Policyholder Services

Does my policy cover me for implanting eye jewelry?

OMIC is currently researching the legal and regulatory status of cosmetic extraocular implants (eye jewelry) as well as the potential liability exposure associated with these implants.

When news reports in 2004 first featured articles about JewelEye, eye jewelry developed by the Netherlands Institute for Innovative Ocular Surgery, OMIC contacted the FDA to determine whether eye jewelry would fall under the jurisdiction of the FDA and, if so, whether they would be regulated as “cosmetic” or “medical” devices. The FDA had not reached a definitive legal determination at that time, nor had it developed any particular regulatory strategy for such products. As of June 2006, the FDA’s position regarding the regulatory status of cosmetic extraocular implants remains unclear.

At least one state is currently considering legislation that would prohibit the implantation of eye jewelry. In April 2005, the Illinois House of Representatives passed HB481 to amend the Criminal Code of 1961 to prohibit the implantation of pieces of jewelry into the mucous membrane of the eye. The Senate continues to debate additional amendments to the Criminal Code included within HB481.

OMIC requests that insureds refrain from performing or advertising cosmetic extraocular implant procedures until the legal, regulatory, and liability issues are further researched by the company. Physicians who have data or other information that would help OMIC evaluate whether the implantation of eye jewelry presents an acceptable insurance risk are invited to submit it to Betsy Kelley, Vice President, Product Management, at bkelley@omic.com or by mail at 655 Beach Street, San Francisco CA 94109.

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