PIERRE BLAIS, B.Sc., Ph.D., C.Chem., F.C.I.C.
1. INFORMATION BIOGRAPHIQUE
Nom: Pierre J.J.B. Blais
Date de naissance: Montréal, Canada, 14 juin, 1940.
Citoyenneté: Canada
Langues primaires: Français, Anglais
Langue secondaire: Allemand
Marié, 2 enfants
Adresse: 496 Westminster Ave.
Ottawa, Ontario
K2A 2V1, Canada
2. POSITION:
Président, Innoval Failure Analysis.
3. FORMATION ACADEMIQUE ET CARRIERE
-B.Sc., Honours Chemistry, Université McGill, Montréal (1962);
-Ph.D. Physico-chimie, Université McGill, Montréal (1966);
-Postdoctoral Fellow, Case-Western Reserve University, Cleveland, Ohio, Materials Engineering (1966-68)
-Adjoint de recherche, Division de Chimie Appliquée, Conseil National de Recherche du Canada, Ottawa (1968-76)
-Adjoint de recherche et Conseiller Scientifique Principal, Direction générale de la protection de la santé, Ministère de la Santé et du Bien-Être Social, Ottawa, Ontario (1976-1989)
-Professeur Invité, Département de Génie Mécanique, Ecole polytechnique de Montréal (1979-82)
-Professeur Invité, Département de médecine communautaire, Faculté de Médecine, Université de Montréal (1984)
-Visiting Professor, Department of Mechanical Engineering, Queen’s University, Kingston, Ontario (1987)
-Visiting Lecturer, Faculty of Pharmacy, University of Toronto, Toronto, Ontario (1989)
-Adjunct Professor, Department of Chemistry, Carleton University, Ottawa, Ontario (1989)
4. DISTINCTIONS:
-Clinicien Honoraire, Ordre des Dentistes du Québec, (1982)
-Clinicien Honoraire, Intra-Ocular Implant Society, (1984)
-Fellowship, Chemical Institute of Canada (FCIC), (1985)
-Canadian Delegate, Ophthalmic Speakers Program, Karolinska Inst. Stockholm, -Sweden (1985)
-Canadian Delegate, ISO TC 150, Medical Implants (1985)
-Canadian Delegate, ISO TC 157, Mechanical Contraceptives (1986)
-Programme d’Education Médicale Permanente, Télémédicine Canada Toronto, --Canada (1986)
-Conférencier, Saskatchewan Association of Optometrists, Continuing Education -Programme (1986)
-Lecturer, American Association of Pediatrics (1986)
-Editorial Board, Implantation Transplantation Today (1987)
-Editorial Board, Biomedical Materials Research Journal (1988)
5. ASSOCIATIONS:
Association of Chemical Professional of Ontario
Membre (1976- )
Vice Président (1980-81)
Président (1981-82)
Chemical Institute of Canada,
Membre (1959- )
Section Chairman (1983-85)
Canadian Biomaterials Society,
Membre (1978- )
Controlled Release Society
Membre (1985- )
Assoc. Can. Fran. Avancement des Sciences
Membre (1969- )
Représent. Régional (1975)
6. PROGRAMMES DE RECHERCHE:
-Synthèses de polymères pour implantation biomédicale et séparation de solutés, contrôle de la fertilité et administration de médicaments.
-Etudes sur la biodétérioration des plastiques.
-Etudes sur polymères réactifs et sur la biocompatibilité des polymères in-vivo.
-Technologie et commercialisation de produits pour chirurgie ophthalmique, oto-laryngologique et reconstructive.
180 articles/chapitres de livres sur les applications des polymères en médecine, sur les biomatériaux et sur les instruments médicaux.
130 rapports et autres documents dans le domaine des science biomédicales et de la règlementation des produits médicaux.
190 présentations orales, cours et symposia, principalement dans les secteurs des biomatériaux, de la planification familiale et du développement commercial des technologies biomédicales.
6 brevets (Canada et Etats-Unis)
7. PUBLICATIONS TYPIQUES:
-P. Blais, Letter to The Editor (The Polyurethane Breast Implant), J. Applied Biomat., 1, 197 (1990).
-P. Blais, " Quality Assurance in Ophthalmic Dispersibles " dans Viscoelastic Substances in Ophthalmology, O.Hockwin, éditeur., Springer Verlag GmbH, Berlin (1990).
-P. Blais, " Vinyls in Medicine " , J. Vinyl Technology 11(2), 71-80 (1989).
-A.S. Chawla, P. Blais, I. Hinberg and D.L. Johnson, " Degradation of Explanted Polyurethane Cardiac Pacing Leads ", Biomat. Artif. Cells Artif. Organs, 16(4), 785-800 (1988).
-P. Blais, A.R. Alexander and E. Napke, " Contact Lenses and Corneal Vascularization - An Emerging Problem ", Transplantion Implantion Today 4(Sept), 6-13 (1987).
-G. Biro and P. Blais, " Perfluorocarbon Blood Sudstitutes ", C.R.C. Critical Reviews in Oncology/Hematology, 6(4), 311-374 (1987).
-P. Blais and R. Guidoin, Biocompatability in Fertility Control Technology, Chap.4 dans Biocompatibility in Clinical Pratice, vol.1, D.F. Williams, éditeur; C.R.C. Press, Boca Raton, Florida USA, (1983).
-M. Smith and P. Blais, " Preliminary Findings on Used Cervical Caps ", Contraception 29(6), 6527-6535 (1984).
_____________________________________________________________
Ottawa, février 1992
CURRICULUM VITAE SUMMARY
PIERRE BLAIS B.Sc., Ph.D., C.Chem., F.C.I.C.
1.BIOGRAPHICAL INFORMATION SUMMARY
Name: Pierre J.J.B. Blais
Date of Birth: June 14, 1940 (Montréal, Canada)
Citizenship: Canadian
Languages: French, English, (German)
Civil Status: Married, 2 Children
Address: 496 Westminster Ave
Ottawa, Ontario
K2A 2V1, Canada
2. PRESENT POSITION:
-President, Innoval, 1989-present (Outline of Innoval on page 5).
3. EDUCATION
-B.Sc., Honours Chemistry , McGill University, Montréal (1962);
-Ph.D. Physical Chemistry, McGill University, Montréal (1966);
-Postdoctoral Fellow, Case-Western Reserve University, Cleveland, Ohio, ------ Materials Engineering (1966-68).
4. PRIOR EMPLOYMENT SUMMARY 1969-1990
-Senior Scientific Adviser, Radiation and Medical Devices, Health Protection --Branch, Department of National Health and Welfare Canada, (1976-1989)
-Research Associate, Division of Applied Chemistry, National Research Council of Canada, Ottawa (1968-76)
-Professeur Invité, Département de Génie Mécanique, Ecole Polytechnique de Montréal (1979-83)
-Guest Lecturer, Bilogical and Chemical Tehcnolohy Programme, Algonquin College, Ottawa, Ontario (1979)
-Visiting Professor, Department of Chemical Engineering Rensalaer Polytechnical University, Rensalaer, N.Y. (1980)
-Professeur Invité, Département de chimie, Université de Montréal (1983)
-Professeur Invité, Département de médecine communautaire, Faculté de Médecine, Université de Montréal (1984)
-Visiting Professor, Department of Mechanical Engineering, Queen’s University, Kingston, Ontario (1987)
-Professeur Invité, Département de chirurgie expérimentale, Université Laval, Québec (1988)
-Visiting Lecturer, Faculty of Pharmacy, University of Toronto, Toronto, Ontario (1989)
-Professeur Invité, Département de Pharmacologie, Faculté de Médecine, Université de Montréal (1988-1991)
5. DISTINCTIONS:
-Clinicien Honoraire, Ordre des Dentistes du Québec, (1982)
-Honorary Clinician, Intra-Ocular Implant Society, (1984)
-Fellowship, chemical Institute of Canada (FCIC), (1985)
-Canadian Delegate, Ophthalmic Speakers Program, Karolinska Institute, Stockholm, Sweden (1985)
-Canadian Delegate, ISO TC 150, Medical Implants (1985)
-Canadian Delegate, ISO TC 157, Mechanical Contraceptives (1986)
-Speaker, Permanent Medical Education Programme, Telemedicine Canada, Toronto, Ontario (1986)
-Invited Faculty, Saskatchewan Association of Optometrists, Continuing Education Prog. (1986)
-Honorary Lecturer, American Association of Pediatrics, (1986)
-Member, Editorial Board, Implantation Transplantation Today (1987)
-Member, Editorial Board, Biomedical Matirials Research J. (1988)
6. ASSOCIATIONS
-Association of Chemical Professionals of Ontario, Member (1976-present)
-Association of Chemical Professionals of Ontario, Vice President (1980-81)
-Association of Chemical Professionals of Ontario, Predident (19j81-81)
-Chemical Institute of Canada, Member (1969-present), Section Chairman (1983-85)
-Canadian Biomaterials Society, Member (1976-present)
-Controlled Release Society, Member (1985-present)
-Association Canadienne Française pour l’Avancement des Sciences, Member (1969-present)
-Association Canadienne Française pour l’Avancement des Sciences, Représentant Régional (1975)
7. RESEARCH AND DEVELOPMENT PROGRAMMES
-Synthesis of polymers for long-term medical applications, separation of solutes, control of fertility and administration of medication.
-Studies on biodeterioration of plastics and on biocompatibility of polymers in-vivo.
-Design, failure analysis, risk assessment, technology development and commercialization studies on products for ophthalamic, neurologic and reconstructive surgery.
-Production technology development and manufacturing practices analysis for single une.
8. PUBLICATION, SYMPOSIA, REGULATORY AND SCIENTIFIC ACHIEVEMENTS
-270 articles/book chapters on applications of polymers in medicine, on biomaterials and on medical technology issues.
-350 reports and documents for restricted distribution in the biomedical sciences and in the regulation of medical products.
-410 oral presentations, courses and symposia, principalty in biomaterials applications, plastics in medicine, family planning and commercial development of biomedical technologies.
-6 Patents on plastics and membrane separation technologies Canada and U.S.
8. TYPICAL PUBLICATIONS
-P. Blais, Letter to The Editor (The Polyurethane Breast Implant), J. Applied Biomat., 1, 197 (1990).
-P. Blais, " Quality Assurance in Ophthalmic Dispersibles " dans Viscoelastic Substances in Ophthalmology, O.Hockwin, éditeur., Springer Verlag GmbH, Berlin (1990).
-P. Blais, " Vinyls in Medicine " , J. Vinyl Technology 11(2), 71-80 (1989).
-A.S. Chawla, P. Blais, I. Hinberg and D.L. Johnson, " Degradation of Explanted Polyurethane Cardiac Pacing Leads ", Biomat. Artif. Cells Artif. Organs, 16(4), 785-800 (1988).
-P. Blais, A.R. Alexander and E. Napke, " Contact Lenses and Corneal Vascularization - An Emerging Problem ", Transplantion Implantion Today 4(Sept), 6-13 (1987).
-G. Biro and P. Blais, " Perfluorocarbon Blood Sudstitutes ", C.R.C. Critical Reviews in Oncology/Hematology, 6(4), 311-374 (1987).
-P. Blais and R. Guidoin, Biocompatability in Fertility Control Technology, Chap.4 dans Biocompatibility in Clinical Pratice, vol.1, D.F. Williams, éditeur; C.R.C. Press, Boca Raton, Florida USA, (1983).
-M. Smith and P. Blais, " Preliminary Findings on Used Cervical Caps ", Contraception 29(6), 6527-6535 (1984).
_____________________________________________________________
Ottawa, février 1992
ETUDES CLINIQUES ABERRANTES
Committee on the Safety of Silicone Breast Implants: National Academy on Science - July 24, 1998
ETHICAL ASPECTS OF BREAST PROTHESES DEVELOPMENT
AND RELATED CLINICAL TRIALS
Ottawa, Ontario, Canada, K2A 2V1.
Early Experimentation in Breast Augmentation:
Regulations in most industrial countries impose special responsibility on pharmaceutical, medical devices and health care supplies manufacturers who conduct clinical investigations of their products on human subjects. Conversely, similar regulations as well as ethical constraints P. Blais, Ph.D., F.C.I.C., Innoval apply when investigators make use of new or modified products. These guidelines and regulations are particularly important in the case of implantable medical devices.
Both manufacturer-promoters and clinician-investigators must cooperate to ensure that subjects enrolled in their studies are not inappropriately placed at risk and benefit to some degree from the development of new technologies as appropriate. Similarly, information about the performance of the product on specific patients and the results of the clinical trials must also be provided to institutional committees and regulatory agencies to ensure timely dissemination of the information and limit the exposure of human subjects to repetitious and meaningless clinical trials where the outcome id already known. Some countries, such as Canada and the U.S., also require that the implant manufacturers keep track of products that are in the field so that upon discovery of information, warning and countermeasures can be conveyed to the users in a timely fashion. In that way, the risks and the outcome of clinical trials can be recorded and documented and adverse reactions can be kept to a minimum.
Breast implants are not exempt from such consideration and this approach to clinical trials was already well established in the sixties. However, the largest number of deviations from these common sense directives took place in the area of plastic surgery of the breast. The early phase of experimentation using impure oil injections and bulk foam implants were perhaps excusable as poorly structured clinical investigations by ill-informed medical professionals. The later phase which included widespread promotion and use of commercial products unfit for human applications are more difficult to rationalize. By the early sexties, much of this activity could only be regarded as deviant medical pratices devold of scientific or clinical value. The subjects were clearly investigational material. Yet they were rarely informed about the nature and risks of these procedures. The procedures were generally misrepresented as established medical options free of adverse reaction and with assured long term results. Some reputable institutions even promoted elective mastectomies with implant substitution.
Later, the manufacturing and the clinical communities relied on prior undocumented implantations and regarded all forms of investigational breast protheses as being substantially equivalent to the popular mid-sixties Dow Corning " Cronins ". They therefore did not deem it necessary to conduct controlled clinical trials with such products before widespread commercialization. The philosophy remains in fashion to this day.
Curiously, the reverse approach was employed for promotion of breast prosthetic systems directed at the surgeons. Breast implants which were trivial variations of existing designs were often presented as radical innovations of great scientific merit. Products that had no perceptible health or aesthetic benefits, even to a layman, were often promoted as major discoveries and were well received by the plastic surgery community. Absurd designs that violated common sense and embodied abvious adverse reaction risks were frequently encountered in large scale distribution and would remain in commerce for many years after being discredited as failures and frauds.
In the seventies, the number of designs proliferated dramatically. Most were sommon variations of one another; many were " name branded " and frequently promoted through the use of prominent and publicly visible plastic surgeons associated with prestigious institutions.
By that time, more than sixty superficially different types of implants bearing the name of surgeons had been commercialized. Amongst the more widely known products were devices credited to Cronon, Jenny, Pangman, Jobe, Birnbaum, Williams, Weiner, Wagner, Rranklyn, Ashley, Snyder, Georgiade, Papillon, Dahi, Perras, Munna, Hartley, Baker, Becker, Arion, Sterling, Capozzi, Cavon, Radovan, Akiyama, Tabari and many others. This led to internal jealousy within the plastic surgery community and the fad was finally abandoned in the eighties.
Scientific and Clinical Basis for Human Use of Foam implants:
Foam implants appeared in medical writings circa 1951. Early investigations facussed on polyvinyl alcohol-formalin adduct materials such as Ivavon sponge. Clinical trials on Ivalon followed a small number of publications claiming successful use in animals for short periods of time. The early work was immediatily extrapolated to human use and all types of chemically uncharacterized foams including those based on polyurethane chemistry quickly followed.
The role of R.Franklyn, a Los Angeles surgeon, is particularly noteworthy. In autobiographical writings, he relates seeing upholstery in the cabin of a captured German aircraft and sampling seats in order to obtain material for implantation. Accordingly, he claims having directly used portions of the seat material for facial repair and cosmetic surgery in the years which followed the end of World War II. He indicates that the sourcing of the original German-made upholstery was later found and semi-commercial breast protheses were manufactured from the foams. It appeats that commercialization of the prostheses took place when production of the polyurethanes was licensed to U.S. Based producers. There is no mention of pre-clinical investigation of follow-up.
The same controversial surgeon is credited with the design of composite polyurethane foam implants which are believed to have been sold in significant quantities in the Los Angeles area. Later participants in the commerce of breast implants include promoters with minimal medical or scientific training, in particular H. Markham. They commercialized avsurd versions of breast augmentation devices based on found materials such as Scotfoamä and Etheron. There is little evidence of credible or conventional clinical study or any form of investigative research on these products. Yet, commercial sales were brisk and the items were widely used.