Thank you very much for accommodating me and allowing me to be a part of this committee meeting today from my hospital here in Toronto.
Mr. Chairman, members of the Standing Committee on Health, thank you very much for inviting me today to address the committee and respond to your questions.
Let me begin by introducing myself. I am a plastic reconstructive and cosmetic surgeon on active staff at Women's College Hospital. I am a full-time academic surgeon and associate professor in the department of surgery at the University of Toronto.
My clinical practice is focused primarily on esthetic and reconstructive plastic surgery of the breast. I have had the honour and privilege of treating thousands of women for problems ranging from congenital abnormal development of the breast, to required reconstruction after breast cancer surgery, to desired aesthetic changes.
Last year I was invited by Health Canada to sit as a volunteer member of both the scientific advisory panel and the expert advisory panel on silicone gel-filled breast implants. I was honoured that Health Canada felt that my clinical experience in using both saline and silicone gel-filled breast implants would be beneficial in helping to answer specific targeted questions relating to applications made by implant manufacturers for their gel-filled devices.
I would like to congratulate Health Canada on the work they have done to put together the scientific and expert advisory panels, as well as the open public forum. I believe that all Canadians should be very proud of and confident in the group of individuals who were asked to form these panels.
In contrast to what we have seen in some other parts of the world, these panels included a diverse selection of individuals, each highly skilled and respected in their particular areas of excellence. Virtually all stakeholders were well represented, and the panel included a balanced mix of expertise, gender, age, and geographic regions.
The panel's report was formed through intense, unencumbered debate, following a thorough review of all provided materials, manufacturers' presentations, and public forum hearings. The panel was asked to answer specific questions based upon the information available to us and our clinical experiences.
I firmly believe that the report submitted to the Minister of Health is a balanced, thoughtful, and complete response to the questions posed. The report has synthesized the views of all members present, and when any dissenting opinion arose, the report clearly states the number of members in agreement or opposition to any statements made. I am proud of my participation in this process, and as a Canadian consumer, I am comforted in knowing that this template exists for the approval of devices in Canada.
Mr. Chairman, I have come here today in support of my patients and their right to make an informed decision about their esthetic and reconstructive breast implant options.
No material has been studied, analyzed, and researched more than silicone. Silicone is presently one of the most commonly used implanted devices in medicine. It is a component of cataract lenses, ventricular peritoneal shunts used in neurosurgery, artificial finger and wrist joints, testicular and penile prostheses, stents, and saline breast implants, just to name a few. Every day in Canada, hundreds of implants are inserted that contain silicone in one form or another. Silicone is used in the processing of medical supplies, in intravenous bags, and is used to coat injection needles. It is estimated that the average diabetic receives 200 milligrams per year of silicone directly injected into their bodies as a result of insulin injections. Silicone is also used in the processing of bottles, glassware, and rubber, and is found in many store-bought food products. Did you know, for example, that measured levels of elemental silicone are substantially higher in store-bought baby formula than levels detected in the breast milk of women with silicone gel-filled breast implants?
There have been many well-conducted research studies evaluating the potential negative health effects of gel-filled implants, and the overwhelming majority of information has failed to demonstrate a connection between the use of these implants and disease in women.
No device is perfect; all implants fail at some point. If you were to ask me today, would I like to know more about the lifespan, failure rates, and long-term risks of any device that I presently use, the answer would most certainly be an emphatic yes. Information is good, and more information is even better. If you ask me, however, when is enough, enough--when do we have enough information so that a reasonable person can make a properly informed decision about the benefits and risks associated with silicone gel breast implants--I would say that time is now.
Silicone gel breast implants are used extensively throughout the world. In almost every country outside of North America, silicone implants comprise 99% of implants used. In the United States, the FDA has provided conditional approval letters to both manufacturers. Once those conditions are met, it is expected that these implants will be available for routine use.
Not all patients are candidates for silicone gel-filled implants. There are advantages with saline implants, and many women achieve excellent results with these devices. In many cases, however, gel-filled implants offer significant benefits. Gel-filled implants are soft, they feel more like natural breast tissue, and they move more naturally under the breast--all important considerations for women undergoing breast implant surgery. As well, they are less likely to produce rippling, a common problem with saline implants, which results in a palpable, unnatural edge at the periphery of the breast margin.
I have been using cohesive silicone gel breast implants in my practice since 2001 and I can emphatically state that no new device or technology has had such a positive impact on what I am able to provide for my patients. They are ideal for treating young women with congenital abnormal development of the breast, and the consistency and shape options produce excellent outcomes for women who have concerns about their breast esthetics following pregnancy and breastfeeding. Results have been far superior to that seen with saline implants, and patient satisfaction has been uniformly high.
In reconstructive surgery, new cohesive gel implants have completely changed what we are able to offer our patients. During the years from 1995 to 2000, 70% of all post-mastectomy breast reconstruction that I performed was large surgical procedures using the patient's own natural tissue, commonly from the tummy. Although these procedures produce excellent results, they are major operations that require scars elsewhere on the body and prolonged recovery times. This is often an unacceptable option, especially for young women with small children, or women who were not prepared to accept that degree of downtime.
The saline implants available at that time produced very unsatisfactory results, with almost 100% of patients developing rippling, an unnatural feel of the breast, and an exaggerated round shape to the breast, often looking very different from the natural, non-operated side.
Women were left with few options but to undergo bigger reconstructive procedures. Since 2001, 75% of all reconstructions are being performed with the new cohesive gel-filled implants--a complete reversal from what I was doing previously. These new gel implants, the ones we are talking about today, are very different from previously developed implants. They are made of a far more viscous, thicker gel, so that if you cut into one, it is very much like cutting into a gummi bear.
These implants come in a wide selection of sizes and shapes, allowing us as reconstructive surgeons to provide outcomes that more closely match the shape of a natural breast and provide for a much more natural-feeling breast. As well, if a device was to break, the gel filler is much less likely to escape from the implant shell in comparison to older-style implants from the 1970s and 1980s.
Since 2001, I have used these implants in over 100 patients for post-mastectomy reconstruction. Results have been excellent, patient satisfaction has been high, complications and re-operation rates have been low, and patients have had a viable alternative to more invasive reconstructive options.
I have concerns about the direction this committee has chosen to pursue. A detailed and thorough report has been submitted to the Minister of Health from a panel of experts who are well qualified to answer the questions put before them. Canadians were invited to, and provided with, a forum to make their views known directly to the panel. Presentations were thoughtful and considerate, whether they were in support of, or in opposition to, the applications.
In fact, Dr. Zuckerman, who is here as a witness, was listed as speaker number 40 on that day, but she did not attend the forum, nor did she present her views to the panel. She is, however, receiving an opportunity to address the committee today without a panel of experts present, a position that I feel is hard to justify to the many Canadian women who support the applications for these devices. Where is their voice? Why are they not invited to speak to this committee today? What is new since the public forum that justifies Dr. Zuckerman's invitation to address the members today?
I would like to read a letter by a woman that I know personally. In fact, she is the wife of a clergy member at my synagogue. She is not my patient, but when she heard about the direction the committee was taking, she asked that I find a way to have her views heard.
I am a 35-year-old woman who was diagnosed with breast cancer two years ago while pregnant with twins. Although I had to make many decisions quickly, I feel that I made very informed ones. As a critical psychologist, I have been well trained in the art of scientific research. I have a lot at stake: my two-year-old twin daughters and their three-year-old brother. As a BRCA1 carrier, I felt that I had no choice but to have a double mastectomy. I spoke with several other BRCA1 carriers to discuss their decisions regarding implants. After consulting with plastic surgeons, doctors specializing in lupus, general surgeons, medical consultants, researchers and oncologists from several top teaching hospitals in Canada and the US, I decided to proceed with reconstruction using tissue expansion and silicone gel filled breast implants. I was well informed of the risks of silicone implants, but felt that the benefits far outweighed the risks. After all of these consultations, my own readings and testimonials, I feel that I made the right decision. As a young professional woman, it is very important for me to look and feel as good as I possibly can. First, I want my girls to develop a healthy body image; and second, for my own body image and self-esteem. In my busy schedule, I wanted life to go on as normal as possible. The implants I have chosen are very realistic and comfortable for me, and I have thus far had no problems with them. I am very happy with my decision, and I would not have done anything differently if I had the chance. I often advise other women like myself to seriously consider cohesive gel implants as an option for reconstruction. It is comforting to know that as a woman, I have the right to decide what goes into my body. Thank you, Melissa Lieberman-Moses
Mr. Chairman, I thank you for the opportunity to be here today, and I look forward to addressing any questions from the committee.