Silicone Gel Breast Implant Litigation
The Aaron Freeman Show
January 26, 1992
18:50 - 44:48
Aaron Freeman: I love bionics, you know the Six Million Dollar Man, RoboCop, and the like. Bionics is where they take inorganic parts and have them carry out human functions. Sort of like Quayle in the White House. I once had a bionic cat, this is true, had little cute furry bionic feline with an electronic purr and a remote control unit. The cat still wouldn't come when I wanted him to. Scientists in England, this is also true, scientists in England have recently announced a bionic brain cell that mimics in many important respects the function of a human brain cell, but of course this is just a piece of animated plastic, which again brings us back to Quayle. Speaking of body parts, perhaps the part of the body which has received the most attention recently is the part that generally receives a lot of attention anyway from girl watchers. I'm of course referring to the female breasts and the implants which for many years have been used to enlarge and enhance breasts for varying reasons. Concern over the safety of silicone breast implants have now been raised and after this break, we'll return with an attorney representing women who've experienced serious side effects from implants and a women who underwent breast reconstruction. Back in a moment.
And now let's meet our guests. Ken Moll is an attorney with the law firm of McDowell & Colontoni and the leading advocate for women who have experienced serious health problems from breast implants. Ken is also a member of the breast implant litigation group of the association of the Trial Lawyers of America. And Margie Bernard is the healthcare consultant and also a national trainer for the Y-Me Breast Cancer Support organization. Margie herself underwent a bilateral mastectomy and received breast implants four years ago having had no problems since. I want to thank you both for being with me. Now Ken, what is the current state of, after the FDA. What's the FDA's current position on the implants? When will they make a final ruling as to the safety.
Kenneth B. Moll: They may never make a final ruling as to the safety, but as of now there is a 45 day moratorium. In other words, Dr. Kessler's asked the manufacturers to stop manufacturing the implants, the silicone gel implants, and the physicians and the American Society of Plastic and Reconstructive Surgeons, not to implant the silicone gel implants. Just the silicone gel implants, not the saline implants.
A. Freeman: Now is this a suggestion, this, there's no penalty if they do continue to do it.
K. Moll: There's no penalty as of yet, however, Dr. Sidney Wolf from Public Citizen Health Research Group believes that any doctor who implants a silicone gel implants after this suggestion is possibly committing malpractice.
A. Freeman: All right now, can we so briefly, can you run through us as far as the different kinds of implants that are available. There's silicone.
Margie Bernard: Well I think today the most common models that we're talking about are the implants that are first devised to have inside them, soft silicone gel.
A. Freeman: I actually have one of these, I have it in my hand here.
M. Bernard: That's a very good illustration for the audience. The second type of implants that patients or individuals may be familiar with is what we refer to as a double-lumen implant. That is an implant that has an inner envelope that contains silicone gel and an outer envelope of saline.
A. Freeman: So it would be like this one here and around it . . .
M. Bernard: There's a second envelope
A. Freeman: OK.
M. Bernard: The third type is the type that is now being mentioned by the FDA as an alternative during this period and that is an implant whose composition inside is largely saline or what the public knows as salt water solution.
A. Freeman: Now, with the implant itself, I think we have a slide here of how this works. That the implant is surgically inserted within the breast.
M. Bernard: They're typically two positions that may be used by the plastic surgeon who's implanting a device. Years ago it was common to put the device right beneath the tissue of a woman's chest.
A. Freeman: All right.
M. Bernard: More commonly today, the plastic surgeon lifts up what we refer to as the pectoral muscle . . .
A. Freeman: OK
M. Bernard: . . . and the implant itself rests against the chest wall with the pectoral muscle serving as a sling to help hold it in place.
A. Freeman: That's the slide on the right here.
M. Bernard: Correct. And that leads to a better appearance on a post-op basis.
A. Freeman: OK. And now the silicone implants are generally considered to be more cosmetically effective, is this true.
M. Bernard: I think the term cosmetically effective may not be as suitable as what patients understand and that is a goal to have here. Normal appearance of the breast on a post-op basis whether the implant is placed for augmentation or enlargement purposes or reconstruction following cancer surgery.
A. Freeman: Now, Ken, as far as you know to what extent do implants, silicone implants been actually tested?
K. Moll: There is to date no substantial long-term tests or studies conducted by the leading manufacture of the silicone gel implant, that's Dow Corning Corporation. They have been on notice that this might cause adverse reactions and they have memos, internal memos that was eluded to by the New York times, just recently in the Wall Street Journal, that we could not talk about because these documents are under protective order and one of the reasons why Dr. Kessler has asked for this moratorium I believe is so he can lift this protective order. . .
A. Freeman: And he is the . . .
K. Moll: . . . the commissioner for the Food and Drug Administration. He's the one who asked for the moratorium and the reason being I believe is to lift the protective order so he can see for the first time all the documents that were used to get a 7.34 million dollar verdict in California, when the jury saw those documents. A 4.5 million dollar verdict in New York when the jury saw the documents and a 5.4 million dollar verdict.
A. Freeman: Ms. Margie, is this your understanding as well that there is no . . ..
M. Bernard: I have to differ on this point because there's a mis-characterization of the facts. As a person who has been in healthcare administration for 15 years and who has worked extensively with the physicians and hospitals' organizations. We have a tremendous array of scientific data that is out there. None of which suggest that where the patient who have implants devices give any evidence that they cause cancer in women that they are solely are responsible for auto-immune disorders or that they trigger joint disorders or inflammation. I'm not telling you that there are not women who have these disorders but we're lacking firm data, that is non-legal in nature and that is non-emotional as people would appeal to a jury to show that scientifically these can be caused exclusively by implants themselves.
A. Freeman: Now you wince when you speak.
M. Bernard: Yes.
A. Freeman: Can you just briefly give us your story.
M. Bernard: Certainly. My own experience is that in 1987 I had a history of multiple breast masses that couldn't be seen in mammography because I had not one but 3 cases of breast cancer in my family. It was suggested as a surgical alternative that I undergo what's known as preventive mastectomy. I represent a silent majority of women around the country because the current controversy as described by the FDA would make it seem that only women with augmentation needs or women who have reconstruction needs after cancer are potentially users of these devices. Since 1987 which was 4 years ago, I've had 4 years to nationally counsel women who are making decisions on treatment and I think we're all amazed with this sudden information that we're being told is new coming from Dr. Kessler that suggests a strong pattern of problems. The entire healthcare community nationwide is extremely disappointed because we have established medical protocols that say if you have scientific data that suggests harm, this is brought into the public arena. You publish your studies in the New England Journal of Medicine, The Lancet, you subject this data to major medical centers to evaluate independently and we've not seen such information forthcoming from the FDA or from the lawyers groups. I'm not going to tell you some people haven't had problems but the questions is can you say are they caused by implants. That's a very difficult allegation to substantiate.
A. Freeman: We'll let you jump in here Ken, for just one second, we will let you jump in in a second, but first we'll take a break and we'll be right back with our guests.
-commercial break -
A. Freeman: Well now you wanted to respond, you wanted to respond to what Margie had said.
K Moll: Yes, with all due respect to Margie's response, it was a response that with blinders up. And a lot of the public is unaware that documents that lawyers have seen through the discovery . . .
A. Freeman: Dr.
K. Moll: through the court file.
A. Freeman: Ok
K. Moll: Now, as I was alluding to before, jurors have seen that and have assessed punitive damages, not just compensatory damages, in other words, they have found that the actions of Dow Corning was so beyond the realm of their corporate policies as to be, to assess punishment to damages against the corporation. Now, what we're trying to do is lift that protective order, let the general public see these documents and let them decide for themselves and I think they'll be alarmed with those documents, allude to.
A. Freeman: It seems to me, that the hoopla or the massive attention that has been attended to this issue is creating a lawyers wet dream. That there's going to be suits just forever of people that are going to be suing for all kinds of for every plastic surgeon is going to be looking at giant lawsuits, isn't this just going to be the case?
K. Moll: We're not suing the plastic surgeons, we have yet to file a lawsuit against the plastic surgeons because we believe they're operating in the dark also.
A. Freeman: OK.
K. Moll: So manufacturers that did not share this information with the FDA with the medical community and therefore the clients are not making an informed consent. There's been a large experiment done on the women in the general public and the women are being used as guinea pigs and that's essentially what's been happening.
A. Freeman: Margie, I'm curious now, assuming that there's a ban for example let's say that implants are banned, silicone implants what would be the affect on women?
M. Bernard: I think there's some very tragic consequences that could be forthcoming from FDA policy and we have to keep in mind that at a national level it's the job of the FDA to safe guard the American public's health. What they have in fact done in this environment is create a very heightened anxiety among the patients as well the families. In terms of what may happen, first of all we have 1990 American cancer statistics that show we now have 5.2 million women in our country who are part of early detection and treatment programs for breast cancer. I stress early detection because when breast cancer is found at the stage when it's still microscopic, or extremely small, we're talking about a 95% cure rate. We're already seeing a pattern of women around our country, it's a technological move backward. Where they are hesitant or refusing to come into physician offices for early exams for mammograms out of fear that reconstruction using silicone implants which is the simplest and medically most safe kind of reconstruction will not be available in the future. Now many people argue that there are other types of reconstruction that can be done.
A. Freeman: Right, right.
M. Bernard: One of them is what we refer to as tissue transfer, where you take a segment of the women's skin and create a flap straight to the chest or with the abdomen. Many people are not willing to acknowledge that these types of procedures carry with them a much higher surgical complication rate, they're much more costly with the length of time with the patient in the hospital and I think it's important to realize I myself would not be a candidate for that kind of procedure because the procedure by definition suggests an excess of tissue in one part of your body that can be transferred. So these are some real dangers. If the FDA truly had safety information about their harm, we would immediately and the lawyers would be part of this effort, would be wanting to have a ban nationwide on all devices that have silicone.
A. Freeman: . . .Ken
K. Moll: There's an alternative to the ban, informed consent. A period of informed consent by the women. You have a silicone implant here and a saline implant here. We're missing that the fact that there's a viable alternative, saline implants. Tell the women that here is your silicone implant. If may cause human adjuvant disease, connective tissue disorder, auto-immune deficiency, scleroderma, sjogrens
-commotion-
K. Moll: . . . cancer and
A. Freeman: . . . you can wait your turn, I'm with you.
M. Bernard: I have to challenge the fairness of it because in our current way of collecting and analyzing health care statistics, we do not have a substantial body of information to make those allegation. We have anecdotal cases of . . .
K. Moll: Dow Corning, right, does.
M. Bernard: . . . is 2300 people as opposed to 2 million women in this country who have a very satisfactory experiences that is .0001% or 1 in ten thousand. I realize Ken's concern and I fully support informed consent when patients, especially women, make choices but having been on the hospital side for 15 years, I know the extremes to which physicians and hospital administrators around the country go through to sit down and tell patients the alternatives. The problem that you have with medical treatment is that often in the crisis of illness, much of what you give patients as to what his options are at the time of surgery is overwhelming and more than a patient can disseminate at that time. Patients don't have the luxury to choose when they get breast cancer. They may have to make decisions in a matter of days or weeks. And our physicians by and large have done an outstanding job to say 'here are the concerns, what is your choice?
A. Freeman: Would you be sympathetic to perhaps a man on say silicone implants for cosmetic use or to have them still be available for medical re . . .
M. Bernard: No. That is totally inadequate because if we're talking about taking breast implant and restricting them in the near future only to breast cancer patients as opposed to augmentation patients. First and lawyers should be very sensitive to this, we're discriminating against women based on different classes of their rights. The second issue that's important is if, 80% of the implants are currently manufactured for augmentation purposes, manufacturers will not have a sufficient volume of business to continue making the device.
A. Freeman: Ken, aren't you sensitive to the needs of . . .
M. Bernard: I wouldn't want Ken . . .
K. Moll: If there was no viable alternative, yes I would be sensitized. But there is a viable alternative, saline implants. I don't understand why it is that we have to subject women to an experimentation by Dow Corning and the silicone implants when there is saline implants which is made of saline solution, salt water solution what the body is made of.
A. Freeman: As I understand it, no more women are being forced to choose saline implants.
M. Bernard: During this moratorium . . .
A. Freeman: Silicone implants. They're not being forced to it. I'm sorry
M. Bernard: During this moratorium
K. Moll: But they're not being given all the information and of the studies conducted by Dow Corning, and I can talk about it now because it was in the New York Times, is the fact that they conducted a study on rats that showed that the silicone caused cancer in those rats. Internal memos said we ought to look into this and do more studies, were they done, no. There are also studies conducted by Dow Corning that say 'hey this silicone is causing an immunological response in the women' in other words their body is looking at other body tissue as foreign and attacking it.
A. Freeman: Hang on, hang on Ken, you can jump on him in just a second.
M. Bernard: Thank you.
A. Freeman: We'll be right back after this break, she'll jump on him. Just dive in there, he can handle it, he's a tough guy.
K. Moll: I have the same . . .
A. Freeman: No, no. I'm kidding, we really don't want any blood here. But you said you wanted to ask a question Ken.
K. Moll: To Margie. There's been shown through the silicone implants you had mentioned you've had them in for 4 years . . .
M. Bernard: Correct
K. Moll: Some of the studies conducted show a latency period of 5 and as high as 25 years. My question is what do you do when you start experiencing some of these reactions. Do you deny it as something in your history or do you say 'hey, there might be a problem with these silicone implants, I'm going to do something about it.'
M. Bernard: Well I think certainly there's a possibility in the future that any person who has any kind of medical or surgical procedure may some day have a consequence or a sequel from it. I think having been very carefully developed my entire professional career in the healthcare industry, I'm the person that stops and tries to rule out the more common kinds of things that may be causing them. Certainly many patients with breast implants today, the 2300 group that I refer to, are reporting what we call chronic fatigue syndrome, cases of joint inflammation. These are extremely difficult disorders to trace back to any one device that has been put in a person's body. And I think that the lack of scientific data is something that people in the American public are concerned about.
A. Freeman: Let me, let me, now you said of course that anybody that undergoes a surgical procedure risks certain reactions, why risk, why are women risking this. What's wrong with like, I don't mean to be flip, but like padded bras. I mean, why risk a surgery . . .
M. Bernard: Well, I think for many centuries and certainly in the decades that I've been alive there's this stigma where people think much of what a woman does to her body is for the gratification of other people in her life. When we talk about breast cancer cases or women who've had breast enlargement, we're talking about the important role in rehabilitation of restoring a women's appearance to near normal after she has been through a major experience in her life such as cancer. For people who have had augmentation, there's significant studies that these kind of devices, just similar to a person who would go out and have braces put on, who would have a nose straightened, who would have a face lift, it enhances their inner sense of self-esteem.
A. Freeman: Ken, you look, you can jump in here.
K. Moll: 95% of my clients did not know they had silicone gel breast implants. 95% of them did not know the reactions that would happen should they have the silicone implants. And they're just finding out, I'm getting calls on a daily basis of women saying 'I didn't know that this silicone implant would cause my joints to hurt, cause me to be bed-ridden and they're just finding this out and the public has, this is the beginning of the end of silicone implants as we see them. A lot more will come out in the future and it will inform the women that there are a lot of risks that we're taking with the silicone implants. The plastic surgeon was making the choice, cause it feels better.
A. Freeman: Is our culture putting an unreasonable expectations on women who to appear . . .
A. Freeman: In a certain way, I guess I mean, it seems like really into this breast thing as a culture and it just makes you, when you look at some of the possible repercussions of the surgery, you, I guess this is kind of a call for an opinion, I guess, but I mean, is this something , isn't there something wrong about a culture that required, that is so intent on having women with large breast that they're willing to risk their lives for it?
K. Moll: We're paying our top models more if you have larger breasts, the public, the media, everywhere you look, the models, there's an article I read yesterday . . .
A. Freeman: Dolly Parton
K. Moll: . . . .where. . ., sure, sure, Dolly Parton, Jane Fonda.
A. Freeman: I mean is this, I mean does this strike you as something slightly not right or no.
M. Bernard: Well I think it's very unfortunate that in American society, many young people today have a sense that their value comes from how they're perceived by others, but the issue . . .
A. Freeman: It's not just limited to the young people either.
M. Bernard: Well an it's not limited to women.
A. Freeman: That's true.
M. Bernard: We have many men who are going out and having pectoral implants put in.
A. Freeman: That's exactly right.
M. Bernard: And chest implants if you don't have time to get to the gym.
A. Freeman: Yeah.
M. Bernard: You can look like you've been there for weeks sweating it out. I think a real concern here though is when we talk about risks, these are very safe devices and when we compare them to other medical devices such as ocular implants, knee replacement, joints, the safety profile of breast implants is unmatched in our country.
K. Moll: This is the same argument I heard with DES, [?] and Dalcon Shield when it was later found out that they are very, very dangerous devices.
M. Bernard: Well, I think one think I've always been concerned about in health care, and you really have to stop and realize, poor outcome does not mean poor care. It does not mean the doctor didn't do his or her best and that the hospitals didn't do their best and the manufacturers didn't do their best.
A. Freeman: Let me ask, there are lots of ads out for various liposuction and various cosmetic surgeries, isn't this leaning to a lot of surgery that doesn't need to be done?
M. Bernard: I can't honestly comment personally on other types of elective plastic and reconstructive surgeries, I did not have them myself.
A. Freeman: Isn't there a lot of unnecessary surgery going on?
K. Moll: Sure, unnecessary surgery and with the silicone implants, an unnecessary risk.
M. Bernard: We have to talk though about the saline alternative that Ken mentioned. Because the American public needs to know the issue is not going to go away, the FDA is scheduling in spring, a review of the saline implants. Are we going to relive this next issue.
A. Freeman: Well you know that's . . .
M. Bernard: With saline . . .
A. Freeman: That question is where we will leave it. Thank you very much Ken Moll and thank you very much Margie Bernard.
K. Moll: Thank you.
M. Bernard: Very much.
A. Freeman: Alright.