Health Committee on June 8th, 2006

[The Chair, Conservative, Rob Merrifield]

I call the meeting to order.

First of all, we have a very interesting meeting ahead of us. I believe we've been anticipating this meeting for some time. I want to thank the Department of Health for being here, also the Public Health Agency of Canada. I will be asking them to present initially.

We have Neil Yeates, assistant deputy minister from the health products and food branch; Ms. Sharma, associate director general, therapeutic product directorate, health products and food branch; and we have the Public Health Agency as well. We have Dr. Stachenko--thank you for being here--and Dr. Mao.

We appreciate your coming forward and being able to share your insight on this issue. We're talking about the study on silicone gel-filled breast implants.

We are going to ask the department, who are at the table right now, to do their quick presentation, then we're going to go to the rest of the witness panels, and we'll ask them to retreat from the table so there's room at the table for the rest.

This is a rather special meeting, and I also want to acknowledge and thank Dr. Mitchell Brown. Dr. Brown, can you hear us and see us?

[Dr. Mitchell Brown, Plastic, Reconstructive and Cosmetic Surgeon and Associate Professor, Department of Surgery, University of Toronto]

Yes, I can, Mr. Chair. Thank you.

[The Chair, Conservative, Rob Merrifield]

Thank you, and you're looking fine. I'm glad this technology is working for us, and I appreciate your giving us your time.

After we listen to the department, we'll have you come forward in the second part, as part of the presenters in the second half of the panel, if that's all right.

Without any more delay, we'll ask Health Canada to start, and then we'll go to the Public Health Agency.

[Neil Yeates, Assistant Deputy Minister, Health Products and Food Branch, Department of Health]

Thank you very much, Mr. Chair and members of the committee. I'd like to thank you for the invitation to appear before you to provide an update on Health Canada's regulatory review of the six pending medical device licence applications for silicone gel-filled breast implants.

As you know, medical devices are regulated under the medical devices regulations and the Food and Drugs Act, which fall under the responsibility of the health products and food branch, for which I am the assistant deputy minister.

My colleague Dr. Supriya Sharma, the associate director general of the therapeutic products directorate, is joining me today.

We welcome this opportunity to come before the committee to discuss the issues raised over the last few weeks and to answer any questions that you may have.

I would like to begin by addressing the two fundamental issues raised recently, first by outlining briefly how medical devices are regulated and reviewed by Health Canada, and second, by outlining the role of external advisory bodies in this regulatory review process, and I will then conclude by providing you with an update on the status of the review of the six pending applications for breast implants.

As you are aware, breast implants—including saline and silicone gel-filled breast implants intended for reconstruction following mastectomy, primary augmentation, or for replacement—are regulated as medical devices in Canada. The importation, sale, and advertisement of medical devices in Canada are governed by the Food and Drugs Act and the medical devices regulations. Through the act, Parliament has created a legislative regime to govern the approval of medical devices for sale in Canada. This regime is given full effect through the medical devices regulations, created pursuant to the act.

Under this regime, the minister has the legal responsibility for approval of licences to permit the sale of these medical devices in Canada. In turn, the minister relies on Health Canada's scientific and regulatory expertise and its processes to execute this responsibility. Decisions are made following an independent, impartial, and objective analysis of the scientific evidence related to the safety, quality, and effectiveness of a medical device included in a licence application. Such decisions are taken in consideration of sound scientific expertise, in an environment that encourages collaboration among a team of experts skilled in a variety of fields and disciplines.

This process reflects the key principles that underpin both the integrity and quality of Health Canada's regulatory decision-making framework and the public's confidence in Health Canada's ability to fulfill its mandate and to make objective, evidence-based regulatory decisions. Health Canada's decision-making framework outlines the key principles that guide such evidence-based decision-making. These include a recognition of the need for comprehensive information; the value of team work and expert opinions, given that sound evidence-based decisions can only come from a collaborative process where varying opinions are encouraged and considered in all phases of an evaluation; and the value of the multiple disciplines of the experts whom we consult and of the Health Canada employees who contribute to our decision-making teams. Such disciplines include microbiology, material sciences, medicine, chemistry, physiology, toxicology, engineering, and ethics.

The medical devices regulations are based on a current, internationally consistent, risk-based approach. I note this point in addition to our recognition of the need for comprehensive information to support decision-making, as they are, together, the core determinants of Health Canada's regulatory approach with respect to higher-risk—or class IV—medical devices such as breast implants. The medical devices regulations and Health Canada's publicly available guidance documents outline that manufacturers of class IV medical devices must submit certain specific information in support of each medical device licence application. This information alone, in addition to any information obtained from external experts and the public, represents a very significant amount of scientific, manufacturing, and quality data, which Health Canada reviews in order to reach a regulatory decision.

I'll also note that the panel was requested to provide its advice in response to very specific questions posed by Health Canada, related to the safety and effectiveness of the silicone gel-filled breast implants described in the device licence applications—advice to inform Health Canada's assessment of those specific medical device licence applications.

The panel was not asked to make a decision on behalf of the minister or Health Canada, nor was it asked to recommend whether any of the specific products should or should not be licensed for sale in Canada. That decision is the responsibility of Health Canada alone, to make on behalf of the minister. As this committee is aware, the advice resulting from the expert advisory panel's deliberations was presented in the panel's final report to Health Canada on December 2, 2005, and, following a review for confidential information and translation, was made publicly available by the previous Minister of Health on January 12, 2006.

The panel's work is now concluded, and its report speaks for itself with regard to the various viewpoints represented on the panel. It is now being taken into consideration by Health Canada as one important piece of information, among others, in the regulatory review of the six pending medical device licence applications for silicone gel-filled breast implants.

Health Canada's decision will be based on a solid, evidence-based, scientific assessment of all the information before it. It is public knowledge that Mentor Corporation and Inamed Corporation each have separate medical device licence applications currently under review by Health Canada. The first of six licence applications was received almost five years ago. The Health Canada review team is led by two scientists, one with a degree in chemistry and the other with a degree in material sciences, and input is received from medical officers and biomedical engineers as required. Together, these individuals have more than 20 years of experience in the regulatory review of medical device issues.

Health Canada has examined more than 65,000 pages of evidence submitted by the manufacturers. Health Canada has reviewed the scientific literature, the report of the expert advisory panel on breast implants, documentation from the American Food and Drug Administration, and submissions from interest groups and interested persons. The scientific literature alone consists of over 2,500 articles, including over 300 review articles dating from the 1960s. In the interest of obtaining comprehensive information to inform the review of each of these applications, Health Canada has most recently in January 2006, during the course of these separate reviews and consistent with the advice received from the expert advisory panel on breast implants, requested that each manufacturer clarify existing information, or provide additional information. Health Canada is continuing with its reviews of these applications, and once these assessments are completed, regulatory decisions will be made in accordance with the responsibilities conferred upon it via the minister's role under the Food and Drugs Act and the medical devices regulations.

The potential decision for each application is one of the following: a licence for general sale in Canada, a licence with post-approval conditions, or a refusal to licence. Once the regulatory decisions have been made, Health Canada commits to reporting publicly to Canadians, through the publication of a summary basis-of-decision document for each application, outlining the nature of the evidence considered and the conclusions reached.

In conclusion, I would like to reiterate that the legislative regime created by Parliament and given full effect through the medical devices regulations to govern the approval of medical devices for sale in Canada and the execution of the responsibilities Parliament conferred upon the Minister of Health through Health Canada's scientific and regulatory expertise and processes is strong. It's built upon the independent, impartial, and objective analysis of evidence that is supportable and is driven by the key principles. These principles support the use of a collaborative process in which comprehensive information and varying opinions from multiple disciplines and consideration of all of the best scientific evidence are integral to regulatory decision-making.

Thank you very much, Mr. Chair. Those are our opening remarks. I do need to advise the committee that, regrettably, I have to leave after the first portion of this hearing, but my colleague Dr. Sharma is available throughout.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

We'll now hear from the Public Health Agency.

[Dr. Sylvie Stachenko, Deputy Chief Public Health Officer, Health Promotion and Chronic Disease Prevention, Public Health Agency of Canada]

Mr. Chairman, members of the committee, I wish to thank you for your invitation to speak to you about the Breast Implant Cohort Study. I am Dr. Stachenko. I am Deputy Chief Public Health Officer responsible for the Health Promotion and Chronic Disease Prevention Branch of the Public Health Agency of Canada. I am happy that Dr. Yang Mao has been able to join us. He is Director of Health Promotion and Disease Prevention at the Centre for Chronic Disease Prevention and Control. He also takes part in the cohort study as a researcher.

The Breast Implant Cohort Study is the largest study ever designed to investigate the risk of cancer and other health outcomes in women with cosmetic breast implants. The first scientific results of this study are now available. As you are aware, an article on cancer incidence was published in English in December 2005 by the International Journal of Cancer. In response to the request of the clerk on May 11, 2005, we at the Public Health Agency have secured permission from the journal's publisher to translate the article and provide it to the committee in French. I understand that the French translation has been provided to her yesterday.

As well, a second article based on the study has been developed. It concerns the relative risk of mortality from breast cancer and from other causes. This article has been accepted by the American Journal of Epidemiology and is expected to be published within the month.

The Breast Implant Cohort Study involved identifying women in Ontario and Quebec who received implants for cosmetic purposes during the years 1974-1989, inclusively, as well as gaining access to their patient records. The study includes information from over 40,000 women aged 18 years and older. It brought together plastic surgery patients records from Quebec and Ontario and linked them to the National Cancer Registry Database maintained by Statistics Canada.

The women and physicians who participated in the study were assured that the study had passed rigorous scientific and ethical reviews.

Since the study was first announced, the frameworks for privacy, information protection, and information access have evolved significantly, both within the Government of Canada and in the provinces of Ontario and Quebec, from which the cohorts were drawn. This has considerably lengthened the time it took to gain access to patients' records and to link them to cancer data, beyond what had been originally foreseen. The study data set was completed in June 2003.

Starting in 2003, our epidemiologists and their colleagues in Quebec, Ontario, and academia have been able to undertake the epidemiological analysis and the development of scientific articles more rapidly than was anticipated.

The first article on cancer incidence found that women undergoing cosmetic breast augmentation do not appear to be at an increased long-term risk of developing cancer. Overall cancer incidence rates among women who received breast implants were similar to those of the other plastic surgery patients. In fact, women who received breast implants had lower breast cancer rates than other plastic surgery patients. As well, no increased risks were observed among the implant population at the other cancer sites examined.

As well, I can very briefly outline some of the key findings of the second article on mortality, which will soon be published. Overall, women who received breast implants for cosmetic purposes had lower mortality rates than those of the general population. A lower than expected number of deaths, mainly from cancer and cardiovascular diseases, accounted for most of this reduction. The article acknowledges that self-selection is a likely explanation for lower mortality rates; women who choose to undergo an invasive cosmetic procedure are, on average, likely to be in better health than the general population.

However, it is of note, and consistent with previous work, that increased rates of suicide were observed among women who received breast implants relative to the general population, but there were no statistical differences relative to other plastic surgery patients. The authors suggest that further studies that collect detailed risk factor data for suicides among both implant and other cosmetic surgery populations may be needed.

In closing, I would like to thank you for the opportunity to share these results with you. The Public Health Agency will be providing an information circular to practitioner organizations and the women's groups who participated in the development of the study.

I'd also like to thank the committee for its interest in the agency's ongoing risk assessment and analysis efforts for cancer and other chronic diseases.

Merci.

[The Chair, Conservative, Rob Merrifield]

I want to thank you for your presentations.

I'd just let the committee know that in the briefing you received, there is one page missing—actually the best page—and we will get that to you.

Thank you very much for your presentations. After the other presenters have presented, we'll open the floor to questioning.

We would ask Dr. Chidwick if he would come forward, and Dr. Zuckerman.

We have, through video conferencing, Dr. Brown.

Dr. Brown, I appreciate your taking the time to be able to teleconference on this important issue. The floor is yours.

[Dr. Mitchell Brown]

Thank you very much for accommodating me and allowing me to be a part of this committee meeting today from my hospital here in Toronto.

Mr. Chairman, members of the Standing Committee on Health, thank you very much for inviting me today to address the committee and respond to your questions.

Let me begin by introducing myself. I am a plastic reconstructive and cosmetic surgeon on active staff at Women's College Hospital. I am a full-time academic surgeon and associate professor in the department of surgery at the University of Toronto.

My clinical practice is focused primarily on esthetic and reconstructive plastic surgery of the breast. I have had the honour and privilege of treating thousands of women for problems ranging from congenital abnormal development of the breast, to required reconstruction after breast cancer surgery, to desired aesthetic changes.

Last year I was invited by Health Canada to sit as a volunteer member of both the scientific advisory panel and the expert advisory panel on silicone gel-filled breast implants. I was honoured that Health Canada felt that my clinical experience in using both saline and silicone gel-filled breast implants would be beneficial in helping to answer specific targeted questions relating to applications made by implant manufacturers for their gel-filled devices.

I would like to congratulate Health Canada on the work they have done to put together the scientific and expert advisory panels, as well as the open public forum. I believe that all Canadians should be very proud of and confident in the group of individuals who were asked to form these panels.

In contrast to what we have seen in some other parts of the world, these panels included a diverse selection of individuals, each highly skilled and respected in their particular areas of excellence. Virtually all stakeholders were well represented, and the panel included a balanced mix of expertise, gender, age, and geographic regions.

The panel's report was formed through intense, unencumbered debate, following a thorough review of all provided materials, manufacturers' presentations, and public forum hearings. The panel was asked to answer specific questions based upon the information available to us and our clinical experiences.

I firmly believe that the report submitted to the Minister of Health is a balanced, thoughtful, and complete response to the questions posed. The report has synthesized the views of all members present, and when any dissenting opinion arose, the report clearly states the number of members in agreement or opposition to any statements made. I am proud of my participation in this process, and as a Canadian consumer, I am comforted in knowing that this template exists for the approval of devices in Canada.

Mr. Chairman, I have come here today in support of my patients and their right to make an informed decision about their esthetic and reconstructive breast implant options.

No material has been studied, analyzed, and researched more than silicone. Silicone is presently one of the most commonly used implanted devices in medicine. It is a component of cataract lenses, ventricular peritoneal shunts used in neurosurgery, artificial finger and wrist joints, testicular and penile prostheses, stents, and saline breast implants, just to name a few. Every day in Canada, hundreds of implants are inserted that contain silicone in one form or another. Silicone is used in the processing of medical supplies, in intravenous bags, and is used to coat injection needles. It is estimated that the average diabetic receives 200 milligrams per year of silicone directly injected into their bodies as a result of insulin injections. Silicone is also used in the processing of bottles, glassware, and rubber, and is found in many store-bought food products. Did you know, for example, that measured levels of elemental silicone are substantially higher in store-bought baby formula than levels detected in the breast milk of women with silicone gel-filled breast implants?

There have been many well-conducted research studies evaluating the potential negative health effects of gel-filled implants, and the overwhelming majority of information has failed to demonstrate a connection between the use of these implants and disease in women.

No device is perfect; all implants fail at some point. If you were to ask me today, would I like to know more about the lifespan, failure rates, and long-term risks of any device that I presently use, the answer would most certainly be an emphatic yes. Information is good, and more information is even better. If you ask me, however, when is enough, enough--when do we have enough information so that a reasonable person can make a properly informed decision about the benefits and risks associated with silicone gel breast implants--I would say that time is now.

Silicone gel breast implants are used extensively throughout the world. In almost every country outside of North America, silicone implants comprise 99% of implants used. In the United States, the FDA has provided conditional approval letters to both manufacturers. Once those conditions are met, it is expected that these implants will be available for routine use.

Not all patients are candidates for silicone gel-filled implants. There are advantages with saline implants, and many women achieve excellent results with these devices. In many cases, however, gel-filled implants offer significant benefits. Gel-filled implants are soft, they feel more like natural breast tissue, and they move more naturally under the breast--all important considerations for women undergoing breast implant surgery. As well, they are less likely to produce rippling, a common problem with saline implants, which results in a palpable, unnatural edge at the periphery of the breast margin.

I have been using cohesive silicone gel breast implants in my practice since 2001 and I can emphatically state that no new device or technology has had such a positive impact on what I am able to provide for my patients. They are ideal for treating young women with congenital abnormal development of the breast, and the consistency and shape options produce excellent outcomes for women who have concerns about their breast esthetics following pregnancy and breastfeeding. Results have been far superior to that seen with saline implants, and patient satisfaction has been uniformly high.

In reconstructive surgery, new cohesive gel implants have completely changed what we are able to offer our patients. During the years from 1995 to 2000, 70% of all post-mastectomy breast reconstruction that I performed was large surgical procedures using the patient's own natural tissue, commonly from the tummy. Although these procedures produce excellent results, they are major operations that require scars elsewhere on the body and prolonged recovery times. This is often an unacceptable option, especially for young women with small children, or women who were not prepared to accept that degree of downtime.

The saline implants available at that time produced very unsatisfactory results, with almost 100% of patients developing rippling, an unnatural feel of the breast, and an exaggerated round shape to the breast, often looking very different from the natural, non-operated side.

Women were left with few options but to undergo bigger reconstructive procedures. Since 2001, 75% of all reconstructions are being performed with the new cohesive gel-filled implants--a complete reversal from what I was doing previously. These new gel implants, the ones we are talking about today, are very different from previously developed implants. They are made of a far more viscous, thicker gel, so that if you cut into one, it is very much like cutting into a gummi bear.

These implants come in a wide selection of sizes and shapes, allowing us as reconstructive surgeons to provide outcomes that more closely match the shape of a natural breast and provide for a much more natural-feeling breast. As well, if a device was to break, the gel filler is much less likely to escape from the implant shell in comparison to older-style implants from the 1970s and 1980s.

Since 2001, I have used these implants in over 100 patients for post-mastectomy reconstruction. Results have been excellent, patient satisfaction has been high, complications and re-operation rates have been low, and patients have had a viable alternative to more invasive reconstructive options.

I have concerns about the direction this committee has chosen to pursue. A detailed and thorough report has been submitted to the Minister of Health from a panel of experts who are well qualified to answer the questions put before them. Canadians were invited to, and provided with, a forum to make their views known directly to the panel. Presentations were thoughtful and considerate, whether they were in support of, or in opposition to, the applications.

In fact, Dr. Zuckerman, who is here as a witness, was listed as speaker number 40 on that day, but she did not attend the forum, nor did she present her views to the panel. She is, however, receiving an opportunity to address the committee today without a panel of experts present, a position that I feel is hard to justify to the many Canadian women who support the applications for these devices. Where is their voice? Why are they not invited to speak to this committee today? What is new since the public forum that justifies Dr. Zuckerman's invitation to address the members today?

I would like to read a letter by a woman that I know personally. In fact, she is the wife of a clergy member at my synagogue. She is not my patient, but when she heard about the direction the committee was taking, she asked that I find a way to have her views heard.

I am a 35-year-old woman who was diagnosed with breast cancer two years ago while pregnant with twins. Although I had to make many decisions quickly, I feel that I made very informed ones. As a critical psychologist, I have been well trained in the art of scientific research. I have a lot at stake: my two-year-old twin daughters and their three-year-old brother. As a BRCA1 carrier, I felt that I had no choice but to have a double mastectomy. I spoke with several other BRCA1 carriers to discuss their decisions regarding implants. After consulting with plastic surgeons, doctors specializing in lupus, general surgeons, medical consultants, researchers and oncologists from several top teaching hospitals in Canada and the US, I decided to proceed with reconstruction using tissue expansion and silicone gel filled breast implants. I was well informed of the risks of silicone implants, but felt that the benefits far outweighed the risks. After all of these consultations, my own readings and testimonials, I feel that I made the right decision. As a young professional woman, it is very important for me to look and feel as good as I possibly can. First, I want my girls to develop a healthy body image; and second, for my own body image and self-esteem. In my busy schedule, I wanted life to go on as normal as possible. The implants I have chosen are very realistic and comfortable for me, and I have thus far had no problems with them. I am very happy with my decision, and I would not have done anything differently if I had the chance. I often advise other women like myself to seriously consider cohesive gel implants as an option for reconstruction. It is comforting to know that as a woman, I have the right to decide what goes into my body. Thank you, Melissa Lieberman-Moses

Mr. Chairman, I thank you for the opportunity to be here today, and I look forward to addressing any questions from the committee.

[The Chair, Conservative, Rob Merrifield]

Thank you very much, Dr. Brown.

We'll continue with the witness list. We have Dr. Chidwick.

The floor is yours.

[Dr. Paula Chidwick, Director of Clinical and Corporate Ethics, and Ethicist, William Osler Health Centre, Brampton Memorial Hospital Campus]

Thank you for this opportunity to present a few brief remarks on the process I experienced, witnessed, and participated in as a panel member; on my role as an ethicist; and on some key ethical considerations related to breast implants.

I was a member of both the scientific advisory panel and the expert advisory panel on breast implants convened by Health Canada. This was the first time I have been asked to be a panel member for such a topic, so I had no preconceived ideas or expectations on what would happen.

First, I'll say a few words on the process. Let me begin with a quote: “There does not have to be agreement about the answers to all moral questions, but we do have to accept that everyone must agree on the procedure to be used in deciding moral questions”. This quote emphasizes nicely how important process is in determining answers to questions.

I can say with confidence that the process I participated in was open, transparent, and rigorous. Panel participants came from diverse backgrounds, with diverse experiences and knowledge. Few of us knew each other when we began, and we spent many hours rigorously deliberating on the issues and facts. All views offered in these discussions were treated with respect and all views were equally respected; in other words, there was not, in my experience, a preconceived right perspective that dominated or directed discussion. I witnessed what I call unity in diversity, where diverse views were offered by panel members contributing together to an emerging consensus.

Our task or role was clearly delineated by Health Canada and is available on their website. We were charged with responding to specific questions for feedback. Health Canada clearly outlined that our task was neither to make recommendations to approve breast implants nor to decide what was good for Canadian women.

The chair, Dr. Wells, did a remarkable job in facilitating the diverse views and in creating an environment for frank and honest discussion of the relevant facts and values. I felt free to express all of my views on this matter and felt free to ask any questions about any aspect of the scientific detail. In the public forum, we likewise heard from diverse views, ranging from strong support and enthusiasm to concern, reservations, and warnings. All views were listened to, respected, and incorporated into all the subsequent discussions.

And now I'll say a few words on my role. The context and field in which I work is called bioethics. Bioethics generally involves critical reflection on moral and ethical problems faced in the health care setting, with a view towards deciding what we should do, explaining why we should do it, and describing how we should do it. Ethicists, therefore, attend to the moral question, what should we do, as opposed to what can we do? We support answers with moral reasoning and invoke moral principles, many of which you are no doubt familiar with, such as autonomy, beneficence, and justice.

There are many myths about what ethicists do, and it's worth saying that we are not moral experts or the arbiters of right and wrong, or legal experts, or risk managers, or the moral police, or the decision-makers, or the all-knowing. Instead, ethicists are resources for health care professionals, patients, the public, and others to access when they need facilitation, negotiation of conflicts, case consultation, policy development, research, and education in ethics.

Key ethical considerations. Within the parameters set out by the questions posed by Health Canada, a key ethical consideration included informed consent. For example, questions arose around who should make decisions about breast implants and whether they were decisions that women patients should make, and around who should define risk, benefit, and harm.

It is generally acknowledged that what is a benefit to one person may not be shared by another. The circumstances in which we can impose what we believe are benefits on another person are very rare.

If we believe that we ought to practise patient-centred care, which is “an approach that consciously adopts the patient's perspective about what matters”, then what the patient thinks will affect the coordination and integration of care. In other words, we need to take our cues from the patient and what the patient believes is meaningful in terms of harm, benefit, and risk. This raises questions about what patients need to know to be informed.

In summary, some key ethical considerations include the following:

One, individuals need to determine what constitutes a risk, benefit, or harm. This would occur in a context of safe and effective devices.

Two, informed consent is a process, not an event. It occurs over time, and people can change their minds.

Three, there are risks, benefits, and harms to every treatment decision, and it is incumbent on those involved to make sure treatments are as safe and effective as possible and patients are informed of all relevant information.

Four, there are always known unknowns. That's data that will be revealed for example in time but that we do not have right now. There are also always unknown unknowns, and these might be unanticipated outcomes that may be risky or they might be beneficial. Both need to be expressed to the patient. Patients need to be informed of this information.

Five, finally, ongoing examination of this issue is important. Getting feedback on the process is crucial in understanding how to improve it for the future.

To close, I understand this process embarked upon for breast implants was the first of its kind for Health Canada. I believe it has proven to be open, transparent, and rigorous, and the results it has revealed can be considered with confidence.

Thank you very much. I'm happy to provide further information and answer any questions.

[The Chair, Conservative, Rob Merrifield]

Thank you very much, Doctor.

We will now move on to Dr. Diana Zuckerman, the president of National Research Center for Women & Families.

[Dr. Diana Zuckerman, President, National Research Centre for Women & Families]

All right, thank you.

I'm Dr. Diana Zuckerman, and I am honoured to be here. Our research centre uses research to improve the health of women, children, and families. I personally come from the perspective of being trained in psychology, epidemiology, and public health, and I was a faculty member and researcher at Harvard and Yale. I then worked on health issues in the U.S. Congress and the U.S. House of Representatives and Senate, the Department of Health and Human Services, the White House, and I worked for non-profit organizations. I'm also currently a fellow at the Center for Bioethics at the University of Pennsylvania.

My current work focuses on breast cancer. I've read every published epidemiological study of breast implants, and I'll briefly discuss what is known and not known. I will also tell you about a criminal investigation of one of the implant companies that has been started by the FDA. I will also mention in my testimony the many calls and e-mails we've received from women in Canada who tell us that they're having a great deal of problems getting leaking silicone breast implants removed in a timely manner.

I'll just start off by saying we've made a lot of mistakes about breast implants in the United States, and I think and hope that Canada can show more wisdom than we have.

Clinical trials are a major source of information on the short-term risks of breast implants. Breast implants have been on the market for more than 40 years, but the clinical trials have studied women for only two or three years. That's a big shortcoming. The clinical trials have been conducted by implant manufacturers as part of their efforts to get approval in the United States and Canada, so for that reason there's some bias in those studies.

In contrast, epidemiological studies are a great way to find out what really happens to women in the real world when they do get breast implants, and have them for more than five years, but almost every epidemiological study that's been published has been funded by implant makers or silicone makers. In fact, Dow Corning has spent many millions of dollars giving money to one particular company in the United States that has published almost every epidemiological study of breast implants. Perhaps it is not a coincidence that all of those studies funded by Dow Corning have concluded that breast implants are safe.

However, if you scrutinize those studies carefully and look in the results section, not just in the conclusions, you'll find that there is some clear evidence of problems even in the studies funded by Dow. For example, one study found that women with breast implants for a long period of time were significantly more likely to report chronic breast pain. Their breasts hurt all the time. They were also more likely to take anti-depressants, but despite that, this study still concluded that breast implants were safe.

Fortunately, there are a small number of studies conducted by independent researchers funded by the Canadian government and the U.S. government, and those are the studies that I'm going to focus on today.

The first study I want to mention was done by FDA scientists to look at rupture and leakage. The FDA scientists found, when they looked at women who had breast implants for at least seven years, that most of those women had at least one ruptured implant, one implant that was broken, but they didn't know it. These were women who were happy, who hadn't sought medical help. When they got MRIs, it was discovered that they had at least one broken implant, and 21% of the women had an implant that was leaking outside the scar tissue into their bodies.

The women who had leaking implants were significantly more likely to report fibromyalgia or several other painful and debilitating diseases. So what this study shows is that it matters how long women have had implants. You really have to focus on women who have had implants for a longer period of time, and if you want to know if an implant has broken, you have to do MRIs. The clinical exams didn't show it.

What happened for these women, and what we found in talking to women, is that most of them are happy with their implants for several years, sometimes for many years, but slowly and surely the implants break. They leak. The women don't know it, and usually, after much longer than seven or ten years, they find out too late that the implants have leaked into their lymph nodes under the arm, and from there can go to their lungs and their liver.

I want to start out by talking about the cosmetic problems with breast implants, since the information about rupture and leakage is important, but it's not conclusive. Here's a 29-year-old woman who had her implants removed after seven years. Her capsular contracture was so painful she would rather look like this than have breast implants. This photograph, by the way, is from the FDA's website.

Obviously this is not a good outcome. This is not how a young woman would like to look. But here's a woman who wasn't so lucky. Her name is Sharyn Noakes. Her ruptured implants had leaked into her healthy breasts and when those ruptured implants were removed, so was some of her breast tissue, resulting in deformed breasts. You can see they're puckered, and they don't look anything like a normal breast.

This is Kathy Nye, a breast cancer survivor who suffered from necrosis. Many of you know that when the skin or the tissue dies, it does not grow back. When that happens, the implant comes out of the breast, and that's what that red orb is. It is the implant, the blood around the implant coming out of the hole in her breast. lnamed, one of the implant manufacturers, found that 6% of their breast cancer reconstruction patients had necrosis. It's a very serious problem.

Now I'm going to talk a little bit about what are called the symptoms of autoimmune disease. This was presented at the FDA meeting, but it is not published anywhere or available widely, so I wanted to share it with you. The implant makers were asked to ask the women what kind of symptoms they had, and they found a statistically significant increase in pain and other autoimmune symptoms after only two years. These are just two of them. I didn't want to give you a complicated slide. But you can see the percentage of women who had these problems at the beginning, at the baseline, and at one year, but by two years and then again it's just statistically significantly going up.

So the question was this. They're getting a couple of years older, and they're only about 30 to begin with, so you don't expect these women to have joint pain or chronic fatigue, but what happens if you control for age? So a statistician controlled for age, and you can see, although it's not as steep in terms of how it increases over time, it is still significantly increasing. These symptoms are increasing over time. The other thing that's not in these slides is that when a study was done they found that for women who had these kinds of rheumatalogical symptoms, when their implants were removed and not replaced, more than 90% of the women got better.

Aleina Tweed, who's an epidemiologist at the British Columbia Centre of Excellence for Women's Health, conducted a study of breast augmentation patients in Canada. Most of those women had implants for at least 10 years. She found the women who had breast implants for augmentation had more doctors' visits, more visits with specialists, and were four times as likely to be hospitalized. So the question is, why hasn't this very important Canadian study been quoted more? For a simple reason: no PR firm was hired to talk about it. When the Dow Corning studies are released and show that implants are safe, a whole PR firm and a whole spin control machine goes into place and talks about those studies. You hear about those studies. They're reported. I'm sure they were reported at the Health Canada meeting. They were certainly reported at the FDA meeting.

The problem with the Dow Corning studies is they tend to include women who've had implants for as short a period of time as one month, sometimes one day. Now, any epidemiologist will tell you the diseases they're looking at, whether it's autoimmune diseases or cancer, take time to develop. You can't study women who've had implants for a month or even a year if you want to look at autoimmune diseases. The Dow Corning studies have reduced the statistical power of the studies by including women who have implants for a very short period of time, rather than focusing on those who had implants for a longer period of time. That's why the Dow-funded studies seem to always have results that look very different from the studies funded by independent--particularly government--researchers.

So although we can't conclude, on the basis of the studies that have been done, that breast implants cause autoimmune diseases, we can't conclude that they don't. It's my understanding that the standard for Canada, as it is for the United States, is supposed to be proof that a product is safe; it is not up to anybody to prove that the product is not safe.

I'm going to talk briefly about the National Cancer Institute study, which is similar to the mortality study you heard about today. I had not heard about this Canadian mortality study because it wasn't published, but it's a similar study. The results are a little bit different.

The National Cancer Institute study included women who had breast implants for at least 12 years, so that's a longer period of time than in the Canadian study, which I believe was nine or ten years. The women in the National Cancer Institute study also had implants for an average of 20 years. For cancer that's very important, because cancer takes 15 to 20 years to develop, usually. It's hard to do these studies, and you really have to study women for a long period of time.

The National Cancer Institute found that those women were twice as likely to have brain cancer, twice as likely to have lung cancer, and twice as likely to kill themselves. So the suicide data were similar to the Canadian data. The data on brain cancer and lung cancer were apparently different.

Like the Canadian study--this excellent research design--they compared them to other plastic surgery patients. That's very important. I don't really know why there is a difference between the Canadian study and the U.S. study, because I haven't seen the Canadian study, but based on what I've heard about the Canadian study, the women had implants for a somewhat shorter period of time.

Last, I want to talk about the quality and integrity of the data. Both Inamed and Mentor started making breast implants years ago and started studying women with breast implants in 1990. If they had continued those studies in 1990, we'd have more than 15 years of data and we'd really be able to say what the long-term risks of these implants are. Unfortunately, the company started the studies, lost track of all their patients, and we have no idea what happened to them.

Just last year, several Mentor employees called me personally, because of the work we've done on this issue, and expressed concern about the accuracy of the data that had been presented at the FDA. It was in American newspapers and they had seen it. After talking to these Mentor employees, I put them in touch with the FDA, and the FDA started a criminal investigation in December, which is still ongoing. It's my understanding that part of the reason the FDA has not made a decision yet on breast implants—it's been over a year, which is very long for them—is that this criminal investigation is under way. One of the engineers at Mentor, for example, said that the implants leaked more than was reported.

Finally, I want to mention that just recently a study came out in analytical chemistry showing a very high level of toxic platinum in the breast milk of women with breast implants, as well as in their blood and urine. This is very important because platinum can cause neurological damage. It's very toxic.

The implant makers have claimed that the platinum used in breast implants is not a toxic form, but these researchers found that while it may not be toxic when it's used in the implant, when the implant is in the body it may change. This is also very important for breast cancer patients. As some as you know, chemotherapy agents often have platinum in them, so if a women is getting chemo with platinum for breast cancer and then gets breast implants, she's getting an especially high dosage of platinum, which could be dangerous.

Finally, I just want to say that we have heard from many women in Canada. Particularly, we've heard from women who tell us that once they find out their implants are leaking and that they need to get them taken out, they have trouble finding plastic surgeons who will do this.

I think Dr. Brown probably can speak to this as well, because he's a very well-respected plastic surgeon. We have heard from several women who have gone to him, and his staff have told them if they want to get their leaking silicone breast implants taken out through the Canadian health care system, they'll have to wait about a year and a half. We think that's a very long time to wait.

In conclusion, if Health Canada does decide to license silicone gel breast implants, we expect more women will get them, and more women will need to have them taken out. It's not clear to me that there are currently enough plastic surgeons in Canada who are very experienced in taking out leaking silicone breast implants so that it can be done in a timely manner.

I'd be happy to answer any questions.

[The Chair, Conservative, Rob Merrifield]

Thank you.

And thank you to the entire panel of witnesses.

We have the departments here--both Health Canada and the Public Health Agency of Canada--and because of time restraints, we'd ask you to come back to the table.

Just to let the committee know, two of our witnesses need to leave a little bit early. They are Dr. Yeates and Dr. Stachenko.

We'll now open the floor to questioning, and you can question whomever you wish.

Madam Brown.

[Bonnie Brown, Liberal, Oakville, ON]

Thank you very much, Mr. Chair.

My first question is to Dr. Chidwick, and I want to thank you for serving on Health Canada's expert panel.

I am looking at the report that has been submitted from your panel to the minister, and the first recommendation says, “The panel felt that questions regarding the potential health effects of any exposure to low molecular weight silicones had not been sufficiently addressed”.

Seeing that this is the first recommendation, and it seems to me to be very strong, do you understand that to mean that the panel is suggesting to the minister he not approve these applications at this time?

[Dr. Paula Chidwick]

What page is that on?

[Bonnie Brown, Liberal, Oakville, ON]

It's on page 6: “...the potential health effects of any exposure to low molecular weight silicones had not been sufficiently addressed”.

[Dr. Paula Chidwick]

So your question to me is whether, based on that, we would not recommend that they approve it?

[Bonnie Brown, Liberal, Oakville, ON]

Yes. If the safety issues have not been sufficiently addressed, isn't the logical conclusion that approval not be granted?

[Dr. Paula Chidwick]

My understanding of the task that we were charged with was not that we were to recommend that they be approved or not. The answer to that question would come from the consultative process for those people in positions to make the decisions.

[Bonnie Brown, Liberal, Oakville, ON]

Then you go on further in your panel's recommendations to say, “the manufacturers must demonstrate that migrated silicone provides acceptable risks of hypersensitivity and autoimmunity by a critical review of company and literature data and, if necessary, by undertaking studies in animal models”.

So once again, recommendation ii suggests there is not enough data to conclude safety.

You're saying that none of your recommendations about the process or none of the findings of your panel are to make any recommendation to the minister as to what he should do or not do, but these two recommendations look pretty clear to me.

[The Chair, Conservative, Rob Merrifield]

Dr. Brown is here. He was on the panel as well, if he's interested in commenting. If you're not getting answers, we'll ask Dr. Brown.

[Dr. Paula Chidwick]

If I can just add--and then maybe Dr. Brown can add as well--that again, I understood my role was not to draw the conclusions of what that might mean. We were to assess what was in front of us, answer very specific questions, and the decision as to what that meant would be determined by the decision-makers.

[Bonnie Brown, Liberal, Oakville, ON]

On page 8 you suggest: “Due to the limited laboratory fatigue data, there is uncertainty associated with the predicted lifetime of the device”, and on page 11, “The data is sufficient to establish how the devices perform in vivo. However they do not address all aspects of long-term safety”.

[Dr. Paula Chidwick]

I was a panel member, and I would stand by these comments. But again, what they mean, what that means related to risk, and what it means related to harm and benefit needs to be determined perhaps by others. Every device will have uncertainties around it, questions that aren't fully understood. That's readily acknowledged by the panel, and what it means will be determined through another process.

[Bonnie Brown, Liberal, Oakville, ON]

Thank you.