Guest guest Posted January 10, 2006 Report Share Posted January 10, 2006 Thanks Lea, ---------------------- BRIEFING NOTE ON FOAM PROSTHESES Early Bulk Foam Implants There are very few individuals who still bear foam core breast implants. Most were implanted nearly thirty years ago with assorted investigational foam breast prostheses or opportunistic volume filling materials of unknown composition and health impact. Many still suffer the consequences of these implant and procedures which had no scientifically supportable basis to be promoted and used on human subjects in such numbers. In the final analysis, the experience and the suffering of individuals who submitted to this technology left few records and no useful scientific legacy. Perhaps because the implanted materials were uncharacterized industrial products and mixtures of unknown or variable composition, there was no means of extrapolating the results to other substances which later entered into medical implant commerce. As a result, the cycle of large scale ad hoc experimentation followed by embarrassed professional silence or denial continued for two more decades. So did the disfiguring explantations, the painful debridement, the costly surgical reconstruction and the chronic medical treatment of affected individuals. To this day, there is no consensus on how these products injured or why the implants or the approaches failed. Retrospective studies were carried out on some of the patients and produced a small number of publications. Some authors attempted to hide the adverse effects. Others simply collected a few anecdotal reports documenting the more salient cases. Yet others tried to minimize the embarrassment of the medical community over the plastic surgery practices of the fifties and sixties. They inferred that these were rare and bizarre practices associated with non-medical entrepreneurs. What is known is that the products were promoted and widely available from major medical supply distributors. It is also clear that the procedures originated from trained and duly licensed clinicians, that breast implantation was highly controversial at the time and that it led to much undocumented morbidity. Eventually, the abuses became so obvious that the field attracted government intervention. The episodes surrounding the early promotion and commercialization of breast augmentation include fraud. They were partly responsible for the hurried enactment of medical device legislation in the mid seventies in industrialized countries. Commercial Precursors; " Surgifoam Devices " According to heresay of the time, a physician from Los Angeles, Dr. lyn, who was visiting Toronto, Canada during the war years, noted a seat cushion in a captured German aircraft. This cushion was apparently made of a unique type of synthetic foam material which he thought would be suitable for surgical implants. He collected specimens from the seat and used small parts of it for facial surgery. After the war, he found U.S. suppliers who made the same product under license and undertook the development of the product for breast augmentation under the name of " Surgifoam " . In the fifties, blocks of bulk material were used for these applications. They would be cut to shape intrasurgically and fitted extemporaneously. Later, molded prostheses with coated surfaces were made under contract. The lyn implants include variations of bulk foam and foam core composite devices. The most common had a supplemental ‘plastic’ film jacket. The devices were made exclusively for Dr. lyn of Los Angeles circa 1958-1965. The lyn devices were polyester foam cores with thin outer film membranes to prevent the ingress of tissue into the structure. Other physicians later claimed credit for the technology. The " lyn Surgifoam " implants evidently did not work. They were highly injurious and were never sold commercially; they may have been made by subcontractors including firms which ultimately became associated with Polyplastic of Santa Barbara, CA. They were made in significant numbers and were extensively but not exclusively used by Dr. R. lyn. The most common versions of " lyns " were composite structures consisting of bulk molded polyester foam cores " wrapped " in a folded polyethylene bag either with a knotted or heat sealed closure. The foam originated from a U.S. producer under a license from the I.G. Farben Corporation in Germany, circa 1950. Through acquisitions, the original licenses eventually became part of Scotfoam Corporation's assets (Eddystone, PA). The main problems with the lyn prostheses had to do with degradation, resorption and disintegration of the foam, perforation of the jacket leading to flooding and swelling of the prosthetic compartment and finally gross inflammation motivating mandatory explantation of the product and debridement of the site. The Commercial Phase Commercial plastic surgery products entered commerce in the sixties. They formed the leading edge of a rapidly proliferating business in medical devices. Some were manufactured by very small venture firms funded and directed by physicians with little or no scientific or research interest. Others were structured to lend credibility to marginal surgical procedures; they would commercialize and promote surgical products associated with the conceptors thus creating the illusion of widespread success and fashionability. Sales promotion emphasized endorsements by notable physicians, large numbers of pleased users and an aura of emerging technology based on recent scientific breakthroughs. This is why so many items of this kind were named after influential surgeons. Eventually, many of these startup firms grew and were absorbed by well established medical supply distributors thus providing even more momentum to the practices. Some of these products were marketed before they could be tested on animals. Others were never tested; they were simply sold and used until it became obvious that they did not work. The implantable foams for tissue augmentation and the shaped breast foam implants were confirmed as failures in the late fifties following post-clinical investigations using animal models. Their use as breast augmentation systems was repeatedly challenged by the mainstream medical communities but the technology remained a strong undercurrent in plastic surgery. The most widely used products of the time included the Pangman-Wallace composite Polyplastic implants. These extended lyn’s technology and incorporated new materials. The product was widely advertised and sold in significant quantities. The popularity lasted until the late-sixties when Pangman, lyn, Cronin, Rees, Sterling and others popularized the more convenient gel-in-bag breast implants which led to erosion in the sale of the bulk foams and composite foam core implants. Their use also overlaps and parallel the injection of silicone oil to the breast. However, foams were far less attractive. Unlike the oils, their use demanded a significant amount of skill and time to produce a acceptable cosmetic result and the practice could not be serialized like the oil injection " seminars " of the sixties. Sterile techniques were difficult to maintain with foams and, on average, they had more immediate and severe adverse effects than the " injectable silicone oils " as reflected in the published literature of the times. Early Commercial Products for Breast Augmentation The most common amongst the early devices were the commercially sold bulk Ivalon blocks which were extemporaneously contoured to serve as " custom breast implants " . Later developments brought the pre-molded breast shaped Ivalon implants in standard sizes. These remained available until the seventies. Competing products included the Etheron bulk sponges, the composites and shaped breast form prostheses. The Etheron was credited by one author, J. Papillon, M.D. of Montreal, Canada, as having a cancer risk exceeding one in four users after 5-8 years in situ. The medical literature of the time is controversial and does not support safety or lasting cosmetic benefits from breast augmentation. It contraindicates the procedure in healthy individuals. There is some tolerance for situations involving mastectomy and deformity but there is admonition on its promotion even for these applications. It perceived the products and their promoters as anomalies. The products themselves were suspect from the onset and most eventually emerged as frauds leading to early clinical failures with severe adverse reactions, pain and deformity. The foam devices were abandoned in the late-sixties. Although they were widely used, few individuals who received the products surfaced to relate their experiences; most hid their misadventures even from their closest relatives. Others disappeared in the cohort of individuals subjected to damaging medical treatments only to reappear many years later with difficultly treatable atypical diseases. Today, even surgeons who published and lectured favorably on this technology often deny that they ever used these implant systems. Concerns of the Times On the basis of publications and reports spanning the fifties and sixties, the main objections and problems of the foam systems included the following: a lack of support for clinical use from the mainstream medical practitioners, ethical issues surrounding the use of surgical materials deemed unsuitable for animals and associated with consistent cosmetic failures, difficult removal of prosthetic debris and repair of the implanted breast, difficult and unpredictable sterilization leading to early or late infection, degradation and spallation of the material with loss of implant integrity, hardening, severe fibrosis and deformity with loss of aesthetic effect, eventual calcification and pain leading to mandatory removal, progressive upper chest muscle damage arising from excision of deeply indurated implants, deterioration of the sternal and intercostal muscles/tendons/cartilage network, susceptibility to inflammation and periprosthetic infection leading to chronic exposure to microbiological toxins with neurological effects, vascular remodelling of the upper chest leading to prominent unaesthetic vessels on the breast, loss of mammography as a practical early cancer diagnostic option. Gross osseotropic mineralization of the implant sites and bone resorption in the chest area stands amongst the more obvious and spectacular side effects of the early technologies. The fear of long term immunologic disturbances arising from chronic tissue denaturation and necrosis processes that takes place around thickly encapsulated implants adds yet another dimension to the these concerns. To some extent, these objections remain valid today with the current styles of breast prosthetic systems that are still being aggressively promoted in some quarters. The appended references provide background on the thoughts of the times. Commercial Activity on Foam Implants Solid foam and foam-covered prostheses have been manufactured since the fifties. Early proponents of the products included lyn and Pangman. The items were regarded as curiosities. However, they appear to have been more widely used than originally indicated in early publications. Commercial activity was brisk and the material was commonly seen at medical conferences and in trade shows. The original " Ivalon " implants were research products designed for general tissue repair and replacement. There were several manufacturers who made these materials but very few were actually entered commerce. The product was manufactured in bulk by Ivano Inc on behalf of the Clay- corporation. Clay- is continued under Becton Dickinson. Smaller distributorships located in the Los Angeles area, such as Beverly Hills Medical, also marketed " Ivalon " -based clinical products labeled by Clay-. Clinical studies based on commercially made breast implants and breast augmentation techniques described in the contemporary medico-surgical literature ever led to comprehensive studies. Most implantations were either short term complications culminating in removal or long term failures with severe and lasting injuries. The detailed history of the Ivalon implants is embarrassing to the medical profession. The material was initially investigated and promoted by the Mayo Clinic, Harvard-related institutions and s Hopkins University Medical Center circa 1945-60. Assorted applications which included cardiac repair and general tissue augmentation were claimed to be successful but the mainstream surgical community later abandoned the product after a series of failures, some of which led to fatalities. During that time, it appears that the plastic surgery community developed a strong dependency on the material and were advertising cosmetic procedures dependent on it. They continued to use the products for facial work and breast augmentation. In some quarters, the surgery was so aggressively promoted that it drew strong objections on the part of the mainstream medical community. There are some publications which address the product and its problems. Most understate the risks and the adverse impact of these implants, in particular, the chronic infection risks. In the final analysis, very few patients retained those devices for very long without encountering major problems which forced them to undergo additional surgery. In most cases, they had to undergo additional investigative surgical procedures to repair the damage from the Ivalons. Few patients emerged from these surgical adventures without major disfigurement and discomfort. The products disappeared from North American catalogues in the early seventies. One of their least documented aspect is the impact of the atypical infections that these implants triggered and maintained. Nevertheless, the ability of Ivalon to resist sterilization, infect and harbor micro-organisms for many years is almost legendary. Today, the Ivalon implants are rarely explanted and are seldom found even in pathology specimen " collections " at major laboratory centers involved in implant retrieval. Retrieval of pathological material from explantation centers confirms abnormal tissue development around fragmented prostheses, widespread disseminated hematomas and seromas, protected infective episodes, extreme calcification and large losses of tissue arising from explantation and debridement. There were several other classes of foam implants. Most were commercial substances assembled into implantable devices. Most used " Etheron " , a common polyurethane-ether sponge or Scotfoam™, an even more widely encountered industrial sponge. Some consisted of blocks sold for intrasurgical cutting and fitting. Pre-shaped devices were sold commercially. The Robbins Corporation of New York advertised Etheron™ breast implants up to the late sixties. In the seventies, the foam coated gel implants emerged as a distinct class of novelty products that incorporated the foam on the surface as a means of immobilizing the implants to the surrounding breast structure. The products derived from the Polyplastic Pangman " membrane enclosed sponge " implants with an added foam surface layer. The usage increased primarily through the marketing of the " " , a gel-filled foam coated implant. Much later, in the eighties the publication of S. Herman of New York gave prominence to the Meme, a simplified polyurethane foam covered implant with a frangible formed -in-place shell created over a " molded " core of gel by dipping. The device was based on a patent by J. Cavon of Los Angeles. Later production of the Meme incorporated very thin-wall shells but the products still failed in large numbers. Still later versions were regular surplus prostheses with conventional shells recoated with the same foam. Other variations of the foam-covered implants in the period 1982-1990 included the Replicon, the Vogue and the Optiman as well a number of their cosmetic surgery implants covered with polyurethane foam. These products reached peak popularity circa 1989 but declined rapidly after that until their eventual withdrawal in 1991. A number of manufacturers still produce substantially equivalent foam-coated implant items from offshore factories. Some of these firms appear to be the consolidated remnants of the dissolved California-based operations. A small number enter the United States and Canada yearly through direct importation from physicians returning from plastic surgery conferences. There is also some informal marketing activity mainly through mail order marketing. In hindsight, it appears that the product's principal selling point, that of reduced or delayed capsular contracture, was ephemeral or illusory. Later animal studies and retrospective surveys could not support the claim. Early successes could be explained in terms of toxic fouling of the prosthetic capsule environment by harsh degradation products and foam impurities. It is even more surprising to note that these substances were known and had well documented occupational health hazards. Foam products which have been sold commercially in significant numbers by established marketing organizations are listed in Table 1. Ivano Inc sold Ivalon products in the early fifties. The product line was distributed widely and later absorbed by Clay- circa 1955-58. Clay- eventually became a part of Becton Dickinson, a large distributor of medical products consisting mostly of syringes and needles. Clay- also sold solid preshaped (molded) Ivalon foam breast shaped prostheses between 1959-69. These were widely distributed in North America. Dow Corning Corporation manufactured foamed silicone blocks and sheets for cosmetic surgery. The products were distributed in the early -sixties and were still found in small numbers towards the end of the decade. The products were sold in bulk form and required intrasurgical cutting and shaping. The silicone sponges elicited unfavorable local reactions and tended to degrade. The product was abandoned early. Robbins Corporation manufactured pre-shaped solid foam Etheron prostheses. These included bulk and shaped articles. A significant number was sold. Rubatex, Prosthex and Polystan were European " Ivalon-like " bulk products of uncertain composition and without North American distribution. Beverly Hills Surgical Supplies Co. sold the patented Pangman composite foam and inflatable core Ivalon as well as polyurethane foam breast prostheses until about 1960-63. Polyplastic Silicone Products of Santa Barbara, CA. This firm contracted manufacturing to other plants such as Heyer Schulte but sold the following products under its own tradename: - Etheron and/or Scotfoam core/silicone cover prostheses associated with Pangman and Wallace - saline/foam core polyurethane prostheses associated with Tabari and Jobe Codman & Shurtleff, Inc. of Boston, Massachusetts. This large medical consumable supplier is now part of the & group. It then had exclusive distributorship for various implants associated with Pangman. The items were sold as Codman & Shurtleff products. Mark-M, Markham Medical, Markham International, Weck Surgical, and other corporations associated with Harold Markham of Los Angeles, CA - silicone gel core/foam cover, internally supported implants - the " " variant of the Pangman implant Heyer-Schulte Corporation of Goleta, CA. This Corporation was a contractor that manufactured numerous types of foam prostheses on behalf of other firms including the preceding ones. - silicone gel core/foam cover, internally supported implants - foam patch fixation devices incorporating only small areas of foam - polyurethane covered prostheses associated with Capozzi and Pennisi Uphoff Corporation of Santa Barbara, CA. This firm briefly produced foam-covered conventional prostheses on behalf of the Markham corporations in the late-seventies. They were variants of conventional gel/foam-coated implants. They briefly held contracts for production of the " Pangman-s " . Natural-Y Surgical Specialties Corporation of Los Angeles, CA. This Corporation marketed devices made by its affiliate, the Aesthetech Corporation of Paso Robles, CA. Both firms were active from about 1979 to about 1986 and were reincorporated under various names. They may have absorbed a third company called " Replicon " . They manufactured the most widely used of the foam-covered devices. These included: the Optimam, Vogue, Replicon, Meme and Sub-clavicular inserts and other foam-coated plastic surgery implants Surgical, Plastic Surgery Division of Paso Robles, CA. This firm acquired the assets of Natural-Y and Aesthetech and continued the same production line but withdrew the Vogue circa 1987. Other foam-coated devices were also made by this firm, including facial prostheses. Medical Engineering Corporation, California Division. They acquired the assets of Surgical and continued the production but withdrew the Optimam circa 1990. They eventually withdrew the whole product line following pressure from the FDA in 1991. Silimed of Rio de Janeiro, Brazil. This firm appears to be an offspring of a Canadian operation and had links with Surgitek/Medical Engineering Corporation. It is currently advertising foam-covered prostheses with a structure similar to the Meme and the Replicon. A German-based affiliate also exists. Several of those devices have been recovered from U.S. patients. Unimed of Santa Barbara (an affiliate of Les Laboratoires Sebbin of France). This firm marketed foam-covered prostheses similar to the Replicon and the Meme circa 1989-92 in California. Several hundreds were implanted in the U.S. and Canada. The products are still manufactured in Europe and are occasionally encountered in North America. Assorted minority offshore corporations in Europe also manufacture similar products. They are seen at trade shows and at plastic surgery conferences. Some of their production spills over into America primarily through ad hoc importation and mail order. Products of this kind are still openly marketed in Europe. The primary firm (PIP Gmbh., Germany) appears to be an offspring of the Surgitek/MEC group. SUMMARY OF CONCERNS WITH FOAM PROSTHESES There are very few surviving individuals foam core breast implants. Most were implanted nearly thirty years ago with investigational breast prostheses or opportunistic foam materials of unknown composition. They retained the implants for only for a few years and many suffered severe adverse reactions with lasting consequences and breast deformity. Users who retained the products for longer faced even worse consequences which often severely affected the rib cage There were few commercial products but their use was evidently widespread. Sales in the U.S. were promoted mainly through testimonials and publications by a small circle of controversial surgeons which included lyn, Pangman, Wallace, Trowbridge and Edgerton. The pre-commercialization testing of these products was very limited. Most were tested retrospectively on animals after commercialization and after having been confirmed as clinical failures. The use of these items as breast augmentation systems was censured by a large part of the medical community and the technology remained an obscure undercurrent in plastic surgery until the late sixties. It paralleled the injection of silicone oil to the breast but was less widely practiced. On average, the foam products had more immediate and severe adverse effects than the injected oils as reflected in the published literature of the times. The larger part of the literature relates to bulk Ivalon blocks which were extemporaneously contoured in surgery to serve as " custom breast implants " and the prepared breast shapes sold by the same distributors. Several types of " Etheron " breast prosthesis were also available at the time; they were credited by one author (J. Papillion, Montreal) as having a cancer risk exceeding one in four. On the basis of early publications and reports, the foam concerns of the time were: -lack of support for clinical use of such products from mainstream medical practitioners -the promotional activities of surgeons engaged in the emerging practice of " breastplasty " -fear of initiating or exacerbating neoplastic diseases in a disease prone area such as the breast -interference of solid, dense implants with radiological detection of malignancies -difficulty in resecting tumors enmeshed in degraded foam structures -controversy about the use of high risk technologies with minimal cosmetic benefits -ethical issues surrounding the use of materials which had consistently failed animal tests -continuing promotion of techniques associated with cosmetic failures and removals -the number of early failures with difficult surgical removals and repair of affected chests -improper sterilization of unstable foam products leading to degradation, early or late infection -the practice of injecting antibiotics into implanted foam to control ongoing chronic infections -swelling, degradation and spallation of the foam-based parts with loss of implant integrity -tissue ingrowth, hardening, fibrosis and deformity with early loss of aesthetic effect -late calcification and chest pain followed by mandatory removal with attendant tissue loss -upper chest muscle damage arising from excision of deeply indurated, calcified implants. -susceptibility of users to chronic inflammation/infection leading to neurological disturbances -egress of toxins produced though necrosis and fermentation at the contaminated implant site -long term immunologic disturbances associated with chronic inflammatory processes Quote Link to comment Share on other sites More sharing options...
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