June 8, 2006
The Chair (Mr. Rob Merrifield (Yellowhead, CPC)): If I could have your attention, if everybody could take their seats.
I’ll call the meeting to order.
First of all we have a very interesting meeting ahead of us, I believe we’ve been waiting and anticipating this meeting for some time. First of all 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 from the deputy minister’s health products and food branch. I believe we have Ms. Sharma, also from the associate director general of therapeutics products directory, 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 you coming forward and to be 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 to come forward, who are at the table right now to do their quick presentation and 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.
I also want to acknowledge, this is kind of a special meeting and I want to 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 do, Mr. Chair, thank you.
The Chair: Thank you and you’re looking fine. I’m glad this technology is working for us and I appreciate you giving us your time.
We’ll have you come forward in the second part, after we listen to the department 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.
Mr. Neil Yeates (Assistant Deputy Minister, Health Products and Food Branch, Department of Health): Thank you very much, Mr. Chair, 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 falls under the responsibility of the Health Products and Food Branch, for which I am the assistant deputy minister.
My colleague, Dr. Supriya Sharma, is the associate director general of the Therapeutic Products Directorate, and is joining me today.
We welcome this opportunity to come before the committee to discuss the issues raised over the last few weeks and answer any questions that you may have.
I would like to begin by addressing the two fundamental issues raised recently by briefly outlining first how medical devices are regulated and reviewed by Health Canada, and, second, the role of external advisory bodies in this regulatory review process, and 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 mastectomies, 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. Parliament, through the act, 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 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 which encourages collaboration among a team of experts skilled in a variety of fields and disciplines.
This process reflects the key principles which 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 which guide such evidence-based decision making. These include a recognition of, one, the need for comprehensive information; two, the value of team work and expert opinions–sound evidence-based decisions can only come from a collaborative process where varying opinions are encouraged and considered at all phases of an evaluation; and, third, the value of multiple disciplines of the experts who we consult, and 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 Device 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 together are the core determinants of Health Canada’s regulatory approach with respect to higher risk or class 4 medical devices such as breast implants. The Medical Device Regulations and Health Canada’s publically available guidance documents outline that manufacturers of class 4 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 their advice in response to very specific questions posed by Health Canadarelated 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 minister or Health Canada, nor was it asked to recommend whether any of the specific products should or should not be licensed for sale inCanada. 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 failed 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 lead 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 1960’s. 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 taken 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 decisions for each application are: 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 report publicly to Canadians, through the publication of a summary basis of decision document for each application on the nature of the evidence considered, and the conclusions reached.
In conclusion, I would like to reiterate that the legislative regime created by Parliament is 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 which support the use of a collaborative process where 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. That’s our opening remark. 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: Thank you very much.
We’ll now hear from the Public Health Agency.
Dre Sylvie Stachenko (administrateur en chef adjoint de la santé publique, Direction générale de la promotion de la santé et de la prévention des maladies chroniques, Agence de la santé publique du Canada): Monsieur le président, membres du comité, j’aimerais vous remercier de l’opportunité de pouvoir discuter avec vous des résultats de l’étude de cohort sur les implants mammaires. Je suis le docteur Stachenko. Je suis administratrice en chef adjointe de la santé publique et responsable de la Direction générale de la promotion de la santé et de la prévention des maladies chroniques de l’Agence de la santé publique du Canada. Il me fait plaisir également que le docteur Yang Mao puisse se joindre à nous. Il est le directeur de la Division de surveillance des maladies chroniques au Centre de prévention des maladies chroniques et aussi un des investigateurs de l’étude de cohort.
L’étude de cohort sur les implants mammaires est la plus vaste étude conçue à ce jour pour enquêter sur le risque de cancer et d’autres effets sur la santé chez les femmes ayant reçu un implant mammaire à des fins esthétiques. Les premiers résultats scientifiques de cette étude sont maintenant disponibles. Comme vous le savez, un article sur l’incidence du cancer a été publié en anglais, en décembre 2005, par l’International Journal of Cancer. En réponse à la demande de la greffière, le 11 mai 2005, l’Agence de santé publique du Canada a demandé, à l’éditeur de la revue, la permission de traduire l’article et d’en faire parvenir une version française au comité. Je comprends que la version française a été remise à la greffière, hier.
En outre, un deuxième article fondé sur l’étude a été rédigé. Il porte sur le risque relatif de mortalité lié au cancer du sein et à d’autres causes. Cet article a été accepté récemment par l’American Journal of Epidemiology et il devrait être publié d’ici la fin du mois.
L’étude de cohort sur les implants mammaires a requis l’identification des femmes en Ontario et au Québec, qui ont eu recours à une chirurgie d’augmentation mammaire à des fins esthétiques, au cours de la période allant de 1974 à 1989 inclusivement ainsi que l’accès à leurs dossiers médicaux. L’étude comporte des renseignements sur plus de 40 000 femmes âgées de 18 ans et plus. Elle a permis de réunir les dossiers de patientes ayant eu recours à une chirurgie plastique en Ontario et au Québec et d’établir des liens entre ces dossiers et la base de données du registre national du cancer tenu par Statistique Canada.
Les femmes et les médecins qui ont participé à l’étude ont reçu l’assurance que l’étude avait été soumise à des examens scientifiques et éthiques rigoureux.
Since the time when the study was first announced, privacy, information protection, and information access frameworks have evolved significantly, both within the Government of Canada and in the provinces of Ontario and Quebec from which the cohorts were drawn.
This considerably lengthened the time it took to gain access to patients’ records and 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 inQuebec, Ontario and academia have been able to undertake the epidemiological analysis and 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 that 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 for the other cancer sites examined.
As well, I can very briefly outline some of the key findings of second article on mortality which will soon be published. Overall, women who received breast implants for cosmetic purposes had lower mortality rates than that 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 would be likely to be, on average, in better health than the general population.
However, it is of note that consistent with previous work increased rates of suicide were observed among women who received breast implants relative to the general population, but there were no statistical difference 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.
Also I’d like to thank the committee for its interest in the agency’s ongoing risk assessment and analysis efforts for cancer and other chronic diseases.
The Chair: I want to thank you for your presentations.
Just to let the committee know that in the briefing that you had received there is one page missing, actually the best page. Just to let the committee know that we will get that to you.
Thank you very much for your presentations, we’ll ask you now to allow room at the table for the other presenters and we’ll call forward…we’ll do this before we do any questions and after the presenters completely present then we’ll open the floor to questioning.
We would ask Dr. Chidwick, if you would come forward and Dr. Zuckerman.
You can just move around onto this side it would be fine.
While we’re doing that we will continue on because we have, through videoconferencing Dr. Brown.
Dr. Brown, I appreciate you, again, I want to say appreciate you taking the time to be able to teleconference on this important issue. The floor is yours, let’s see if the technology works and you’re open to continue.
Dr. Mitchell Brown:
Are you able to hear me okay, Mr. Chairman?
The Chair: You’re coming through loud and clear.
Dr. Mitchell Brown: Great.
Thank you very much for accommodating me and allowing me to be a part of this committee meeting today from my hospital here inToronto.
Mr. Chairman, member of the Standing Committee on Health, thank you very much for inviting me today to address the committee and to 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 aesthetic and reconstructive plastic surgery of the breast. I have had the honour and privilege to treat thousands of women for problems ranging from congenital abnormal development of the breast, to women requiring reconstruction after breast cancer surgery, to women desiring aesthetic changes to their breasts.
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 my clinical experience 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 that 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, manufacturer presentations, and public forum hearings.
The panel was asked to answer specific questions based upon the information available to us and our clinical expertise 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 dissent of opinion arose, the report clearly states the number of members in agreement or opposed 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 aesthetic 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, 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 used in the processing of bottles, glassware, 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 from 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 asked me, however, when is enough, enough; when do we have enough information that a reasonable person can make a properly informed decision about the benefits and risks associated with silicon gel breast implants, I would say that time is now.
Silicon gel breast implants are used extensively throughout the world. In almost every country outside of North America, silicon implants comprise 99% of implants used. In the United States, the FDA has provided conditional approval letters to both manufacturers, and once those conditions are met it is expected that these implants will be available for routine use.
Not all patients are candidates for silicon 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 that results in a palpable unnatural edge at the periphery of the breast margin.
I have been using cohesive silicon 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 in women who have concerns about their breast aesthetics 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 1995-2000, 70% of all post-mastectomy breast reconstruction that I performed was with large surgical procedures using the patient’s own natural tissue, commonly from the tummy. Although these procedures produce excellent results, they are major operations requiring scars elsewhere on the body and prolonged recovery times. This was 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 that 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 were 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.
I have used these implants in over 100 patients for post-mastectomy reconstruction since 2001. 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 that this committee has chosen to pursue. A detailed and thorough report has been submitted to the Minister of Health from a panel of experts well-qualified to answer the questions put before them. Canadians were invited 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 today as a witness, was listed as speaker number 40 at 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 in support of 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 going in, she asked that I find a way to have her views heard.
|I am a 35-year-old woman 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 inCanada and the United States, 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, because 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.|
|Melissa Lee (inaudible)|
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: 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 in which I experienced, witnessed, and participated, as a panel member, my role as an ethicist and 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 HealthCanada. 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 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, experience, and knowledge. Few of us knew each other when we began and we spent many hours rigorously deliberating the issues and facts. All views offered in these discussions were treated with respect. All views were equally respected. In other words, there was not, from my experience, a preconceived right perspective that dominated discussion or directed discussion. I witnessed what I call “unity and diversity”, where diverse views were offered by panel members together contributing to an emerging consensus.
Our task and role was clearly delineated by Health Canada and is available on their website. We were charged with specific questions for feedback. Health Canada clearly outlined that our task was neither to make recommendations to approved breast implants nor decide what was good for Canadian women.
The Chair, Dr. Wells, did a remarkable job facilitating the diverse views and creating an environment for frank and honest discussion of the relevant facts and values. I felt free to express all my views on this matter. I 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.
A few words on my role. The context and field in which I work is called bioethics. Generally bioethics involves critical reflection on moral and ethical problems faced in the healthcare setting 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 reasonings 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 we’re saying 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, public, and others to access when needed to provide facilitation, negotiation of conflicts in case consultation, policy development, research, and education in ethics.
Key ethical considerations. In this context within the parameters set out by the questions posed by Health Canada a key ethical consideration included informed consent. For example, questions arose around: (1) who should make decisions about breast implants and is this a decision that women/patients should make?; and (2) 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 where we can impose what we believe are benefits on another person are very rare.
If we believe that we ought to practice 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.
So in summary, some key ethical considerations include, 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 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 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: Thank you very much, doctor.
We will now move onto Dr. Diana Zuckerman, President of National Research Center for Women & Families.
Dr. Diana Zuckerman (President, National Research Centre for Women & Families): I am Dr. Diana Zuckerman and I am honoured to be here.
Dr. Diana Zuckerman: 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 for non-profit organizations. I’m also currently a fellow at the Centre for Bioethics at theUniversity of Pennsylvania.
My current work focuses on breast cancer and 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 that’s been started of one on the implant companies by the FDA. I will also mention in my testimony the many calls and e-mails we’re received from women in Canada who tell us that they’re having great problems getting leaking silicone breast implants removed in a timely manner.
Just to start off by saying, we’ve made a lot of mistakes about breast implants in the United States, and I think and hope thatCanada can show more wisdom than we have.
Clinical trials are a major source of information on the short-term risks of breast implants and breast implants have been on the market for more than 40 years, but the clinical trials have only studied women for 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 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 an 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. What the FDA scientists found was that 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, but 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 they break you have to do MRIs because 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, 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 from 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 that she would rather look like this than have breast implants. This photograph, by the way, is from the DFA’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 which many of you know is when the skin or the tissue dies, it permanently dies and 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 auto-immune disease and 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 what they found was after only two years there was a statistically significant increase in pain and other auto-immune symptoms. These are just two of them. I didn’t want to give you a complicated slide. But you can see what the percentage was 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, well, they’re getting a couple of years older, of course, they’re only about 30 to begin with, so you don’t expect these women to 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 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 Columbiacentre of excellence for research on women, conducted a study of breast augmentation patients in Canada, most of those women had implants for at least 10 years. She found that 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? Well, it’s 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 that the diseases that they’re looking at, whether it’s auto-immune 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 auto immune diseases.
So what the Dow Corning studies have done is they 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 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’s study, which is similar the mortality study you heard about today. I had not heard about this Canadian mortality study because it’s not 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 the Canadian study, which I believe was nine, or perhaps ten years. Also, the women in the National Cancer Institute study 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 study found that for those women, they 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 other, the brain cancer and the lung cancer, apparently, were 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 cause I haven’t seen the Canadian study, but I can say, 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 have started making breast implants years ago and started studying women with breast impacts 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 are the long-term risks of these implants. But, unfortunately, the company started the studies, lost track of all their patients, and we have no idea what happened to them.
Then, just last year, several Mentor employees called me personally because of the work that 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 why the FDA has not made a decision on breast implants—it’s been over a year, which is very long for them—is because 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 do 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 that’s used in breast implants is not a toxic form, but what these researchers found was it may not be toxic when it’s used in the implant, but when the implant’s 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 that could be dangerous.
Finally, I just want to say that we have heard from many women in Canada and particularly we’ve heard from women who tell us that once they find out that their implants are leaking and once they find out that they need to get them taken, they’re having trouble finding plastic surgeons who will do this.
I think Dr. Brown probably can speak to this as well because he’s a very, very well-respected plastic surgeon and we have heard from several women who have gone to him. And his staff have told them that 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, more women will need to have them taken out, and it’s not clear to me that currently there are enough plastic surgeons in Canada who are very experienced in taking out leaking silicone breast implants so that it could be done in a timely manner.
I’d be happy to answer any questions.
The Chair: Thank you.
And thank you to the entire panel of witnesses.
Because of time restraints we have the departments–both Health Canada and the Public Health Agency of Canada. We’d ask you to come back to the table.
Just to let the committee know, there are two of our witnesses who are needing to leave a little bit earlier. That is Dr. Yeates as well as Dr. Stachenko.
We’ll now open the floor to questioning and you can question whomever you wish.
Ms. Bonnie Brown (Oakville, Lib.): 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 as that is the first recommendation and seems to me to be very strong, do you understand that to mean the panel is suggesting to the minister that he not approve these applications at this time?
Dr. Paula Chidwick: What page is that on in the–
Ms. Bonnie Brown: Page 6.
“The potential health effects of any exposure to 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?
Ms. Bonnie Brown: 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 that we weren’t 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.
Ms. Bonnie Brown: And then you go on further in your panel’s recommendations to say,
|Manufacturers must demonstrate that migrated silicone provides acceptable risks of hypersensitivity and auto immunity by a critical review of company and literature data and if necessary, by undertaking studies in animal models.|
So once again, recommendation 2 suggests there is not enough data to conclude safety.
But you’re saying that none of your recommendations about the process or 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: I’ll just say (inaudible) to here. That’s fine.
It would be fair. 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. 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.
Ms. Bonnie Brown: On page 8 you suggest: “due to the limits of laboratory fatigue data, there is some certainty 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 would say that 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.
Ms. Bonnie Brown: Thank you.
The Chair: Because of the complexity of the technology, Dr. Brown, do you have anything to add to that? If you do, just raise your hand or something and I’ll
Dr. Mitchell Brown: Yes, I would like to make a few comments.
I think one of the outstanding features of the expert advisory panel was its diversity of membership. To ask Dr. Chidwick or myself to respond specifically about the panel’s recommendations as it relates to fatigue testing, rupture rates, toxicology, etc., and immunology in one of her points that she mentioned. The beauty of our panel is that we had experts from each of these different areas that helped us as a group to put together a response to the questions put forth to us by Health Canada.
I do not put myself out as a biomaterials expert or an expert in immunology. I was part of the consultation process to put together this report. There was certainly debate about what is safety, when is enough information enough, and it’s reasonable to request that further information will be helpful and useful. The question becomes a determination of when is enough information there that we have adequate information for a person to make a reasonable, informed decision based on the risks laid out in front of them.
Ms. Bonnie Brown: My next question is for Sylive Stachenko.
The Chair: Did you want further comment on that, Mr. Yeates?
Ms. Bonnie Brown: No. I don’t want to hear any more about that. I want to ask Sylvie Stachenko….
Mr. Neil Yeates: No, I can leave it. That’s fine.
The Chair: Okay.
Go ahead, Madame Brown.
Ms. Bonnie Brown: Sylvie Stachenko, who thankfully brought forward a summary of the epidemiological study that we have been trying to get to this committee for about the last three years.
Looking at your notes, you said: “the suicide rates for silicone gel breast implant patients were about the same as for all plastic surgery patients, but even so, greater than for the general population”. What about the cancer rates? The cancer rates in silicone gel breast implant patients were the same as for regular plastic surgery patients, but were they greater than the general population? No?
Dr. Sylvie Stachenko: No. The answer is no.
Ms. Bonnie Brown: Okay.
So the only sort of you found was….
Dr. Sylvie Stachenko: Was the suicide mortality.
Ms. Bonnie Brown: Mortality? Death and usually by suicide?
Dr. Sylvie Stachenko: By suicide. Correct.
Ms. Bonnie Brown: Okay.
Thanks very much, Mr. Chair.
The Chair: Okay. Thank you.
Mme Nicole Demers (Laval, BQ): Merci, monsieur le président. Je vais commencer par adresser mes questions au docteur Brown.
Do you hear me?
Dr. Mitchell Brown: Yes, I can, thank you.
Ms. Nicole Demers: I can see that I’ll have to address my questions in English, I believe.
I also have some letters from some of your patients, they are not so encouraging, though. One of them tells us that before she could get a meeting with you in order to get her breast implants extracted was a 9 month wait, and then after that it would take 12 more months to get them extracted because you have too much work doing implants and reconstruction.
The same person tells us that if she was ready to pay $4,800 to get ahead of the list paid by the Ontario Health Insurance Program so she could get ahead in the list, and you would be ready to operate on her before the other patients, who were supported by the Ontario Health Insurance Program. On top of that she had to give you an $800 deposit, which was not refundable if she decided not to have the operation with you. Can you explain why you have such a practice with people who are desperate to get their implants extracted?
Dr. Mitchell Brown: Thank you, Madame Demers.
I must start by saying that you are quite incorrect with the information that you have just requested of me. That is absolutely not the facts as they exist, so let me please explain.
I see patients, who come to me with concerns about their breast implants, on a very regular basis, or just to have them checked, because their surgeon may not presently be around, may be deceased, etc. If a woman comes to me with a problem with a breast implant, and she requires through informed consent to have something done—to replace, reposition, remove her implant, etc.—I would like to operate on her immediately, if it’s at all possible. There is no incentive for me to have a patient wait.
In Canada, at least in Ontario at the present time, women who come to my office, who have concerns with medical problems related to their implants, are offered surgery under the Ontario Health Insurance Program. It is a medically insured service. In those instances, I must provide surgery in a publicly funded hospital where I work, at Women’s College Hospital.
I am only provided a certain amount of operating time. Every bit of operating time that I am provided is directed at reconstructive patients, such as the patients that you have described. All of the aesthetic surgical work that I do that is not covered by the ministry of health is done outside of the hospital, so as not to impact on the times that I have available in the hospital.
I can only use the time that is provided to me. I have had four days removed from me for surgery during the summer, because of summer hospital slow-down. I have days removed from me, because there are not enough nurses to staff the operating facility. I have days removed from me, because there are not enough anesthetists. So I do the work that I can—
Ms. Nicole Demers: Excuse me, Dr. Brown. Can I tell those women that they’ll get their deposit refunded to them?
Dr. Mitchell Brown: Excuse me. I will finish my remarks.
Ms. Nicole Demers: No, I’m sorry, you have a very short time, and that was not my question. My question was, do you charge those women $4,800 to pass ahead of the others? That was my question.
Dr. Mitchell Brown: The answer is a very clear no. Patients who come to see me—
Ms. Nicole Demers: So they can get a refund?
Dr. Mitchell Brown: I will now complete my answer.
Patients who come to see me with a concern that is medically related, where there is a medical problem, are only offered service in the publicly funded hospital, without a penny being charged to them from my office.
If a patient comes to my office, because she has implants that have been in through her choice for many years, there is no medical indication for their removal, and she wishes to have them removed, that is her choice. That is not a medical indication. That is something that is not an insured service in our province, and patients are charged a fee that is appropriate for that type of procedure.
Ms. Nicole Demers: Thank you, Dr. Brown.
Dr. Brown, how many call MRI machines would you say are available in Canada?
Dr. Mitchell Brown: I do not know the answer to that.
Ms. Nicole Demers: Don’t you suggest to your patients, once they’ve had the surgery with the implant, that they should, every year or other year, have a test with an MRI machine in order to make sure that there isn’t a leak? Isn’t that proper procedure?
Dr. Mitchell Brown: No, it is not, Madame Demers. There is no consensus to suggest that routine screening of MRIs is appropriate. That is not the standard of practice in Canada, and that was not the recommendation of the radiologists who sat on our expert advisory panel.
Ms. Nicole Demers: Even women who have to get their breasts examined every year, after 50 years old?
Dr. Mitchell Brown: Yes. The present standard in Canada is regular monthly self-examination, mammograms and ultrasound as required. MRI is used as a secondary or tertiary screening if a problem potentially is noted to exist.
The Chair: Madame Demers, your time has gone.
Mr. Fletcher, you have five minutes.
Mr. Steven Fletcher (Charleswood—St. James—Assiniboia, CPC): My interest is in the process. Did women with breast implants have any input into the Breast Implant Cohort Study?
Dr. Sylvie Stachenko: Yes, they did. There was a consultation process back in 1992 and 1995, and the women actually participated in these consultations in terms of the protocol and the design of the whole study. So, yes, they were involved at the inception.
Mr. Steven Fletcher: Was this study ethical?
Dr. Sylvie Stachenko: This study underwent rigorous ethical reviews. As you know the women came from two provinces, Ontario and Quebec and the investigators in these provinces, particularly Quebec came from Laval University, and from Ontario came from Cancer Care, and in those two provinces reviews were done by the University of Toronto ethics review as well as l’Hôpital du Saint-Sacrement ethical review process.
There were other review processes during the time of the record linkage which happened later, as I mentioned. That also required extensive ethical review processes. So the answer to that is this study actually met all the rigorous ethical reviews that are necessary.
Mr. Steven Fletcher: Who funded this study?
Dr. Sylvie Stachenko: The funding came initially from the Government of Canada Treasury Board but the provinces also contributed particularly in kind and the total amount for this study over the period from 1995 right to this time is about $2.5 million. A good deal of it is also in kind resources in terms of the researchers, the epidemiologists, and the analysis.
Mr. Steven Fletcher: You mentioned the researchers, how did they get the patient’s records, the health records?
Dr. Sylvie Stachenko: This is another process that also was…as you know epidemiologiological cohort studies require rigorous approaches and one of which is access to information and basically in Quebec there’s a body there, which I don’t know the name, perhaps Dr. Yang Mao could tell but there’s a body there that was required to be consulted in terms of release of information.
Also, in Ontario there’s a regulation of the…I think the Ontario Medical Act, that we also need to go to in terms of releasing the information of patients by the physicians. So those two bodies were certainly consulted and agreed to the release but definitely there was a strong provision for making sure that the individuals were anonymous.
Perhaps Dr. Yang Mao, as being part of the methodology he might want to add some further answers to that.
Dr. Yang Mao (Director, Health Promotion and Disease Prevention, Public Health Agency of Canada): The in Quebec is come from Med-Echo, and surgery record and from the plastic surgeon’s office. These records, we put public announce and send it to the patient if they do not like to participate they can call a number of respond with the card we provide. So it the data has come from Med-Echo surgery office and from the plastic surgeons office.
The Chair: Thank you.
Ms.Priddy, you have five minutes.
Ms. Penny Priddy (Surrey North, NDP): Thank you, Mr. Chair.
My first question is to Dr. Zuckerman. I didn’t realize until I did some recent reading about platinum and breast implants, could you tell me, if you look at what I would call generation one, generation two, and generation three, breast implants, whether the level of platinum is the same or has significantly decreased?
The second part to that question would be, I think it was partly on the screen but what the two or three most common or perhaps most serious results you would see with women who’ve had significant amounts of platinum in their body, that stays in their body because I think some of the other examples are not platinum that stays and reacts in the body?
Dr. Diana Zuckerman: One of the common complications that women complain about, who have problems that seem to be related to their implants and that get better when the implants are removed, has to do with concentration and memory loss. The women are in their 30’s often and they feel like they’re in their 70’s. They’re having trouble concentrating; they can’t remember things; they can’t speak coherently. It’s these kinds of neurological problems that could be related to the platinum
There is no data on comparing the different generations. The platinum seems to come from the shell, not from the gel. Platinum is used to thicken silicone to make the elastomer that makes the shell. So that’s not the natural form of silicone. So that’s why it’s used. It’s possible–and some research is underway–to see whether these new gummy-bear implants have more platinum. Because to thicken the gel so much may require platinum.
The amount of platinum used to make breast implants is supposed to be really microscopic, very tiny amounts. What we don’t know is whether in manufacturing some end up having more platinum than they’re supposed to and perhaps that would explain why some women get very sick from breast implants and other women don’t.
Ms. Penny Priddy: I think this is to Health Canada, but I’m not sure whom. Because breast implants are a medical device, could you tell me the number out of 100 or the percentage of “medical devices” that are applied for that are breast implants?
Mr. Neil Yeates: Sorry, I’m not sure understand the question.
Ms. Penny Priddy: For the sake of the discussion, let’s 100 people apply for a medical device–
Mr. Neil Yeates: Regarding the special access program, okay.
Ms. Penny Priddy: Yes. What percentage of that 100, or however it goes larger, what percentage would be for breast implants?
Mr. Neil Yeates: Thanks for that clarification.
I can give you some numbers from last year, just to give you a sense of this. We had approximately 11,000 requests for all medical devices. About 8,500 were for silicone gel implants. I should add, though, some of those requests that we get for other types of things might be in lots of several hundred, for other drugs and devices and so on.
Ms. Penny Priddy: Thanks. That’s helpful.
Do I have some more time?
The Chair: For a short one.
Ms. Penny Priddy: All right.
Just a point about the expert panel, and maybe it’s just a comment but I will waste my time on the comment. Three people were listed as patient experts and they were all nurses. Do I assume because they were all nurses, they were also patients who had breast implants? Was there a real patient as a patient expert on the panel?
When somebody said “patient expert” I expect they’ve been a patient of that particular procedure.
Dr. Paula Chidwick: Nobody on the panel discussed openly their medical status. The people who I–
Ms. Penny Priddy: The people who were listed as patient experts were actually nurses with additional training who worked with patients.
Dr. Paula Chidwick: They were people who worked with patients, but whether or not they had personal experience as a patient, it was not discussed at the panel.
Ms. Penny Priddy: So there may very well not have been a patient as part of this patient-centred set study.
The Chair: Thank you very much.
Ms. Davidson, you have five minutes.
Mrs. Patricia Davidson (Sarnia—Lambton, CPC): I wanted to ask Dr. Brown a question please. In order to obtain the silicon-gel-filled breast implants, physicians are required to seek authorization through special access. “Special access” is defined as,
|…access to a medical device for emergency use or if conventional therapies have failed, are unavailable or are unsuitable.|
So with respect to the silicone-gel breast implants, could you explain the meaning of “emergency use” and of “conventional therapies?” Further, do you apply for special access for breast implants? And could you provide the committee with some estimate of how often your special access requests are for replacement of a failed implant, for reconstruction, or for cosmetic augmentation?
Dr. Mitchell Brown: Thank you.
Yes, I do apply through the special access program for silicone jell-filled breast implants. I would estimate that approximately 40% to 50% are for reconstructive breast surgery for women who have undergone mastectomies or lumpectomies, and that the remaining 50% to 60% are divided between women undergoing implant replacement who have likely had silicone jell breast implants in the past, or for women who are undergoing primary breast augmentation with specific indications such as an abnormal tuberous shape to the breast where defined devices that are presently available, i.e. saline breast implants, would likely cause significant problems and elevate the re-operation rate in those particular patients.
Examples would be patients who have very minimal tissue in certain areas, like in a tuberous breast patient, or in a patient who has undergone mastectomy where there is little tissue to cover an implant in a certain area where a salient implant to be extremely palpable, unnatural to the feel and unnatural to the look. Those are circumstances where conventional devices that are presently available would not be suitable.
Mrs. Patricia Davidson: Thank you.
In your experience, how long are these implants lasting? When you see your patients, how long is it before some of them are experiencing a problem and what seems to be the percentage of people who do experience that problem?
Dr. Mitchell Brown: We’ve just finished looking at our data in the first five years that I’ve been using these devices, since 1002. Of course, I would like and hope to have longer data as the years go by. At the present time, my re-operation rate for any indication—that would be any patient coming whether for reconstruction because they’ve had changes to the breast because of breast feeding, because of replacement on an implant—is 5.7% over that period of the study, and that could be for a variety of reasons. It could be for mal-positioning or turning or changing in the position of the implant. It could be for asymmetry, which is a common potential problem, especially when you’re reconstructing a single breast and trying to match it to a natural breast on the opposite side. It could be for issues related to scar tissue or contracture around the implant.
I have not, as of yet, identified a ruptured gel implant that I’ve used in my practice. There may be some there that I have not identified which would only be identified through longer follow up or through MRIs of every single patient, but I have not seen a ruptured device yet.
Mrs. Patricia Davidson: Thank you.
Do I still have some time?
The Chair: You can have a very short one if you want.
Mrs. Patricia Davidson: Okay, just very quickly, I’d like to ask Dr. Zuckerman, please, testicular implants made of similar substances are also on the market. Could you comment on those from the FDA? How do they assess the clinical data regarding that safety?
Dr. Diana Zuckerman: Much less is known about them, but I believe that testicular is a harder silicone. I don’t believe that it’s gel, but if it were gel the amount of gel would be much less.
One of the problems with breast implants is that there is so much silicone so that if it breaks and leaks, there is an enormous amount of silicone that can get into the body, whereas if you have a very small implant, like a testicular implant, even if it were gel and even if it did break, the amount of silicone that the body would be exposed to is much less and so the chances for problems therefore would be less. Also the number of men who get testicular implants is very small compared to the number of women who get breast implants, so we know much less about it. When you have millions of women getting a product in the United States, you see a lot more problems. Even if the proportion is the same, it’s easier to keep track.
Also, for women with breast implants it’s taken 40 years or 30 years to start talking openly about it. I don’t think men with testicular implants are speaking very openly about it yet.
The Chair: Thank you. This is getting to be a very sensitive area.
Ruby Dhalla. You have five minutes.
Ms. Ruby Dhalla (Brampton—Springdale): Thank you very much.
Thank you to all of the people who have taken the time to come today. It’s an extremely important issue to a number of my constituents in Brampton—Springville, along with many of the other colleagues around this table, and to women in general across this country.
There a couple of concerns I have on perhaps how Canada could best address them. They took a look at establishing a panel to consider scientific medical and clinical evidence, and the panel was put together—and perhaps with a yes or no answer in light of time—were the individuals who were appointed to this panel required to declare a conflict of interest?
Mr. Neil Yeates: They were required to identify interest that they had yes.
Ms. Ruby Dhalla: Thank you.
I find it quite alarming then in light of the fact that we know that they were required to declare a conflict of interest that three out of the nine members did identify a conflict of interest with a couple of the individuals actually acting as paid advisors for companies that actually produce these medial devices. Why was any action not taken by Health Canada in ensuring that this panel would provide objective and unbiased advice?
Mr. Neil Yeates: We felt it was very important that we have access to people who are involved in the fields. So some of these interests and affiliations are unavoidable if we’re going to get people who’ve got the real world experience. So we feel we need that. The expert panel report actually was delivered with a very high degree of consensus and represented a very wide spectrum of view. So we think given the nature of what we were dealing with here it was very important to have people who had that real world experience.
Ms. Ruby Dhalla: With all due respect though I think when we took a look at the numbers of plastic surgeons that exist in this country, and perhaps if we had to go out which I wouldn’t imagine, but if we had to go into the U.S. could Health Canada not go beyond the number of individuals that they had on that panel to find other individuals who did not have a conflict of interest. Now you can imagine for colleagues around this table it’s very difficult for us to have recommendations put forward by an advisory panel which has declared conflict of interest and nothing has been done by Health Canada to address those conflicts. When an individual’s been paid by a company that has been producing those silicone implants many women around this country are going to question the validity of the recommendations that they put forward.
Mr. Neil Yeates: We felt these people who served on the panel served the panel well. We felt we had affiliations. We didn’t feel they had a conflict of interest. We think to some extent this is unavoidable given the nature of what we’re dealing with. Experts such as Dr. Brown who is also presenting today his experience we feel is very important and we need to hear from that part of what is used here in Canada. I think we need to know that.
Ms. Ruby Dhalla: With all due respect to Dr. Brown and the great work that he’s done for women I’m sure there’s many other plastic surgeons around this country who do not have that conflict of interest. Were any efforts made by Health Canada to look beyond individuals that perhaps wouldn’t have a conflict of interest? If so why types of efforts were made by Health Canada?
Mr. Neil Yeates: I’ll ask Dr. Sharma to speak a little further that went into the selection of panel members.
Dr. Supriya Sharma (Associate Director General, Therapeutic Product Directorate, Health Products and Food Branch, Department of Health): Just to speak about the conflict of interest, and I’m sure Dr. Brown can speak to this as well, a lot of the concerns that the committee has raised in the past about conflict of interest have focused on the plastic surgeon panel saying that they somehow received some sort of enumeration based on their recommendations. I’m sure Dr. Brown will reiterate that, but we do have saline implants on the market so there’s no incremental advantage in terms of monetary funds for them doing the surgery. In picking the panel there were equally patients, representatives, or other people that had opinions that were different than the plastic surgeons.
In terms of going through and picking the panel members it’s important to remember that these panel members are volunteers. We actually do have a slate of plastic surgeons that we do go to, but there’s always challenges in terms of finding people who are available and who are able to come and represent themselves.
In terms of for instance some of the other conflict of interest that had been raised, Dr. Brandon I think was another name he is the North American expert on ruptured data. So to find someone who is the North American expert that has never given advice for example to other governments, or to industry is definitely a challenge.
The Chair: Thank you.
Mr. Dave Batters (Palliser, CPC):
Thank you very much, Mr. Chair.
I appreciate all of your being here, Mr. Brown being here by videoconference.
I’m going to start by just making a few observations from 35,000 feet, as a new member to the health committee, just some observations that I’ve noticed, sitting here, on this topic, and then I’ll ask perhaps representatives from Health Canada to comment, perhaps Dr. Zuckerman as well, on this first comment.
First of all, this is obviously quite a heated debate and there are some very passionate viewpoints on both sides. Being a new member on the committee, I think everybody could perhaps gain by dialing it back a little bit, and look at what’s truly in the best interests of patients, and go from that perspective.
I guess I’d say to Health Canada, looking at this issue and doing the reading, the entire process seems very arduous and awkward. We’re talking about these implants where Health Canada asked that they be pulled from sale in 1992–that’s 14 years ago–we’re talking about 19,000-plus requests under the special access program per year–this just looks like an absolute nightmare.
You’ve conducted multiple studies, you’ve had more than one expert group look at this issue. There are studies on the issue. I’m anxious to hear Dr. Zuckerman’s take on the experience in the United States. At what point do you make a decision, do you make some recommendations to the minister?
I tend to agree with Dr. Brown in that enough is enough. When you believe you have enough information…perhaps you’re not at that point, maybe that’s your argument, but we’ve gone 14 years. At what point do you say, “Here’s the information, minister, make a decision”?
Minister Clement is a very busy man, I’m sure that he doesn’t have time, maybe you can explain the process for this apparent minister’s permit for the special access program. There are thousands of requests for this.
Maybe you can tell me what I’m missing here. Multiple have been studies conducted, at what point do we make a decision and put this before the minister?
Mr. Neil Yeates: Well, the member’s quite right that the process has been extensive to date. We are nearing the end of the process in terms of our analysis of the studies that have been done, and looking at the literature. As I say, we’re approaching the end of that.
I should clarify that it will not be the minister making this decision; it’s made by the department. That authority is delegated to Health Canada.
Mr. Dave Batters: HPB?
Mr. Neil Yeates: Yes, to our branch.
So we are nearing the end of what has been, yes, a long process, but as you’ve noted there has been a lot of interest in this issue, a lot of concern regarding the products in question. So we want to make sure that we do a very thorough job on reviewing all of the safety data, the efficacy data, the quality data, to make sure we have all the information we need to make a decision one way or another. And, yes, we are reaching the end of that process.
Mr. Dave Batters: Definitely, Dr. Yeates, but we talk about the backlog in drug approvals, this looks absolutely ridiculous to me. If I were a woman in Canada, whether I were seeking an implant for cosmetic reasons or–God forbid–for reconstructive procedure following surgery, this would be an absolute nightmare and I don’t know how I’d make this decision. It must be a nightmare for physicians as well, but I really commiserate for the patients.
If I have a little bit more time, Mr. Chair, I’d like to ask Dr. Brown a couple of questions. How much time do I have? One-and-a-half minutes?
Dr. Brown, I just want to cover a few areas, if you could touch on a couple of things for me. In terms of aesthetic procedures of breast augmentation, my initial concern sitting down was waiting to hear how that would affect wait times in our hospitals. You seem to indicate those procedures are done in your private clinic. Is that true, sir, that all these are done in private clinics? A primary–
Dr. Mitchell Brown: I can only speak for–
Mr. Dave Batters: I’m sorry, I’m talking about primary surgery for augmentation.
Dr. Mitchell Brown: I understand. I can only speak for my personal practice.
I use every bit of time that’s provided to me at Women’s College Hospital for my reconstructive practice. Any time on top….
Mr. Dave Batters: Thank you, sir. I just want to keep going because my time is very limited.
Maybe you’d agree with me that there’s desperate need for it. Maybe there are firm guidelines in place. Take this in the spirit which it’s intended, sir, I’m not trying to trap you up at all, can a woman who is having problems with her implants, whether they were implanted under the publicly funded system or in your private clinic, if they’re having problems with them, can these implants be removed if they pay to do so if they decide that they can’t afford the wait for their scheduled surgery time in the public hospital?
Dr. Mitchell Brown: My understanding is that if a procedure is to be covered as a medically necessary procedure that it would contravene the Canada Health Act for a person to be able to provide payment and have that procedure done quicker in a different method. That’s my understanding.
The Chair: Thank you, Mr. Batters.
I’m being informed that Mr. Yeates and Mr. Stachenko have to leave at this time.
I thank them for coming forward and I appreciate that very much.
We’ll continue the questioning with the remaining panel.
Ms. Tina Keeper (Churchill, Lib.): Thank you.
I had a question for the Public Health Agency. I’m wondering if Ms. Sharma would be able to answer that question as she works for Health Canada.
Dr. Sylvie Stachenko: I’ll answer.
Ms. Tina Keeper: Thank you, doctor.
The results of the cancer incidence and a cohort of Ontario and Quebec women study has found that there was, as you mentioned, no correlation between increased rates of cancer in women that had received breast implants. Is that a position or statement that’s going to be made by the Public Health Agency of Canada? Will that affect how you promote safety or risk around breast implants for women in Canada?
Dr. Sylvie Stachenko: We will simply state what the study says, which is there is no increased rate of cancer from the study. Obviously if you’re looking at safety and other issues, which is really with the regulations, we’re only one input. This is a population study that is one input among others in terms of the very complex decision-making process.
There’s more than just the issue of the long-term impact, there’s other issues which we’ve discussed here. Basically our position is from the population based study which is consistent, by the way, with other cohort studies. One of the things that’s very important to note is that this is one that allows more statistical power because we have more women than any other cohort study. In practice, this is an important thing to say and in terms of looking at specific categories and subgroups it has more power to be able to make some assertions.
The second thing, and it was mentioned by Dr. Zuckerman, when you’re looking at long-term impact you have to have follow-up periods that are more than five years, particularly when you’re talking about cancer. This study actually has a mean follow-up time of 15 years, some of which is even 25 years. In terms of this specific study versus other international cohort studies we had more power and a fair follow-up period to be able to validate the other studies. What we’re finding is very consistent.
I think when we discuss population health impact it is going in the same direction. We are adding to that base of knowledge and we’re adding it from a point of a view that has actually got more statistical significance given the statistical power of the study.
Ms. Tina Keeper: You also mentioned you found there is an increase in the suicide rate among these patients. I would like to ask from a public health perspective, had you looked at other factors in terms of fibromyalgia, immune system disorders, or those types?
Dr. Sylvie Stachenko: One of the issues around these studies is that we are looking at mortality. Obviously, from that perspective we weren’t able to look at morbidity, and that’s the question you’re asking.
Ms. Tina Keeper: Does the Public Health Agency or the federal government plan to seek additional studies to examine these other issues?
Dr. Sylvie Stachenko: Given those results we will be discussing with our provincial, academic, and federal government partners in the next step. Obviously, this is a cohort study. As you know there’s many databases in this country. There are risk factor databases to the community health survey. What we can do is perhaps see if there are any opportunities to link and do further linkage to understand some of these questions that you’re raising. It’s in discussion, no firm decision, and we are now looking into opportunities for further research.
Ms. Tina Keeper: One more quick question?
The Chair: Very quick.
Ms. Tina Keeper: Dr. Zuckerman, what you found was that there were, indeed, increased rates of cancers. Could you explain a little bit about that study and how you came to those conclusions?
Dr. Diana Zuckerman: Sure.
It’s not my study. It’s a study by the National Cancer. Institute It’s comparable, perhaps not quite as large as the Canadian study that was just described, but it did have women who had implants for an average of 20 years rather than 15 years. So it was a little longer.
I put the slide up. They had a doubling of brain cancer deaths, a doubling of lung cancer deaths, and a doubling of suicides. This was compared to women with other plastic surgeries. Women who have plastic surgery are more likely to smoke. So it’s important to look at them compared to each other, not to the general population.
When they looked more carefully at lung cancer, for example, they found that the women who smoked and had breast implants were more likely to die from lung cancer than women who smoked and did not have breast implants. Perhaps it was that double vulnerability of smoke and leaking silicone that made the difference. But who knows?
It’s possible that if they study these women for longer periods of time, it’ll look different. If you look at people who smoked for an average of 10 or 15 years, most of those people will not die of lung cancer yet. But if you study them for 25 years, many of them will. It takes time.
The Chair: Thank you.
Mr. Dykstra is yielding his round to Mr. Batters.
Mr. Batters, five minutes.
Mr. Dave Batters: Thank you again, Mr. Chair.
I want to follow up on my earlier line of questioning with Dr. Sharma and then with Dr. Zuckerman.
Regarding the process that’s in place, Dr. Sharma, what can we expect to see as the next step in all this? How does Health Canada move from its consideration of scientific and other evidence to a regulatory policy decision on this device? Where are we and what are the next steps? Can you give us a timeframe?
Dr. Supriya Sharma: I’m assuming that when you’re asking about a regulatory policy decision, you’re talking about a decision on licensure of these products.
Mr. Dave Batters: Right. Exactly.
Dr. Supriya Sharma: We’re actually in the final stages of the scientific review, and as you’ve mentioned, it’s been going on for some of the applications for approximately five years. Just to put that into context, normal review times for class III and class IV medical devices are either 75 or 90 days. So this is definitely an extensive and a much more indepth look than for other medical devices.
We are coming to the end of that process. At the end of that process, there’s a recommendation. The recommendation can take one of three forms. There’s a recommendation to license. In that case, the implants would be available for general sale. It can be a recommendation to license with conditions, so there may be conditions placed on that licensure. Or the decision would be to not license. I said that we’re in the final stages of that, but information can come up in those final stages that prolongs the process.
Mr. Dave Batters: Absolutely.
I have one more question for Dr. Sharma.
Right now, when we talk about the Special Access Programme–again, we’re talking about thousands of applications here, many of which are granted–how extensively are the decision-makers looking at these applications? To my reading, that’s the minister. We’re talking thousands of applications.
I can’t believe–maybe it’s just my personal bias–that every time Dr. Brown or one of his professional colleagues make an application, there’s a detailed study done patient by patient. Or maybe that’s the case. Can you tell me what kind of process this involves, every time one of these Special Access Programme requests are granted or denied?
Dr. Supriya Sharma: Absolutely.
And there is a clarification on an earlier point. We were talking about numbers. For breast implants in the last fiscal year, it was approximately 8,000. Although the number of requests for other medical devices is smaller, as Mr. Yeates said, sometimes they come through Special Access. For instance, a drug-eluding stent that goes into your heart would release about 8,000, so it’s comparable to breast implants.
Every application that comes in through the Special Access Programme is an individual physician making a request for an individual patient for breast implants. Each application is looked at, screened, and analysed against four sets of criteria that must be fulfilled before the minister–and that’s delegated down to the department–can authorize that request. Every application is like that.
Mr. Dave Batters: Thank you.
Dr. Brown, is this an absolute nightmare in terms of getting patients approved? Is it a long, arduous process to get patients approved?
Dr. Mitchell Brown: No, it’s not particularly long and arduous. We try to only apply for Special Access when I feel that it’s very appropriate and when there’s a specific indication for it. In those instances, where I’ve essentially pre-screened the process by not applying when there’s not an appropriate indication, I have generally received approval.
Mr. Dave Batters:
Thank you, sir.
Dr. Zuckerman, what’s the experience in the United States regarding the process right now for patients that can get silicone gel implants? What is the process in the states?
Dr. Diana Zuckerman: The process is somewhat similar. Silicone is supposed to be restricted to women who need reconstruction after breast cancer or need an implant replaced, however their idea of reconstruction in the United States includes women whose breasts don’t look as young as they used to because they breastfed. I was surprised to find out that was a deformity, but apparently it is, and so a very large percentage of women in the United States are getting silicone gel breast implants because their breasts look like they’re 35 years old instead of looking like they’re 20 years old.
It’s very easy for those women to get breast implants because all they need is a doctor to say this is reconstruction. And, as I said, their definition of reconstruction is not what I think the women here would probably think of as reconstruction.
It is a problem in the sense that these women are supposed to be studied. In the United States, if they get implants through special access, they’re supposed to be studied over a long period of time and they are not. They’re not studied at all, actually.
The Chair: I’m sorry, your time is gone.
Madam Barbot, you have five minutes.
Mme Vivian Barbot (Papineau): Merci.
Comment pouvez-vous dire que le docteur Brown, qui utilise ces implants depuis 2001, ne profite pas directement de la décision qui sera prise, alors que les implants mammaires ne sont pas couverts par l’assurance?
Dr. Supriya Sharma: What I was saying is that because saline-filled implants are licensed for sale in Canada—and they have been basically since 1971—that if somebody is seeking a breast implant and there’s a fee charged for that service, then whether it is a saline implant that is implanted or a gel-filled implant that is implanted, there’s no difference in terms of remuneration.
Mme Vivian Barbot: D’accord. En ce qui concerne les implants mammaires, y a-t-il actuellement des recours collectifs contre Santé Canada et quel est le motif de ces recours?
Dr. Supriya Sharma: There are a number of issues before the courts. Some of them have actually been dismissed and settled and there was no money paid by the Government of Canada in the settlement of those—and those were the ones that were happening out in British Columbia. The rest of them, because they’re before the courts, I can’t comment on them, but we maintain that the regulatory and scientific decisions that were made, that dealt with those issues, were scientifically sound.
Mrs. Vivian Barbot: Okay.
I have a question for Dr. Brown.
What would you say about the fact that cancer survivors with implant experience have more complications and are more likely to need additional surgery to correct those problems compared to augmentation patients?
Dr. Mitchell Brown: Thank you.
That is not the least bit surprising, that fact. Breast reconstructive surgery is very complex and very difficult and very challenging surgery for the plastic surgeon whether it is with the use of an implant or whether it is with the use of tissue taken from other areas of the body. Breast augmentation surgery is generally a fairly straightforward procedure where we’re dealing with a natural part of anatomy, a normal part of anatomy, and changing its feature. And if done properly, it can and should be done with a very low complication rate.
Reconstructive surgery is trying to reconstruct, build or create a new breast essentially from nothing. It is a much more difficult procedure, it is a much more complex procedure, not to mention it’s often a unilateral procedure. And many of the re-operations that are quoted in these studies are re-operations to fine-tune balancing and symmetry issues. For example, lifting or reducing an opposite breast to try to make it look more like the breast that’s been reconstructed.
So that data does not surprise me in the least.
The Chair: Thank you very much.
Ms. Bonnie Brown: Thanks very much.
Dr. Sharma, of the over 8,000 applications for these devices, how many Health Canada employees are reviewing those applications and what are their qualifications?
Dr. Supriya Sharma: And you’re referring to the Special Access Program–
Ms. Bonnie Brown: Special access, 8,000 silicone-gel.
Dr. Supriya Sharma: At any given time there’s usually two or three people who are reviewing those. The Special Access Program for medical devices is actually led by a physician, a health care practitioner, and the people who are reviewing them are chemists and people who have expertise in materials, primarily.
Ms. Bonnie Brown: Okay. So they’re not all reviewed by physicians, but by chemists?
Dr. Supriya Sharma: No, they’re all, ultimately, reviewed by the physician because that’s the person that’s in charge of that program.
Ms. Bonnie Brown: Well, he’s in charge of those staffers, and they make a recommendation to him, and then he has to approve or not approve? Or can they say “yes” on their own?
Dr. Supriya Sharma: No. He has to approve or not approve, and he actually reads every single special access form.
Ms. Bonnie Brown: Okay. Of the more than 8,000 requests, how many were turned down last year?
Dr. Supriya Sharma: I actually don’t have the statistics. It’s a very small number ,and it would be less than a hundred that would have been turned down.
Ms. Bonnie Brown: Now, considering the advisers, expert panel, and it’s report, it seems to me, at least in those discussions, which I’m sure you monitored, there was a lot of negativity about saline implants. Certainly at the public hearing I attended, I heard a lot about the negative effects of using saline, and that’s why the plastic surgeons wanted to get approval for this newer silicone.
Because of all that negative conversation about saline, is Health Canada considering removing saline from the marketplace?
Dr. Supriya Sharma: There’s actually probably two separate points in that.
One was in terms of the commentary around saline implants. Most of the commentary around saline implants was actually in comparison with gel-filled implants for specific indications. As a result, the conversations were fairly negative, because you were talking about, for instance, patients with a very thin chest wall that don’t do very well with saline implants. Patients had a higher risk of contracture, for example. So it didn’t really reflect the body of knowledge that we have on saline implants, in general.
As I said, saline implants have been available since 1971, and they are continuous monitored, as are other class 4 medical devices. So there’s a program by which we look at risk, we look at adverse events that have been associated with it. There is a rereview. So that is continuing, and at this moment, there hasn’t been enough evidence to warrant the withdrawal of saline implants from the market.
Ms. Bonnie Brown: Dr. Sharma, do you know how many plastic surgeons there are in Canada?
Dr. Supriya Sharma: I do not.
Ms. Bonnie Brown: But however many there are, you’re saying, in trying to select two or three for your panel, your choice was so limited that you had to pick two who had already had a monetary connection to the two companies applying for the device to be approved to be licensed?
Dr. Supriya Sharma: There were a number of plastic surgeons that were, for instance, approached, and then declined, either because of availability or because of lack of availability for an honoraria to be provided. But we did look extensively for plastic surgeons to sit on the panel.
Ms. Bonnie Brown: How many did you invite, before you settled on these few?
Dr. Supriya Sharma: I would have to go back and look at how many were actually—
Ms. Bonnie Brown: Could you get that information to us?
Dr. Supriya Sharma: Sure.
Ms. Bonnie Brown: Thanks very much.
The Chair: Thank you very much.
We have actually two more questioners, and if I could ask that we split the time. We have five minutes left, we go two-and-a-half each.
Mr. Dykstra, and then Madam Demers.
Mr. Rick Dykstra (St. Catharines, CPC): Thanks, Mr. Chair.
I’ll be specific. I had got a couple of questions, and I’ll try to get them as quick as possible.
One is the process, and I’m not sure who to direct this question to.
If a leak is found in a woman’s breast and it’s known, what is the process to deal with it? How does it work through? The indication is that there is wait times that are extensive, and probably damaging, obviously, to the health of the women. What is the specific guidelines that we use, either from an Ontario, or, better yet, from a federal perspective to deal with it? Or are there?
Dr. Supriya Sharma: I can actually just speak to the special access program, if we’re talking about gel-filled implants, because if a gel-filled implant is actually accessed through the special access program, there’s a requirement to report back to Health Canada within 72 hours any adverse event that is associated with it. So in terms of getting that information on the device, there is a requirement to do that.
In terms of how it’s dealt with at the practitional level for removal, that is actually a “practice of medicine” issue, so I would probably, I guess, direct that to Dr. Brown.
The Chair: Dr. Brown, any comments on that?
Dr. Mitchell Brown: The issue is to have a discussion with your patient about what you’ve found, to lay out for them the options. There is not general consensus that, even in the presence of a known leaking implant, that is necessarily an indication for removal. So options are presented to women about observation, about the likelihood of there really being a leak, even if it’s been identified potentially on mammogram or an MRI or an ultrasound, about the options for removal, removal and replacement, and they are laid out, and then the procedure is scheduled for the patient, if it’s required.
I try to triage my patients as best as I can. If a women has a very noticeable leak of an implant, it looks like it may have come out from the capsule that forms around the implant, then I try to move surgery and get that woman in as quickly as possible to deal with it.
It’s essentially done on a case-by-case basis.
Dr. Zuckerman, a quick comment.
Dr. Diana Zuckerman: I just wanted to say that at the FDA meeting it was clear that the decision was that leaking implants should be removed as soon as possible, and that almost always it isn’t obvious that an implant is leaking and that’s why the MRIs are so important. I guess that is one difference between the Health Canada panel and the FDA panel. They felt very strongly that once it starts leaking, well, even when it’s broken, it’s going to start leaking and that it should be removed right away.
The Chair: Thank you.
Madame Demers, very short.
Mme Nicole Demers: Merci beaucoup, monsieur le président.
Madame Sharma, la question s’adresse à vous.
Diriez-vous que Santé Canada a une certaine responsabilité relativement au bien être et à la santé des Canadiens et des Québécois en général?
Deuxièmement, puisque les renseignements requis afin de présenter une demande d’autorisation d’accès spécial afin d’obtenir des implants mammaires exigent que le médecin et le patient tous deux signent le formulaire de déclaration, comment se fait-il qu’il n’y ait pas d’endroit désigné sur le formulaire afin que le patient signe?
De plus, comme on l’a vu dans le reportage de Radio-Canada, comment se fait-il que les médecins n’informent pas le patient qu’il doit signer un formulaire pour obtenir des implants mammaires?
Dr. Supriya Sharma: To the first part of the question in terms of the mandate, and I’ll speak specifically to the mandate to the health products and food branch and how it relates to health products.
Absolutely, we have a mandate. Our mandate is to maximize the safety of the products that we do regulate while minimizing those risks and that contributes to the health and safety of Canadians. Absolutely, that is our raison d’être.
In terms of the signing, the requirements are that the practitioner, the requester, sign the form and it’s a declaration that the practitioner has actually discussed the risks and benefit of the device with the patient, but there is no requirement for the patient to sign the actual form.
Mme Nicole Demers: C’est votre responsabilité?
Dr. Supriya Sharma: I’m actually referring to the regulations that govern the special access program for medical devices. In section 22, the Medical Devices Regulations, it stipulates only that the practitioner sign a declaration that says that he or she has discussed the risks and benefits of the patient. I can take a look at the document that you’re referring to but that’s not in the regulations.
The Chair: Thank you.
Our time is gone.
I want to thank the panel for being here and presenting this information to the committee. I thank the committee for their questions, particularly Dr. Brown for the technology and for your taking time out of your practice.
Just to let the committee know, we will be discussing this on Tuesday as to whether we want any further action with regard to this as we go into the report on Fetal Alcohol Spectrum Disorder.
Mme Nicole Demers: J’aimerais déposer une motion.
The Chair: I’m sorry, I missed it.
Mme Nicole Demers: J’aimerais déposer une motion avant de terminer.
The Chair: You can table a motion at any time.
We’ll call this meeting adjourned.