By November 2021, over
2,185,000 adverse reactions to dental implants,
have been reported to the FDA in America.
Second only to glucose tests
See The FDA Report and Video at the end of this paper Here
This page is about Dental Implants. There is a whole world of issues with other medically placed implants. Please see also the information from Rebecca Dutton about metal sensitivity and medical devices on the links page HERE (Scroll down to the Medical Section)
At present, dental implants are regarded as the ultimate state-of-the-art replacements for missing teeth. Every dentist and his dog claims expertise in placing and working with implants. Even undergraduate dental students are trained to place implants. That ‘must make them good’. Surely the professors wouldn’t teach students a technique which could hurt people! You will hear things like implants are safe and effective. An implant replaces the root of your tooth. Implants save the bone height. Implants are the ‘GOLD STANDARD’ for replacing missing teeth. Talk about mixed metaphors! At best they are a Titanium standard which is not a terribly high one.
The reality is that an implant offers a dentist a massive financial return for minimal effort. The profit margin is hard to pass up if you need to have that overseas ski holiday.
There are many holistic dentists who are doing implants. They claim to do it better and that their methods are holistic and biological. The implants that they place are the same as every other dentist places. The problems associated with them are the same. The cost may be a bit more than other dentists charge.
Most people would expect that spending $10,000 on an implant would ensure that it would stay there safely forever. Not True. Many FAIL. Most dental research papers suggest that ten years is about the maximum lifespan of an implant. Some oral surgeons claim on their websites a 25 year life. Very few make it to ten years. That would be about a thousand $ per year. In my practice I saw many implants fail after just a few years. They were not mine, as I have never placed an implant in my whole career and would still refuse to do so. In dentistry, the only measure of success or failure of an implant is its mechanical retention in the bone. Systemic effects are never considered because dentistry simply refuses to acknowledge that its treatments could have a negative impact on your health. If systemic effects were included, then implants could be seen to fail, after less than a year in most people. Did you know that Specialists & General dentists, who do implants, pay a higher premium for their professional indemnity insurance than those who do not? Do we really need to wonder why?
An implant fails when;
- Infection occurs around the implant – called peri-implantitis.
- The implant breaks.
- The bone refuses to heal around the implant and it stays loose or falls out.
- Nerve and tissue damage when placed too close to the nerve.
- Titanium ions released from the implant cause the bone to dissolve – the implant then becomes loose. This cause of failure is rarely mentioned in the literature.
There are many studies that look at the success and failure rate of these implants and most claim a failure rate of about 5-10%. Long term success rate is about ten years. A 5 year success rate is considered acceptable by dentists. I’m not sure if many patients would be happy about this. There are many people that just should not have a dental implant.
Patients who were over age 60, smoked, had a history of diabetes or head and neck radiation, or were postmenopausal and on hormone replacement therapy experienced significantly increased implant failure compared with healthy patients.
Dental Implant Failure rates and associated risk factors. P.K. Moy et al. Int J Oral Maxillofac Implants Jul-Aug 2005;20(4):569-77.
Several methods and criteria are used to measure the success or failure rates of implants. It is almost impossible to get a real picture because most studies use only some of these criteria and they are usually different. They include pain, rate of bone resorption around the implant, mobility, gum health around the implant, function, comfort and aesthetics from the patient’s point of view.
The reported success rate consistently decreased when the number of parameters included for the assessment of success was increased.
Criteria for Success in Dental Implants: A Systematic Review Nurul Syamimi binti Mohd Azlan Sunil , Dr. Ashok , Dr. Dhanraj International Journal of Science and Research (IJSR) ISSN (Online): 2319-7064 Index Copernicus Value (2015): 78.96 | Impact Factor (2015): 6.391
As with many other dental procedures, the success or failure of an implant is only measured by its mechanical ability to stay functioning in the mouth. Dentists are trained to value their clinical judgement rather than published science. Local reactions are therefore all that is looked at. Systemic effects are simply not considered. There are at least two known mechanisms that cause mechanical failure of an implant and also act as a source of infection to the rest of the body. The first is infection in the gum and bone around the implant.
In over 50% of implants that were removed and sent for pathological testing, actinomyces were present and associated with the pathological picture.” [1]
The second is that of the direct electrical currents generated by the implant fixtures, posts, abutments, and replacement crowns i.e. a Galvanic reaction. We need to move away from the constraints imposed by the dental teachers to get a better understanding of what happens in the rest of the body. (Read the page on Electrical Interference and Corrosion)
The majority of implants are made from a titanium alloy. These titanium (Ti) alloys may also contain aluminium, vanadium, iron, palladium, silver, zinc, indium, tin, Rhenium, copper, platinum, gallium, ruthenium and boron. What a cocktail – you can take your pick as to which of these might make you sick. Some dental implants are made from a porcelain material called Zirconia. Dentists are taught that titanium, like gold, is inert and is totally safe to place in everyone’s body. The training that dentists receive about implants is almost exclusively of a mechanical nature. How much weight can it take? How much bone is present? How many crowns can you swing off it? The balance of education about implants is how much money can be made from it. As I said, most of the research is done or funded by the implant manufacturers.
A study published in 2018, demonstrated that massive amounts of titanium are released from Ti implants into the surrounding bone. All were accompanied by varying degrees of fatty osteitis in the bone around the implant, caused by a lack of blood supply. All were accompanied by increase cytokine production.
“This may contribute to disease patterns like rheumatic arthritis, multiple sclerosis, and other systemic-inflammatory diseases, …”
Titanium implants and silent inflammation in jawbone—a critical interplay of dissolved titanium particles and cytokines TNF-α and RANTES/CCL5 on overall health? Johann Lechner, et al EPMA J. 2018 Sep; 9(3): 331–343. Published online 2018 Jun 8.
Titanium in the bone means the spread of titanium throughout your body!
Some Mechanical Issues – not considered by dentistry
A real tooth is supported in, and attached to the bone by, the periodontal ligament. A thin layer of ligamentous tissue that attaches the tooth to the bone and also provides a cushioning effect when we bight down on our teeth. Usually this is not noticeable because it is so much a part of our beings. The fact is that teeth do move – just a little. This ligament is full of nerves and blood vessels and is an essential part of maintaining the health of the tooth the bone and the gums. It is also subject to infection and disease when you don’t clean your teeth.
It is a vital part of the biomechanical feedback of your jaws and skull. It is a vital ingredient in the correct functioning of the Jaw Joint. (Temporo Mandibular Joint – TMJ). The TMJ effects and is affected by the correct movement of your skull, spine and pelvis. This is a complex biofeedback system which affects and the autonomic nervous system – the part of our nervous system that regulates all the unconscious functions of our bodies. – heart rate, breathing rate, digestion, release of hormones, constriction and opening of the Iris in your eye, blood supply to the legs and arms, blood pressure etc. It is the part of the nervous system that controls the fight/flight response. So much of our whole being is affected by those tiny ligaments that hold the tooth to the bone.
An example that many people may relate to, is when a filling that was done in your tooth, is left just a tiny bit too high. It interferes with your bite perhaps just a tinny amount, and if you keep biting normally on such a tooth it will become painful very quickly. Most people will then, unconsciously, close their jaws slightly differently to compensate and take the pressure off the tooth. This will change the position of the Temporomandibular Joint (TMJ) – the jaw joint – and then cause a slight rotation and torsion of the first couple of vertebrae in your neck. This change in the bones of your neck, will be compensated for, the whole way down your spine. This will affect the position and movement of the pelvis. Back pain is then usually felt in the mid thoracic and lower lumbar regions where the bends in the spine are greatest.
Implants do not have a periodontal ligament. They are surrounded only by bone. There is no impact control, and the biofeedback mechanism no longer exists. When you bight down on an implant, you create a shock wave through the whole of the cranio-sacral mechanism. This will be reflected in the autonomic nervous system, it may cause a locking up of the bones of your skull which results in dysregulation of the movement of the spinal fluid. It may even affect the alignment of the spine.
Oseointegration
Dentistry calls a successful implant one which oseointegrates with the bone. Oseointegration is another one of those big dental words that suggests that we know what is happening in the bone while denying the true effect. It is a misnomer which implies that the bone and the implant become one. There is some magical connection that is created that allows the titanium or the ceramic implant and the bone to become a single unit. What actually happens, is that the bone grows around the implant and due to the forces applied, the bone responds by becoming denser and incredibly hard.
I once asked a professor at Sydney University about this at the only implant seminar I ever attended. He showed slides of what he called perfectly integrated implants. The bone around the implants was dense and white for about 1cm around each implant. I had the ‘audacity’ to ask him if this was “oseointegration or condensing osteitis”. He must have known the implications of my question, as he simply turned his back and moved away from me. I left the lecture as there was no more to be said or heard.
Condensing osteitis is commonly found around teeth and implants when the immune system is severely compromised. When it is seen around root canaled teeth, it is a sign that more serious disease states may be associated with the dead tooth. It is a reaction in the bone caused by the immune system being unable to cope with the toxins that are coming from the tooth.
I accept that this may not be the case with implants that are not usually as toxic as a dead tooth, but the fact remains that this is not a great condition for the bone. I have never been able to find any research to answer this question.
Roll out the red carpet
Where the implant protrudes through the gum, to get into the mouth, is an area of major concern. The gum does NOT form a fibrous seal with the titanium post, as it does with the root of a tooth. Instead, there is a ‘very tight’ inflammatory reaction in the gum surrounding the implant. This leaves a space, which although difficult to get a dental probe through, is like a red carpet down the Champs Elyse, for bacteria and all other micro-organisms. The gum and bone around the implant will be permanently infected and inflamed – dentistry cannot control this reaction so instead they have given it the name of ‘Peri-Implantitis’.
To pretend that the bone will not be infected is nonsense. This is true for both titanium and porcelain implants. Osteomyelitis is not pretty… or comfortable. It will be present no matter how good your oral hygiene is. This inflammation is the key to most implant failures and also as a source of systemic infection and disease.
“Peri-implantitis is a pathological condition occurring in tissues around dental implants, characterized by inflammation in the peri-implant connective tissue and progressive loss of supporting bone.”[2]
When a medical/dental condition is recognised, it is given a name, and with that name comes the assumption that we know all about it and what to do to fix the problem. The opposite is true. When dentistry has no idea of how to fix the stuff-up, then the particular stuff-up is given a name that no one can pronounce. Dentistry has NO idea about how to stop the bacteria getting into the bone and your body. Infection in the gum and bone around the implant means that there are bacteria and other micro-organisms entering the rest of your body the whole time from this peri-implantitis.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
There is also evidence that the titanium released by the implant itself is one of the factors causing peri-implantitis.[3]
There are higher concentrations of titanium in the tissue which makes up this inflammation.9
In other words the titanium implant itself is responsible for the inflammation and bone loss, which is one of the main causes of mechanical failure of implants. Yep, you read it right.
One of the main causes of implant failure is the implant itself.
Titanium is far from inert.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
If Implants weren’t “Safe & Effective”…
Titanium implants are NOT inert. They release small amounts of titanium all the time and it would only make sense that the other metals in the alloy, such as palladium, may also be released. (Palladium is highly allergenic.) Even the Australian Dental Journal discusses the release of Titanium from implants to the rest of the body.[4] These titanium atoms are carried to every cell of your body. [5],[6],[7],[8],[9]
The release of titanium from these implants is increased dramatically when they are exposed to fluoride, as is put into our mass medicated drinking water. [10],[11],[12] By the way, fluoride also causes lead to come into our drinking water from older soldered joints. (i.e. almost all our drinking water.) Neither lead nor titanium poisoning are considered in the arguments to add fluoride to our water supplies.
Titanium can interfere with cell function and promote inflammation.[13] The immune system very often creates a reaction to these atoms, and this can easily lead to a range of autoimmune diseases. [14],[15],[16],[17],[18]
“Like all metals, titanium releases particles through normal corrosion. These metal ions enter the body and then bind to body proteins. For those who react, the body will try to attack this structure. This starts a chain reaction which can lead to many symptoms including Chronic Fatigue Syndrome (CFS) or, in the most severe cases, Multiple Sclerosis (MS).” 14
It is worth noting that apart from implants, there are many other sources of titanium. Some are in the diet e.g. cakes which are decorated with shiny colours. Nano particle sized Titanium Dioxide is increasingly being used in our food to make it prettier! It is also an active constituent in cosmetics like shiny lipstick and mascara. Titanium dioxide can be made in a supposedly ‘food grade’ form, which is considered safe! It is also in many pharmaceutical drugs. The number code is E171. Avoid all foods with this additive. Believe it or not the purpose for adding TiO2 is aesthetic only. Icings and lipsticks can shine. Other products are made whiter to look better. Health is not a consideration.
A Sydney University study published in 2019 looked at the effects of E171, it said:
“There is increasing evidence that continuous exposure to nanoparticles has an impact on gut microbiota composition, and since gut microbiota is a gate keeper of our health, any changes to its function have an influence on overall health.” … “This study presents pivotal evidence that consumption of food containing food additive E171 (titanium dioxide) affects gut microbiota as well as inflammation in the gut, which could lead to diseases such as inflammatory bowel diseases and colorectal cancer,” [19] (My emphasis)
Titanium Dioxide crosses the intestinal barrier and passes into the bloodstream. This causes and promotes colorectal cancer and alters intestinal and systemic immune response.[20] Are you wondering about the term ‘Food Grade’ yet? Are you wondering about the studies demonstrating the safety of titanium implants? (Most are done by the manufacturers.) Are you wondering why everyone over 50 is advised to have a screening for bowel cancer?
Titanium (Ti) is NOT inert. Titanium is released from every source implanted into the body. Ti can have profound effects in the body especially when in nanoparticle size. Increasing rates of dementia, auto-immune diseases, cancer metastasis, eczema, asthma, and autism are among a growing list of diseases that have been linked to a soaring exposure to nanoparticles. A small taste of the published literature demonstrates some of the effects:
- Ti damages human bronchial cells [21]
- Ti stimulates bone resorption, which is one of the main reasons for these implants getting loose and falling out. [22] That’s right, the titanium causes the bone to resorb away. It causes the failure of the implant all by itself.
- Ti can cause an antibody mediated immune responses and autoimmune conditions like Hashimoto’s and other diseases. [23],[24],[25],[26]
- Generalized allergic reactions [27],[28]
- Amalgam and Titanium in the same mouth increases corrosion of the amalgam and creates an increased release of mercury, copper and tin. [29]
- Titanium and amalgam together produce dramatic ph changes and a change in taste sensation [30]
- Some are carcinogenic [31] (it is possible that NiTiSMA particles are directly carcinogenic)
Electrically Charged
All metals placed in the mouth will generate electrical currents. These will be between all the different metals and also between the metals and the tissues of your body. All metals in the mouth are connected by saliva which acts as a great electrolyte. Like water, the saliva transmits the electrical current and thus a battery is generated. It’s called a Galvanic Cell. This is the basis of silver plating where the silver ions are put into solution and then carried and bonded to the less noble brass spoon or fork. (This is also the principal used when zinc plates are welded to the metal hulls of ships. The zinc plates are called sacrificial anodes and will corrode faster than the metal of the hull saving the rest of the boat.) In the mouth it doesn’t matter if the metals are touching or not. When immersed in saliva all of the metals that are in a mouth are reacting with each other and producing a massive variety of massive electrical currents – it constitutes a permanent galvanic cell. These currents can even affect heart function and the Central Nervous System. Although this galvanic reaction is discussed in the dental literature, the practical application of this knowledge would mean that implants and most other forms of metallic dental devices could not be used. Titanium implants are routinely used in the mouth with other metals. See the Electrical Effects Here
The galvanic cell created, and the consequent galvanic corrosion of the different metals, means there is a corresponding distribution of these ionic forms of the metals, throughout the body. It just depends on which metal is higher on the atomic scale as to which one dissolves. When gold and amalgam fillings are in the same mouth there will be a massive dissolution of mercury from all the amalgam fillings in the mouth. As mentioned previously when titanium and amalgam are in the same mouth the mercury, tin and copper will be forced into solution and then the rest of the body. This is 24/7. There is no escape. There is no taking it out as you could a denture.
High electrical currents are generated between titanium implants and other metals in the mouth. [32],[33] Levels of over 100 micro amps have been routinely mentioned in research and in my own clinical findings. These currents, although in the range of only microamps, are in reality 1,000 times higher than what the brain operates at (ie nanoamps). These currents will have a profound effect on the whole organism and in particular, on the brain and the heart.
“Rarely mentioned in any research in this day is the impact of direct currents on the tissues around the metal implant—corrosion impact. Human cellular structures operate electrically in all actions in pico-amps (10-12 amperers). Currents greater than pico-amps (in the direction of nano-amps 10-9 amps and micro-amps 10-6 amps) will cause cell destruction while currents smaller than pico-amps stimulate cellular growth” [34]
Thus, the electrical currents generated in the implants will have a negative effect on the tissues that are supporting the implant – the bone and the soft tissue. These currents are a potential cause of mechanical failure of the implants. I routinely measured electrical currents in my patient’s mouths, and it was common to have currents above 100 micro-amps when measuring between the different metals of gold crowns, titanium implants, metal bridges, metal partial dentures and amalgam fillings and when measuring these structures through the tissues of the cheek. This is the norm for dentists who measure these currents, and the effects are also supported by the published literature. [35]
These currents are in the order of
1,000 times
that which the brain and CNS operate at.
They do have an effect!
Radio Head
This is not just the name of a really cool rock band. Even in the dark ages when I was a student, we heard about the occasional person who heard the radio in their heads. The voices were real, and the people were laughed at. No one understood that the amalgam fillings were acting as antennae for AM radio waves.
Now there is a new kind of electrical stress on the human body. Electro Magnetic Radiation (EMR) is all around us. We are bathed in it almost all day. From the battery operated watch to the latest 5G tower built next to your house. A new threat has been identified.
All metal fillings and implants in the mouth can act as antennae for microwave transmissions and will increase the ‘Specific Absorption Rate (SAR) of this radiation into the body and especially the head. [36]
The presence of metal in or near the body can significantly increase a person’s wireless exposure. Metal can reflect and refocus wireless radiation, resulting in much higher absorption rates. “Electrically conductive objects in or on the body may interact with sources of RF energy in ways that are not easily predicted. Examples of conductive objects in the body include braces, orthodontics and implanted metallic objects. Examples of conductive objects on the body include eyeglasses, jewelry, or metallic accessories.” [37],[38],[39], Metal piercings have a similar effect of increasing the radiation into the tissues, and if made from stainless steel, will also release of nickel from these implants. [40],[41] Note that orthodontic bands are Stainless Steel. They release nickel, and when exposed to EMR they release nickel more abundantly. Nickel is highly carcinogenic. It might be a good idea to remove the phone from all teenagers who have orthodontic appliances. Good Luck with that – but it is a thought. Metal Framed eye glasses will increase the Specific Absorption Rate into the eye and the brain up to 29%. [42]
You might remember ‘JAWS’ from the old James Bond movies. His metal mouth is only a bit less subtle than what is being done daily in dentistry. The main difference is that nowadays the metal is hidden under porcelain and plastic. Dentistry will happily combine all sorts of metals in crowns with amalgam fillings and titanium implants and chrome cobalt dentures all in the same mouth. The perfect metal mouth is also the perfect antenna for microwave radiation. This radiation is focused within a couple of centimeters from your brain. Of course, it will affect the central nervous system and associated functions of the body. This has been linked to such symptoms as inexplicable fatigue, constant headaches, and mental confusion. [43] With metal dental work, your electrosensitivity is heightened and consequently the potential health risks of EMFs are much higher.
Increased electromagnetic radiation in the head causes a reduction in the flow of blood inside your head. [44] Symptoms that have been reported include balance difficulty, lumbago, shoulder stiffness, neck pain, hip joint pain, and facial pain. [45],[46] Cell phone radiation was also found to have dangerous effects on the salivary glands, facial nerves and cells of the tissue that lines the mouth (oral mucosa). [47] Other reports indicate sleep disturbances, anxiety and other neurological problems, thyroid dysfunction, digestive problems and heart problems are associated with increased EMR exposure. [48]
Because the symptoms of EMF exposure are often psychological and varied, the psychiatric conclusion is often that these people are “delusional” and “paranoid”. It seems to never occur to these highly trained, drug pushing doctors, that the complaint may be real and thus they would have an explanation as to why their antipsychotic drugs don’t work. Heaven forbid there is a DENTAL cause.
Medical people are trained to NOT look at dentistry as a cause of anything!
There is another reason to worry about cell phone use mixed with metals in the body. It has now been verified that Electro Magnetic Radiation alone can cause cancer.[49] 2018 saw the publication of a study conducted by National Institutes of Environmental Health Sciences – National Toxicology Program Study on Cell Phone Radiofequency Radiation Cancers and DNA Damage which
“… found statistically significant increases in DNA damage, heart damage, malignant glioma tumors of the brain, and malignant schwannomas of the heart. The increased incidence of heart tumors were considered by the expert peer-reviewers and staff of the NTP to demonstrate “clear evidence of carcinogenic activity” of modulated cell phone radiofrequency radiation. [50]
This is the latest of a series of studies linking cell phone radiation to acoustic neuromas, gliomas and Schwannomas of the heart. “The malignant schwannomas of the heart seen in the Italian study are the same as those described by the U.S. National Toxicology Program (NTP) earlier this month as the basis for their concern that cell phone radiation, both GSM and CDMA, can lead to cancer.” [50]
The Italian study comes from the Ramazzini Institute in Italy and published in August 2018 and concludes with;
“These tumors are of the same histotype of those observed in some epidemiological studies on cell phone users. These experimental studies provide sufficient evidence to call for the re-evaluation of IARC conclusions regarding the carcinogenic potential of RFR in humans.” [51]
We are all living in a new environment that just 40 years ago didn’t exist. The quantity and intensity of Electro Magnetic Radiation has affected everything on the planet. Our bodies are still trying to catch up. All these effects are being compounded with the metal that dentistry calls state-of-the-art treatments. These devices go deep into the bone. All this extra radiation is taken deep into the bone. Is dentistry inadvertently adding to the increase in brain cancers by using implants which act as antennae, focusing this radiation deeper into the body?
Lightning Rods
Another way to regard these implants is as a charged battery implanted into bone on top of acupuncture meridians. They act like lightning rods. For over twenty years the orthopaedic surgeons have known that it is dangerous to place dissimilar metals in the body. Dentists obviously think they know more than the bone surgeon specialists.
Each tooth is associated with a different acupuncture meridian and thus with different organs and functions in the body. Just as a dead tooth will act as a Neural Interference, so too will the electrical current generated by the lightening rod implant. See the Neural Medicine page here, and the EAV Chart here.
What Are You Paying For?
The titanium implant will usually have other metal devices attached to it. This could be in the form of porcelain fused to metal crowns, arch bars that connect the implants one to the other, and metals which are set into dentures that attach to the implants.
Nowadays most laboratory work (crowns and bridges and even some dentures) is sent to Asia as it is much, much cheaper for the dentist. There is little control and even less knowledge about the types of metals that are used in these appliances. Some may be precious metals such as gold, silver and platinum, but usually non-precious metals are used – cheaper, cheaper, cheaper! Many of these metals such as palladium, cadmium, tin, nickel, copper, zinc, and beryllium have profound effects on the immune system and are toxic to many other tissues in the body. All of these metals are used all of the time in dentistry! It is really luck of the draw as to what is placed in your body. All of these metals will corrode releasing their ions into your body.
The dentists who place implants, love to sprout off about the mountains of great scientific research that shows how good implants are. The Journal of Evidence Based Dentistry is rarely mentioned. In 2006 it published an evidence-based review of the outcomes of both root canal procedures and implants, and noted that;
“…if evidence-based principles are applied to the data available for both treatment modalities, few implant or endodontic outcome studies can be classified as being high in the evidence hierarchy.” [52]
Recently (Nov 9 2021) a video has been placed on Youtube, discussing the horrendous rate of reported adverse events from dental implants. Over 2 million in the USA alone. This may be the “other side” to what your dentist is telling you. See the FDA Report Below
WARNING – This is a very scary documentary.
This video is removed at times – the last link is https://www.youtube.com/watch?v=nnhjAbdLodY
From the FDA Adverse Events Reporting System
The adverse events for the dental implants listed below, are almost all related to physical failure of the implant, or the local reactions in the mouth or bone. They do not summarize the adverse systemic effects to these devices. Just as dentistry only looks at local events in the mouth to asses a good or poor result of any treatment.
Dental implants are the second most reported device
in the history of adverse event reporting
(second only to blood glucose tests)
Through August, 2019 there have been over 2.2 million adverse events reported for dental implants.
2.1 million of these were only recently made available in a data dump of summary reports in June.
1.6 million of these were serious injury reports.
The Office of the Inspector General estimates that only 14% of adverse events are reported to the FDA
The vast majority of problems associated with dental implants are due to loss of osseointegration or failure of the implant to integrate with the bone.
Device Problem
- Failure to Osseointegrate
- Loss of Osseointegration
- Implant, removal of
- Fracture
- Positioning Failure
- Implant Mobility
There is no single device company reporting these device failures
The types of metals used in devices are not regularly included in device labeling. Often the materials include alloys containing nickel. Women typically know if they are allergic to nickel, but patients are not informed that this metal is going to be implanted in them.
The Unique Device Identifier (UDI) contains a field to collect whether the device contains latex, but not nickel, cobalt, chromium, etc.
Allergy testing for any device material implanted in the body should be compulsory…even staples and clips. Not all sensitivities and allergies can be detected in advance, but this will help physicians determine whether sutures or a different type of device/procedure should be considered. Physicians and other care providers need to know what materials are in the devices they use, and that requires that manufacturers disclose this to the FDA, on the label, and in the UDI Database.
The Unique Device Identifier (UDI) should be updated to include metals and alloys contained in devices. This would allow Electronic Health Records to pull through data to the patient file that would help care providers know what might not compatible with their patient. And finally: The FDA should strongly consider sending all types of physicians a Dear Doctor Letter to alert them to the systemic issues (allergy, autoimmune, toxicity) caused by metal-containing devices. They should be asked to review relevant patient files for under diagnosis of these issues and be asked to report adverse events directly to the FDA so that the FDA has better and more information on which to base future regulatory and labeling decisions.
FDA media release. Links above.
References
[1] Actinomycotic Oral Infection (Modern Dental Implants and Root Canals) R.S. Carlson BioCore Oct 2017
[2] Peri-implantitis Frank Schwarz , Jan Derks , Alberto Monje , Hom-Lay Wang J Periodontol 2018 Jun;89 Suppl 1:S267-S290.
[3] Release of titanium ions from an implant surface and their effect on cytokine production related to alveolar bone resorption. Wachi T et al Toxicology. 2015 Jan 2;327:1-9.
[4] Australian Dental Journal (Aust. Dent. J.) ISSN 0045-0421 2002, vol. 47, No3, pp. 214-217 Frisken et al
[5] Journal of the Indian Prosthodontic Association 2005 Vol 5 Iss 3 P126-131
[6] Changes in nonosseous tissue adjacent to titanium implants. Meachim G, Williams DF. J Biomed Mater Res 1973;7:555-72.
[7] In vitro corrosion testing of titanium surgical implant alloys: an approach to understanding titanium release from implants. Solar RJ, Pollack SR, Korostoff E. J Biomed Mater Res 1979;13:217-50.
[8] InCompatibility of Biomedical Implants, Merrit K, Brown SA. Kovacs P., Istephanous NS. Editors, Proc.-Vol.94-15, The Electrochemical Society: Pennington NJ; 1994. p. 14.
[9] “The ionization of metal implants in living tissue”. Ferguson AB, Jr, Laing PG, Hodge ES. J Bone Jt Surg 1960;42:76-89.
[10] Corrosion of titanium and amalgam couples: effect of fluoride, area size, surface preparation and fabrication procedures. Johansson BI Bergman B Dent Mater (1995 Jan) 11(1):41-6
[11] In vitro corrosion of titanium. Strietzel R, Hosch A, Kalbfleisch H, Buch D. Biomaterials. 1998 Aug;19(16):1495-9.
[12] Influence of fluoride on titanium in an acidic environment measured by polarization resistance technique. Boere, G. J Appl Biomater, 6(4):283-8, 1995.
[13] What is the impact of titanium particles and biocorrosion on implant survival and complications? A critical review. Mombelli A et al Clin Oral Implants Res. 2018 Oct;29 Suppl 18:37-53.
[14] Metal allergy as a cause of implant failure in shoulder arthroplasty Jia-Wei KK et al. Orthopedics. 2017 Sep 1;40(5)
[15] Metals as a common trigger of inflammation resulting in non-specific symptoms: diagnosis and treatment Stejskal V. Isr Med Assoc J. 2014; 16: 753–758
[16] Metal-induced inflammation triggers fibromyalgia in metal-allergic patients Stejskal V, Öckert K, Bjørklund G. Neuroendocrinol Lett 2013; 34(6):559–565.
[17] Diagnosis and treatment of metal-induced side-effects Stejskal V, Hudecek R, Stejskal J, Sterzl I. Neuro Endocrinol Lett 2006; 27(Suppl 1): 7-16
[18] www.melisa.org
[19] Impact of the Food Additive Titanium Dioxide (E171) on Gut Microbiota-Host Interaction Wojciech Chrzanowski et al Front. Nutr., 14 May 2019
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