logo 220 Winter Newsletter 2018
Together with the British Society of Ecological Medicine we are planning a memorial conference on the theme of "Systemic effects of metal exposure in clinical practice" inspired by Prof Vera Stejskal's work. The conference will be held on Friday 9 November 2018 in Central London.
This quarter we look at inadequate medical device regulation and how it may jeopardize patient safety: from silicon breast implants to metal-on-metal hips to Essure contraception; they are not subject to the same stringent testing as new drugs. We also highlight how metal allergy screening can improve the outcomes for shoulder arthroplasty and how hypersensitivity - particularly to mercury - may explain the development of Takotsubo syndrome.
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Medical device regulation is woeful and inadequate 
Prof Carl Heneghan, Evidence-based medicine group at Oxford University, has previously questioned the effectiveness of medical device regulation in both the UK and US. Saying that medical devices (artificial hips, breast implants, vaginal meshes etc) "do not have to face the same rigorous test new drugs do". The metal-on-metal hip implant disaster means that 49,000 hip patients will be annually screened to monitor potential problems. "To put it bluntly device regulation is in disarray: the evidence requirements at the time of approval are woeful" He believes that metal allergy may be a problem with Essure and again criticizes regulatory bodies saying 'the regulations are fit for deciding whether a plug can be put on a kettle and that’s about it."
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Severe illness caused to reaction to metals in orthodontic braces
Teenager Kennedy Odom suffered from a myriad of unexplained symptoms for 9 months. They included: fevers, blisters, fatigue, headaches, enlarged spleen, 30lb weight loss and intense pain. Finally, Kennedy was diagnosed with metal allergy triggered by her metal braces; she is allergic to both nickel and cobalt. Within days of having her braces removed, she was feeling better, had more energy and was less prone to infections. She's had some minor set-backs, for instance a reaction after drinking from a metal can. In common with those suffering from allergies she is learning what to avoid to maintain her health. Nickel free and ceramic braces are available for those suffering from metal allergies.

Metal allergy and failed shoulder arthroplasty
This recent article recommends screening patients to confirm suspected metal allergy to avoid implant failure. Metal allergy is unusual but "may be a clinically significant cause of unsatisfactory shoulder arthroplasty." In this study, both patch testing and MELISA testing was used for this purpose. Unusually, none of the metal allergic patients displayed any skin rashes, which are commonly associated with metal allergy. The authors write: “Identifying patients with metal allergy prior to their index procedure can allow for the use of nickel-free implants and avoid the inferior results of revision surgery.” Metal allergy was diagnosed in 5 patients prior to surgery and in 6 post-surgery.

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Delayed metal hypersensitivity and Takotsubo syndrome
This study looked at the rare Takotsubo syndrome, a temporary heart condition with symptoms similar to those of a heart attack: chest pain, breathlessness etc. The researchers used MELISA to identify whether hypersensitivity to the metals contained in their dental fillings, implants, cigarette smoke etc play a part in the development of the syndrome. They found a link between metal allergy (mercury allergy in particular) and those suffering from TS. Levels of allergy were statistically more frequent than in the control group.

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Severe dermatitis caused by metal allergy from nitinol stent
There are several recent articles from vascular surgeons about metal allergy and stents, once stents are removed rashes and symptoms disappear. This is obviously an invasive avoidable procedure and bio compatible alternatives should be developed for those with metal hypersensitivity. Some vascular surgeons mention "carbon-coated stents, which have been found to prevent significant leaching of nickel, chromium, and other metal ions". Metals commonly used in stents can be found here.

Metals in cosmetics may cause rashes in susceptible users
We've recently been contacted by several women with known metal allergies wishing to avoid metals in cosmetics. In response to this we've produced a leaflet to give some guidance. Eye shadows and blushers appear to be the biggest culprits, actually the deeper the pigment and the more expensive the product, the more likely they are to contain metals. Even natural brands like Lavera contain the following metals in a single eyeshadow: titanium, tin, bismuth, iron and aluminium.

MELISA Diagnostics
E-mail info@melisa.org
Phone +44 20 8133 5166
Web www.melisa.org
MELISA testing
Exposure to metals through dental fillings and implants, joint prostheses, environmental pollutants and medication can create health problems in hypersensitive individuals. Metals may trigger Type IV cell mediated allergies. MELISA is a blood test which can identify which metals a person is exposed to that can contribute to health problems. MELISA testing has been developed to test for Lyme disease and for allergy to a small number of foods.

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MELISA Diagnostics · Warren Place · Birch Vale · Cobham, Surrey KT11 2PX · United Kingdom

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