Ethical and Cultural Aspects of Cosmetic Surgery of the Breast:

Misadventures and adverse reactions surround cosmetic surgery of the breast and create a large population of individuals in need of medical care and rehabilitative services which would otherwise have been unnecessary.

The care of patients who suffer such misadventures from plastic surgery procedures has been difficult in recent years. Firstly, the mainstream medical community has little affinity for users of aesthetic surgery services and a limited understanding of the diseases that they often contract as a result of flawed surgery or because of deficiencies in the standard of care.

Progress in medicine depends on research, medical technology and health care products development. However, medically meaningful research and development work in plastic surgery of the breast has been rare and difficultly supportable in the light of other more pressing health care priorities.

From the onset, the practice of breast augmentation has been regarded as a remote confine of aesthetic medical practices. As a result, it has attracted more than its share of practitioners who do not have the same commitment to the clinical sciences and medical ethics that is generally expected of other health care specialties. There are exceptions but they are rarely found amongst the community that has historically depended on the promotion of serial breast augmentation and other low skill, high profit margin elective surgical services.

Conversely, the general medical community does not habitually treat patients who suffer adverse reactions from plastic surgery. They are relegated to the plastic surgeons who are deemed to have the expertise to resolve problems created by their practice. In some circles, professional interference within this sub-discipline is also discouraged because plastic surgery of the breast is perceived as lucrative and promotable by administrators within deficit-prone health care institutions.

Promotion and Growth Phase of the Culture and its Technology

In the mid-eighties, procedures dramatically increased in numbers and well organized promotional campaigns were undertaken by plastic, cosmetic and aesthetic surgery associations to further enhance the market. Much was written in the media and some of this promotional material percolated into technical journals in subtle forms. It created an aura of acceptability and popularity which obscured medical and technical publications on dramatically rising rates of adverse reactions.

These negative publications and reports had been gradually increasing in number since the mid-seventies but the large volume of promotional and quasi-scientific material provided a dense cover for the medical repercussions of faulty plastic surgery of the breast. Specialty journals and professional associations, fearing loss of revenue and legal repercussions also exercised some degree of selectivity and often discouraged the submission of negative results.

Nevertheless, the mainstream medical community remained suspicious. Consequently the sector became more remote. Many practitioners felt hindered by the institutional environment and large dedicated cosmetic surgery facility became fashionable. The separation of the community continued and became even more unlike the other medical specialties because of aggressive promotion and a certain amount of secrecy with respect to their practices and procedures.

The concentration of such surgery in private offices with limited professional oversight, poor record-keeping and low standards of care added new problems. Much of this surgery deviated markedly from established medico-surgical principles. Because of these factors the treatment of patients who suffered sequelae from plastic surgery misadventures also tended to be difficult and attempted treatments were often unrewarding. Recent audits of practices in plastic and reconstructive surgery supports the view that a large part of the specialty still does not comply with normal standards of care.

The Surgical Marketplace and its Implant Problems

Cosmetic surgery has a singular dependence on low cost technologies and simple, low skill, rapid and instantly gratifying procedures. Implants are ideally suited for that and most fulfill these criteria admirably. Overall procedure costs affect price and this influences market demand. In turn, client throughput rate and volume affect profitability. Low cost implants are therefore staple items for this technology where profitability depend on selling the surgery to as many individuals as possible. Additional returns are also assured by returning clients who must undergo refit and replacement to maintain the cosmetic result.

Implants had been failing at endemic rates for more than two decades and replacement rates were brisk, in particular for the last five years. Device replacements and secondary surgery to correct untoward results were so common that surgeons rarely bothered to report the events. Control of bad publicity and management of adverse effects became progressively more difficult as the number of affected users and the severity of the sequelae increased. This forced the involvement of other medical specialties.

The question of systemic diseases, in particular degenerative tissue diseases associated with long term prosthetic failure, has historically been addressed by rheumatologists but only a few developed the experience to provide clinical management strategies for these atypical diseases. Similar situations exist for most of the other disciplines that are involved in the treatment of breast prostheses sequelae. Even the plastic and reconstructive surgery community lags in suitable techniques for cosmetic reconstruction in individuals who suffer misadventures with implants.

Injuries can arise from many factors. Technical problems, professional problems and inadequacies in the standard of care in addition to shortcomings in the implants and their peripherals, can individually injure a prosthetic patient. However, these factors in combination magnify the risks enormously. General cleanliness and care play a large role in adverse reactions from breast prosthetic patients. Post-surgical care and long term follow-up add additional dimensions to the problems inherent in the widespread use of this technology; the current situation is partly rooted in the history of plastic surgery of the breast and its relationship to mainstream medical practice.

he ethos of medicine is based on millennia of tradition and there is no need to change it. Ethical principles valid then remain valid today for all disciplines and specialties that touch health care. Medical practice is based on experience and knowledge; it depends on the sharing of clinical experiences and an in depth understanding of the physical, chemical, biological and engineering principles that regulate life processes. It allows intervention to achieve health benefits and cure from disease. Absolute directives emphasize protection of the patient and forbid illogical and adventuresome treatments with high risks and minimal benefits. These are summarized in the prime admonition "Above All, Do No Harm".

Secondary directives instruct practitioners to learn from experience and draw from collateral disciplines that harbor meaningful knowledge and to teach what has been learned.

Plastic and cosmetic surgery are not exempted from these guidelines. However, in some respect, the directives are blurred because the benefits are not related to health. Some may be perceived only by the patient or the professional who offers the service. These benefits may not even be real in the sense that they derive from socio-behavioral aberrations in certain classes of patients or certain societies.

On Risks and Benefits:

Every medical procedure entails risks. If an internal prosthesis is left in the patient as part of the procedure, there can be supplemental risks which depend on the condition of the patient, the time of contact, as well as the nature and the location of the device.

Different medical procedures confer different benefits. Some may be lifesaving or can greatly improve the quality of life. Others provide non-essential amenities such as temporary improvements in appearance. For cosmetic surgery of the breast, it can be argued that the benefits are of a psychological or subjective nature and that only the patient can see their value.

This would be true if it were not for the aggressive promotion of plastic surgery services and if plastic surgeons had a tradition of reporting poor as well as good results. Cosmetic surgery services are delivered under a unique kind of medical contract between the prospective client and the surgeon. The aim is to change or improve appearance, not to treat a disease or mitigate an infirmity. Because the client-patient accepts significant surgical hazards for non-essential benefits, a plastic surgeon may appear mandated to make long-term health concerns secondary to short term aesthetic considerations.

This perception may find support in some quarters but it is not acceptable when obvious complications must be treated later as surgical misadventures or diseases. It is also unacceptable as a guiding principle for the design of aesthetic surgery procedures and products.

Guiding Principles in Standards of Care, Procedures Design and Choice of Technology:

A procedure or a product with long term health risks that provides a marginally more aesthetic short term result than a safer alternative may be tolerable if the patient consents knowingly to the risk. However, making, using and promoting such a procedure or product without explicit cautionary information is ethically inadmissible.

Reconstructive surgery of the breast following disease is subject to similar constraints. It may come closer to mitigating an infirmity or restoring health but it is still not essential surgery. The reconstructive procedure must not diminish the patient's prospects for recovery nor enhance her risks of contracting other infirmities or diseases that may require additional treatments or entail morbidity.

Breast augmentation and repair using implants were once common plastic surgery procedures. In North America, promotion of the procedure by plastic surgeons was widespread. Implantations peaked at about 130,000 annually in 1985-86. Then presented as a risk-free commodity with lasting aesthetic benefits, it had become the principal source of income for more than half of all plastic surgeons.

Considered as an entitlement in many quarters, breast augmentation later led to a secondary market for reconstruction of chests where failed implants had caused major anatomic and functional damage. The services associated with frequent re-operations and the treatment of adverse reactions have now become a major source of income for the medical community. A collateral industry that makes consumables and replacement implants gives it additional momentum.

To this day, problems associated with the technology are not generally well exposed to patients. On the contrary, there is a tendency to understate the risks and inflate the benefits.

This is not new. The promotion of lucrative but controversial invasive cosmetic surgery practices increased drastically in the seventies and eighties. Abuses of the technology motivated governments into action at various times. More recent examples include large area liposuction, the renaissance in tissue augmentation using injected silicone oils, the indiscriminate promotion of permanent "make up", in particular malar pigmentation or "blush", eyebrow, eyelid and lip tattoo), "lip injection enhancement", as well as cosmetic breast and cosmetic muscle implants.

Many seasoned clinicians habitually avoid this class of patient. Many fear entanglements with malpractice actions or friction with colleagues and hospital administration. Others perceive the work as difficult and unrewarding. Still others consider these treatments as misuse of health care resources that are made necessary only because of deviant medico-surgical practices, inadequate standards of care and borderline technologies that disregard basic principles of anatomy or physiology. Breast prostheses failures make up a large part of this activity.

In summary, the profitable, easy and rapid implementation of breast augmentation technologies and the immediately gratifying results have historically attracted marginal surgeons working out of facilities with substandard equipment and marginal staff. The illusory benefits of the procedure and the distorted views presented by surgeons whose practices depend on augmentation will continue to attract clients.

Even with the wider publicity surrounding adverse effects and the disappearance of domestically available low cost implants, aggressive and often coercive promotion of augmentation and replacement will continue for many years with predictable results.

The impact of past and future implantations on direct and indirect health care costs due to adverse effects will continue to be elevated. Mainstream medical practitioners will have limited success in treating patients affected by the broad range of iatrogenic diseases associated with these faulty elective cosmetic technologies.