I.A.S. IMPLANT AWARENESS SOCIETY

e-mail: rmatthew@radiant.net

It has come to our attention that the Mentor Corporation has been marketing its saline breast implants in Canada, and very aggressively in British Columbia (2200 pairs in 1998) and also in Québec. This despite the fact that it is being investigated by the FDA for very poor quality control of its breast implants. The FDA is currently fining Mentor $10,000 a day for non-compliance.

Health and Welfare Canada’s track record on the regulation of saline breast implants does not bear scrutiny. The deadline for the manufacturers of the device to prove its safety expired nine years ago. To the best of our knowledge there has never been any data forthcoming concerning the safety of saline breast implants either from the manufacturers or Health Canada! Our experience with the device has led us to believe that they are inherently angerous and should be withdrawn immediately. The complications associated with these follows:

1. Formation of a hard, fibrous capsule around the implant. This can cause gross distortion of the breast and severe pain, especially with McGhan implants.

2. The implant can become displaced. We have encountered many women whose saline breast implants have migrated to other parts of their bodies: under the armpits, into the neck, down the arm, etc. When these implants, which have silicone elastomer shells, are removed, more often than not they are black with mold and fungus and resemble tarpaper.

3. During mammography (not recommended by Health Canada for women with implants) the hard, fibrous tissue of encapsulation, as well as the implants, can conceal cancerous breast tissue.

4. The risk of breast implant rupture or deflation is very high, especially during mammography, breast feeding, sports, etc.

5. During a woman’s lifetime, the breast implants have to be replaced many times. The cost of which is very high: $4,500 to $6,000 for each procedure.

6. Over time, the outer silicone elastomer shell is attacked and literally devoured by the immune system’s macrophages. In this way, the shell, which is made of highly toxic fumed silica, is distributed throughout the body and stored in major organs.

7. The outer shell is semi-permeable and, as the outer shell deteriorates, it becomes an even more permeable membrane through which body fluids and warm saline pass and then combine to form a toxic soup of yeast, mold, and bacteria. The toxins are taken up by the lymphatic system and distributed all through the body. The effects of this is not unlike having a permanent sepsis in the body.

Very young women are signing waivers before undergoing implantation in the private surgical suites of plastic surgeons. Recently, we have had concerned parents calling us who have been placed between "a rock and a hard place" regarding their GP’s recommendation that their teenage daughters be implanted with saline breast implants if one of their daughter’s breasts has not fully developed. This is a common phenomenon and usually the problem is rectified by the early twenties or during pregnancy. When parents object to this procedure, they are quoted the Child Act and told that it will be done with or without their consent.

It is very clear to us that Health Canada has no alternative but to place a moratorium on saline breast implants, especially those manufactured by Mentor, or risk being sued by women who have already suffered or will suffer damages from this medical device. Health Canada is derelict in its duty to enforce the Food and Drug Act regarding saline breast implants. It is also failing to report the damages of saline breast implants to the Provincial Ministries of Health, and thence to GPs and plastic surgeons.

We would like to bring your attention to two statutes that are applicable to this situation:

The first is The Doctrine of Legitimate Expectation based in English common law and ratified by Canada, the USA, and the UK in the 1940’s. This law states that if there is a government department headed by a Minister of The Crown that has the mandate and the power to enforce an Act of Parliament, the public has legitimate expectations that this will be done and that a drug or medical device will be 100% safe. Obviously, the law fits Health Canada’s Health Protection Branch, headed by Alan Rock, and its Food and Drug Act. Health Canada’s mandate is to enhance and protect the health of Canadians and also to anticipate any problems with a device or drug. The Doctrine of Legitimate Expectations is very clear on this and states that the government department is not just morally and ethically bound to enforce the Food and Drug Act, but also legally!

The second statute is The Precautionary Principle of International Customary Law. This law, also ratified by Canada, states that if a product is banned in its country of origin, it should not be exported to other countries.(Imperfect implants should be destroyed and not sent to Canada.) This law takes precedence over NAFTA or GATT. Whenever there is scientific debate as to the safety of a product, the precautionary principal should prevail and the product should not be marketed.

Saline breast implants are being touted as 100% safe by plastic surgeons and GP’s. Obviously this is not the case. There isn’t even a provincial registry of women implanted with these devices, neither is there any genuine informed consent! We trust that this issue will be addressed and that appropriate pressure will be applied to Health Canada’s Health Protection Branch to ban all breast implants until such time as they can be deemed 100% safe.

We must have a moratorium on saline breast implants in British Columbia and Québec. When you review this documentation, both of our societys strongly feels that you will agree. Canada gets the worst of already imperfect implants. It is no wonder that women get on a treadmill of constant surgery due to failure of these implants.

We must establish a total ban on all breast implant advertising in Canada. In the magazine Her’s, there was flagrant advertising promoting these devices as safe and approved, which is far from the truth.

We want you to know that our society has many members and, through affiliated groups, many thousands of followers. We are also organizing in other provinces to bring about the ban on all breast implants. Let British Columbia and Québec be the first to protect its women and begin now.

The I.A.S. Implant Awareness Society provided information to the RCMP (four pounds of Dow Corning and Dow Chemical’s own laboratory documents, seized by courts, that prove disease from implants in 1964-1990) that launched a criminal investigation in April 1998. The investigation is proceeding very, very well. We also have the names of particular doctors, such as Dr. Cordelia Bains, Dr. Walter Peters, Dr. Birdsell, and Dr. Birkill who have published false reports. There are five other doctors who will be included in special reports. Time has a way of allowing the truth to come forward.

Mentor also makes eye implants. The very same factory that produces the breast implants using the same materials. They also send the imperfect ones to Canada and other countries.

When a woman pays the shot ($6,000.00) for cosmetic reasons, her return visits to the plastic surgeon is then on the British Columbia and Québec Medical. We all pay the costs for flawed implants that, by law, we should be protected from. A gunshot wound is referred to as a local injury and so is breast implant surgery. This has, for whatever reason, never been discussed with the women. Breast implants produce a greater injury site, for their surgery is greater, and the implantation is only the beginning.

Copies of this file are being delivered to British Columbia offices of Effie Henry, Director of the Women’s Health Bureau, Ministry of Health; the Honourable Minister Penny Priddy; The Honourable Susan Hammell; Ombudsman Dulcie McCallum; and Florence Harvey.

Copies of this file is also being delivered to the offices in Québec of, M. L’Honorable Premier Ministre M. Lucien Bouchard; Monsieur Daniel Jocoby Avocat; L’Honorable Ministre de la Santé Madame Pauline Marois; L’Honorable Ministre de la Justice Madame Linda Goupil; Régie de l’assurance maladie du Québec Madame Suzanne Doyon Md; Député de Saint-Maurice Claude Pinard; and Député de Lévis-et-Chutes-de-la-Chaudière M. Antoine Dubé.

It is our understanding that the above offices have the power to place a moratorium on the advertising and sale of breast implants in British Columbia and Québec. We urge you to exercise the law. Please read the documentation provided and reply at your earliest possible convenience:

1. The FDA is taking legal action against Mentor Corp.

2. Dow Chemical Trial Abstracts.

3. National Academy of Sciences Institute Of Medicine

4. The Laws of Doctrine Of Legitimate Expectation and Precautionary Principle.

Thank you for your time and consideration.

Sincerely,

Micheline B. Lambert, President

Adella Matthiew, President