DATE: October 15, 2007
TO: Michigan DEQ/DNR – Kennecott Comments
FROM: Clayton A. Peimer, MD, FACS, FAAOS
Clinical Professor of Surgery (Orthopaedics),
College of Human Medicine, Michigan State University
SUBJECT: Microparticulate-Induced Reactions in Humans and Animals
Risks of Sulfide Mining – Kennecott Permit Application
I write in support of verbal testimony I provided at the DEQ/DNR hearings at West Branch Community Center, Forsyth Twp., MI (recorded on record) in September, with regard to the serious health and safety hazards of microparticulate load in the air and water concerning Kennecott’s application for a permit to engage in Sulfide Mining in Michigan’s Upper Peninsula.
As I understand it, “health and safety” risk is a critical issue in this application for permission to engage in this type of mining. Is the proposed industrial venture an undue – and non-remediable – risk to animals and humans both directly in this region and downstream/downwind of the venture? This question bears directly on several clinical and bench research studies for which I was senior author in peer-reviewed publications, as I will enumerate below, and to which I will confine my scientific remarks. I would be remiss, however, in not reminding the DEQ/DNR that the medical staff of Marquette General Health System (the region’s largest health care provider, only Level II Trauma Center and a teaching hospital for the College of Human Medicine of Michigan State University) voted unanimously to recommend against this application on the basis of the specific concerns that I will outline as well as numerous other human health risks.
My own clinical and scientific research in the area of microparticulate-induced reactions began as a result of poor clinical outcomes and secondary complications we began to see in orthopaedic surgery in the mid-late 1970s subsequent to long-term use (i.e., “exposure”) after upper and lower extremity joint replacements (i.e., arthroplasty, hemi-arthroplasty and “total joint” arthroplasty) with silicone rubber, cobalt-chrome, steel and titanium implants, both with and without bone cement. Indeed, the major late complicating problems following knee and hip replacements became the unfortunate development of significant areas of peri-prosthetic bone destruction leading to implant loosening, implant and bone failure (i.e., pathologic fracture of bones).
The host (patient’s) tolerance for and prosthetic wear of metal and silicone implants and bone cement, all originally thought to be “benign and biologically inert,” came to be understood as much more of a problem than originally conceived, mainly because, frequently, these significant complications did not become apparent until years after the implant surgery (Figure 1).
Fig. 1: X-ray films taken 39 months after silicone rubber scaphoid (blue arrow) implantation for localized nonunion now show multiple, large osteolytic defects (starred, bone destruction) in the lower forearm/radius, and throughout the several carpal bones.
What became widely known in orthopaedics, through the long-term experience with patients’ complications of secondary bone destruction was that these materials, which as a class, had been shown as “non-toxic” in animal and tissue culture studies were not truly “biocompatible” in certain situations. 1-11
There is no longer any dispute in orthopaedics about whether or not prosthetic materials may fracture, fragment, wear and deteriorate; what has become clear, however, is that bone destruction will result from the generation of microparticals (“shedding”) from load-induced wear. These microparticles cause a marked inflammatory reaction through the cellular-based immune system in the bodies of not only humans (i.e., patients) but also in all species of mammals studied in experimental analysis. 12-16
Serious long-term “complications and problems” after implant surgery became widely known in the lay press with regard to complications following silicone breast implant “augmentation” surgery. 17-21 What became frighteningly apparent was that patients’ “reactions” included lymph node enlargement with inflammation (lymphangitis) as well as a host of other reactions. Congressional hearings, FDA hearings (and removal of these implants from use), and endless lawsuits followed.
The “single common biologic pathway” illuminated was that the microparticles themselves, even those coming from “safe, approved, non-toxic” substances (such as a silicone rubber, commonly used today as the preferred intravenous and urethral catheter for chronic use, or from metals still widely used in orthopaedics for fracture stabilization, repair and joint reconstruction) caused inflammation and tissue destruction.
When “non-toxic” materials are large pieces introduced into the body, they are recognized (from invertebrates through humans) as “benign and foreign” and are simply “walled off (i.e., a “capsule” of scar forms around the foreign body, implant, piece of glass, wood, etc.). Where microparticles are produced/shed/ or directly introduced into the body, through the lungs (i.e., asbestosis, berylliosis, wheat dust, coal dust, and others) there is an intense inflammatory reaction and secondary, sometimes extensive and continuing destruction of tissues (Fig. 2, 3)
If the shedding/dosing process continues unchecked and unmodified, the chronic inflammation may be associated with even more serious secondary problems (e.g., asbestosis → leading to fatal mesothelioma) or direct destruction of tissues needing additional remediation, when possible, through added surgery (Figure 4). 22-24
Therefore, with respect to the pending application, there is, in my opinion and experience, based on my own research and publications, as well as an otherwise large body of published literature (some of which I have cited), that there is strong scientific basis to urge the DEQ/DNR, in the most clear and unqualified terms, to reject the Kennecott application as entirely unsafe.
The atmospheric and water load of particles and microparticles has been estimated by the company at a minimum of over 20 tons per year. With particle sizes of 1 – 100 microns, aspiration and ingestion by humans and animals will, without question, lead to secondary inflammatory complications even if all the particles are of “non-toxic” materials. Where “toxic” particles are produced and extruded into the atmosphere and water, more immediately severe but continuing inflammatory and destructive reactions will be produced.
In my opinion, based on these studies and the scientific literature, the most serious and heretofore “unseen” threat is the generation of supposedly “benign and non-toxic” microparticles that will enter into the lungs and digestive systems of animals, children and adults. That all of this company’s prior and existing attempts at sulfide mining have left permanent pollution problems of a “super- fund” magnitude, and that acid pollution of the air and water has occurred in all of their other sites, and that they have been unable to remediate their pollution (which, as I understand it, was the basis for Wisconsin’s rejection of a similar application), I will leave to others to underscore. In the area of my own scientific expertise, I find the company’s predicted outcomes, based on their current techniques and knowledge, to be incompatible with the health, safety and welfare of the residents of Michigan and its surrounding geographic areas. The basis for rejection of Kennecott’s application can be clearly and strongly founded on the scientific material herein shared, even if the other issues are ignored as detrimentally unacceptable.
As a scientist and a clinician, I have full faith that there will come a time in the future when generationally improved techniques that replace the current sulfide method mining can be safely done and will be justifiably welcomed. As that day has not arrived, I am absolutely opposed to their application based on published science and personal scientific experience.
References
1. van Noort R, Black MM: Silicone rubbers for medical applications. In Williams DF, editor: Biocompatibility of clinical implant materials II. Boca Raton, 1981, CRC Press Inc, pp 79-98.
2. Inber G, Schwager TG, Guthrie RH, Gray GF: fibrous capsule formation after subcutaneous implantation of synthetic materials in experimental animals. Plast reconstr Surg 54:183-6, 1974
3. Irving IM, Castilla P, Hall EG, Rickham PP: Tissue reaction to pure and impregnated silastic. J Pediatr Surg 67:72409, 1971
4. Jauregui PH, Gascia CE, Angulo AG: Morphology of the connective tissue grown in response to Implanted silicone rubber: A light and electron microscopic study. Surgery 75:631-7, 1974
5. Marzoni FA, Upchurch SE, Lambert CJ: An experimental study of silicone as a soft tissue substitute. Plast Reconstr Surg 24:600-8, 1959
6. Rees TD, Ballantyne DL, Jr, Seidman I, Hawthorne GA: Visceral response to subcutaneous and intraperitoneal injections of silicone in mice. Plast Reconstr Surgery 39:402-10, 1967
7. Rigdon RH, Dricks A: Reaction associated with a silicone rubber gel: An experimental study. J. Biomed Mater Res 9:645-59, 1975
8. Robertson G, Braley S: Toxicologic studies, quality control, and efficacy of the silastic mammary prosthesis. Med Instrum 7:100-3, 1973
9. Roggendorf E: The biostability of silicone rubbers, a polyamide, and polyester. J Biomed Mater Res 10:123-43, 1976
10. Swanson JW, Lebeau JE: The effect of implantation on the physical properties of silicone rubber. J Biomed Mater Res 8:357-67, 1974
11. American Society for Testing and Materials: 1984 Annual Book of ASTM Standards, V 9.01-.02: Rubber, material and synthetic-general test methods: Carbon black. Philadelphia, 1984, ASTM: D412-
83 D624-81; D813-59 (1976); F604-78
12. Harris WH, Schiller AL, Scholler JM, Freiberg RA, Scott R. Extensive localized bone resorption in the femur following total hip replacement. J Bone Joint Surg 1976;58A:612-8.
13. Jasty MJ, Floyd WE III, Schiller AL, Goldring SR, Harris WH. Localized osteolysis in stable, non-septic total joint replacement. J Bone Joint Surg 1986;68A; 912-19.
14. Agins HJ, Alcock NW, Bansal M et al. Metallic wear in failed titanium-alloy total hip replacements. J Bone Joint Surg 1988;70A:347-56.
15. Maloney W, Jasty M, Harris WH, Galante JO, Callaghan JJ. Endosteal erosion in association with stable uncemented femoral components. J Bone Joint Surg 1990; 72A:1025-34.
16. Willert HG, Bertram H, Buchhorn GH. Osteolysis in alloarthroplasty of the hip: the role of bone cement fragmentation. Clin Orthop 1990;258:108-21.
17. Rigdon RH, Dricks A. Reaction associated with a silicone rubber gel: an experimental study. J Biomed Mater Res 1975;9:645-59.
18. Robertson G, Braley S. Toxicologic studies, quality control, and efficacy of the silastic mammary prosthesis. Med Instrum 1973;7:100-3.
19. Minamikawa Y, Peimer CA, Ogawa R, Fujimoto K, Sherwin FS, Howard C. In-vivo experimental analysis of silicone implants used with titanium grommets. J Hand Surg 1994;19A.
20. Wickham MG, Rudolph R, Abraham JL. Silicone identification in prosthesis-associated fibrous Capsules. Science 1978;199:437-8.
21. Howie DW, Vernon-Roberts B, Oakeshott R, Manthey B. A rat model of resorption of bone at the Cement-bone interface in the presence of polyethylene wear particles. J Bone Joint Surg 1988;70A:257-63.
22. Bullough PG. Letter to the editor (reply). J Bone Joint Surg 1983;65A:281.
23. Wintsch W, Smahel J, Clodius L. Local and regional lymph node response to ruptured gel-filled mammary prostheses. Br J Plast Surg 1978;31:349-52.
24. Jasty MJ, Floyd WE III, Schiller AL, Goldring SR, Harris WH. Localized osteolysis in stable, non-septic total hip replacement. J Bone Joint Surg 1986;68A:912-19.
