Affidavit of Douglas R. Shanklin concerning 2nd Generation ~ from TDN

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   10:48 PM, Monday, June 28th,1999.



                     Affidavit Of Douglas Shanklin, M.D., F.R.S.M.

                                       Written: June 24th, 1999

                                             Received 6/28/99


Many women have come to recognize that having children after receiving silicone based implants may put those children at risk. Since they were not informed on this beforehand no guilt or bad feeling should follow, only a resolve to find out the status of their own kids and to try to contribute to learning more, on behalf of all such children. They can be assessed by appropriate laboratory tests just as the women themselves, as a baseline for the future as well as current health status.
The following is an affidavit for the Dow Corning Bankruptcy hearing in Michigan. It summaries the situation in a compact manner:

"The future health of children born after their mothers received silicone devices remains unclear and troublesome. It is now five years since the initial report in the medical literature on this condition [Levine, J.J. and N.T. Ilowite:Scleroderma-like esophageal disease in children breast-fed by mothers with silicone breast implants. J. Amer.Med.Assoc. 271:213-216, 1994]. Newer evidence suggests that transplacental passage of chemical breakdown products is more likely the primary route of sensitization, affecting the immature system of the fetus [Smalley, D.L., J.J. Levine, D.R. Shanklin, M.F. Hall and M.V. Stevens: Lymphocyte response to silica among offspring of silicone breast implant recipients. Immunobiol. 196: 567-574, 1996/97] from which observation one understands a potential for secondary immune re stimulation by breast milk containing organosilicon substances [Annelin, R.B.: Trace analysis oforganosilicon in human urine and milk. Dow Corning Toxicology Department File3135-1, May 29, 1980] "Levine and his more immediate co-workers have published other studies on this new medical condition [Levine, J.J. and N.T. Ilowite: Scleroderma-like esophageal disease in children breast-fed by mothers with silicone breast implants.Clinical Research 41:320A, 1993; Levine, J.J., N.T. Ilowite, M.J. Pettei and H.Tachtman: Increased urinary No3+No2 and neopterin excretion in children breast fed by mothers with silicone breast implants: evidence for macrophage activation. J.Rheumatol. 23:1083-1087, 1996; Levine, J.J., H. Trachtman, D.M. Gold, M.J. Petell: Esophageal dysmotility in children breast-fed by mothers with silicone breast implants. Diges.Dis.Sci. 41:1600-1603, 1996].

"The study of autoimmune aspects of this problem is a recent endeavor. Levine and others published a preliminary paper which was unrevealing [Levine, J.J.,H.C. Lin, M. Rowley, A.Cook, S.S. Teuber and N.T. Ilowite: Lack of autoantibody expression in children born to mothers with silicone breast implants.Pediatrics 97:243-245, 1995] but Teuber and Gershwin published a clear and positive report [Teuber, S.S. and M.E. Gershwin: Autoantibodies and clinical rheumatic complaints in two children of women with silicone gel breast implants.Int.Arch.Alle.Immunol. 103:105-108, 1994] which is consistent with evidence we are obtaining.

 "The University of Tennessee Department of Obstetrics and Gynecology established a clinic in February 1996 to follow individuals with medical problems whose histories suggested a relationship with implanted silicone devices. My colleagues and I are writing a paper (available as a first draft) on scleroderma in found children whose mothers received silicone devices around age 20 years (two kindred's); these two family groups have three examples of pediatric scleroderma, one from birth, now gravely ill [Shanklin, D.R. and D.L. Smalley, Scleroderma in children of women with antenatal silicone devices. J. Invest.Med. 47:107A, 1999]. We are revising the paper because we had an additional case in the clinic a few weeks ago, after our presentation at the Southern Society for Pediatric Research in New Orleans, February 1999. We now have many tests for autoantibodies on children and mothers which confirm, by a very sensitive test method, the basic message of Teuber and Gershwin. These children have many of the autoimmune markers for lupus and for scleroderma.The most recent case also has atypical juvenile rheumatoid arthritis at age 11 years and is no longer able to participate in physical education classes in school.

 "Fourteen years of intensive work in this field, three plus years of seeing personally over 200 patients, and reviewing the medical records, diagnostic tests and tissue slides, and talking with 800 other individuals not registered in the clinic, have convinced me beyond any doubt of the reality of a new medical condition named siliconosis by Bornestein [Borenstein, D.: Siliconosis: a spectrum of disease. Sem.Arthr.Rheumat.24: Supp. 1:1-7, 1994]. This is reviewed in extensive detail in a major paper published in December 1998 [Shanklin, D.R. and D.L. Smalley: The immunopathology of siliconosis: history,clinical presentation, and relation to silicosis, and the chemistry of silicon and silicone. IMMUNOL.RES. 18/3:124-173, 1998].

 "The effects of silicones, substances alien to biological systems, are subtle but pervasive. Silicones invoke both the innate and the adaptive inflammatory and immune systems, degrade proteins, and stimulate cellular immune memory and antibody production. We have a paper in press which, among other details,shows that silicones greatly delay the healing of the surgical wound necessary to the implantation process. We are currently working with several thousand Western blot tests (for autoantibody peptides) which show those resulting from silicone exposure are a mixture of peptides found in lupus, scleroderma, and sicca syndromes, plus several potentially unique to siliconosis [For a small,representative sample, see: Smalley, D.L., R.M. Dreiman, M.F. Hall, and D.R.Shanklin: Western blot bands and clusters in siliconosis. FASEB J. 13:A1131,1999].

 "In my opinion, one gets a feeling that some poorly informed persons believe that all relevant aspects are already known on these subjects but this is no so.Comprehensive science is built by small steps within a more general framework. Again, in my opinion, we would be further along if the information in Annellin(supra) had been available when that work was done and no 13 years later and only as a result of the release of Dow Corning documents to the general public in 1993. Among the points for future investigation are direct chemical toxicities of small amounts of oligomeric siloxanes as break down products of silicone devices. Another feature for future research is whether the second generation effect is wholly immunological or also has some element of chemical toxicity. From a basic knowledge of immunopathology, however, one can predict with some assurance that children sensitized immunologically in utero to siloxanes will have often severe, potentially fatal reactions to any subsequent internal use of a silicone device, including but not limited to Port-A-Cath or Med-I-Port silicone catheters used for long term intravenous fluid administration. Young girls with in utero sensitization would be at risk should they choose later to have quasi-permanent sterilization using any one of several devices on the market for that purpose, such as the Falope Ring and the Filshe Clip, both of which contain silicone. In fact, we have already observed a complete silicone reaction in individuals with their silicone exposure limited to such devices. Many cosmetics contain absorbable silicones. We use a well known one for skin testing for sensitivity to silicone (Lipzone) [unpublished observations].

 "In my opinion, the full spectrum of second generation toxicity may not be known until many of these children reach middle age when other autoimmune processes become clinically noteworthy. We have received reports concerning but have not yet examined any children with potential third generation effects. So far we have examined only two blood samples for cellular immune memory from third generation children . Both showed none but in light of the prevalence of positive tests in second generation cases, this small sample has no meaning either way. "All opinions expressed in this affidavit are made to a reasonable degree of medial certainty derived from extensive study of patients and the medical and general scientific literature. I certify that the descriptive summaries of the literature herein cited are accurate to my best knowledge and ability.  Douglas R. Shanklin, M.D.  Professor of Pathology and of Obstetrics and Gynecology, University of Tennessee                      ____________________________________________