The following article is a condensation of a 12-page paper sent to the I.A.S.

Implant Awareness Society by Dr. Pierre Blais Ph.D., F.C.I.C., in November 2001.

Breast and facial tissue augmentation with oil injections predates the Second World War. Augmentation with implants has been performed widely since the late fifties. Surrounded by dubious advertising, secretive techniques and widespread adverse effects, the procedures acquired a seedy reputation and were strongly censured by the health care community.

In the late fifties, at the height of abuses, some private plastic surgery practitioners feared intervention by governments, insurers, and medical associations. These practitioners attempted to refurbish the image implant augmentations had acquired over the years. Publications on techniques, some claiming follow-up on large cohorts of patients, appeared in medical journals and clinical symposia. Hospitals became more tolerant of cosmetic surgery within their facilities. An open confrontation between mainstream practitioners in plastic, reconstructive, and burn surgery and the supporters of private ‘beauty clinics’ was somehow avoided. By the early sixties, primarily because of a small number of influential surgeons and skillful image polishing, cosmetic surgery clinics had again become attractive business options.

Implant-dependent procedures were ideally suited for these undertakings. They required minimal skill, time, and equipment. Above all, they were immediately gratifying, often producing spectacular changes in the patient’s appearance and self-perception. A commercial implant industry was emerging and medical suppliers’ catalogs were replete with new implants and related instruments of all kinds, some of remarkable absurdity. Promotion of cosmetic, aesthetic, and plastic surgery services explains proliferation of these procedures of the late sixties. By the seventies, demand was brisk, attracting increased numbers of marginal health care professionals to the sector and making the area much more accident-prone.

Breast implants overwhelmingly dominated the sector, outnumbering facial implants manyfold. Shoddy design, spotty quality, and poor durability, which had plagued the area from the outset, crested. What followed led to the most elevated adverse reaction levels ever recorded for a widely performed surgical procedure. Because of the latency of implant failure symptoms, the magnitude of the problem did not become fully manifest to outsiders until the late eighties. Promoters had been largely successful in hiding morbidity and costs.

Breast augmentation, which fell into disfavor following the FDA Moratorium, has been increasing in popularity since about 1994 and now exceeds the pre-Moratorium level. New users are primarily young women. For the year 1998, 132,378 new users were reported in the U.S. For the year 2001, it is projected that there will be more than 1 new breast implant user for every 100 women.

Clinical trials supervised by the FDA under special exemptions have led to a small number of implantations with gel-filled implants, in particular for mastectomy patients. The rationale presented to the public for reintroducing gel implants is that they appear more ‘natural’ than the salines and that such products are "safe". This in turn translates to lesser liability risks from early failures.

Be that as it may, gel-filled implants remain basically unchanged since the sixties. They are still made by successors of the same firms who went into receivership in the seventies and eighties, using the same technologies. In many cases, even the same production equipment is used.

The media are replete with slick advertising by promoters in much the same way as in the sixties. The difference is, much of the promotion is disguises a ‘news’ or ‘medical’ information. Mostly hidden, is that adverse effects are as numerous and as severe as ever, and that augmentation procedures inevitably converge to permanent, essentially irrecoverable, chest damage.

Without promotion, there would be no plastic surgery as we know it. Direct and indirect promotion is everywhere, intermingling indiscriminately with medical news and commercial advertisements. Much of it is paid for by plastic surgery associations and surgeons who often employ full-time public relations specialists and ‘beauty’ consultants.

Controversy and morbidity have surrounded breast implants from the outset but the demand is cyclic. At intervals of about 7-9 years, crises with widespread public concern occur. The cycles repeat at regular intervals, peaking soon after a promotional campaign.

A silicone gel-filled implant is basically a saline implant shell filled with a mixture of silicone oils with added thickening agents. The filling substance ranges from a thick syrupy liquid to a hard bouncy material depending on brand, time of manufacture and the fashion of the time.

On March 1-3, 2000, in compliance with U.S. Congressional directives, the U.S. Food and Drug Administration (FDA) held Hearings regarding saline inflatable breast implants. The Hearings revealed that, in FDA-supervises clinical trials on products made by the two leading saline implant manufacturers, the Mentor Corporation and the Inamed/McGhan Group, adverse reactions were reported for about 73% of post-mastectomy users within 5 years following surgery. For cosmetic users, the level was 43% of users being compelled to undergo secondary surgery within 3 years of the initial insertion. At the Hearings, data from these corporations were made public for the first time.

One of the most surprising recent turn of events is the persistent nostalgia some plastic surgeons express about the old gel implants. Perhaps this is a reflection of promotion in some quarters. There have been repeated claims about the imminent return and rehabilitation of the silicone gel implants of the eighties by the FDA. These products still sold in some European countries and the far east, continue to elicit morbidity and have not significantly improved in quality, safety, or durability. Large quantities of unsold gel-filled implants were exported from the U.S. shortly before and after the FDA Moratorium on the product.

In September 2000, the FDA issued a new brochure on breast implants, emphasizing risks of disfigurement and serious infection, as well as the inevitability of continued medical treatments and repeat surgery. The brochure highlighted that implants permanently and irreversibly alter the breast, even if the implants are subsequently removed, and drastically diminish the reliability of cancer detection procedures.

The events of the last 15 years give credence to views widely held by many in the biomedical field that the current corporations engaged in the breast implant trades are the same entities who, from the early seventies, have released countless untested, high-risk products into commerce. Their actions and omissions have culminated in much morbidity with enormous health care costs that overshadow any potential commercial benefit that could ever accrue. These events further demonstrate that the breast implant trades have used unethical processes and deception to maintain their products in commerce and have suppressed knowledge of adverse effects from their products.

In summary, users can expect saline inflatable breast implants to have a short service life, to impart severe discomfort, to induce repeated disfiguring surgery, and to eventually elicit serious adverse consequences that will demand extensive care disbursements, in particular from third party health insurers. Of special concern, is the widespread promotion of saline inflatable breast prostheses on the basis that they constitute only a small probability of adverse effects as opposed to a certainty of failure and the continuing misrepresentation that such products contain only ‘water’ and ‘natural’ products.

-------------------------------------------------------------------------------------------------------

In a letter to silicone breast implanted women dated 1999/03/30 Al Levin,

M.D.,J.D. states:

I am writing to you as an old physician/scientist and a new attorney. I served as an expert witness in these and many other cases I have studied and practiced clinical immunology, immunopathology and clinical medicine for over three decades. I have published extensively in peer reviewed medical literature on the subject of cancer, clinical immunology and immunopathology. I have been on the faculty of Harvard Medical School and the University of California at San Francisco (UCSF), two of our country’s best medical schools. I continue to hold an appointment at UCSF. I am very familiar with silicone, its adjuvant and immune activation properties,

I will tell you without reservation that there is no better case for disease causation than the silicone gel breast implant cases. All one has to do is look at the patient’s biologic response to the implant. The patient mounts a chronic foreign body reaction. This is nature’s way of saying this material is not good. It is harmful and offensive and the body needs protection by walling the material off. The granulomatous reaction is identical to the human body’s response to syphilis and tuberculosis. Syphilis and tuberculosis are human diseases with systemic consequences. Silicone induced granulomatous disease is human disease with systemic consequences. Of this there is absolutely no question.

The answer is simple. The defense attorneys are paying scientists and physicians to tell half truths and lies. Using lies and deceit as well as word games in their writings, these attorneys are requesting judges to rule that foreign body reactions and granulomatous are "normal reactions". Absent strong, intelligent objection, some judges are being taken in by these deceptive practices. Dr Lavin adds "it is not okay for doctors to lie in court. They will be held to their testimony given under oath. Their testimony will be made public where it will reach their peers who assess their competence to practice medicine and perform scientific research. It is not OKAY for a judge with an eighth grade education in science to rule that a Nobel Laureates science is flawed. This outrages many physician/scientists I know and should outrage you."

Alan S. Lavin, M.D., J.D. , Diplomate: American Board of Allergy/Immunology,

Diplomate: American Board of Pathology, Attorney at Law, PO Box 4703, Incline

Village, Nevada 89450.

Sincerely,