Re: BRIEFING NOTE ON FOAM PROSTHESES

[Guest guest]

Thank you Sweetheart, this is perfect. We should take my 's e-mail off

the end of the article. He might get some nasty people writing to him, but

he can handle it. Many women have died at this university, a lawyer who had

implants. Then one of the English teachers died of lung cancer and there was

another professor who died...all were in their forties.

Love always...Lea

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BRIEFING NOTE ON FOAM PROSTHESES

>

> 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

> difficulty 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 ScotfoamT, 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 EtheronT 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

> intra-surgical 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 & amp; Shurtleff, Inc. of Boston, Massachusetts.

> This large medical consumable supplier is now part of

> the & amp; group. It then had exclusive

> distributorship for various implants associated with

> Pangman. The items were sold as Codman & amp; 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

>

>

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>

> Opinions expressed are NOT meant to take the place of advice given by

> licensed health care professionals. Consult your physician or licensed

> health care professional before commencing any medical treatment.

>

> " Do not let either the medical authorities or the politicians mislead you.

> Find out what the facts are, and make your own decisions about how to live

> a happy life and how to work for a better world. " - Linus ing,

> two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace)

>

>