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Are you thinking about getting silicone breast implants? Before you do, you want to checked to see if you have a silicone allergy or, more specifically, a silicone hypersensitivity to determine if the surgery is going to have an affect on you. Our silicone hypersensitivity tests check for sensitivities to silicone rather than silicone levels already in the body which means that you should be tested before your surgery. Get tested for a silicone allergy here.

What is silicone?

When people think of silicone they often confuse it with silicon, but they are not the same! Silicon (Si) is the second most abundant element on the earth’s crust and has an atomic number and weight of 14 and 28.086, respectively. In humans, Si is an important constituent of our skeleton and a biological cross-linking agent for glycoproteins, such as osteonectin. In the environment, Si is a component of glass, sand, clay, and steel (24). Si is rarely found in nature as free Si, but rather as the oxide or silicate.

Although Si and carbon (C) have many similar chemical characteristics, including their ability to polymerize, Si forms covalent bonds naturally with only oxygen (O), not itself (24). However, compounds containing C- Si bonds, or silicones, can be synthesized, and are similar to organic materials from a biologic and chemical perspective.

The term silicone, therefore, refers to a family of polymers synthesized from the heating of silicone dioxide (SiO2) in the presence of C (Figure 1.) Next, Si is reacted with methyl-chloride, a process that results in the formation of methylchloro-silanes. After hydrolysis, low weight linear and cyclic prepolymers are formed; the primary polymer is reacted with catalysts to form the high molecular weight polydimethylsiloxane or PDMS.

These inorganic polymers have elastomeric properties and exist in liquid, gel, and solid forms, depending on thepolymer length and the degree of cross-linking.

Medical grade silicone elastomers were first used during World War II, when silicone was used to lubricate glass syringes (8). Today, silicone is used in many medical products, including dialysis and cardiac-bypass technologies (8) and prostheses for reconstructive and cosmetic surgery. For example, silicone widely used in prostheses for the correction of hand deformities and for

breast reconstruction or augmentation. Early implants were filled with either saline or silicone oil, but more recent implants are filled with a silicone gel. The manufacturing process is regulated, and the implants must pass several quality control tests, including measurements of heavy metals and volatile compounds (24).

 

What is the current status of silicone breast implants?

It is estimated that between 1 and 2 million woman have breast implants (17,19), and that 150,000 women receive implants each year (1). Thus, it’s natural that controversy erupted when numerous reports associating these implants with connective tissue disease began proliferating.

On April 16, 1992 after a review of the literature, the Food and Drug Administration (FDA) announced that breast implants filled with silicone gel would be accessible to women requiring reconstructive surgery only if they participated in controlled clinical trials (12).

This decision polarized certain women’s groups who believed the action was patronizing and abdicating their right to make a decision (1). Other women viewed the FDA decision as protecting them from risks that might otherwise bring about ill health.

Some medical groups believe the available scientific evidence relating silicone to immune-related disorders and systemic diseases is weak (8), whereas others applaud the decision as scientifically justified. Many respected organizations, including the AMA, the American College of Physicians, and the American College of Rheumatology, to name a few, believe the benefits of implants have not been adequately weighted (8).

Clearly, it is an emotional issue that will continue to arouse heated arguments and cause emotional turmoil. Ideally, silicone breast implants would be available to all women, but tests would be conducted first to identify those women who would later develop immune reactions to silicone. For example, a genetic predilection for silicone hyper-sensitivity has been proposed since abnormalities in the HLA serotype have been found in connection with AI disease (14).

In addition, women who suffer froma variety of biochemical deficits or an immuno-logic overload from chronic exposure to foreign antigens or toxicants may be most susceptible to developing a delayed silicone allergy. These women would need to be identified, and we believe that methodology to do so is already available.

 

Are there currently any procedures to diagnose a delayed silicone allergy?

silicone allergy

No clinical procedures to assess a delayed silicon allergy have been used in any studies conducted to date, but one is currently available. The ELISA/ACT ® LRA test, an immunological test used to indicate toxic burden and hypersensitivities, is one of the only clinical procedures that can be used to test for reactivity to silicone.

Delayed silicone allergy is a recent addition to the LRA by ELISA/ACT ® panel of over 400 foods, food additives, and environmental chemicals and toxins. This is the most comprehensive assessment of the human immune system by any laboratory in the world.

In a sample of 100 randomly selected autoimmune disease treatment resistant patients, 3% had a strong reaction, and 3% had an intermediate reaction. In a repeat study of 108 randomly selected autoimmune disease patients, 1% had a strong reaction, and 3% had intermediate reactions. Although testing continues, it appears that a delayed silicone allergy may occur in approximately 3% of the population. These intriguing results may allow state-of-the-art testing, either to prevent or assist in the diagnosis of silicone- induced immune dys-regulation.

 

What are the clinical and immunological manifestation of silicone hypersensitivity, and how widespread are the problems?

Silicone was believed to be inert for many years, despite brief case reports in the literature suggesting otherwise (2,5,10,21). The earlier complications reported in the United States were primarily related to silicone elastomer finger prostheses. In 1974 Aptekar et al (2) described a woman who developed a foreign body reaction with detritic synovitis following fracture of her metacarpophalangeal joint prosthesis.

Osteolysis and lymphadenopathy have also been reported in association with finger implants (5,10,11). In fact, based on past and current data, it appears that 25% of hand prostheses develop fractures with the subsequent release of silicone particles and resultant foreign body reactions (5) and/or other silicone-related complications. In addition to hand prostheses, silicone-induced lympha-denopathies have been noted 5 to 9 years following implantation of silicone prostheses of the toe, hip, and wrist (24).

Silicone breast implants are, however, the leading cause of silicone-related complaints. Breast implants are prepared by repeatedly plunging a prosthesis mold into a silicone rubber mixture until the desired thickness is achieved; the implant is then filled with either saline or silicone gel. The literature now shows that a significant number of women with gel-filled implants have presented with a multitude of medical symptoms.

Specific complaints have included swollen joints, morning stiffness, early afternoon fatigue, pain in selected joints and limbs, breast discomfort, lymphadenopathy, and scleroder-matous skin (3,4,6,7,13,16, 17,20-24).

Less frequently, hair loss, dry eyes and mouth, chronic fever, Raynaud’s phenomenon, and selected neuro- logic symptoms have been reported (7,22).

Currently, many patients with silicone breast implants have been diagnosed as having connective tissue autoimmune (AI).

Do you plan on getting breast implant surgery soon? If so, it would be best to test yourself for a delayed silicone allergy. Better safe than sorry, especially with such a big decision. Get tested for a silicone allergy here.

Note: Getting tested for a silicone allergy does require a blood draw. See our blood draws for silicone allergy here.

For more information on silicone, click here.

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References

1. Angell M. Breast implants – protection of paternalism? N Engl J Med. 1992;326:1695-1696.

2. Aptekar RG, Davie JM, Cattell HS. Foreign body reaction to silicone rubber: A foreign body reaction. Radiology. 1983;149:69-72.

3. Brautbar N, Vojdani A, Campbell AW. Silicone implants and systemic immunological disease. Toxicol Indust Hlth. 1992;8:231-237.

4. Bridges AJ, Conley C, Wang G, Burns DE, Vasey FB. A clinical and immunological evaluation of women with silicone breast implants and symptoms of rheumatic disease. Arthritis Rheum. 1992;35:S65.

5. Christie AJ, Weinberger KA, Dietrich M. Silicone lymphadenopathy and synovitis: Complications of silicone elastomer finger joint prostheses. JAMA. 1977;237:1463-1464.

6. Endo LP, Edwards NL, Longley S, Corman LC, Panush RS. Silicone and rheumatic diseases. Sem Arth Rheum. 1987;17:112-118.

7. Fenske NA, Vasey FB. Silicone-associated connective tissue disease: The debate rages. Arch Dermatol. 1993;129:97-98.

8. Fisher JC. The silicone controversey – When will science prevail? N Engl J Med. 1992;326:1696-1698.

9. Goldblum RM, Peley RP, O’Donel AA, Pyron D, Heggers JP. Antibodies to silicone elastomers and reactions to ventrialo-peritoneal shunts. Lancet. 1992;340:500-513.

10. Groff GD, Schned AR, Taylor TH. Silicone-induced adenopathy eight years after metacarpophalangeal arthroplasty. Arth Rheum. 1981;24:1578-1581.

11. Harboldt SL, Gumley GJ, Balogh K. Osteolysis after silicone arthroplasty. Am J Clin Pathol. 1992;98:594-597.

12. Kessler D. The basis of the FDA’s decision on breast implants. N Engl J Med. 1992; 326:1713-1715.

13. Lin RP, DiLeonardo M, Jacoby RA. Silicone lymphadenopathy: A case report and review of the literature. Am J Dermatopath. 1993;15:82-84.

14. Love LA, Weiner SR, Vasey FB. Clinical and immunogenetic features of women who develop myositis after silicone implants (MASI). Arthritis Rheum. 1992;35:S46.

15. Naim JO, Lanzafame RJ. The adjuvant effect of silicone-gel on antibody formation in rats. Immunol Invest. 1993;22:151-161.

16. Press RI, Peebles CL, Kumagai Y, Ochs RL, Tan EM. Antinuclear autoantibodies in women with silicone breast implants. Lancet. 1992;340:1304-1307.

17. Silver RM, Sahn EE, Allen JA, Sahn S, Greene W, et al. Demonstration of silicon in site of connective-tissue disease in patients with silicone-gel breast implants. Arch Dermatol. 1993;129:63-68.

18. Sluis-Cremer GK, Hessel PA, Nizdo EH, Churchill AR, Zeiss EA. Silica, silicosis, and progressive systemic sclerosis. Br J Indust Med. 1985;42:838-843.

19. Stone R. Toxicologists – and snow- descend on New Orleans. Science. 1993;260:30-31.

20. Varga J, Schumacher HR, Jimenez SA. Systemic sclerosis after augmentation mammoplasty with silicone implants. Ann Int Med. 1989;111:377-383.

21. Vargas A. Shedding of silicone particles from inflated breast implants. Plast Reconstr Surg. 1979;64:252-253.

 

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