The below article was written by Dr. Pierre J.J.B. Blais the president of Innoval - Canada.
INJURY MECHANISMS FROM SILICONE GEL-FILLED MAMMARY PROSTHESES
The insertion of ill-conceived or defective implants in a disease prone area has predictable morbidity and a potential for injury which rises with the dwell time of the product. It is well established that the implants cause major structural, physiological and biochemical changes in the breast environment.
They also act as "time release systems" for pharmacologically active compounds. It is necessary to review the mechanisms by which such devices can affect the patient's health, appearance and comfort in order to understand their risk and their shortcomings.
Prosthetic injuries in breast implant users can be attributed to at least six major mechanisms:
( 1) "Normal" surgical trauma and surgical misadventures resulting in damage to functional/sensorial parts of the chest and the upper limbs;
( 2 ) Biomechanical effects induced by the presence of large foreign Objects that cause compressive trauma, excoriation, distention, atrophy and restrictive adhesion of tissues or compressive/occlusive ischemia of the vasculature within the pectoral-axillary area;
( 3 ) Locally injurious biochemical effects from reactive dispersible substances that induce fibrotic, inflammatory or destructive tissue changes;
( 4 ) Long term tissue remodelling and deviant repair processes leading to hyperplasia, densification, mineralization and dehydration of the implant site;
( 5 ) Implant-capsule-oil adjuvant interactions leading to tissue degeneration or denaturation to produce host tissue-derived antigens that elicit antagonistic host-directed antibodies (autoimmune disturbances);
Protected intracapsular infections remaining for a substantial period of time have the ability to enhance capsular fibrosis. Such micro-organisms in protected compartments tend to resist antibiotics. Over the long term and with large colonies, the formation of pharmacologically significant quantities of toxins becomes possible. Health effects associated with chronic low grade infections and microbiological metabolites such as toxins may account for some of the disturbances noted in long term prosthetic users of aqueous media filled implants.
If the infection is allowed to remain within the capsule space, the capsule integrity is eventually lost, and the material escapes. Eventually the number of antibodies directed against such autogenous tissue antigens rises to the point where it can create rheumatoid-like and other degenerative tissue disease symptoms. The process, termed "Adjuvant Effect", was investigated in laboratory studies with model .silicone compounds by Dow Corning in the early-seventies. Studies and patent applications pertinent to these issues are discussed in confidential reports issued circa 1974 (LeVier and Boley studies on adjuvant effects of silicone compounds) and 1975 (Lake and Redonovich studies on pharmacology of silicone derivatives). Journal publications discussing some of those studies are also found circa 1974-77.
Innoval Failure Analysis Ottawa, Canada K2A 2V1 November 2010
About Dr. Blais and Innoval
J.J.B. Pierre Blais, B.Sc., Ph.D., C.Chem., F.C.I.C.
Consultant in polymer chemistry, material sciences and manufacturing technology as related to health sciences applications; polymer synthesis, compounding and processing; design and testing of medical products; regulatory aspects of health care products; pre-clinical investigations; product failure analysis; implant and tissue retrieval programs; training of paramedical and technical personnel for hospitals, government and industry; polymer science education; materials analysis techniques; design of test systems and simulators; publication of texts and manuals, scientific papers and educational material pertinent to health care technology.
Founded 1989 and located in Ottawa, Canada, Innoval specializes in the development of health sciences and materials technology education programs as well as the training of paramedical and technical personnel for hospitals, government and industry.
Ommiletta 11:26, February 7, 2012 (UTC)
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