have through ah.. court discovery received documents under protected orders that the physicians themselves have not seen. Without this information the doctors are not to blame for the fault that the manufactures knew about it.
M: they're flying blind?
M: yes
M: they do not have this information
M: just give us an example of information that they don't have that you know is going to come out.
M: an example is will......is what was alluded to them in the New York times the memos the internal memos the Dow Corning Corporation ah.. doctors saying 'what's going on? are we going to do some tests or studies with this why are we pushing?' Dow Corning hired a task force to get these implants on the market in 1975 to compete with the competitor LcCan Medical Corporation. They did not, they were implanting the silicon implants in women without doing any conclusive tests, studies and today they have not done one substantial long -term study as to the effects of silicons.
M: Alright now I want to go to Nancy Lawsen, and I want to remind our viewers we're taping this on Wednesday for Thursday and the weather on Wednesday made it impossible. Ms. Lawsen was good enough to try to get to airport when all the way to the airport she tried to get to Chicago, but that storm was hitting through Ohio, and so Ms. Lawsen we thank you for being with us by telephoning. What, what do you have to say generated what Mr. Moll has said.
F: Yes, I would like to respond to Mr. Moll, first of all, he is absolutely incorrect when he says that there are' t any safety studies um.. that Dow Corning has conducted. Dow Corning has conducted safety studies on silicons and specifically on silicons and breast implants. (interruption) let me finish please. For thirty to forty years and the task force that he's referring to in 1975 was a task force to ah.. develop an improved product. It had nothing to do with a new product, in 1975 breast implants had been on the market for ten, eleven or twelve years and there were over a hundred studies ah... relating to those breast implants. So is absolutely incorrect to say that there were no studies in 1975 relating to breast implants
M: in referring to one of those studies referred to right now was' t it concluded that rats developed cancer from the silicon injections?
F: ah.. in 1975 no that's not correct you are referring to a study that was carried out later in which rats did developed what's called solid state tumors. Um.. all of this was reported to the FDA, and the FDA concluded as the Dow Corning's that these are specific cancers that develop in rats and in rats only, and it does not have any relationships to what happens in humans. And there is no scientific data to support the theory that silicon breast implants cause cancer. And on the other issue relating to the auto immune disease there's also no scientific evidence that silicon breast implant cause auto immune disease. The statistics are that women with breast implants do not have a higher incidence of auto immune disease or really any other disease that women without breast implants.
M: Ms. Lawsen, I know that Dr. McCany wants to get in on this, but I have just one follow up question, and that is the New York Times made a great deal how to report on some of the scientist that use to work for Dow Corning had suggested that in the research that had gone into this that there have been no research with animals with respect to the ah.... implants in breast tissue, is that true?
F: the question is whether there was ah..whether there was studies in animal breast tissue?
M: yes
F: yes, I think there were studies of animal in breast tissue, and just let met make a comment on those memos because I have seen allot of those memos.
M: please
F: these memos some of them are wrong first of all, where individual of Dow Corning makes a certain statement of about testing that that individual beliefs have not been done, but it actually had been done.......
M: so in other words you're simply saying that this is in dispute
F: right right
M: alright
F: also memos that say I think we should do such and such task, and the task is latter done, and I think if we are talking about safety which is really what the issue is here. We need to look at the body of scientific test and that's what the FDA should be looking at and they should be hiring the best scientists they can to look at that data and to evaluate what that data says and I think if they do that they will see that the breast implants are safe.
M: Dr. McCany
F: one more, one more thing the AMA American Medical Association very recently reviewed the safety of breast implants and looked at the data and they concluded there safe and I believe they have advise Dr. Kessler of the FDA that he should con....
M: ok Dr. McCany wants to get in
M: I want, I want to jump in for just a moment because this is terribly important. These are the two major questions that I get 'do they cause cancer, and do they cause connected tissue disease.' To simplify the whole thing they do neither, they do neither.
M: but what if I were your patient and I said do they tend to leak? What would you say?
M: let me answer the cancer connecting tissue
M: ok please follow up
M: because that's extraordinary important. People with breast implants have a lower incidence of cancer in the breast. So should we all have implants to protect ourselves against cancer so drop the cancer issue. It won't hold water..... The second one is on connected tissue disease is the last thing that has been brought up and in earth material cannot cause an immune disease that changes all of science, but again as a scientist I will look at this very carefully cause I want to be the first to know if I'm harming something. And to have an attorney present the science to me would be like having me present the law to you. It doesn't work.........
M: we take the blinders out and show you the documents that doctors compiled. Now the argument that Dow Corning try to assert is the fact that there were not they are no studies to prove this they are trying to benefit from the fact that they didn't conduct the studies that they were required to do prior to putting the implant on the market that arguments there in California........(interruption)
M: wait wait now we're trying all to talk at the same time let Mr. Moll finish please.
KM: there was a jury verdict for $7.34 million to a women out there now the jury the jurist all were allowed to see these documents to review for themselves and they came down with that verdict. There was a $4.5 million verdict in New York because that jury saw the same documents, and there was another verdict in Alabama for $5.4 million so once you will see the documents you will see the safety studies that were conducting.
M: as a scientist I'll look at anything, but law suits are show biz it's got nothing.
KM: now keep doctors and manufacturers in line without law suits...
M: what keeps the lawyers in line there are now a hundred people unemployed
F: clearly clearly the legal profession is gonna benefit greatly if there are big law suit......
KM: what you're failing to realize is there is a viable alternative saline implants
M: wait what are you saying, I'm sorry Doctor, (interruption) hello wait wait hang on a minute. The doctor is saying something would you repeat that.
Dr: the saline implant is a balloon made of silicon it's filled with salt water so if if if silicon is this vicious instrument why is this going to make anything?
KM: because it's a sol.... it's more viscous, again we have to look at silicone (interruption) what you have is scavenger cells that eat up the silicon.
Dr: what's a scavenger cell?
M: I want to get Dr. Hough back in the conversation.
M: what do you say to the women who's watching this program who says 'look I am I am really now confused, I've already got an implant I'm worried about it' what do you say to her.
F: I say there is not yet the kind of data you are looking for, and if you are not having any problems why worry about it if you're having a problem get the implant taken out.
M: or at least get an examination and see what the problem is.
M: let me answer one thing for Dr. Hough? because I have spoken to the people who are doing work on the roomatology and removing implants. There's a plastic sergeant who's doing this in Florida who's doing this. I gave her her ..... as a matter of fact. I talked to her the fall meeting, and I made darn sure I made no mistake of this. I said is there evidence that if someone if having these symptoms I should take them out she said no.
M: the other question I wanted to ask, if you were to talk to the FDA with respect I mean this 45 days is going to be going pretty quickly. If you were to talk with respect to the future would you advise them to try to make any distinction between the cases involving cosmetic surgery, which I am told represents 80% of the cases of implant verses the reconstructive surgery. Is there distinction that ought to behave.
F: yes yes yes, I would make a strong distinction for several reasons. The major one being that the women who is considered a ?? a cosmetic procedure whether she gets it done now, or whether she gets it done you know in a few months hopefully when we have a better understanding of what is going on here if anything. ?half more of a dozen? For a women facing cancer surgery if she does not have an implant put in or is scared off of doing an implant. She has two choices one is a much more involved plastic procedure for reconstruction and the second choice is to have a delayed surgery later on after the controversy is settled so she is facing a known risk for the second surgery. By taking the implants off the market the FDA is limiting the choices of women that essentially may put them in a position of having them later in surgery.
M: one last question anybody can answer it and Doctor perhaps you're the person. Ah doctor McCany maybe you want it, when there are problems what are the symptoms?
M: joint pains
M: wait wait I'll like a doctor to answer this question.
M: I love the lawyer answering the science (interruption)
M: symptoms of what?
M: of problems if the person is having problems with an implant what might the symptoms be?
Do you feel the implant breaking I mean in some cases?
M: no, they get hard but that's not necessarily a problem that has to be treated. They don't get hard themselves they get scar tissue around it, but I wanted to answer one thing that's terribly important that doctor ?? brought up. And that's the alternative of this big flat procedure, and I just finished one that's why I was a little late to the program it took eight hours to move the tissue from the abdomen to the chest. Because the silicon had not worked for this particular individual for different reasons, which would not involve you, and this is a more dangerous operation great operation. But the silicon is much simpler, but I want to get to one other thing because this is always brought up. What's the difference between cosmetic and reconstructive?
M: what is?
M: I don't know because if I got a little sixteen year old girl that's got no breast on one side.
F: yes
M: and she's got a huge breast on this side and I build up a silicon breast is that cosmetic? Should we deny that girl that chance.
M: so you're saying that entire.......
M: for two months yes but they won't give us a answer in two months. They voted last fall that they should be kept on the market that's why the FDA ......
M: Nancy Nancy Lawsen I want to go back to you in Cincinnati, if I read the Wall Street Journal correctly there' re saying 'hey good luck Dow Corning but you're out of business Ralph Nader and the lawyers have gotten you on the ropes you're closing down plants have a nice day science lost again are they right?'
M: yes
F: well I I I don't think that the that the battle is over um... I think the science is certainly on Dow Corning side to show that there' re safe. Whether Dow Corning will decide from a business decision that it's just not worth it and go out of business is not my decision.
F: this is exactly what happened to IUD's of these a few years ago the company that made them pull off the market the U.S. was women was going to Canada to get their IUD's because they could' t get them in the U.S. And I will be willing to bet Mexico and Canada will start..... starting business with the breast implants.
M: and we should go back and revisit DES ???
F: and IUD's are back on the market and women who are getting them put in everyday...(interruption)
M: alright the hold a couple of examples of symptoms of people who are having problems what would they be?
F: well the major problems would which a women might consider having an implant removed would be pain and discomfort in the sight of the implant. It is very unclear if chronic ??, joint pains I think ........(interruption).
M: now we have to thank Dr. McCany, Dr. Houhg, Ms. Lawsen, and Mr. Moll for being with us and our thanks to you for being with us I'm John Callaway thank you and good night. I have a final question while the credits are rolling and that is the forty-five days people are saying what's a forty-five day moratorium about I mean do we have the science or don't we if we do.............(interruption)
M: wait wait I'm sorry, Ms. Lawsen hang on a second
F: ..... application and it does' t have anything more now then it had in July, and I don't think that the forty-five moratorium really will do anything.
KM: as soon as counselor looks at the documents I believe what he is trying to do is use that time to lift the protective orders so he can look at the documents himself, and once he looks at the documents they will show the Dow Corning
F: Kessler has all the documents and had almost . . .