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 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 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 trial 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 is 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, warnings 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 considerations 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 sixties, much of this activity could only be regarded as deviant medical practices devoid of scientific or clinical value. The patients- subjects were clearly investigational ‘material’. Yet they were rarely informed about the nature and risks of these procedures. The surgery was generally misrepresented as an established medical option 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 prostheses 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.

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 presented as radical innovations of great scientific merit. Products without 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 obvious 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 common 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 Cronin, Jenny, Pangman, Jobe, Birnbaum, Williams, Weiner, Wagner, Franklyn, Ashley, Snyder, Georgiade, Papillon, Dahl, 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 focussed on polyvinyl alcohol-formalin adduct materials such as Ivalon 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 immediately 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 prostheses were manufactured from the foams. It appears 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 or 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 absurd versions of breast augmentation devices based on found materials such as Scotfoam™ 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.

Adverse reactions were predictably widespread. Yet, publications appeared in the late-sixties attempting to exculpate the early surgical adventures and the commercial marketing of these products. No reference is made to the unsanctioned clinical use which followed. The impression was deliberately created that these implants were used by non-medical adventurers or unauthorized physicians. The publications of Edgerton and others in the late-sixties are particularly noteworthy in this context.

Even more surprising is the history surrounding the development and evolution of late foam-coated gel prostheses such as the Meme and Replicon. These items reached peak popularity in the mid-eighties. In spite of repeated clinical failures of the antecedents such as the Ashley Natural-Y and the Pennisi/Capozzi variations of foam-coated silicone gel-filled implants, the Meme and its analogs were not withdrawn. It took outright intervention by regulatory agencies such as the U.S. Food and Drug Administration following gross violations of established manufacturing practices in the production of the implants to terminate the commercial activity surrounding the foam products. It is also surprising to review the retrospective publications of the early-nineties which attempted to place an aura of scientific validity on the widespread use of these items for cosmetic purposes.

The apparent efficacy of testimonials which were presented in lieu of clinical data by promoters of foams in the early and mid-eighties is symptomatic of deep-rooted problems within the industry which caters to plastic surgery interests. It suggests numerous anomalies in the processes which allow high risk medical products to pass from pre-clinical testing to open marketing with so few questions asked by so many. It suggests that authorization and conduct of clinical trials surrounding non-essential surgical implants can take place without due process or minimal patient safeguards.

In retrospect and for practical purposes, there appears to have been no clinical trial of any kind conducted in connection with the late foam implants. If such trials were conducted, in camera, records were either not kept or were subsequently lost or hidden. At any rate, assuming that some requirements for the conduct of clinical trials were met, there would have been no basis to expect success from such studies and the benefits that could have been accrued by early subjects who submitted to these experiments would not have been commensurate with the expected benefits. In essence, the near totality of the history of polyurethane foam prostheses and their continuing clinical use into the late-eighties violates the substance, spirit and the word of the Code of Nuremberg with reference to medical experimentation.

Clinical Trials and Human Experimentation in Plastic Surgery of the Breast:

Government authorities in most countries impose special responsibilities on health care supply manufacturers who conduct or sponsor clinical investigations of their products on human subjects. Conversely, similar regulations as well as ethical constraints apply when clinical investigators make use of experimental products. These guiding principles are particularly important for high risk implantable medical devices.

In summary, manufacturer-promoters and clinician-investigators must ensure that human subjects enrolled in their studies are not placed at risk unnecessarily and that they benefit to some degree from the studies. In addition, the information obtained from such studies is to be appropriately recorded and made available so that it may contribute to the body of medical knowledge. Finally, data on the performance of the product and the results of the clinical trial must also be collected and analyzed to limit the exposure of human subjects to hazardous, repetitious and meaningless clinical trials and their associated public health costs.

The guiding principles for the conduct of clinical trials are set forth in the Code of Nuremberg. The Code demands the fulfillment of the following conditions:

a) the trial must have a reasonable probability of significant benefits to the patient or a meaningful gain in the state of medical and scientific knowledge;

b) the patient must be fully advised of the risks and benefits of the trial and must not be subjected to misrepresentation or coercion;

c) adequate records must be maintained and the methodology used must ensure the recovery of medical and scientific knowledge from the experiment;

d) the data and the pathological material issuing from the work must be retained for further study if adverse effects take place and as much information as possible be gathered to treat patients who suffer adverse reactions as sequelae to the study;

e) untoward effects must be reported openly to minimize the risk of repetitious and unnecessary human experimentation for approaches which are known to have failed.

The promotion of breast prostheses in the sixties and seventies infracted these directives. Similar promotional activity with flawed logic continued into the eighties and nineties. Even today, there is still continuing promotion of systems which have no hope of long term success.

In the early experimental phase, all investigational breast implants and their constituent materials ought to have been investigated according to established protocols. This was not done and little regarding the performance and the adverse reactions was documented. It was therefore inappropriate to directly market the original faulty products or newer investigational implants on the basis that they were ‘substantially equivalent’ to what was already available. In the eighties, some designs that became fashionable had no rational basis. It was reprehensible to market most of these products; even proposing clinical trials was inappropriate. The outcome of such undertakings was predictably injurious and would have had no benefit to the subjects.

During this period of nearly 30 years with high level usage of these marginal products, data should have been collected and analyzed according to established protocols but it was not. Pathological material removed from user-subjects ought to have been studied in a systematic way but it was not. Adverse reactions and morbidity ought to have been reported in a timely and accurate way, but little of this activity took place.

Finally, adverse reactions which surfaced incidental to widespread usage were disregarded. Much of this was hidden thus enlarging the pool of morbidity. Published studies and anecdotal results confirming widespread complications or reporting major clinical or technical problems were distorted, delayed or even suppressed through coercive measures from editors and peers, or through other unethical activities on the part of manufacturers and product promoters.

A Canadian Note:

Canada played a major role in the development and usage of breast implants. However, this is not widely known and it is even less widely acknowledged. Key events in the history of breast implants took place in Canada and contributed strongly to dissemination of the practice. Clinical trials and commercial development of these devices were also conducted in connection with early technologies for breast augmentation.

A Royal Canadian Air Force (RCAF) flight training center on Toronto Island, now Toronto Island Airport, became the starting point for breast implantation involving solid foam implants. Dr. Robert Franklyn, a young visiting surgeon attached to the facility’s medical treatment services unit, during his examination of a captured German aircraft, noted unusual upholstery in the seats. In his biographical essay, "The Beauty Doctor", he relates how he sampled portions of the upholstery and subsequently implanted it in the face of disfigured victims to replace lost tissue. Upon returning to his medical practice in Los Angeles at the end of World War II, he obtained larger samples of this material from a German manufacturer and implanted breast-shaped larger pieces to augment women’s breasts. His practice blossomed into the fifties and sixties, it included a number of celebrities. At the peak, he had technicians manufacture these devices from the foam in stock sizes for serial implantation.

Towards the end of World War II, another surgeon, William J. Pangman, also became interested in reconstructive surgery and augmentation of the breast. Trained in Alberta, he later emigrated to Los Angeles and continued his medical practice. Many of his patients were also celebrities. Some underwent early forms of breast augmentation using commercially made sponges of a material which had been investigated and later rejected at the Mayo Clinic for cardiovascular repair. In the late-fifties and early-sixties, he published papers describing the procedures and lectured widely, both in Canada and the U.S. This strongly stimulated public demand and gave the practice some respectability, something that it did not have previously.

Parallel events took place for direct silicone injection to the breast. Dr. Pangman and an associate, Dr. Franklin Ashley also of Los Angeles, are both associated with cosmetic injections of silicone oil. Contrary to generally held beliefs, the technique did not start in Japan. Instead, it appears to have started simultaneously in New York, Los Angeles, Las Vegas and Montreal. Advertisements in New York, Nevada and California further promoted "silicone oil" breast augmentation until legislation outlawed the practice. Canadian surgeons in the Montreal, Toronto and Vancouver areas continued the practice into the seventies, some broadening its applications to emphasize lip contour ("lip enhancement") and other facial areas as late as 1996. Shipments of illicit silicone oils deemed of "medical grade" and labeled for "injection" were found on Canadian import manifests to several Montreal surgeons during this period. The fashion of silicone injections continued in Canada long after its demise in the U.S.

By the seventies, Dr. Pangman had been credited with 5 patent applications of which 3 were granted. All dealt with prefabricated breast prostheses consisting of foam, fluid compartments, valves, fabric and other components assembled into breast-shaped forms. These items were commercialized by several southern California firms in the early-sixties and continued to be sold into the seventies. Variations of the same items evolved into the foam-coated, gel-filled prostheses of the eighties which triggered regulatory action by the FDA in the early-nineties against all gel-filled mammary prostheses.

In the late-sixties, a Montreal surgical group consisting of Dr. Jacques Papillon and Dr. Colette Perras, performed clinical investigations and commercial development studies on yet another type of gel prostheses using a different kind of plastic shell mixed with Dacron fabric. The work was done on behalf of the Medical Engineering Corporation of Racine, Wisconsin and led to the issuance of a patent in the name of the two physicians. Continuing work by the Montreal team led to full commercialization of this device, known as the "Perras-Papillon prosthesis", and was sold until the early-eighties. The shell was assembled mostly from a General Electric material based on a polycarbonate-silicone copolymer. This plastic was an experimental industrial elastomer which had not previously been used or tested for implant applications. Its durability parameters were unknown. The items developped leaky shells early and the material became brittle with time. The substance was not subsequently used for other breast implants.

Perhaps the most influential Canadian connection occurs through the Dow Corning and Dow Chemical Corporations. The most celebrated breast prosthesis, termed the "Cronin Silicone Gel Breast Implant", sold for the first time in the early-sixties and had its beginnings in Canada. In interviews and conference notes, its primary inventor refers to "plastic blood bags" as having been the source of the silicone bag breast implant. The device, although known as the "Cronin", is primarily credited to Dr. F. Gerow, a Canadian physician trained at the University of Toronto, who practiced at Baylor Methodist College of Medicine in Houston, Texas until his death in the early-nineties. Dr. Gerow holds the patent for this device jointly with Dr. Thomas Cronin of the same institution and performed many of the clinical studies.