December 2, 1998
A study concluded that silicone breast implants do not cause systemic illness. The findings could have serious impacts on numerous lawsuits filed against the manufacturing companies. Susan Dentzer explains.
JIM LEHRER: Now, a development in the long-running story about breast implants. Here to tell us about it is Susan Dentzer of our health unit, a partnership with the Henry J. Kaiser Family Foundation.
JIM LEHRER: Susan, the development was the report of four neutral scientists to a federal judge in Birmingham. What did that panel say?
SUSAN DENTZER: Jim, the panel was asked to look into a highly contentious area involved in litigation concerning silicone breast implants and the effect on the human body. In effect, this area had to do with whether silicone breast implants seemed to cause - whether there was any causal connection between implants and so-called "connective tissue" diseases, systemic illnesses that have to do with the immune system, specifically illnesses like Lupus, like Scleroderma, which is a hardening of the skin and of the organs, like Rheumatoid Arthritis. There had been a lot of contentiousness around whether the research indicated there was a link or not, and the judge asked the panel to look into this.
JIM LEHRER: Go ahead.
SUSAN DENTZER: What the panel said, in effect, was that looking at all the studies that had been done over the years on this, there was no consistent, clear scientific evidence that showed a link. They did not look at other issues. They did not say that, for example, silicone implants are free of harm. They did not say they don't rupture and sometimes cause problems from that. They looked solely at this area of connective tissue disease, in particular, and said there's no consistent clear link.
JIM LEHRER: Now, the reason this is important and the reason the judge asked them to do this was because -
SUSAN DENTZER: Because of this huge controversy and because -
JIM LEHRER: And the lawsuits out.
SUSAN DENTZER: And because of so many lawsuits that have been brought. In fact, there are now actively an estimated ten to twenty thousand lawsuits involving silicone breast implants. Many, many more have already been disposed of, settled, and whatnot. And in one particular case involving one of the manufacturers, Dow Corning, there is now a proposed settlement on the order of magnitude of $3.2 billion that would deal with an estimated 170,000 claims that have been brought involving alleged instances of Dow Corning implants.
JIM LEHRER: And that proposed settlement would give claimants anywhere from $5,000 to $100,000, depending on how the thing was adjudicated?
SUSAN DENTZER: Well, actually up to a little bit more than $300,000.
JIM LEHRER: $300,000.
SUSAN DENTZER: Yes, assuming they could show some legitimate evidence of disease.
JIM LEHRER: Now, how does this report yesterday affect that kind of thing?
SUSAN DENTZER: Well, the manufacturers, of course, instantly issued press releases claiming victory. They had always pointed to the ambiguity around the medical evidence here and were willing to proceed with settlements in spite of that. They now hope, for example, in the case of Dow Corning that the 170,000 claimants will now vote to approve the settlement once it goes through a couple of other procedures in court and that basically people will determine that because of this ambiguity around the scientific evidence it's in their interest to proceed with a settlement and be done with it. On the other hand, I spoke today with one of the attorneys for the plaintiffs who said that in his opinion the majority of cases that his firm is handling will, in fact, continue to go forward because they don't necessarily involve this area of allegation of connective disease. They, rather, involve things like rupturing, pain, chronic inflammation, and many other things that are claimed to stem from implants.
JIM LEHRER: But the connective tissue issue would be - the way this report would be handled in any case, whether it's Dow Corning or any of the other lawsuits, it would just be part of the evidence, would it not? There's nothing official about that.
|An original study.|
SUSAN DENTZER: Yes, indeed. And, in fact, the judge specifically said when this panel was appointed that this panel should be viewed as four additional witnesses in the case. This is not an attempt to wipe out litigation or solve things for all time, and, indeed, it won't do that.
JIM LEHRER: Why won't it do that? What still remains to be resolved here?
SUSAN DENTZER: The panel pointed to a number of areas that are problematic. One question is how good were the original studies that they looked at in the first place? Keep in mind they didn't do any new studies. They looked at all the studies that have been done to date, some of which are quite small and have been known to be flawed for various reasons. They looked at - put together many of these studies in a statistical technique called meta analysis, which has some potential problem with it and will be closely scrutinized by lawyers, who are going to be interviewing these panelists over the next couple of months. There are other studies that will be coming down the pike. For example, the National Institutes of Health has a very broad study underway under congressional mandate.
JIM LEHRER: This is an original study. This is not a complication study, an overview study, right?
SUSAN DENTZER: That's exactly right. This is basically a new set of studies, as well as a look at former studies. In attempting to determine whether a whole range of disease conditions are linked in any way to silicone breast implants, that will be coming out presumably sometime next year, so there's much more yet to be said on the subject, and I think that it's very clear that as much as each side wants to claim some victory here, that's really - it's really not accurate to say that that's possible at this point.
JIM LEHRER: But how important then is this development? How would you rank it, because you've been covering this story? How would you rank this?
SUSAN DENTZER: It's important in the sense that this was a group of four sophisticated people: an immunologist, a toxicologist, who studies ingestion of diseases and harmful effects - ingestion of substances rather - an epidemiologist, serious, substantive people. These were not people who were allied with breast implants issues before. They did not have an ax to grind on -
JIM LEHRER: On either side.
SUSAN DENTZER: On either side.
JIM LEHRER: Right.
SUSAN DENTZER: So it was a very important effort to take independent, sophisticated people, and have them exercise some scientific judgment, so there's a lot of validity in what they said just on that basis. On the other hand, as I say, they pointed to some witnesses in the study. They pointed to areas that have yet to be studied adequately. And they said, in fact, quite clearly that they were not attempting to ram home one point of view or another on this. They were basically looking at the studies today and saying that there was no consistent scientific evidence showing a causal link.
|Billions of dollars.|
JIM LEHRER: I know there are billions of dollars involved in this. Is there a ballpark figure about how many women are actually involved in this, who have made claims or have some kind - who are in some way attached to one of these claims or lawsuits?
SUSAN DENTZER: It's very hard to get one's hands around - as I say - in terms of active lawsuits, the number appears to be anywhere between ten and twenty thousand. Again -
JIM LEHRER: Now, some of those involve more than one patient, right?
SUSAN DENTZER: Well, ten or twenty thousand lawsuits, which may - as I think - as much as we can say - on the basis of what we know. What we also know, though, is that it - just in the case of Dow Corning it's 170,000 individual claims have come in. And so your guess is as good as mine. I think it's basically about a couple of hundred thousand women, and, of course, many of these cases have already been decided and disposed of.
JIM LEHRER: All right. We have not heard the last of this.
SUSAN DENTZER: Not at all.
JIM LEHRER: Susan, thank you.