Transcript - Breast Implants - McNeal/Lehrer News Hour - September 13, 1995

Silicone Gel Breast Implant Litigation
The McNeal/Lehrer News Hour
September 13, 1995

39:20 - 49:28

Jim Lehrer: Next tonight, the controversy over silicone gel breast implants.

Three years ago the FDA put tough limits on their use. But those three years have brought new research and complicated legal developments. Elizabeth Brackett of Chicago Public Television station WTTW has this update report.

Elizabeth Brackett: Dr. David Ross is one of Chicago's busiest plastic surgeons. This was his fifth breast implant surgery of the week. Though he used to do more, before the Food and Drug Administration in 1992 limited the use of silicone gel for implants. Now Dr. Ross uses saline or water filled implants, but he would like to still be using silicone gel. He thinks the results are better and he is convinced silicone gel is safe.

Dr. David Ross: I think that they are one hundred percent safe. I believe in the studies and I believe in my own personal experience and the experience of my colleagues in this field and we're all, I'm sure, very confident that this is a good product.

E. Brackett: Dr. Ross's confidence was bolstered further with the release of several recent studies. Studies by both the Mayo Clinic and the Harvard Medical School published in the New England Journal of Medicine, found no association between silicone gel implants and connective tissue disease. A somewhat surprising finding because of the many cases of the disease reported by women with those implants.

But Doctor Matthew Yang, one of the co-authors of the fourteen-year Harvard study that looked at the medical records of eighty-seven thousand nurses in the Boston area says they concluded that connective tissue disease was no more likely to occur in women with silicone breast implants than in the general population.

Dr. Matthew Yang: We found in a very large group of nurses who had breast implants that there was no increase risk of having connective tissue diseases like rheumatoid arthritis, scleroderma, systemic erythematosus and other connective tissue diseases.

E. Brackett: As a result of these latest studies plastic surgeons and others have begun to question the 1992 decision by the FDA to limit the use of silicone gel implants. In early August a congressional subcommittee called in FDA chief, David Kessler, to explain why there had been no change in the FDA position. Kessler told committee members he had made the initial decision because breast implant manufacturers and not supplied him with enough data on the implant is safety. And despite the recent studies, Kessler says, he still does not have that information.

David Kessler: The Harvard nurses study is a good study as I said this morning. I mean it does provide that, with the Mayo Clinic study, it provides reasonable assurance. If you look at from a epidemiological point of view, it provides reasonable assurance, that there is not a large increased risk of typical connective tissue disease.

Rep. David McIntosh: It looks to me like we're being asked to study this literally to death in order to prove something that is perhaps statistically unprovable. And I think the chairman's question is a good one: How many more studies will we need all of which conclude that there is not a connection before the agency is willing to make that statement and go forward with the product approval.

D. Kessler: Look as a doctor I would love to be reassuring, you always want to be reassuring, you always want to tell patients don't worry. The chairman asked us to come and talk about the state of the science, very detailed analysis of the state of the science. I think it answers some questions, doesn't answer others. It allays some concerns, but it raises other concerns.'

E. Brackett: Silicone gel implants are still available for women who want them for breast reconstruction following cancer surgery or an accident. But the women must agree to enroll in a nation wide study conducted by the Mentor Corporation an implant manufacturer.

The FDA approved the protocol for the study and hopes it will help determine whether or not the implants are safe, but the results won't be available for at least the next five years. And that's not the only reason the FDA has held off on a final decision on whether or not silicone gel implants are safe.

The FDA is also feeling the pressure from the large number of women who say their implants made them sick. Forty-one-year old Laura Tufano was in good health before Dr. Ross performed breast surgery with silicone implants five years ago. Now she and her husband struggle to pay the medical bills from all the problems she has had since then. Her first attack occurred about a year after she had gotten the implants.

Laura Tufano: My throat closes up and I feel like I'm suffocating, and my face, I get hives on my face and my chest and I've had where I went to the emergency room where my tongue was swelled shut in the back of my throat and it's an ongoing thing and it doesn't stop. You know I'm always feeling like I'm going to suffocate as I'm doing any part of my day.

E. Brackett: Tufano has had frequent attacks since then. She also suffers from chronic fatigue syndrome and generalized aches and pains throughout her body. At first none of Tufano doctors recognized any links between her illnesses and her breast implants. She was then referred to rheumatologist Dr. Carrie Dachman. Dr. Dachman has treated over two hundred women complaining of illnesses following silicone gel implant surgery.

Dr. Carrie Dachman: They present with generalized aches of pains and memory loss and it's my hypothesis as well as others that perhaps there is significant sleep dysfunction triggered by an immune response of the silicone. The end result is severe fatigue, memory deficit, and disability.

E. Brackett: These are pretty amorphous symptoms, right?

C. Dachman: That's correct.

E. Brackett: I mean they're pretty hard to link through cause and effect?

C. Dachman: That's correct.

E. Brackett: When did you first start thinking that this could be because of the silicone gel implants?

C. Dachman: You know I must tell you when it was first deposed in a legal situation for silicone, I didn't believe there was any association between implants and disease. Then I began to see patient after patient after patient, now out of two hundred and fifty patients, two hundred and twenty-five give me the same exact history. On the basis of that I've recognized that something is going on.

E. Brackett: But Dr. Dachman says he agrees with the Mayo and the Harvard nurses study findings, that these women do not have evidence of connective tissue disease as a result of their implants.

C. Dachman: However, there is a strong relationship between implants and this obscure fibromyalgia or chronic fatigue syndrome which was not addressed in this particular article. Harvard study author Dr. Yang, said they did look for some atypical connective tissue disease symptoms.

M. Yang: The problem is that the people who think that this causes a unique syndrome really haven't defined it very well, and the real question is whether those atypical features occur more frequently in women with implants then those who don't. Things like fatigue and difficulty with concentration which has been reported in this unique syndrome are very common symptoms, I have them from time to time, and the question is whether it occurs by chance or any more frequently in women with breast implants.

E. Brackett: Laura Tufano and 440,000 women like her did not think their illnesses had occurred by chance. They sued. And last September the breast implant manufacturers agreed to pay out 4.2 billion dollars in the largest product liability settlement in U.S. history. But so many women filed even the 4.2 billion will not be enough to pay all the claims. And the settlement is now in danger of falling apart. Plaintiffs like Tufano are not sure when or if they will ever see any money to help pay for their medical expenses. That angers Tufano's husband.

L. Tufano: We have collection agencies calling us up and 'what about the bill when she was in the hospital and this and that.' You give them so much a month, but these hospitals are something else. But I really believe, I think that something should be done, I mean it has to be done. There's lots of people like my wife out there and they should be compensated.'

E. Brackett: The pay out is stalled in part because in May, Dow Corning filed for a Chapter 11 bankruptcy. Richard Hazleton chairman and CEO of Dow Corning, once the largest manufacturer of silicone gel implants told the sub-committee after the FDA limited silicone implants his company decided to get out of the business all together.

Richard Hazelton: From a business judgement and viability point of view for my company it was our conclusion that we could no longer participate in that business, but it was also our judgement based on the way things developed after the FDA moratorium, that there was not going to be a viable business for silicone breast implants at least for the foreseeable future.

E. Brackett: Tufano's attorney, Kenneth Moll, called the action cynical.

Kenneth B. Moll: By Dow Corning filing bankruptcy they've manipulated the legal system to avoid their responsibility in paying compensation to implant victims. Women are frightened, they're aggravated. They have been waiting years to receive compensation to have their implants removed and to pay for the cost of the medical treatment from the injuries that they received and now they don't know where to turn to, to receive compensation.

R. Hazelton: Our intention in our bankruptcy process now is to still try to find some resolution including some kind of a global settlement, a modification of the original one, perhaps something different, but something which fairly and equitably deals with all of the claims that are valid of all women, those that were members of the settlement class and those who were outside of it.

E. Brackett: The U.S. District Judge who oversaw the breast implant global settlement says he will make a decision by the end of the month as to whether or not the thousands of women in the settlement can opt out and file individual suits against the manufacturers. Though that can mean more bankruptcies among the remaining manufacturers and lengthy individual trials. All of which lessens the chance for women who say they were injured by their implants of ever receiving any compensation.