ADVERSE PHENOMENA FROM BREAST IMPLANTS - GENESIS OF THE PROBLEMS

Injury Mechanisms From Mammary Implants Based on Surgitek and Related Technologies:

The insertion of ill-conceived or defective implants in a disease prone area has predictable morbidity and a potential for injury which rises with the dwell time of the product. It is well established that the implants cause major structural, physiological and biochemical changes in the breast environment.

They also act as "time release systems" for pharmacologically active compounds. It is necessary to review the mechanisms by which such devices can affect the patient's health, appearance and comfort in order to understand their risk and their shortcomings.

Prosthetic injuries in breast implant users can be attributed to at least six major mechanisms:

(1)"normal" surgical trauma and surgical misadventures resulting in damage to functional/sensorial parts of the chest and the upper limbs;

(2) biomechanical effects induced by the presence of large foreign objects that cause compressive trauma, excoriation, distention, atrophy and restrictive adhesion of tissues or compressive/occlusive ischemia of the vasculature within the pectoral-axillary area;

(3) locally injurious biochemical effects from reactive dispersible substances that induce fibrotic, inflammatory or destructive tissue changes;

(4) long term tissue remodeling and deviant repair processes leading to hyperplasia, densification, mineralization and dehydration of the implant site;

(5) implant-capsule-oil adjuvant interactions leading to tissue degeneration or denaturation to produce host tissue- derived antigens that elicit antagonistic host-directed antibodies (autoimmune disturbances);

(6) pathologic effects from bacterial, viral or fungal colonization of the capsule space leading to low grade chronic infections and toxic phenomena from microbiological metabolites. Users of double lumen and saline-filled implants are particularly subject to such problems.

For most long term users, all of these effects are present to some degree concurrently. Their severity generally increases over the period of use. However, the early occurrence of intracapsular infection, seromas and hematomas appears to be a strong accelerating and intensifying factor for implant adverse reactions and related diseases. Atypical infection may be a primary factor leading to systemic effects.

Protected intracapsular infections remaining for a substantial period of time have the ability to enhance capsular fibrosis. Such micro-organisms in protected compartments tend to resist antibiotics. Over the long term and with large colonies, the formation of pharmacologically significant quantities of toxins becomes possible. Health effects associated with chronic low grade infections and microbiological metabolites such as toxins may account for some of the disturbances noted in long term prosthetic users.

Capsule problems are common in prosthetic patients in general. Literature makes reference to cases where incompletely removed capsules with prosthetic debris led to continuing disease processes even after removal of the implant.

It is most probable that the early encapsulation of an implant that can leak oil and related chemical debris establishes a condition which produces bioactive mixtures of silicone compounds with dispersions of denatured proteins. Furthermore, the site often attracts bacterial contamination and the oil ensures long term survival of the entities even in the presence of systemic antibiotics.

If the infection is allowed to remain within the capsule space, the capsule integrity is eventually lost, and the material escapes. Eventually the number of antibodies directed against such autogenous tissue antigens rises to the point where it can create rheumatoid-like and other degenerative tissue disease symptoms.

The process was investigated by Dow Corning in the early-seventies and appeared in confidential reports issued in 1974 (LeVier and Boley studies on adjuvant effects of silicone compounds and 1975 (Lake and Redonovich studies on pharmacology of silicone derivatives). The validity of these studies was confirmed independently by others.

Risk Factors and Clinical Practices:

Virtually all devices have been sold as sterile products since the late seventies. But implants with surface oil layers occluding viable micro-organisms have been found at various times. They may be explained simply as improperly sterilized products.

This problem beset this industry for many years and forced the introduction of specialized sterilization technology in the eighties. Because of the closed internal configuration of these devices, there is limited accessibility of the interior compartments to the sterilant gasses. Therefore, the validity of traditional sterilization techniques for sealed gel-filled implants is a contentious issue. Whereas sterility of the exterior may be sufficient for an implant that retains its integrity, dormant viable entities contained within the gel constitute a theoretical problem of significance. More often, non-sterile compartments can lead ultimately to grossly contaminated periprosthetic spaces when perforation or rupture takes place.

Additional pitfalls include re-sterilization attempts following unsanctioned device re-use. Some of these procedures for recovery of used implants have been published and were once very popular. A few remain in use by some surgical centers to this day.

The Prosthesis and its Extravasated Debris as Fermentation Reactors:

Perforated implants with vacuoles of aqueous substances of biological origin can easily become inoculated. Nutrients may not be present at the outset but long dwell times may provide the necessary opportunity for inoculation from ingress of incidental pathogens periodically present within biological fluids. An overt risk exists when there is a significant amount of pathogenic material. In the early post-surgical period, the processes may be no more than survival of the most hardy entities and may not be sufficient to cause problems. However, with time and late shell perforations, conditions for proliferative colonization of compartmentalized fluid pockets encompassed in gel and tissue will be met. The cul-de-sac or "blind pocket" geometry of the area forbids irrigation by physiologic fluids or administered antibiotics. The limited oxygen permeability of the silicone-based material favors anaerobic processes. Egress of this contamination eventually takes place in response to movement and pressure applied to the breast area. Dispersion of this material may periodically become available systemically and there is opportunity for it to establish secondary colonies outside of the periprosthetic area. Symptoms of infection should appear at this stage but may resolve temporarily or may be masked by other problems, some of which are prosthetically-induced.

Complications and Clinical Considerations:

Patients suffering adverse reactions from gel-filled prostheses may present with problems different from individuals affected by direct "inert" oil injections that lead to systemic dissemination of emulsified, bioincompatible, reactive or degraded oils.

They may require novel diagnostic and infection control strategies that, in addition to the usual nosocomial pathogens, also address anaerobes, mycobacteria, fungi and the sequelae of long term infections in spaces protected by scar tissue membranes.

Protracted exposures to oil-based adjuvants complemented by proteins and toxins from atypical micro-organisms that thrive in poorly irrigated environments such as periprosthetic scar tissue, granulomas and occluded lymph structures may also have immunologic and neurologic implication worthy of re-examination.

Role and Risks of Intracapsular Hematomas and Seromas:

Contamination of the space between the capsules and the implants by viable micro-organisms, as well as oil and gel impurities, compounds the problems of implant compatibility and accelerates the damaging phenomena. Severe contracture usually leads to displacement of the devices. The problem can be credited to common microorganisms from the skin which enter and populate the intracapsular space; some of these organisms are occasionally revealed in post-surgical workup when patients infect grossly and require additional surgical treatments. In most cases, atypical organisms are involved and cultures and diagnostic stain studies are not sufficiently detailed and prolonged to confirm the presence of unfamiliar entities. Contaminants are often introduced during surgery and would otherwise be adequately controlled by antibiotics but the closed semipermeable capsule and the nature of the prostheses with their hydrophobic surface contaminants (silicone oils) ensures long term survival by protecting the colonies.

Capsule formation further protects the viable entities from natural body defenses and post-surgical antibiotics. This is also a common situation which leads to progressive contracture over a brief period of time. Secondary fibrosis of capsules as a result of low grade chronic intracapsular infection, is well documented in plastic surgery literature (Truppman, Burkhard and others). The microorganisms receive additional nutrients from leakage of blood and plasma into the space. Closed compression capsulotomies, or frequently-prescribed "implant movement exercises", often lead to rupture of small blood vessels and intracapsular bleeding. This may occur early, in particular, if the patient complies with recommendations from plastic surgeons for preventing "contracture". Additional complications result from major blood infiltration leading to hematomas and seromas contiguous to the prosthetic space.

When this happens, it is necessary to have the devices removed, the area debrided, disinfected and the hematomas evacuated. Hematomas are often discovered by surgeons who describe "malodorous and serosanguinous exudates" surrounding the prostheses. A capsule left in situ constitutes an ideal site for seromas and hematomas that can evolve into a unique environment for protein denaturation and microbiological activity. The space simply needs to fill with fluid or blood to create sites where deviant biochemical reactions can take place freely.

Hematomas and seromas habitually precede rapid and painful contracture as well as other serious complications. The exact health impact of these events and the way by which they produce damage are not described in published literature but the problem is widely known within the plastic surgery community. At any rate, such events should be causes for concern. In addition, the key role of silicone/oil impurities in the biological mixture of denatured proteins was not widely recognized until the release of confidential corporate documents on adjuvant effects of silicone derivatives. These addressed the problems of autoimmune diseases induction from dispersed silicone gel-oil mixtures.

Such phenomena were also in the published literature on diseases induced by weak immunogenic proteins in the presence of bacterial debris. The issues are still actively researched and belong more appropriately to the field of immunology and immunochemistry, two areas which have not received adequate attention by the medical community, in particular, the plastic surgery and the medical implant manufacturing circles.

Implant Re-use, A Popular Yet Forbidden Practice:

The reuse of any implant under any condition is not appropriate. Firstly, once implanted, most implants acquire tenaciously-bound impurities which cannot be removed under field conditions. Secondly, the surgery and even a brief period of use severely compromises the durability of the implant. Thirdly, exhaustive decontamination, disinfection and sterilization of implants is a specialized series of procedures suitable only for laboratory and industrial facilities. Even the momentary removal of an implant to resolve a complication with subsequent reinsertion is illogical as most often the cause of the implant complication resides within the implant and most probably will carry over as it is reinserted. Therefore, any such procedure is self-defeating and, on detailed analysis, cannot be justified in terms of actual manipulative cost. At any rate, the risks are so elevated as to invalidate any possible saving.

Nevertheless, the practice is widespread in plastic surgery and was at one time so common in plastic surgery of the breast that even manufacturers complained of lost revenues. There are no policies or standards that would apply to the refurbishing, reconditioning and clinical reuse of medical devices of this kind. There has been no cohesive survey on the extent of the practice but an estimate based on random sampling of records, suggests that it may have reached as high as 30 percent of all cosmetic breast augmentation procedures in certain metropolitan areas.

The reuse of complex medical/surgical devices and diagnostic systems with brief contact time may be tolerable or even necessary if the items are too costly to discard and suitable technologies exist that allow safe reconditioning and reuse. However, implants, in particular cosmetic surgery implants, are not in that category. These are low cost items; they cannot be reused under any condition. The rationale is that structural features of these devices render them extremely fragile. In addition, exhaustive cleaning from endogenous substances, tissue, adventitious microorganisms and proteinaceous contamination create a very elevated bioburden. They cannot be satisfactorily cleaned and sterilized by any process. Furthermore, the devices are inherently weak and a single cycle of use creates major shell and valve damages which will inevitably cause premature failure of the product.

A double lumen device intended for breast implantation is the most extreme example. It has an internal fluid compartment which cannot be accessed by the cleaning and disinfection process. Even when new, the valve, which provides for filling of the item, is not secure; the product generally fails by a combination of infective, inflammatory and material deterioration processes and is normally left with a perforated outer shell. Any attempt at recycling this device into the same patient, or a new patient, will reintroduce the same problems into the breast pocket and will account for much of the patient’s subsequent misadventures.

Paradoxically, such procedures are still condoned by the plastic surgery community. Surprisingly, they were implicitly supported by most of the manufacturers, at least prior to 1987. Virtually all product inserts described detailed procedures to perform "resterilization of contaminated implants". These gave instructions on recycling which could be easily interpreted as supportive of the practice. After 1985, a few manufacturers included contra-indications or statements indicating that the products were "for single use only".

Residual Capsules as Long Term Risk Factors:

Contamination of the space between the capsules and the implants by micro-organisms, silicone oils, degradation products and gel impurities constitutes a major problem which potentiates the risk of implants. Such problems include inflammation, infection, deposition of mineral debris, as well as certain autoimmune phenomena. These problems can be present when implants are in situ and are often attributable to the implant. The logical expectation is that, upon removal of implants, adverse effects will cease. This is an unjustifiably optimistic view. It is well documented from case histories that removal and/or replacement of implants without exhaustive debridement of the prosthetic site leads to failure and post-surgical complications.

Plastic surgery procedures tend to favor speed and immediate cosmetic results. For these reasons, leaving or "reusing" tissue from an existing capsule may seem more "gratifying". However, adverse effects resulting from the practice are widespread but have not been well documented. Typically, patients who require removal of faulty implants and undergo immediate re-implantation in the same prosthetic site habitually relapse with the same problem which motivated the previous surgery; the most common example is exchange of implants and/or sectorizing or bisecting the capsule without removing it completely.

Such patients rarely achieve significant capsular correction and often return for more similar surgery. An illustrative situation is where patients do not receive replacement implants. They form the basis of knowledge for evaluating risks arising from remaining capsules. An example is described in a paper published in 1993 (Copeland, M., Kressel, A., Spiera, H., Hermann, G., Bleiweiss, I.J.; Systemic Inflammatory Disorder Related to Fibrous Breast Capsules after Silicone Implant Removal; Plastic and Reconstructive Surgery; 92 (6), 1179-1181,1993); reported problems derived primarily from immune phenomena and inflammatory syndromes with pain, swelling, serologic abnormalities and alarming radiologic presentation.

Numerous similar cases have been noted amongst implant patients but have not been the object of publications. Some are cited in FDA Adverse Reaction Reports. Others appear in the U.S. Pharmacopoeia Reporting Programs.

A residual capsule is not a stable entity. It may collapse initially upon completion of surgery and remain asymptomatic for some time, however, it will fill with extracellular fluid and remain as a fluid-filled space with added blood and prosthetic debris. As the wall matures and the breast remodels to accommodate the loss of the prostheses, the capsular tissue shrinks. Water as well as electrolytes are expelled gradually from the pocket or else the mixture is concentrated from leakage of water from the semipermeable capsular membrane wall. In most cases, calcium salts precipitate during that stage and may render the capsule visible as a radiodense and speckled zone in radiographic projections. Prosthetic debris is also radiodense and may be imaged to further complicate the presentation. The average size of the residual capsules after 6-12 months is in the 2-7 cm range; most are compact, small and dense. Surgical removal should present no difficulty for most patients if adequate radiographic information is available.

Later stages of maturation include the thickening of the capsule wall, sometimes reaching 0.5-1 cm. Compression of the debris into a cluster of nodules which usually become calcified follows for some patients. A few mimic malignancies. Others appear as small "prostheses" during mammographic studies. They are alarming to oncologists and are habitually signalled for further studies or biopsies by oncologic radiologists.

In the light of present knowledge and considering the probable content of these residual closed capsules, an open or needle biopsy is not advisable. The risks of releasing significant amounts of hazardous contamination and possibly spreading infective entities outweighs the advantages of the diagnostic. At any rate, such a capsule requires removal for mitigation of symptoms and a more direct surgical approach appears more economical and less risky.

A capsule with a dense fibro-collagenous wall behaves as a bioreactor. Worse yet, it is fitted with a semi-permeable wall that may periodically open to release its content to the breast. The probability of finding the space colonized with atypical micro-organisms is elevated and the control of infective processes by pharmacologic approaches is difficult.

Such closed capsular spaces may be comparable to "artificial organs" of unpredictable functions. Their behavior will depend on the content and the age of the structure, its maturity and the history of the patient. There is a high probability that these capsules will continue to evolve for many years, adding more layers of fibro-collagenous tissue and possibly granulomatous material. If bacterial entities are present within the capsule space, they can culminate in large breast abscesses which resist conservative treatments.

Even with less active capsules containing mostly oily and calcific debris, the thickening of the wall leads eventually to solid "tumor-like structures" and are, by themselves, alarming on auscultation and self-examination. At best, such structures are unique environments for protein denaturation and aberrant biochemical reactions with unknown long term consequences.

Impact of Electrosurgery Techniques in Contaminated Fields:

Electrodissection and electrocoagulation (Bovie surgery) involving fields contaminated with alloplastic material require special care. Typical situations involve surgery for removal of old implants and adventitious debris such as projectiles and fabrics arising from perforating trauma.

Removal of failed prosthetic systems generally entail the removal of peripheral foreign material dispersed within tissue. Secondary natural phenomena, such as fibrosis and calcification, in response to the foreign material can also alter the characteristics of tissues and complicate the surgery with additional risks for the patient and the surgical personnel.

Surgery of the breast for removal of prosthetic systems is complicated by the presence of disseminated silicone oils, degradation products from polyurethane coatings, Dacron fabric, and degradation products of polymers used in implants. Electrosurgical techniques may further degrade the products into harmful substances which remain at the prosthetic sites to cause late reactions or generate airborne gaseous toxic entities with risks to the staff.

Other complications include failure of Bovie cutting action during procedures that require resection through intracapsular calcification zones. Calcified tissues often accompany prosthetic materials and, in sufficient quantities, they impede or forbid electrosurgical dissection. In most cases, they simply lead to mineralized zones of pyrolyzed debris. These indurated composite pockets cannot be left in situ as they have unknown toxic potential and cannot be cannot be easily removed with conventional soft tissue cutting instruments.

Electrosurgical procedures are widely used in breast implant work. They facilitate the removal and the replacement of failed devices. They allow accessing the prostheses without risking perforation or permit conservative removal of non-malignant masses. They can also accelerate dissection and minimize bleeding during procedures which would otherwise lead to significant blood loss.

Whereas such procedures are desirable and can be safely used for coarse removal and debridement of tissue surrounding prostheses, they cannot be without appropriate secondary debridement to remove the pyrolysis products and the burnt tissue. In other cases, they cannot be used at all because the level of contamination is such that it resists cutting action or presents an occupational risk to the staff.

Silicone-impregnated tissue is not easily dissected using such methods. It also creates large amounts of pyrolytic silica in tissue. Carbon-based materials such as tissue can burn and eventually become catabolized. However, the combustion of silicone using electrocautery leads to silicon dioxide (silica) and complex silicates.

Organosilicone-silica composites are also reaction products. They are different from the starting materials and are equally difficult to remove. If left in-situ, they lead to granulomas, adhesions and fibrotic masses which may require secondary surgical revisions. The sequelae of silica and silicates in tissue are described in the medical literature. In addition to local problems, the compounds are associated with long term adverse autoimmune effects.

Polyurethanes and Dacron can present similar surgical problems but the residual combustion products and the pyrolysed debris are not as insidious or aggressive. However, they generate irritating vapour and, polyurethanes in particular, can lead to significant quantities of toxic airborne products.

Dacron fabrics and particles, under such circumstances, will melt and consolidate to lumps of partly carbonized plastic which are associated with inflammatory granulomata. As a general rule, electrosurgery and thermal cautery in plastic-contaminated fields is undesirable unless the cut tissue edges can later be retrieved totally by secondary sharp dissection.

Resection through fields that are extensively contaminated by debris from burst prostheses, in particular devices where the filling material is partly degraded and liquified, is contra-indicated. At any rate, extracapsular dissection of the fibrous tissue that generally surround the failed prosthesis is a preferred removal technique under such conditions. Blind dissection through thick suspect capsules aiming to reach into a contaminated periprosthetic pocket is rarely necessary or desirable.

Bovie electrosurgery and electrocoagulation can be used without such risks once the field has been satisfactorily debrided of contaminated tissue. Electrocoagulation of small cut vessels presents no problem in tissue where there is no dispersed silicone oil.

Conversely, inability to achieve satisfactory hemostasis in the periprosthetic area after repeated attempts therefore suggest a field rich with contaminated tissue. It has been empirically found that difficult hemostasis and abnormal behavior of the Bovie probe on small blood vessels can be used as a sensitive test for alloplastic and calcific debris in tissue.

Retrospective on Cosmetic Surgery of the Breast - Medical Ethics Issues:

The care of patients who suffer 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 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 Role in 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 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.

Interactions between Surgical Staff, Facilities and Device Technology:

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.

The Role and Responsibility of the Surgeon and his Support Staff:

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 respects, 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.

These considerations apply in principle to individuals engaged in the design, fabrication and marketing of implants, even if they are not technically ‘medical practioners’. The obligation to learn from previous experience and teach what has been learned so that others may not repeat the mistakes, are as much the obligation of technologists as they are of the physicians.

In the context of medical implant commercialization and clinical investigations, it is of overwhelming importance for individuals connected with these programs to identify faulty products even if it is their own. Furthermore, it is essential to curtail the use of such products as soon as the risks become known. At that point, like the physicians, they have an ethical responsibility to warn potentially affected user-subjects. They must establish the mechanism of injury and take appropriate measures to minimize attendant morbidity. Lastly, they are further required to correct the product defects or revise the procedure or circumstances of use as appropriate. If reliable explanations for adverse phenomena cannot be found over the short term, they must restrict further use of the products. If the item is deemed to provide an essential amenity, there may be some flexibility in allowing continuing use for lack of suitable alternatives. However, no such caveat exists for cosmetic plastic surgery technology, in particular that of the breast.

The breast implant industry and individuals who had a policy role during the early period have a dominant share of the blame for the morbidity surrounding the technology they promoted. Corporations such as MEC have a disproportionately large share of this blame as they were involved in high risk products but yet allocated only minimal resources and had no long range commitment to study the performance and risks of their products.

Through acquisitions and promotion most breast implant manufactures evolved into major forces in the distribution of cosmetic plastic surgery products. Nearly all became parts of large health care products manufacturing groups. By the early eighties, they had access to know-how and resources which would have been ample to perform basic evaluation and product revisions to ensure a reasonable level of safety and efficacy. This was not done. Instead, efforts appear to have been oriented at commercial acquisitions of dubious value, increasing the rate of production, cutting costs, outselling competitors via self-destructive pricing practices, embellishing performance claims and promoting products devoid of clinical merit.

When morbidity became impossible to hide, enormous resources were used to silence sources of unwelcome information. Even more effort was mobilized to mitigate the overwhelming adverse publicity by exaggerating claims of success and minimizing the impact of adverse consequences. Still later, an outright campaign was undertaken to silence or control independent research activities in order to avoid exposing the extent of the risks of the product lines.

One can debate the motivation for such misguided efforts. It is possible to surmise dishonesty for the sake of profit. It is also possible to perceive it as a matter of self-preservation in attempting to salvage a tarnished corporate reputation. A review of business documents reveals numerous anomalies within all levels of corporate activity. Collectively, these documents suggest an embarrassing degree of incompetence on the part of executives, inadequate preparation and lack of qualifications on the part of technical staff and most surprising, a consistently low profit margin and elevated litigational costs which ought to have been a vivid warning of what was yet to come, if corrective measures were not implemented.

The events which preceded the cessation of commercial activity and the dissolution of MEC, appear unique in the history of health care products manufacturing. They show that in response to serious problems at all levels, collectively the corporate body did not possess enough insight, technical skill, business acumen or management ability to evaluate risks and benefits of their products either from the medical or from the financial point of view.Thus, they defaulted their clients and their shareholders.

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 nonessential 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. The reconstructive procedure must not diminish the patient's prospects for recovery nor enhance her risks of contracting other infirmities or diseases that require additional treatments.

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. 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 risks and inflate the benefits. 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. Most 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 and the immediately gratifying results have historically attracted marginal surgeons working out of facilities with substandard equipment. 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.