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May 04, 2015

Tantus’ Metis Black Addresses ‘Silicone Allergy’ Issue

SPARKS, Nev.—Metis Black of Tantus Inc., recently wrote a letter to various members of the adult entertainment industry regarding “silicone allergies.” Her letter is as follows:   Recently I’ve been hearing claims of “silicone allergies” from sex toy consumers. Wondering if the industry as a whole is seeing this as well, I reached out to a silicone expert. The expert I reached out to is a Ph.D. in toxicology as well as being a DABT, a Diplomate of the American Board of Toxicology. Part of their job is biocompatibility testing and working with the FDA on 510K (medical device) submissions. Personally, I’ve only met one person with a silicone “allergy” which was really a heightened immune response. She’d undergone a medical procedure for a silicone implant (not breast) and her auto immune system saw the implant as a foreign invader and had become extremely sensitive to silicone. Now I’m hearing stories from consumers who get rashes and irritations from being in contact with silicone (ie using silicone dildos). When I asked about allergies to silicone, I also added: Because of my industry, where labeling is sometimes misleading, I don’t know if these reactions are to other materials, mislabeled as silicone; to other materials believed to be silicone; to lesser grades of silicone; or exposure such as happened with latex. The expert replied: The basic platinum-catalyzed silicone rubbers—RTVs, LSRs, and HCRs—have not shown any allergenicity when we’ve tested them and I am unaware of any reports of allergic responses to these materials from customers, workers, or consumers.  Similarly, I have not seen any reports of allergic responses to polydimethylsiloxane (PDMS) fluids. From time to time I have heard (or read) of people claiming “allergic” rashes from lingerie coated with silicone textile treatments to enhance gripping (like the textile coatings on the tops of thigh-high stockings to keep them in place).  Rather than allergic responses, these have been irritation rashes, resulting from heat and moisture under the silicone band. Irritation responses are different from allergic responses. It is possible that there could be additives in some silicones that might trigger an allergic reaction. Similarly, some functionalized silicones or silanes might also have allergenic potential but I could not name any silicone substances or products used in medical devices, cosmetics, or consumer applications that have been identified as allergens under conditions of use. Biological reactions and effects from deliberate mis-use of products, of course, could be a whole different story—and these stories show up in the news with sad and alarming regularity. They also added: I have become aware that some of the newer biocompatibility tests for sensitization (allergenicity), conducted as a part of no- or reduced-animal testing program, may not be suitable methods for testing the sensitization potential of silicone-based products. Some of these tests give false positive results demonstrated when the test results are compared against results from standard Guinea pig or human patch testing results. Conclusion: I’m not sure what is causing skin reactions, but it doesn't seem to be silicone.

 
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