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Injury From Saline Inflatable Breast Implants - Part I
05-05-2006, 12:01 PM
Post: #1
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http://implants.clic.net/tony/Blais/020.html

INJURY FROM SALINE INFLATABLE BREAST IMPLANTS

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[font=Geneva,Arial]Where Implants Go Wrong[/font][font=Geneva,Arial]:

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[font=Geneva,Arial]A mammary prosthesis can injure a user in many ways. Some implants need not even suffer frank shell rupture or gross perforation to induce major health problems. Effusive loss of mobile impurities, errors in material formulation, incorrect sterilization, tissue-incompatible surface coatings, inappropriate shell designs and adverse interactive effects between implants and capsules can initiate or worsen serious diseases.

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[font=Geneva,Arial]The physiologic consequences of inserting large, coarsely manufactured foreign bodies in a disease-prone part of the human body can lead to mechanical or physiologic damage such as deformity, discomfort, pain, neuro-sensorial changes, ischemia and other lasting problems.

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[font=Geneva,Arial]In some cases, the problems are simply the result of forcibly fitting a device of a significant size in a space that was never meant to contain it. However, other adverse effects have more complex mechanisms that have to do with pharmacological, infective and immunological processes that take place within the space between the implant and its surrounding semipermeable tissue capsule.

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Where the Surgery Goes Wrong:

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[font=Geneva,Arial]Inappropriate implantation procedures and flawed surgery often create additional problems and exacerbate pre-existing diseases. The surgery which evolved in support of this technology was optimized for speed and early aesthetic gratification as opposed to lasting comfort or breast health. The environment where such surgery is carried out is frequently inappropriate. Many surgical suites are totally unsuited for implant procedures in terms of design, instrumentation, environment control, cleanliness and microbiological safety.

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[font=Geneva,Arial]Sterility is important in any surgical context but it is a key consideration in procedures which involve implants. The surgical fields that receive "permanent" implants are susceptible to tenacious infective processes. Elaborate measures for control of sterility in the implant space are required to ensure even a modest success.

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[font=Geneva,Arial]Extemporaneous office settings and improvised stand-alone surgeries are unsuited for this medical technology. Even with ideal implants, "improvised" surgical settings are subject to serious sterility pitfalls with lasting consequences for the patient. In retrospect, these factors account for much morbidity in cosmetic and reconstructive breast surgery.

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[font=Geneva,Arial]There are important variations between patients which make some more vulnerable than others to deficient implants and marginal surgical practices, in particular deficiencies in implant design, material composition, implant site preparation and infection control.

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Importance of the Patient's History:

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[font=Geneva,Arial]The background of the implant user predetermines the" service life" of the surgical procedure and the severity of late implant problems. There are significant variations amongst different individuals ability to tolerate implants, in particular large surface area, debris releasing, low quality devices such as breast implants. Some of these variations may be traceable to genetic or disease history of the individual. Others relate to prior medico-surgical treatments.

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[font=Geneva,Arial]The special vulnerability of albino, celtic, nordic and northern caucasian phenotypes (depigmented skin tone, "freckled", red or pale blond hair, gray or blue eyes) to tissue diseases and surgical complications is reflected in adverse reaction risks to implants and poor long term prognosis when complications set-in. Conversely, negroid phenotypes are generally recognized as prone to proliferative tissue and scarring phenomena; many present with intractable implant capsules and post-implant complications. Individuals subjected to thyroid and thymus gamma irradiation as children, treated with certain pharmaceuticals (novobiocin, chloromycetin, etc) also show selective problems which appear creditable to such treatments.

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[font=Geneva,Arial]However, the breast surgery history of an implant user inevitably decides the long term outcome of a new implant procedure. Replacement of implants is commonplace and patients with records of five or more replacement surgeries are not rare. Failed implants also tend to leave long lasting local and systemic damages.

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[font=Geneva,Arial]Most cosmetic and plastic surgeons try to replace unsatisfactory implants and patients feel compelled to accept replacement for fear of deformity. Regrettably, there are generally no lasting cosmetic benefits or remission of symptoms with simple implant replacement. The errors of past breast surgeries and earlier implant misadventures are generally cumulative. Replacement may provide a temporarily gratifying result but, after a brief remission, the problems return.

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[font=Geneva,Arial]It is not uncommon to encounter implant-bearing patients with ongoing disease processes induced by failed implants removed many years before. This sometimes explains why recently implanted and nearly new prostheses are removed from symptomatic patients. Their problems may stem from prior prostheses while their current implants and the capsules maintain conditions suitable for ongoing disease processes.

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Capsule-Implant Relationships:

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[font=Geneva,Arial]The capsules which form around the prostheses are difficult to assess. They are not "normal" connective tissue structures. They are often the decisive factors that complicate existing diseases or create new ones. Such capsules can contain large amounts of prosthetic debris and modified natural substances with scope for adverse effects. Typically, they incorporate prosthetic debris, oils, coarse mineral deposits and denatured tissue.

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[font=Geneva,Arial]Deep colonization by atypical micro-organisms and embedded solid metabolites from the entities are also frequent. Granulomatous reaction products to foreign debris of synthetic or micro-biological origin generally co-exist with the tissues. Failure to retrieve this material at explantation delays healing. It can also have lasting adverse consequences.

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[font=Geneva,Arial]Slow Progress in Mammary Implant Technology:

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[font=Geneva,Arial]Mammary prostheses have long been marginal products aimed at a professional community that has not habitually been concerned with product quality or long term safety and durability of implants. Furthermore, the implants themselves have mostly been common low cost items based on faulty scientific and engineering concepts. Manufactured in large volumes with minimal quality assurance and considerable variations from batch to batch, their marketability was dependent on aggressive promotion, protection from adverse reaction reporting and exaggeration of performance and benefit claims. It seems that the industry was driven primarily by the appeal of widespread cosmetic augmentations as opposed to post-cancer reconstruction procedures.

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[font=Geneva,Arial]In spite of three decades of implantation and the production of more than 6 million units, the devices and the implantation techniques have not progressed significantly. Preferred quoted research focusses principally on favorable or trivial aspects of the art. Adverse results receive little attention. Well publicized but superficial epidemiological and psycho-behavioral surveys emphasize illusory benefits and infer the absence of adverse effects. Promotion by manufacturers and cosmetic surgery clinics continue in the U.S. and abroad. Official disclosure of serious long term problems to government agencies, clinicians and users were very rare.

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[font=Geneva,Arial]In retrospect, the technology appears to have deteriorated since the seventies and the basic product designs have become worse with time, reaching their nadir in the early -eighties. Evidently the surgical community and the industry that supported it failed to learn from past failures and consistently disregarded well established biomedical principles in favor of speed, volume and profitability of a promotable cosmetic procedure. The mechanisms of injury may appear to vary from case to case but the pattern of failure and the type of implant-associated diseases are predictable and consistent with the accumulated adverse reaction information.

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Injury Mechanisms:

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[font=Geneva,Arial]The insertion of ill-conceived implants in a disease prone area has 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 degrade and the debris may include pharmacologically active compounds.

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[font=Geneva,Arial]Prosthetic injuries in breast implant users can be attributed to at least six major mechanisms: (1) surgical trauma and surgical misadventures resulting in damage to functional/sensorial parts of the chest and the muscle of 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 interactions leading to tissue degeneration or denaturation to produce host tissue- derived antigens that elicit antagonistic host-directed antibodies (autoimmune disturbances); (6) pathologic effects induced through bacterial, viral or fungal colonization of the capsule space leading to low grade chronic infections and toxic phenomena from microbiological metabolites.[/font]
[font=Geneva,Arial]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.

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[font=Geneva,Arial]Atypical infection may be a primary factor for systemic adverse effects. Protected intracapsular infections that remain for a long time have the ability to enhance capsular fibrosis and 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 these toxins may account for disturbances noted in some long term prosthetic users.

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The Role of Capsules in Implant-Related Diseases:

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[font=Geneva,Arial]Capsule problems are common in prosthetic patients in general. The 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 produce chemical debris establishes a condition which produces bioactive mixtures of silicone compounds with dispersions of denatured proteins.

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[font=Geneva,Arial]The site often attracts bacterial contamination and the oil ensures long term survival of the viable entities even in the presence of systemic antibiotics. If the infection is maintained, capsule wall lysis takes place. When capsule integrity is breached, accumulated denatured (lysed) tissue, prosthetic silicones and proteinaceous material from the bacterial and/or fungal colonies escapes.

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[font=Geneva,Arial]This mixture has properties similar to Freund's complete adjuvant; mixed with denatured autogenous tissue, it can elicit the formation of antibodies against the denatured autogenous tissue proteins. Eventually, with time, sensitization to the protein itself becomes possible (autoimmunity). Clinically evident damages result when the titre of auto-antibodies rises to the point where the rate of destruction of natural tissue becomes greater than the rate of repair.

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[font=Geneva,Arial]There is a long standing consensus that many silicone-based compounds similar to those found in mammary implants are pharmacologically active. It is also well known within the chemical professions that many members of the silicones family can act as dispersants, emulsifiers, biological adjuvants and promoters of immune phenomena as well as facilitate the absorption of toxic chemical entities which would not otherwise enter living organisms. The silicone elastomers also contain silica.

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The Role of Silica:

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[font=Geneva,Arial]Implant studies document long term biodegradation and bio-erosion of shell materials. The effect is particularly notable for saline inflatables and multi-lumen prostheses filled with aqueous solutions. The deterioration processes results in embrittlement of the material, erosion of the polymer as well as spallation of silica fillers particles in the form of reactive agglomerates.

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[font=Geneva,Arial]This bioactive silica originates from the silica reinforcing fillers incorporated in silicone elastomers. These compounds are an intrinsic component of most shells. They are present in the finished products at levels of 10-30%. Other types of fillers such as titanium dioxide and aluminum oxide are also encountered as fillers and opacifiers in some brands of implants.

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[font=Geneva,Arial]The resulting biodegraded silica agglomerates are coarse, bioactive structures and co-exists with intracapsular calcific crystalline structures which further enhance the tissue interaction by abrading against the contiguous tissues. Silica in the form of natural aggregates of similar size has been recognized as an occupational hazard since the turn of the century. It is associated with tissue fibrosis and atypical auto-immune diseases when in prolonged contact with soft tissue and organs.

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Capsule Calcification:

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[font=Geneva,Arial]The formation of mineralized tissue is commonplace in long term implant users and the process is often a decisive limitation on the ultimate service life of the device. This situation prevails for biologically derived implants such as animal tissue cardiac valve prostheses and stabilized tissue vascular prostheses. Totally synthetic implants can also induce the deposition of minerals in their surroundings. However, these situations are drastically different from what is routinely encountered in users of early breast prostheses.

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[font=Geneva,Arial]Individuals with early style implants incorporating tissue fixation systems are very prone to the process. The very early Dow Corning devices fitted with large Dacron fabric backplates offer some of the most spectacular examples of gross atypical mineralization.

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[font=Geneva,Arial]Many other devices without fixation systems also calcify abundantly in different ways after about 15-20 years in situ. Saline filled implants manufactured prior to the mid eighties are commonly found with grossly calcified shells where the mineralization process has penetrated deeply into the elastomer rendering it permeable and brittle.

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[font=Geneva,Arial]More recently marketed items are also occasionally found with significant amounts of finely divided mineralization dispersed in the periprosthetic tissues. Anecdotal observations of such mineralization are numerous and many pathologists routinely describe the calcific entities as "dystrophic breast calcification".

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[font=Geneva,Arial]Implant-related mineral deposits are evidence of catabolic activity and are unlike entities found in implant-free breasts which include small spheroidal calcific concretions (frequently seen in mammograms of normal breasts from older patients). They are also unlike spicular calcific microcrystals arranged in clustered or radiating patterns that are also encountered in breasts without implants but with aggressive tumors; their presence is regarded as reliable radiodiagnostic criteria for neoplastic anomalies.

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[font=Geneva,Arial]The aetiology and the basic mechanism of formation for these "natural"structures are not the same as prosthetically induced mineralization but appear nevertheless related insofar that they are pathological and reflect ongoing tissue destruction. They are unlike true osseotropic phenomena such as bone mineralization which are primarily driven by epitaxial crystal deposition on specialized structural proteins.

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[font=Geneva,Arial]The formation of periprosthetic, dystrophic and tumor-associated calcification are deemed to be sequelae of chronic tissue destruction and necrosis occurring over long time spans. The morphological differences between the entities formed are primarily creditable to the mechanism and the rate of catabolic processes and the differences in the environment where the tissue destroying activity is taking place.

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[font=Geneva,Arial]Tissue destruction can result from mechanical (abrasion, disruption, comminution), chemical (toxicological, hypoxic, desiccative) and microbiological (lytic, proteolytic) damage to cell organelles and structural proteins. All of these conditions are met in the closed space around an implant. Unique physico-chemical, physiologic and biochemical environments develop early around such prostheses and eventually the intracapsular space becomes a specialized isolated compartment with a composition that deviates markedly from extracellular fluids, where non-equilibrium conditions prevail and where otherwise unfavored or forbidden biochemical processes take place. Its characteristics compare to that of an active wound site with foreign debris, synthetic oils and catalytic substances surrounded by a diffusion-controlling barrier membrane. In effect, these compartments become self-regulating environments with a capacity to form chemical and biological products that reflect local composition as opposed to normal tissue metabolites.

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[font=Geneva,Arial]This favors aberrant anabolic and catabolic processes. After several years, the periprosthetic implant space becomes heavily contaminated by leached synthetic impurities released from the implant. Capsular tissues and extracellular products trapped in the zone also deteriorate to form metabolites. These entities would normally be removed from the site and eliminated or converted elsewhere via natural processes. Thus the damage would appear elsewhere if it were not for containment by the capsule wall.

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[font=Geneva,Arial]As it matures, the capsule densifies and becomes progressively more contaminated by shell debris; it is a diffusion controlling membrane which regulates the intracapsular environment. Later, the capsule becomes much less permeable and the environment becomes stagnant. The traumatic effects of sharp perforating crystalline inclusions in vascularized tissue causes periodic leakage of blood and blood proteins into the compartment thus increasing the diversity and the reactivity of the incubating mixture.

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[font=Geneva,Arial]Eventually the integrity of the capsule membrane is lost through erosion, lysis and excoriation. The semi-fluid mixture of denatured proteins, fine calcific debris, cell and tissue fragments and grossly contaminated extracellular fluids escape into the breast and the regional lymph nodes. Shell particles and silicone oil emulsion adds to the diversity of the mixture, generally triggering systemic symptoms. Finally, the site becomes very uncomfortable from accumulated coarse solid calcific and prosthetic materials and the removal of the prosthetic debris becomes mandatory.

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[font=Geneva,Arial]The removal of the implant remnants is, however, difficult. Resection of the thickly encapsulated devices and their the associated contaminated tissues, add to add to the implants' injuries and complicate the post explantation recovery. Conditions leading to injuries from prosthetic mineralization processes , are reconstructed as follows:

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[font=Geneva,Arial](1) Fixation accessories such as the large surface area open Dacron fabric "patches" or related structural irregularities on the posterior side of the device such as protruding valve stems, shell patches or "suture loops" initiate inflammation. (2) Fibrosis locks the item deeply into the chest wall. (3) A thick fibrotic zone of dense pannus develops on the posterior face of the implant and the area loses much of its vasculature and permeability. (4) Hyperplasia and contracture of capsule tissue then accelerates and diffusion limitations causes tissue hypoxia and necrosis to set in. (5) Denaturing of tissue and other aberrant biological processes continue for many years with and a gradual release of soluble minerals in the form of ions takes place. (6) Intracapsular fluid supersaturation and poor fluid exchange in the are causes precipitation of the salts and complexes as solid crystalline entities. (7)t The intracapsular space becomes filled with grossly atypical minerals in the form of large, densely clustered plaques or compacted concretions of microcrystalline debris. (8) Some of these crystals develop sharp edges and form cutting structures which cause additional tissue trauma on movement. (9) Intracapsular bleeding takes place resulting in for deposition of hemosiderin within the capsule; low hematocrits and abnormally elevated haemoglobin nay be noted. (10) Continuing osseotropic remodelling affect the thoracic area and cause pain or limitation in expanding and contracting the thoracic cage. (11) Anatomic and physiologic changes affect the area; deformity or drastic changes become evident in the mechanical characteristics of the upper chest area. (12) Eventually the accretion of sharp, rigid debris becomes radiographically evident or even palpable in the vicinity of the prostheses and motivates the patient to seek removal of the devices. (13) The explanting surgeon then encounters a major problem in resecting the offending implants; in view of the large amount of surrounding mineral inclusions which cannot be penetrated by Bovie or sharp instruments. As a result, improvisation is required and extemporaneous methods are used to explant the prostheses and their fixation appendages.

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[font=Geneva,Arial]Ultimately, such patients may require staged surgery in order to regain a reasonable level of comfort. Secondary surgery may also become necessary to retrieve residual prosthetic debris and secondary mineralization products. Radiographic follow-up is sometimes necessary during the post-operative period to ensure appropriate healing and the absence of fluid-filled pockets with risks of their own.

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Background and Problems with Saline-Containing Implants:

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[font=Geneva,Arial]Breast implants consisting of containers filled partly or wholly with aqueous fluids have been described in medico-surgical publications and in patents for more than forty years. Numerous variations exist. Several types were commercialized during the sixties and seventies. Shell durability, aesthetic deficiencies and filling port closure reliability emerged as problem areas from the outset. The same problems remain without resolution today. Patient dissatisfaction, replacements and adverse reactions has surrounded the use of the products for at least 20 years.

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[font=Geneva,Arial]Conceptually and predictably, the most serious problem of "saline-inflatable" breast implants is their ability to sustain microbiological activity within the saline-containing compartment; the most widely cited problem is their susceptibility to rapidly lose their saline filling charge because of valve or filling port failure or late shell perforation as a result of material fatigue and physico-chemical deterioration.

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[font=Geneva,Arial]Most "inflatables" ultimately fail through classical fatigue-related shell wall perforation, a process termed by industry as "benign late spontaneous deflation of unknown aetiology". When reviewed against a background of microbiology, parasitology and infection control, late shell integrity failures have a much more ominous prognosis. They are the end stage of a sequence of events which begins by inoculation of a warm, protected micro-environment which can later receives nutrients at librium. This is followed by florid colonization of the aqueous medium within the object. Chronic release of secondary inoculae through faulty valves and shell defects takes place concurrently. Ultimate deflation with release of the fluid charge amounts to a direct high volume injection of viable entities of mixed type including mycobacteria which are well suited to survive the closed environment of a saline implant.

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[font=Geneva,Arial]Contributing Factors to Saline Implant Misadventures:

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[font=Geneva,Arial]Contrary to expectations, saline prostheses have water permeable shells. Their permeability to larger molecules increases with dwell time in vivo. For typical products made with conventional acid catalyzed shells ("RTV"), ingress of extracellular solutes such as amino acids and proteins becomes significant after about 5-7 years. Gradual loss of volume then takes place and capsule contraction forces the shells to involute and pleat on themselves. Continuous movement from the user’s daily occupation erode and fatigue the material. The shell later perforates at pleats and pucker points. Cracking of the material with loss of particles then takes place . Rapid deflation usually follow with release of the filling charge and its acquired contaminants. These contaminants frequently include a large bioburden of viable micro-organisms which colonized the charge with the aid of nutrients that permeate the shell. This also complies to multi-compartment systems such as double lumen implants which have aqueous fluid. Such prostheses also share problems of assembly and valve security.

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[font=Geneva,Arial]Valves and filling ports are not secure. Whereas the early models such as the Arion, the Jenny and the Birbaum designs achieve irrevocable closure of the filling port by forcibly inserting a plug into the orifice, the more recent versions use valves that leak. Ideally, the leakage rate is low and takes place in response to compression from contracture of the capsular tissue. This is expected to achieve a kind of decompression. Even late versions of the "Jenny" incorporate a valve plug that is easily avulsed from the orifice. This feature appears to have been deliberately designed into the product in order to justify the claims of ‘low capsular contracture’ even at a cost of product safety.

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[font=Geneva,Arial]Saline prostheses obscure mammograms. Contrary to product claims and often repeated opinions by proponents, silicone elastomer shell and valves are radiodense. Mammograms of saline users clearly show the prostheses and eclipse nearly as much information about possible tumors as do gel filled devices. Thus they can significantly delay or preclude meaningful tumor detection depending conventional mammographic techniques. All presently used salines are markedly radio-opaque and have radiographically visible fine structure which greatly complicate the interpretation of radiographic projections. In the late stages, most undergo severe calcification at the tissue interface. These crystalline entities are in the same size range as "micro-calcifications" used as criteria of malignancy by radiographic oncologists. In tumor screening and post resection cancer follow-up procedures, the implants have the ability to obscure even large and dense proximal malignancies. They also introduce complex artifacts which further confuse the results.

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[font=Geneva,Arial]Such characteristics, independently and in combination have long term safety implications. From studies on recovered implants and medical records of their users, deflated implants, grossly leaky valves, frangible and degraded shells, atypical periprosthetic infections and their sequelae account for a large part of morbidity in what ought to be a healthy segment of the population. Paradoxically, these risks are not well explained to potential users or else termed "remote" by promoters.

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[font=Geneva,Arial]The diagnostic of saline implant-related diseases and the clinical management of patients bearing saline inflatables present medical and technical costs which far exceed the benefits that the devices provide. For individuals who prefer to retain the devices in spite of their obvious risks, the area requires additional study to quantify the probable life of each shell type, the factors involved in colonization, the identity and the population of organisms present in the charge and the best treatment modalities for users of implants that chronically release small quantities of inoculae into the periprosthetic space.

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[font=Geneva,Arial]Similar problems have been encountered with other classes of implantable devices that harbor stagnant aqueous fluids such as trans-cutaneous "port" drug administration devices (Hickman-type catheter systems) and inflatable penile implants. Presently, saline-filled devices are increasing in popularity and anecdotes of misadventures abound. Yet complications surrounding the use of saline filled devices appear drastically under-reported and the literature on the topic seems incomplete or possibly manipulated. There are numerous claims of long term success by proponents but there is a paucity of credible data on properties and performance of the devices. Results of preliminary studies performed on explants by many centers are discordant with commercially distributed information. Replacements and treatment for chronic sequelae from the devices boost public costs associated with the use of this technology.

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[font=Geneva,Arial]Historical Overview of Saline Implant Technology:

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[font=Geneva,Arial]Saline mammary implants were introduced commercially in the mid-sixties. Early models were simple and robust. All were sold non-sterile. They required individual hospital sterilization as well as meticulously clean intraoperative procedures. Many gave excellent service for more than two decades and a few are still in use in original patients.

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[font=Geneva,Arial]As demand grew, the quality diminished and many unsatisfactory designs were introduced. Most were promoted on the basis of lower prices, faster surgical implantation and more gratifying immediate appearance. By the late-seventies, the quality and performance had degraded to the point where seasoned clinicians avoided their use. Implants were deflating after several months and most perforated within 1-2 years following implantation.

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[font=Geneva,Arial]Worse still, many were being explanted in grossly contaminated states with assorted viable and non-viable entities, sometimes visible to the naked eye. Intraoperative errors, manufacturing problems and inappropriate sterilization procedures were generally credited with the problem but its etiology and clinical significance were not widely recognized. Some of these problems appeared as official adverse reaction reports and a few articles on the topic were printed in plastic surgery journals.

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[font=Geneva,Arial]Many clinicians abandoned the products by 1980. Some successfully sued the manufacturers for loss of wages and damage to their reputation. The products then nearly vanished from the marketplace until their "renaissance" in the nineties following a successful bid by the U.S. Food and Drug Administration to regulate the popular but problem-plagued gel-filled implants and other abuses surrounding silicone-based cosmetic surgery practices.

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Microbiological Issues and Pharmaceuticals in Saline-Containing Implants

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[font=Geneva,Arial]The instillation of pharmaceuticals to solutions in saline inflatable implants and in the outer lumen of multi-compartment prostheses started in the early seventies following a publication by Perrin. By the late seventies, several influential authors in plastic surgery of the breast were advocating the procedure and its use became widespread. Other contemporary publications were outlining serious adverse affects. The procedure was also meeting with strong objections from pharmacologists and from the makers of drugs used in connection with the claims.

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[font=Geneva,Arial]The use of assorted antibiotic and bacteriostatic pharmaceuticals was predicated on the basis that they would prevent proliferation of microorganisms inside or outside the shell. Anti-inflammatory steroidal preparations and other drugs were believed to prevent or mitigate capsular contracture by slowly diffusing out through the leaky implant wall. Eventually the fashion was extended to gel prostheses where the additives were sometimes injected as a bolus through the shell wall.

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[font=Geneva,Arial]The first commercially attractive saline inflatable designs are credited to Jenny, Arion and Birnbaum. The derived multi-compartment or double lumen implants are attributed to Hartley. All of these products appeared in the early seventies. Early double lumen products had large volume saline compartments and were mostly ‘saline’ as opposed to gel. They behaved like saline inflatables. In their original form, they were designed to address capsular contracture through optional deflation of the outer compartment. This is made clear by Hartley in his patent on double lumen implants entitled "A Deflatable Mammary Augmentation Prosthesis".

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[font=Geneva,Arial]By the mid -seventies, another variation of the double lumen appeared. It was specifically intended to convey pharmaceuticals to the surrounding capsular tissue. The drugs were added to the saline in the outer lumen at the time of implantation. Such special variants of double lumen prostheses had very small saline volumes. They were designed in response to demand created by advocates of the drug-release procedures.

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[font=Geneva,Arial]Such devices with low outer (saline) volume were manufactured by most of the firms at the time. They initially promoted the technique but evidently met with objections from the pharmaceutical manufacturers whose products had been extemporaneously diverted for these applications. As a result, implant makers were later compelled to modify their product inserts to reflect that the inclusion of pharmaceuticals was an initiative of the surgeon.

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[font=Geneva,Arial]By the late seventies, any individual skilled in the art would have been knowledgeable regarding the risks of contamination and the possibility of leakage of the outer compartment in double lumen or saline inflatable devices. Other studies had documented the rapid growth of microorganisms in the outer shell of double lumens and salines. Several widely read journal had published articles on the topic.

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[font=Geneva,Arial]It is noteworthy that the surgical community as a whole always feared infection and growth of bacteria or fungi inside liquid-filled implants; this was a frequently-noted phenomenon. It ought to have been forecast that the instillation of pharmaceuticals designed for other purposes would enhance the risk of microbiological contamination of the compartment. This would magnify risks arising from substances created by the deteriorating pharmaceuticals. Therefore, even to an unsophisticated practitioner, the risks of the procedure would have perceived.

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[font=Geneva,Arial]The existence and continuing promotion of the low outer volume double lumen prostheses by manufacturers is by itself contradictory. In the light of published risks and failures to perform according to claims, the product would logically have been abandoned. At any rate, its use would appear, a priori, contrary to established standards of care surrounding the use of implants with aqueous media . The implant shells and their filling valves were generally known to allow the passage of chemical and even microbiological entities. Yet, these properties were exploited clinically by the very use of extemporaneously added pharmaceuticals (anti-inflammatories, antibiotics, cytotoxic agents, bacteriostats, etc).

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[font=Geneva,Arial]These procedures fell into disuse when it was learned that the products interacted and degraded quickly to toxicologically uncharacterized substances, some of which damaged the shells. Others such as steroidal anti-inflammatories were ineffective and were shown to entail significant health risks. There never was a scientific basis for claimed benefits from the procedure.

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[font=Geneva,Arial]Microbiological Risks for Saline-Containing Systems:

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[font=Geneva,Arial]All saline-filled devices have been sold as sterile products since the late-seventies. Saline chambers with small amounts of viable micro-organisms occur occasionally and recalls take place. It appears that improperly sterilized products have beset the industry for many years and forced the introduction of specialized sterilization technology in the eighties.

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[font=Geneva,Arial]Because of the closed internal configuration of these devices, the validity of current sterilization techniques is still a contentious issue. Non-sterile compartments also reflect contaminated devices. Contamination can take the form of surgically introduced pathogens during in situ filling as opposed to sterile field filling. Given the non-sterile character of the mammary gland, the introduction of viable entities from contact with extracellular fluids and breast tissue is very probable.

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[font=Geneva,Arial]Additional pitfalls include resterilization attempts following unsanctioned device re-use or extemporaneous filling with non-sterile substances. Deviations from established filling recommendations were commonplace in the recent past. Some of these procedures have been published and were once very popular. A few remain in use by some surgeons to this day.

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[font=Geneva,Arial]Such procedures typically include filling with non-parenteral grades of electrolytes or colloids and extemporaneously prepared solutions of oral pharmaceuticals such as anti-infectives and anti-inflammatory steroids. The long term fate of these degraded mixtures in a closed environment is also worthy of consideration as "nutrients" to late arriving micro-organisms and in the context of chemically-mediated adverse reactions after shell rupture.

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[font=Geneva,Arial]An inoculated prosthesis may remain in a biologically dormant state until the viable entities are provided with nutrients. If the filling substance contains no nutrient, no biological activity will take place. Alternately, the inocula may die spontaneously.

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[font=Geneva,Arial]However, on balance of probability, some proteinaceous matter will eventually enter the compartment through valves, shell defects or late perforations. Paradoxically, very few valve designs demonstrate concern about this issue. Very few are secure even when new and definitive "plugs", cement seals and valve caps are rarely used even when available. Most valves are simple variants of unidirectional flow control devices. They were developed for consumer applications or hydrocephalus drainage shunts. They allow inward flow and can be made to function as pumps that transfer liquid from the capsular space to the fluid compartment by manipulating the prosthesis-capsule assembly. There are therefore no reliable means of preventing nutrients from reaching an inoculum in these systems.

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[font=Geneva,Arial]The Prosthesis as a Fermentation Reactor:

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[font=Geneva,Arial]Inoculated devices with nutrients may not present an overt risk until the biological processes involve sufficient mass transfer to produce significant amounts 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 faulty valves and late perforations, conditions for proliferative colonization of the compartment will be met.

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[font=Geneva,Arial]Even if sterile at the onset, leaky saline compartments constitute nearly idealized incubation zones for adventitious pathogens in the capsular space. Adjuvant-like impurities from leaky gel cores further complicate the chemistry of these pockets. They add to the denatured proteins, decaying tissue, fermenting pharmaceuticals and active micro-organisms. Scar tissue also re-form and can act as temporary plugs for the perforations, thus further improving the environment for less competitive micro-organisms such as anaerobes.

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[font=Geneva,Arial]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 wall 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 invade the prosthetic capsular space and may establish secondary colonies outside of the prosthesis. Symptoms of infection should appear at this stage but may resolve temporarily.

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[font=Geneva,Arial]
Composition of Aqueous Solutions Within Used Breast Implants

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[font=Geneva,Arial]The composition materials placed in the interior of breast implants is not constant with time. Observations on silicone gel and saline-filled implants removed after in vivo dwell times of a few weeks show measurable amounts of particles evidently dislodged from the shells as well as uptake of water, ions, amino-acids, proteins, lipids and other substances originating from the host. Even "solid" silicone elastomer implants absorb and sometime reprecipitate endogenous materials. After several months of use, the amounts are often visible to the eye unaided.

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[font=Geneva,Arial]This is in contrasts to the behavior of most substances used for long term implants which include metals, inorganic glasses and other plastics widely used in medicine (Dacron™, Prolene™ etc). These materials have no detectable uptake of biological solutes even after many years of use.

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[font=Geneva,Arial]Silicones of the type used here are permeable. They also incorporate large amounts of leacheables. They are compounded mixtures of large and small molecules that include unbound oils and mineral fillers. When made into shell membranes, they are very water and gas permeable from the outset.

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[font=Geneva,Arial]As implants age shell permeability increases. Frank perforations ultimately develop when fatigue leads to fine crevices that propagates across the full thickness of the shell. The physical properties of the shells further change as soluble components leach out causing embrittlement and leaving microscopic sites of porosity. Bonding between filler particle and the polymer also weakens through interaction with water and lipids as more porosity develops.

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[font=Geneva,Arial]Biological solutes absorb, dissolve and penetrate the shell materials on the outside of the implant. They reappear on the inside with added impurities leached from the implant shell. Thus, shells of breast prostheses are imperfectly closed semi-permeable membranes that allow bi-directional transport of most low molecular weight substances encountered in biological systems. They also add their own impurities to the fluid on the interior via leaching, disaggregation and extraction of plasticizing oils, filler particles, degraded polymer debris and incidental fabrication impurities.

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[font=Geneva,Arial]Valve Designs and their Problems:

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[font=Geneva,Arial]Saline-filled mammary augmentation devices first appeared commercially in France circa 1965. Made by Simaplast S.A., they consisted of a silicone bag made by joining two half-shells and forming a filling tube integrally by bonding a strip extending from the perimeter of each half shell. Closure was achieved by knotting this seamed tube or by inserting a solid Teflon™ plug in it. These devices were credited to H. Arion, a French physician. These were imported to the U.S. by Roger Klein Associates Corporation which later became the Mammatech Corporation.

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[font=Geneva,Arial]The first true valved implant was the "Jenny" style inflatable made commercially by the Heyer Schulte Corporation from about 1968. It incorporates a diaphragm valve at the apex supplemented by a push-plug. Other systems were introduced in the seventies by Roger Klein, 3M/McGhan, Dow Corning, Cox-Uphoff and the Medical Engineering Corporation. Heyer Schulte adapted another style of valve used originally on its hydrocephalus shunt; it used a flattened tube. Most of these valves were used on saline inflatables as well as bilumen implants.

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[font=Geneva,Arial]The Heyer Schulte Corporation also released a number of unusual implant designs. One variant consisted of a thick shelled conventional gel-filled implant presented as a "variable" size implant. The instructions for use were remarkable. They recommended the direct injection of supplemental saline through the user’s skin and the shell wall in order to increase the implant size. To this end, a volume of saline or other aqueous-based solution was instilled into the gel mass and dispersed as a separate phase within the silicone gel. This technique of ‘post-filling’ implants spread widely in plastic surgery of the breast.

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[font=Geneva,Arial]Numerous surgeons attempted to increase the volume of conventional gel-filled implants by transcutaneously injecting aqueous-based solutions into previously implanted devices. The system did not work. The hypodermic syringe perforations did not heal and aqueous fluids leaked out. Damages created by the hypodermic syringe also led to initiation points from which ruptures later developed. The concept was abandoned and no explanation was provided to the clinical community. Yet, the concept was superficially attractive. At first, the shell was reinforced with fabric to forestall propagating tears. Later, shell formulations were changed to include ‘gel-like’ sandwich layers which were designed to self-heal. However, such structures were stiff and it was impractical to incorporate into the whole implant surface.

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[font=Geneva,Arial]Variations on the self-seal ‘patch concept’ appeared at Dow Corning and later at the Medical Engineering Corporation. Both distributed saline inflatable implants which used small self-seal ports. These were thick, fabric-reinforced elastomer/gel laminates which were supposed to resist leakage after puncture by hypodermic needles used for fluid filling. This concept is analogous to injectable vial closures which have been in use since the late-forties.

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[font=Geneva,Arial]Dow Corning Saline Inflatable Systems - The Varifil™ Series:

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[font=Geneva,Arial]Following the early commercial success of the Arion-Simaplast saline-filled prostheses imported from France, Dow Corning became involved with saline-filled implants. Their early versions were made in the seventies. Some included knotted tube filling systems. Others had self-seal patches. The later versions became known as the Dow Corning Varifil™ or Series 200 Saline Inflatable Mammary Prostheses. These devices used a large volume grease seal system. It was assembled from elastomer sheeting and had a space to accept a viscous substance that would prevent leakage through the channel once filling was complete. Critical portions of the shell and the valve assembly were delegated to outside contractors.

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[font=Geneva,Arial]By 1977, parts of the 200 Series, as well as components of a structurally similar combination gel-saline, Series 300 implant, were fabricated extramurally. A competitor was chosen for the work. The items were fabricated by Cox Uphoff Corporation of Santa Barbara, California, then a new and small offspring corporation founded by former employees of Heyer Schulte who had previously worked for Dow Corning.

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[font=Geneva,Arial]The Cox Uphoff valve technology used discoid parts and slit-like openings to minimize leakage of the occlusive grease away from the sealing channel. The item remained on Dow Corning products until the early-eighties. Cox Uphoff also used this valve on their own saline filled products. Later, Dow Corning developed its own simplified version of the grease seal valve using exclusively die-cut sheet parts.

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[font=Geneva,Arial]Roger Klein and Simaplast Systems:

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[font=Geneva,Arial]Saline filled devices from Klein and Simaplast used mostly knotted or plugged filling tubes. Several variations were made and some continued to be sold through other distributorships into the mid-seventies. The devices were also employed extemporaneously as ‘tissue expanders’. This was done by severing part of the filling tube and coupling the stem to silicone tubes sometimes externalized through an opening for post-operative filling. Hickman-type percutaneous catheters or Port-a-Cath™ chronic drug infusion ports as well as PIC catheters designed for percutaneous drug delivery were also used. Such ports would be buried in tissue at sites remote from the implant (axillae, abdomen).

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[font=Geneva,Arial]The concept was borrowed by corporations such as Heyer Schulte and Surgitek and semi-commercial versions of devices with remote ports were made. These products were designed for post implantation filling using percutaneous injection ports. In some quarters, the products were presented as variable volume prostheses which gave the patient the ability to change her breast volume post-operatively. The approach was not successful and morbidity resulted in significant quantities, primarily through infection. However, the concept of remote port filling was retained for applications requiring gradual expansion of tissue. Commercial products of this kind were widely sold and reached peak popularity in the late-eighties. Numerous versions are still in commerce both from U.S.-based manufacturers as well as offshore producers.

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[font=Geneva,Arial]Remote Fluid-Filling Ports and Other Complex Fluid Filling Systems:

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[font=Geneva,Arial]Tissue expanders and percutaneous drug-delivery catheters such as Port-a-Caths and Hickman style catheters produce tough, convoluted capsules that are infection and inflammation-prone. They are often more than 5 mm in thickness and incorporate debris from multiple prior failed prostheses, bacterial entities, suture remnants in addition to granulomatous tissue formed from leakage of oil-based contaminants such as gel.

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[font=Geneva,Arial]Such capsules are ideally suited for complications that include tenacious infections, painful abscesses, seromas and other local problems. Ultimately, they calcify and many degenerate into infected abscesses if not attended to in a timely fashion. Generally, clinicians who encounter the capsules upon removal of the devices will resect the surrounding tissue in order to ensure closure of the wound site.

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[font=Geneva,Arial]Port-like devices, does not lend itself to easy capsule resection. The Becker Tissue Expander is particularly hazardous because its use is predicated on its easy conversion from its "expander mode" to its "permanent implant mode" by simply "removing" the port. This is done habitually from a small incision which allows extracting the percutaneous port and its attached filling tube by exerting traction on the fixture. This allows the sleeve valve at the main prosthesis to release the filling tube which slides conveniently through the capsule "tunnel" and thus the accessory exits in toto from the small incision. A priory, this may be an attractive option. However, on closer examination, the procedure has obvious risks and contravenes basic concepts of surgery. Extracting the tube causes the gel-coated item to drag along the encapsulating tissue leaving most of the gel and oils in the tunnel. The port site incision is then closed off with an appropriate suture.

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[font=Geneva,Arial]Unfortunately, Beckers as well as most percutaneous port devices, have colonized capsule spaces which are often the primary cause of local and systemic problems. To attempt the extraction of the filling tube assembly spreads the micro-organisms present within the saline or the ones harbored within the main implant capsule. As a result, the capsule formerly occupied by the port, becomes innoculated; closure later takes place at both ends thus ensuring an ideal protected micro-environment for the contaminants and the organisms.

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[font=Geneva,Arial]Mentor Saline Implants:

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[font=Geneva,Arial]In 1984, the Mentor Corporation acquired the product line originally developed by Heyer Schulte and American Heyer Schulte in addition to associated firms such as Polyplastic and Schulte Medical. A small amount of intellectual property was also acquired at the same time and included technology for tissue expanders and saline inflatable prostheses. Mentor continued to manufacture saline-filled implants originally developed by the Heyer Schulte Corporation. They included the early Style 1600, round, with anterior valve and its oval counterpart. Posterior leaf valve implants were also made under product numbers 1800M and 1900M respectively for round and oval styles. However, these latter two were not derivatives of the original Heyer Schulte designs which bear the same code. The original items had Schulte leaf valves. The Mentor versions included instead a modified broad leaf valve dependent on a grease-like sealant; this feature was copied from other manufacturers, specifically 3M/McGhan who had employed this style of valve since the mid-seventies on its own versions of salines and double lumen implants. Cox Uphoff was also using a similar style of valve closure.

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[font=Geneva,Arial]Mentor also introduced changes in the shell design. Textured Siltex™ variations were introduced for all of the products circa 1987-88. These variants were of substantially the same styles known as the Style 2600 (round, anterior valve), Style 2800 (round, posterior valve), Style 1700T, (modified smooth wall oval), Style 1800M (posterior leaf valve), and Style 1900MT (oval with posterior leaf valve).

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[font=Geneva,Arial]The most widely sold items were the Style 1600 and its more recent derivatives incorporating the anterior valve system with a small cap. These implants are colloquially known as "Jenny" designs and are essentially the same as when they were first released in 1968. Only the apex valve was changed; it introduced major undesirable features such as deflation and new long term health risks because of its tendency to expel the valve cap, leak part of the filling fluid and recontaminate with viable organisms.

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[font=Geneva,Arial]The product is widely copied. It is also frequently encountered as an explanted device. The quality of the devices and their performance are very variable. Failures taking place within a few months of implantation occur in significant numbers. Conversely, reports of more than 25 years of continuous use are not rare. Durability problems stem largely from the composition of the shell and the quality of the valve parts. Processing conditions for the shell and valve assembly techniques impact on durability and resistance to leakage. After long dwell times, the shell walls deteriorate, become brittle and fragments of silica-laden degraded polymer spallate and disperse in the vicinity of the implants to become embedded in capsular tissue; adverse reactions are known to occur from dissemination of such materials into the lymph nodes.

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[font=Geneva,Arial]Capping and valving failures are also commonplace. These lead to early deflation. Underfilling of the saline shells is associated with early shell failure due to pleating and puckering. It culminates in frank perforations and spontaneous deflation. The problem is particularly acute for the thick shell Siltex™ which has a poor compliance and a low tear strength. Overfilling is habitually done by experienced physicians in order to delay the phenomenon. Perversely, the valve does not seal for many production items and the excess volume leads to early avulsion of the cap with slow valve leakage. The partly deflated implants pleat more readily and perforations ensue. Colonization of the filling fluid ensues either from retrograde flow of extracellular fluid with adventitious micro-organisms and proteinaceous matter from the user or from residual surviving inoculae. Serious problems with such devices remain and are widely encountered but official reporting is comparatively rare, perhaps for fear of attracting adverse public attention or FDA scrutiny.

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[font=Geneva,Arial]McGhan, 3M/McGhan and McGhan/Inamed Systems:

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[font=Geneva,Arial]Several variations of saline inflatable prostheses were manufactured by McGhan and 3M/McGhan. Some of these concepts were later continued by successor and affiliated companies such as Cox Uphoff and Inamed. Early devices appeared in the mid-seventies. Unlike contemporary products from other manufacturers, they had very thin shells and several types were manufactured using shells made from platinum catalysed, thermally cured elastomer as opposed to the older acetoxy-based technologies. Some were round, others oval.

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[font=Geneva,Arial]Two styles of valve were used: the small bore apex diaphragm valve similar to other products of the same era and the classical McGhan leaf valve. The Style 90 had anterior (apex) and posterior leaf valve variants. Anterior valve versions had multiple patches, usually the main patch being on the posterior side with subsidiary patch and valve flanges on the anterior side. Valves and patches were centrally located. The shells had thin, highly stressed and failure-susceptible areas.

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[font=Geneva,Arial]Saline implants of this kind were intended for ‘small incision’ surgery; they were be inserted in the deflated state and filled to their optimum size during the surgery. The instructions for use emphasized in-situ inflation with later (‘blind’) extraction of the filling tube. The posterior valve variant was preferred for surgery involving infra-mammary access; the apex valve variants were favored for periareolar surgery. Style 90 valves were fragile. The diaphragm valves frequently did not retain the obturators (‘push-cap’) and the diaphragm was subject to displacement during the filling operation.

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[font=Geneva,Arial]The leaf valve types had similar filling systems to that of double lumen products such as Styles 76, 77 and 78. The valves were little more than flattened tubes with grease seals, sometimes without the added grease sealant. Plugs and obturators were not used on leaf valve filling systems. In addition, the filling tube used to fill the device stressed the shell during surgical manipulations and the shell/valve assembly was often damaged incidental to filling procedures. [/font]
[font=Geneva,Arial]This predisposed the shells to early tears and deflation, in particular for the anterior (apex) valve implants. The items were widely sold. During the late-seventies, they failed in large numbers and were replaced repeatedly by most users.

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[font=Geneva,Arial]The shells were so failure-prone and deflation was so common that even surgeons complained publicly about complications. The product was withdrawn by the manufacturer and as a result, saline implants from all sources became unpopular. By 1984, the saline-filled devices had nearly vanished from commerce. Litigation from dissatisfied patients and embarrassed surgeons had risen dramatically. Several manufacturers discontinued salines outright. Others sold them only as custom made items.

Continued..............
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