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TOPIC: Early Experimentation in Breast Augmentationhttp://groups.google.com/group/alt.support.breast-implant/browse_thread/thread/27bbff76c7f27c46?hl=en================================================================================ 1 of 1 ==Date: Sat, Aug 16 2008 2:00 pm From: Ilena Rose www.BreastImplantAwareness.orgEarly Experimentation in Breast Augmentation:Regulations in most industrial countries impose special responsibilityon pharmaceutical, medical devices and health care suppliesmanufacturers who conduct clinical investigations of their products onhuman subjects. Conversely,

similar regulations as well as ethicalconstraints P. Blais, Ph.D., F.C.I.C., Innoval apply wheninvestigators make use of new or modified products. These guidelinesand regulations are particularly important in the case of implantablemedical devices.Both manufacturer-promoters and clinician-investigators must cooperateto ensure that subjects enrolled in their studies are notinappropriately placed at risk and benefit to some degree from thedevelopment of new technologies as appropriate. Similarly, informationabout the performance of the product on specific patients and theresults of the clinical trials must also be provided to institutionalcommittees and regulatory agencies to ensure timely dissemination ofthe information and limit the exposure of human subjects torepetitious and meaningless clinical trials where the outcome idalready known. Some countries, such as Canada and the U.S.,

alsorequire that the implant manufacturers keep track of products that arein the field so that upon discovery of information, warning andcountermeasures can be conveyed to the users in a timely fashion. Inthat way, the risks and the outcome of clinical trials can be recordedand documented and adverse reactions can be kept to a minimum.Breast implants are not exempt from such consideration and thisapproach to clinical trials was already well established in thesixties. However, the largest number of deviations from these commonsense directives took place in the area of plastic surgery of thebreast. The early phase of experimentation using impure oil injectionsand bulk foam implants were perhaps excusable as poorly structuredclinical investigations by ill-informed medical professionals. Thelater phase which included widespread promotion and use of commercialproducts unfit for human applications

are more difficult torationalize. By the early sixties, much of this activity could only beregarded as deviant medical practices devoid of scientific or clinicalvalue. The subjects were clearly investigational material. Yet theywere rarely informed about the nature and risks of these procedures.The procedures were generally misrepresented as established medicaloptions free of adverse reaction and with assured long term results.Some reputable institutions even promoted elective mastectomies withimplant substitution.Later, the manufacturing and the clinical communities relied on priorundocumented implantations and regarded all forms of investigationalbreast prostheses as being substantially equivalent to the popularmid-sixties Dow Corning " Cronins ". They therefore did not deem itnecessary to conduct controlled clinical trials with such productsbefore widespread commercialization. The philosophy

remains in fashionto this day.Curiously, the reverse approach was employed for promotion of breastprosthetic systems directed at the surgeons. Breast implants whichwere trivial variations of existing designs were often presented asradical innovations of great scientific merit. Products that had noperceptible health or aesthetic benefits, even to a layman, were oftenpromoted as major discoveries and were well received by the plasticsurgery community. Absurd designs that violated common sense andembodied obvious adverse reaction risks were frequently encountered inlarge scale distribution and would remain in commerce for many yearsafter being discredited as failures and frauds.In the seventies, the number of designs proliferated dramatically.Most were sommon variations of one another; many were " name branded "and frequently promoted through the use of prominent and publiclyvisible

plastic surgeons associated with prestigious institutions.By that time, more than sixty superficially different types ofimplants bearing the name of surgeons had been commercialized. Amongstthe more widely known products were devices credited to Cronon, ,Pangman, Jobe, Birnbaum, , Weiner, Wagner, Rranklyn, ,Snyder, Georgiade, Papillon, Dahi, Perras, Munna, Hartley, Baker,Becker, Arion, Sterling, Capozzi, Cavon, Radovan, Akiyama, Tabari andmany others. This led to internal jealousy within the plastic surgerycommunity and the fad was finally abandoned in the eighties.Scientific and Clinical Basis for Human Use of Foam implants:Foam implants appeared in medical writings circa 1951. Earlyinvestigations facussed on polyvinyl alcohol-formalin adduct materialssuch as Ivavon sponge. Clinical trials on Ivalon followed a smallnumber of publications claiming successful use in

animals for shortperiods of time. The early work was immediately extrapolated to humanuse and all types of chemically uncharacterized foams including thosebased on polyurethane chemistry quickly followed.The role of R.lyn, a Los Angeles surgeon, is particularlynoteworthy. In autobiographical writings, he relates seeing upholsteryin the cabin of a captured German aircraft and sampling seats in orderto obtain material for implantation. Accordingly, he claims havingdirectly used portions of the seat material for facial repair andcosmetic surgery in the years which followed the end of World War II.He indicates that the sourcing of the original German-made upholsterywas later found and semi-commercial breast prostheses were manufacturedfrom the foams. It appears that commercialization of the prosthesestook place when production of the polyurethanes was licensed to U.S.Based producers. There is

no mention of pre-clinical investigation offollow-up.The same controversial surgeon is credited with the design ofcomposite polyurethane foam implants which are believed to have beensold in significant quantities in the Los Angeles area. Laterparticipants in the commerce of breast implants include promoters withminimal medical or scientific training, in particular H. Markham. Theycommercialized absurd versions of breast augmentation devices based onfound materials such as Scotfoamä and Etheron. There is littleevidence of credible or conventional clinical study or any form ofinvestigative research on these products. Yet, commercial sales werebrisk and the items were widely used.