After users of Essure, a contraceptive IUD, developed severe allergic reactions and filed a mass litigation suit, an expert in allergies and toxicology was called in to discuss the use of nickel for the device. Multiple patients seeking a simple, permanent contraceptive instead faced hair loss and severe immune reactions after the Essure coil was implanted. It was alleged that the nickel-based device had not been tested for possible allergic reactions, an oversight that the manufacturing company would not confirm during trial.
Question(s) For Expert Witness
- 1. Please briefly describe your toxicology experience with nickel and nickel related allergies.
- 2. Have you ever published or lectured on this topic?
Expert Witness Response E-084951
I have a lifetime of experience with in vitro nickel toxicity and nickel-induced morphological and neoplastic cell transformation, and have also published in these areas. However, I do not have much experience at all with nickel allergies, as I am not an Immunologist. In the past, I have lectured on the in vitro toxicity of nickel compounds, and their ability to induce toxicity to cultured human and mouse cells and morphological and neoplastic cell transformation.
Expert Witness Response E-014412
I am a medical toxicologist with more than 25 years of experience as an active consultant and treating physician. I have extensively reviewed the scientific literature regarding local and systemic reactions to metallic implants as a consultant on litigation regarding orthopedic devices and joints. Nickel induced allergic contact dermatitis is relatively common in females. There are some reports of cutaneous reactions following implantation of metal devices to which a person has been demonstrated contact allergy.