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MARGARET WARNER: Now, the controversy over whether to let silicone breast implants back on the market. Ray Suarez has that.
RAY SUAREZ: More than a decade after silicone breast implants were banned from much of the U.S. market, an FDA panel voted yesterday to approve their use again. The advisory panel voted 9-6 to recommend that a new generation of implants should be made available for breast enlargement or reconstruction. Nearly 240,000 American women a year seek cosmetic enhancement from saline implants. Another 70,000 get implants after a mastectomy. The new silicone implants are made by a California company called Inamed Corp. The FDA first restricted the use of silicone implants in 1992 after thousands of women complained of ruptures and leakage and said the implants were linked with autoimmune disease. The government limited further use of silicone implants to women who had undergone mastectomies or were in clinical trials.
But several studies since then could not find a definitive connection between the implants and disease, including a large review of many studies by the institute of medicine in 1999. An Inamed study of more than 900 women with the new implants found that more than 90 percent were satisfied, but it also found that between 20 percent and 40 percent of women required a re-operation within three years. Over the past two days, the panel heard emotional testimony from more than 100 women on both sides of the issue.
PAMELA DOWD: The silicone in my chest and vascular system will never go away. My chest constantly itches and burns from the residual silicone. My bones still scream with pain. In 1995, when I underwent explantation, my chest had to be scraped and cauterized to clean out the residue of the previous ruptured implants.
LISA BANARZ: I’m thrilled to have my silicone gel implants. My breasts are soft and feel like natural breast tissue. I’m extremely satisfied with the surgery and would not hesitate to have the procedure again. I would strongly recommend silicone gel implants to friends and, yes, even my daughter if she expressed an interest at an acceptable age.
RAY SUAREZ: The panel approved the implants but only with long-term tracking of patients’ health. The FDA is not bound by the recommendation, but usually follows the lead of its panels.
RAY SUAREZ: More now on the panel’s decision and its impact on women. Dr. Scott Spear is the chief of plastic surgery at Medstar- Georgetown University Hospital. He is also a consultant for Inamed and will monitor the company’s ongoing clinical studies. And Diana Zuckerman is a scientist and president of the National Center for Policy Research for Women and Families. She is a former congressional staff aide who first brought the issue to national attention more than a decade ago.
Dr. Zuckerman, since that time, has enough research been done to look into the complaints that women had in the early ’90s, the panel has made its vote, though not unanimously. What do you think?
DIANA ZUCKERMAN: The good news is that there is research that’s been done now. In 1990, there was no published research. Now there are studies, and they really do show that there is not much concern about diseases in the short term. But the problem is we don’t know very much about what happens after seven or ten or 15 years. The kind of testimony we heard the last couple of days, a lot of those women had … were very happy with their implants for the first few years, but after 15 or 20 or sometimes 25 years, had really terrible problems when the silicone implant broke in their body.
RAY SUAREZ: Dr. Spear, even some of the panel members who voted to remove the heavy restrictions on the use of silicone implants noted their own concern about the lack of long-term data.
DR. SCOTT SPEAR: Well, the long-term data is sort of a Catch 22. If you have a device you bring out today and you want to use it if you have to wait 25 or 30 years for long-term data, by the time you have that data, that device will be obsolete. So unfortunately, you have to find a balance somewhere. I don’t think any surgeon, or any scientist would not want long-term data. The question is: How much data do you need? How long do you need it before you can go ahead and do something in and I think the panel rightfully struggled with that issue yesterday, and I can understand why they struggled with it. I think, as a surgeon, you’d want to know that what you use is as safe as possible. The question is: How much information do you need before you know it’s safe?
RAY SUAREZ: Well, how much information do you need? People want the benefits that they perceive that the product, silicone implant, will bring them. How much more research would you really want to see?
DIANA ZUCKERMAN: I think the greatest controversy is that this is an implant that’s been on the market for 40 years now, and it’s changed over time. But the implants that are being sold in recent years, and the ones that Inamed would like to bring to the market are very, very similar to what was sold ten years ago. So our question was: Why didn’t they study these ten years ago? Why didn’t they start studies in 1990 and finish them last year so that we would have 12 years of research data?
Instead, they had a study they started in 1990, and they just lost track of the patients. They ended the study after five years with almost nobody in it. So maybe 30 years is too much to expect I’m sure most people would think so. And perhaps 20 years is too much to expect. But I don’t think ten years is too much to expect for a product that’s been on the market that long.
RAY SUAREZ: Let’s take these points one by one. Has the product been redesigned in ways to answer some of the complaints that were heard about them in the ’80s on the ’90s?
DR. SCOTT SPEAR: Well, I think it’s clear that the device that this company is trying to bring to market is an improved version of a device that was available in 1990. But it’s not a totally different device. It’s a similar device, much like an automobile that’s a similar model, but they’ve made changes to it. It’s been improved in terms of the thickness of the shell, which in theory should make it sturdier, and the cohesiveness of the gel inside, which in theory should make it less likely to travel anywhere. And it probably will work better. Again, the only way you can get ten years’ data is to get ten years’ worth of data, and I frankly agree with Dr. Zuckerman that I wish we have had ten-year data today. And it’s a shame that those kinds of studies weren’t started in 1990 or ’92. But there are a lot of things that happened during that time, frankly, both legal and regulatory that frankly made it so it couldn’t happen.
But the FDA has been given a mandate by this panel to work with this company to answer these questions, and I’m hopeful — honestly I’m hopeful that some of these things can be answered in an expeditious fashion. For example, these devices are available in Europe and have been since 1990. There are patients walking around with these devices for ten and 12 years. It’s not impossible to look at that population, even though it’s in Europe, if the FDA and the manufacturer can work together and answer some of the questions a little quicker than waiting another six or seven years.
RAY SUAREZ: If you were to do that, Dr. Zuckerman and add the limitations put on this … the use of the device now suggested by the panel: Consent forms; educational material for women who are choosing to get the implants; annual exams recommended; the quick removal of ruptured implants. Does this meet halfway some of your concerns about needing as much data as possible?
DIANA ZUCKERMAN: Sure. It certainly meets some of the concerns. I do want to mention, though, that the company’s own data that they presented the last couple of days did talk about some new results that were surprising to me, and I imagine to Dr. Spear. They found that, on many different symptoms that some people think could be early signs of autoimmune disease, things like fatigue and joint pain, hair falling out, rashes, that there was an increase in those kind of symptoms among women before they got the implants, compared to two years later. Now, two years is not a very long time, and even in that short time, there were increases in those symptoms. Also, they asked questions about quality of life, mental health questions, self-esteem. And again, I’m sure they expected to find that the women felt better about themselves, felt better in general two years after getting the implants, compared to before. But in fact, what they found on most of these measures, the women felt not as good. There was a decline in those measures, and the one thing they felt better about was their sexual attractiveness in terms of their body. That — they did feel better.
But in terms of self-esteem, in terms of how they felt about social interactions in their lives, they felt worse. So these are signs that are a little bit worrisome. We don’t know what they mean, and I think it is unfortunate to think about studying them on women who, you know, might go in to this thinking that this is a safe implant if the FDA has approved it, because that’s the seal of approval, and we might not find out till years later that maybe it’s not as safe as we would like it to be.
RAY SUAREZ: Dr. Spear, is that a fair description of the results?
DR. SCOTT SPEAR: Well, it’s interesting. To drill into the detail here a little bit more, the FDA asked the manufacturers to collect a long list, sort of a laundry list of symptoms — frankly, not looking for the data. They asked them to direct this list so that if there were people that had a lot of stuff, they could then refer them to rheumatologists to see if they had a problem. In fact, virtually no one wound up in the study as being diagnosed with a problem. But the FDA and the manufacturers are left with this laundry list of symptoms, now they don’t know what that means, and frankly, I don’t think anybody knows what it means. One of the things you learn in science, is the more questions you answer, the more questions you find to answer. So I think what was proposed by the panel was if we really wanted to look at symptoms, we’d have to have what we call a control group because what this did was track people over three years to see if they had any new aging symptoms compared to three years ago, and frankly it’s not surprising that most of us get worse with time. So the question is: Is this more worse than people who were just getting three years older?
RAY SUAREZ: David Feingold, the director of the FDA Center for Devices and Radiological Health, in response to this new hearing and the panel recommendation and the questions that are being raised said, “it is reasonable to let consumers decide if they want to take the risk for the potential benefit.” When you’re looking at a medical device, is that a fair standard to use?
DR. SCOTT SPEAR: I have to tell you that I feel pretty strongly — this may surprise Dr. Zuckerman — that I think the labeling for this device has to be very emphatic, that because unlike other devices it has its own sort of biology. It is a lifelong device we believe for most people from 30 on. They replace it with a new device, much like we’d replace a dental cap or something like that, but they need to understand that what the known risks are and what the things we don’t know about it. I think patients should really be informed because we don’t want to have people thinking that once the FDA has approved it, that it means it’s okay.
RAY SUAREZ: Dr. Zuckerman, same question.
DIANA ZUCKERMAN: The one thing I do want to point out about the vote that I think is interesting is that the plastic surgeons on the panel all voted to approve the product and the majority of scientists and other doctors on the panel voted against approval. I think there’s really a different perspective on what’s acceptable risk for a product that really is cosmetic. And so of course there has to be a risk-benefit and every product has risks. But when you look at the benefits and when you look at the alternatives, I think the question is: Is it worth having perhaps millions more women getting silicone gel breast implants before we know what happens to it if it breaks inside the human body? And actually a big issue that was talked about is that, when it breaks, women, don’t always know that it’s broken, it a lot of times there’s no symptoms and then it can leak into the lungs, into the lymph nodes and go throughout the body. So that’s important.
RAY SUAREZ: Dr. Zuckerman, Dr. Spear, thank you both.
DIANA ZUCKERMAN: Thanks.
DR. SCOTT SPEAR: Thank you.