Galvanic corrosion

The human body is not a hospitable environment for an implanted metal alloy: a highly oxygenated saline electrolyte with a pH of around 7.4 and a temperature of 98.6°F (37°C). All devices will be subject to corrosion inside the body, releasing metal ions, which may interfere with physiological functions. In 2019, the US FDA said the following about how metal corrosion leading to an increase in metal ions can affect human health: “When released in sufficient quantities, these corrosion by-products may lead to adverse biological effects.” (1)

It is important to consider total exposure to metals when testing for hypersensitivity. Although symptoms may appear when, for example a titanium implant is placed, it is possible that the reaction is more complex, and that the new implant may contribute to a hypersensitivity reaction to metals previously tolerated at lower levels. Certain combinations of dissimilar metal alloys, may lead to increased corrosion. For instance with a combination of stainless steel and cobalt chromium or titanium alloy, the stainless steel will corrode more quickly.  As stainless steel contains 10% nickel this may be problematic for these with nickel hypersensitivity.

Galvanic corrosion in dentistry

In dentistry, a galvanic current is created when there are dissimilar metals in the mouth, for instance gold crowns and amalgam fillings. The effect is like a battery in the mouth, with saliva acting as an electrolyte.  Thus, the corrosion of the alloys – and subsequent release of metal ions – is increased.

Toothpastes and mouthwashes containing fluoride can also increase corrosion in the mouth (2,3,4). Eating hot and cold food, changes in pH (alkaline products like milk or acidic like tomatoes and dressings) all speed up the corrosion process (5).

You can read more about galvanic corrosion and oral galvanism:

• The International Academy of Oral Medicine and Toxicology (IAOMT) website: https://tinyurl.com/4h8765az
• Watch a video about biocompatibility & oral galvanism: https://tinyurl.com/6k2266ex
• Watch a video on sensitivity to dental materiale: https://tinyurl.com/yxhh76xe

Systemic galvanic reactions

Dr Scott Schroeder, a foot and ankle surgeon, has been involved in a 12-year study which has included the surgical removal of over 1,000 implants in over 400 patients.

The research was initiated when Dr Schroeder was following up with his patients and found that a surprisingly high number had significant life-changing negative effects post-operatively, after foot and ankle surgery involving metal hardware. Wondering about the causes, he started to look more widely into the issue and investigated what other types of metals they had in their bodies, including in their mouths.

In some cases, he observed “what certainly appeared to be galvanic reactions between dissimilar metals in different parts of the body which were NOT in contact with each other. In these cases, metal I removed from the foot had incredibly significant positive life changing effects, not in the foot but in other areas of the body where symptoms were present.”

You can see Dr Schroeder’s testimony to the FDA about the adverse effects of metal implants and how they may contribute to fibromyalgia, migraines, nerve symptoms, joint pain, severe fatigue, dermatological issues, exacerbation of rheumatic conditions and joint pain in susceptible patients here: https://www.youtube.com/watch?v=iYa5nb1xjvg

References

[1] FDA Biological Responses to Metal Implants. 2019

[2] J. Noguti, F. de Oliveira, R. C. Peres, A. C. M. Renno, D. A. Ribeiro, The role of fluoride on the process of titanium corrosion in oral cavity, Biometals 25 (2012) 859-862.

[3] F. Rosalbino, S. Delsante, G. Borzone, G. Scavino, Influence of noble metals alloying additions on the corrosion behaviour of titanium in a fluoride-containing environment, Mater. Sci. – Mater. Med. (2012) 1129–1137.

[4] E. M. Anwar, L. S. Kheiralla, R. H. Tammam, Effect of fluoride on the corrosion behavior of Ti and Ti6Al4V dental implants coupled with different superstructures. J Oral Implantol. (2011)

[5] Hamoon Zohdi, Mohammad Emami and Hamid Reza Shahverdi. Galvanic Corrosion Behavior of Dental Alloys (2012)

This is an example of how the MELISA test results might be presented. Each laboratory will have its own particular report format and the language used may vary.

To help interpret results from MELISA testing, here are some pointers of what to look for:

The higher the Stimulation Index, the stronger the reaction to the allergen. A value of 2-3 is usually regarded as a weakly positive reaction (borderline allergy), a value over 3 is a positive reaction (allergy found) and a value over 10 is a strongly positive allergy. The negative control is the normal reactivity of the blood sample, without any substance added to the cells. Normal values are between 1000-3000 cpm (counts per minute). If the value is higher, this could mean that the patient is fighting an infection and that the cells are more reactive than they would normally be. The positive control is a substance that all patients should react to. Normal values are anything over Stimulation Index 100. If this value is low, that is under 50, there is a possibility that the patient is immuno-suppressed (by medication, for example) and that the reactions to the metals would normally be higher.

A graph on page 2 is showing the Stimulation Index and the metals tested. A value over 3 is regarded as a positive result (definite allergy) and a value over 10 strongly positive (strong allergic reaction).

MELISA regular test kit - detailed instructions for creating a FedEx shipping label with a FedEx account can be found HERE

MELISA winter test kit - detailed instructions for creating a FedEx shipping label with a FedEx account can be found HERE

Please note that these instructions were designed for US FedEx. 

FedEx is frequently updating their website. If the instructions do not fit what you are experiencing, please let us know at This email address is being protected from spambots. You need JavaScript enabled to view it..

Once you are provided with the MELISA test kit blood draw needs to be arranged.

Are you unsure who to approach regarding scheduling a blood draw? Here are some general suggestions:
 

• Check with your primary care doctor’s office to see if they can help with a blood draw
• Check with local labs, hospitals or urgent care centers to see if they will draw blood for an outside kit
• Do a web search on “blood draw + [your location]”, “mobile phlebotomy + [your location]”

 
Some labs might ask you for a copy of your lab order before scheduling your appointment as they need to verify the specimen processing and handling requirements. You can provide the lab with THIS document to acquaint the provider with processing and handling of samples for MELISA. Always check if your local lab will draw blood for an outside kit. Fees for phlebotomy services are usually not covered by insurance.
 

MELISA testing is currently only available in two laboratories in Europe and one laboratory in Israel.

The lab in Israel is only able to provide MELISA for residents, samples from abroad are not accepted.

The lab in Spain is not able to accept blood samples from areas outside the EU.

The lab in Switzerland has very limited capacity for MELISA testing. Testing must be booked well in advance and samples can only be sent on the agreed date. 

Blood samples must be delivered within 48 hours after the blood draw and the courier needs permission to ship blood samples. Special shipping documents are required.
In case you are able to arrange transport from your location to 1227 Genève-Acacias in Switzerland it should be possible to provide MELISA testing for you.
FedEx is the usual option but shipping within 48 hours is not available from all locations. Please contact your local FedEx office to check if shipping within 48 hours is ppossible. FedEx International Priority Express by 12 PM service is usually the correct option for shipping with FedEx.
Based on our experience, it is almost impossible to arrange shipping within 48 hours from Australia or New Zealand. It is not possible to use FedEx and available courier service can be very expensive.

There is an option to proceed with MELISA while you are travelling. You can schedule a phlebotomy appointment directly at the lab and your samples will be processed immediately.
Alternatively, in case you are travelling we can help to arrange shipping of your samples from locations in the European Union to the lab in Spain.

We are working to establish cooperation with new lab partners to make MELISA testing available to patients worldwide. Due to the complexity of the test and the associated requirements, this can take some time. 

The implication of positive and negative controls in the MELISA test

To ensure the accuracy and reliability of MELISA testing, both positive and negative controls must be performed alongside antigen testing. These controls confirm that the test has functioned correctly and that lymphocytes respond appropriately and specifically to the tested antigens.

Positive Control – Pokeweed Mitogen (PWM)

The positive control uses Pokeweed Mitogen (PWM), a substance that should trigger a strong immune response in all individuals. This step verifies whether the patient's immune system is capable of mounting a cellular reaction.

If the cells fail to react properly to the positive control, it suggests that the immune system is not functioning optimally or that cells are weakened. Possible reasons for this include:

• Immunosuppressant medication, which may dampen the immune response.
• Cell viability issues after sample collection - weakened or damaged cells (e.g., due to prolonged transport, transport conditions, incorrect temperature range).

For the test to be considered valid, the reaction to PWM must be not just present but also very strong. A weak response to PWM indicates reduced test sensitivity, making it harder to detect weaker immune reactions to specific antigens.

Negative Control – Baseline Cell Activity

The negative control measures the baseline activity of the immune cells, with expected values typically ranging between 500 and 3,000 cpm. A low negative control ensures a clear distinction between normal background activity and responses to the antigens being tested.

If the negative control values are too high, the overall test sensitivity decreases, making it harder to detect weak/slight responses and/or to differentiate weak, moderate, and strong specific reactions to antigens.

An elevated negative control suggests that the immune system was already stimulated at the time of blood collection, which can be caused by:

• Recent or ongoing viral/bacterial infections
• Recent vaccination
• Exposure to mold
• Organ transplantation

Stimulation Index (SI) – Evaluating Immune Response

The Stimulation Index (SI) of PWM must be at least 100 for the test results to be fully interpretable.

• SI between 50-100: Indicates reduced test sensitivity, making it harder to distinguish subtle immune responses to antigens. In such cases, the morphology analysis becomes even more essential for interpretation.

• SI below 50: Results are generally unreliable and cannot be evaluated.

By ensuring appropriate positive and negative control values, the MELISA test maintains high sensitivity, allowing for the detection of even weak immune responses to tested antigens.

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MELISA Guide for Phlebotomists - UK

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Please check the nearest location for mobile phlebotomy or on-site service HERE.

MELISA testing for patients with planned surgery - important consideration

MELISA tests for Type IV hypersensitivity, which is mediated by T-cell memory. This immune response requires prior sensitization - meaning that if the immune system has never encountered a particular metal, it will not have developed a memory response to it. However, complete avoidance of metal exposure is nearly impossible, as metals are present in everyday environments, including food, and cosmetics. Some patients may not realise they are already exposed via dental metals when undergoing pre-testing for orthopedic implants. From an immunological perspective, metals may provoke the same Type IV response, regardless of whether they are used in dental or orthopedic applications.

MELISA can be used for metal hypersensitivity testing prior to surgery if there are indicators that an allergy may be present. For instance, skin reactions to metals, previous failed surgery and repeated unexplained infections following surgery using metal devices, pins or plates.

There are recommendations available on managing patients with potential metal hypersensitivity prior to undergoing joint arthroplasty or implantation surgery. Schalock et al. (1) recommend that patients who report cutaneous metal allergy should be tested prior to device implantation. Granchi et al. (2) also recommend patch testing for any patient with previous signs or symptoms of metal allergy. Granchi et al. further add that patients with positive skin reactions should not have an implant containing the metal allergen if possible (2).

Some orthopaedic surgeons who suspect that a patient may have problems with metals, for instance, nickel, will pre-test for a whole panel of metals.  Titanium was traditionally thought of as bio-inert, but there are increasing reports that it may cause problems in hypersensitive patients (3). Studies show that in vitro blood lymphocyte transformation tests such as MELISA are better suited for diagnosing possible metal sensitivity than patch testing (4, 5, 6). Also, the relationship between skin hypersensitivity and systemic hypersensitivity is ill-defined. Lymphocyte transformation test sensitivity is higher than patch testing and provides quantifiable data and is highly reproducible (7).

However, even in a paper that recommends using pre-operative allergy testing in patients with self-reported metal allergy, there are limitations in testing. The authors report that the frequency of allergy increases after the operation (2). The magnitude of exposure differs significantly - a large orthopedic implant introduces a substantially higher and more prolonged exposure than dietary or cosmetic sources of titanium. Granchi et al. say that the frequency of positive tests increases post-operatively, especially in those patients with failing implants or metal-on-metal devices.

The immune system is dynamic, and sensitivity may develop over time with increased exposure. Testing provides a snapshot of immune reactivity at a specific moment but cannot predict how the immune system will respond to prolonged or intensified exposure in the future. Therefore, the MELISA test cannot guarantee that an allergy will not develop during in vivo, long-term, high-level metal exposure post-surgery.

Article by Rebecca Dutton: Scoliosis research update

As a team member of MELISA Diagnostics, I see many connections between heavy metals and illness. We asked for your help with on-going research into scoliosis and the possible link to heavy metals. The results of this research can be seen in the video "Scoliosis, Spinal Surgery and Metal Allergy" (available HERE).

You may want to know more about my own story. During the 1970‘s I was employed by a dentist as a practice manager and nurse for three years. I spent many hours each day mixing amalgam fillings in a rubber finger stall, exposed to mercury vapour from the action of rubbing silver alloy and mercury together. I had no personal protection equipment, gloves or mask and no ventilation system to filter the mercury. When I became pregnant during the latter part of my employment, my duties remained the same, apart from not being present when X-rays were taken. My daughter was diagnosed with a neurological condition and scoliosis at 16 years of age.

I firmly believe this was the result of her exposure to mercury in my womb. Her test results appear to support my theory, showing mercury on her DNA, a high sensitivity to mercury and displacement of essential minerals, necessary for the function of the cells. At 17 years of age, she underwent major spinal surgery to correct her curvature, which involved the removal of 6 intervertebral discs, a rib and the placement of a titanium rod in her spine. This caused many problems as the spine is designed to be flexible, not rigid. The psychological impact was huge, living with restricted movement and physical limitations. My daughter‘s experience made me determined to research the possible causes of scoliosis and to investigate alternative treatments which may prevent the need for surgery.

In 2008 I was asked to set up the website understandingscoliosis.org with the former Culture Correspondent of BBC Newsnight, Madeleine Holt. Our aim is to encourage people to investigate alternatives to surgery for spinal curvature, and to examine the possible causes of scoliosis. Madeleine developed scoliosis as a teenager (though she never had spinal rods) but now, after removing all heavy metals, is completely pain-free.

Scoliosis surgery has never been proven to eliminate spinal curvature, reduce pain, improve lung function or correct the deformity of the ribs and torso. The rate of complications may be higher than reported as may the long-term risks. Despite these facts, there is little or no interest in the orthopaedic community in finding methods of scoliosis treatment that do not involve scoliosis bracing or surgery.

I believe that there is a link between mercury and scoliosis, often as the "initial insult", and I have written a hypothesis on the connection. This was spurred partly by my observation that a pattern was emerging: many patients who contacted me with mercury sensitivity also had scoliosis. I contacted Professor Vera Stejskal, Associate Professor of Immunology and inventor of the MELISA test and asked if we could conduct a research study to see if mercury may be implicated in the development of scoliosis. She very kindly offered to put a questionnaire on my website. This was pioneering research, as yet not endorsed by the medical establishment, which hopefully, could play an important part in understanding why idiopathic scoliosis develops in the first place.

In 2014, I was appointed lead activist to represent the UK in the Global Minamata Treaty, to ban mercury pollution. One of the successful outcomes of this was the new EU regulation to ban dental amalgam use in children under 15 and pregnant and nursing women. This came into force in July 2018, in 28 EU countries including the UK.

In 2018, Dr Shideh Pouria, consultant Nephrologist, asked me to present at a conference in London: "Systemic Effects of Metal Exposure in Clinical Practice: Protecting Patients and Optimising Outcomes”. My presentation was on "Scoliosis, Spinal Surgery and Metal Allergy’" and included my research study on the link between mercury and scoliosis.

MELISA testing is best used to check if any ongoing metal exposure is causing unexplained symptoms. It can be chronic long term symptoms or new symptoms that appeared after surgery. Generally, all ongoing exposure should be considered, even if the symptoms started after, for example, placement of an implant. The reason being that galvanic effects between different metal alloys can lead to increased corrosion and release of metal ions, which can fuel symptoms. Also, removing dental fillings or crowns are usually preferable to removing implants.

MELISA can also check pre-operatively for specific metal allergy in patients presenting with a history of suspected metal allergy (e.g. dermal reactions to jewellery, contact dermatitis, etc.) to ensure the biocompatibility of the new implant. Studies have shown patients who reacted to a
single metal have an increased chance of co-sensitization to another metal, so self-reported nickel allergy may indicate hypersensitivity to other metals. However, it is crucial to understand that increased metal exposure after implant-placement may lead to a stronger immune response (metal reactivity). For more information, see Pre-testing.

You may need to check with your healthcare professional for the exact metal content of a device or implant.

To decide what to test for in MELISA consider the following:

Do you have any dental restorations; silver/amalgam fillings, crowns, bridges, implants and orthodontic braces/retainer?

Do you have any orthopaedic devices; knee, hip, shoulder replacements, pins and plates?

Do you have any cardio and vascular devices: embolization coils, stents, septal occluders, implanted defibrillators and pacemakers?

What about environmental or occupational exposure; jewellery, cell phones, coins, certain foods and medications etc.

A detailed overview of metals found in frequently used dental and orthopaedic restorations as well as an overview of metals present in our environment can be found at Metal exposure.

Please see Testing panels for more information on what metals can be tested in MELISA.

Do not send your samples for MELISA testing to the lab in Germany due to the closure of the lab. More information HERE.

Each MELISA lab will offer its own set of testing panels. Below is an indication of what the testing panels may look like. Recommended selection is based on the composition of frequently used dental and orthopaedic restorations.

Panel A - Amalgam dental fillings
Copper, Inorganic mercury, Nickel, Silver, Tin 

Panel B - Non-noble dental crowns & bridges
Aluminium, Beryllium, Copper, Cobalt, Chromium, Manganese, Molybdenum, Nickel, Niobium, Tantalum, Tungsten

Panel C - Noble or gold dental crowns & bridges
Copper, Gallium, Gold, Indium, Iridium, Palladium, Platinum, Ruthenium, Silver, Tin 

Panel D - Cobalt Chrome / Vitallium / Stainless steel
Chromium, Cobalt, Manganese, Molybdenum, Nickel, Tungsten

Panel E - Pure titanium / Nitinol / Titanium alloy Ti-6Al-4V
Aluminum, Nickel, Titanium dioxide, Titanium sulphate, Vanadium

Panel F - Titanium-based alloys (extended) 
Aluminium, Cobalt, Molybdenum, Niobium, Nickel, Tantalum, Tin, Titanium Dioxide, Titanium Sulphate, Vanadium, Zirconium, Zirconia* 

Panel G - Zirconium-based alloys (orthopedic use) 
Chromium, Niobium, Tin, Zirconium, Zirconia*

Panel H - Surgical/orthopedic panel 
Aluminum, Chromium, Cobalt, Manganese, Molybdenum, Nickel, Niobium, Tantalum, Tin, Titanium dioxide, Titanium sulphate, Tungsten, Vanadium, Zirconium, Zirconia*

* The clinical relevance of a positive Zirconia test has not been established