Mesh Medical Device News Desk, June 25, 2018 ~ In some mesh-implanted patients, an autoimmune response is incited.

There are far too many cases to be just considered coincidental to the  average observer, but how might that observation become science and what is happening within the body of an implanted patient?

Mesh, Autoimmunity, Allergies and Vitamin D

Jan Willem Cohen Tervaert, is the Director of Rheumatology at the University of Alberta, Canada.

His current fields of interest are inflammation and autoimmunity caused by not only genes but environmental factors such as low levels of Vitamin D, S. aureus (Staph. Aureus bacterium), silica and the foreign body implantation of silicones, such as breast implants and polypropylene mesh. All appear to be factors in the development of autoimmunity disorders.

As a result of his interest, women with systemic reactions to their mesh, as well as men implanted with hernia mesh, are being referred to him.

The similarities to silicone breast implants are tough to deny.

The reports are numerous, pain, rashes, muscle aches, weakness, brain fog, even Lupus, and cognitive impairment. Treating doctors says there is no evidence.  You are alone, no one else reports these symptoms. Maybe they are in your head.

Professor Cohen Tervaert believes large scale studies are needed into the link between mesh and the development autoimmune disease.

In women with silicone breast implants Professor Tervaert has identified ASIA – Autoimmune/Autoinflammatory Syndrome induced by a spark called an adjuvant, an additive that activates a response.  Adjuvants are added to vaccines to make them work in the body.  It has been demonstrated that silicones also act as an adjuvant.

Remove the implant tends to cure the symptoms.

If silicone acts as an adjuvant, might polypropylene (PP), the main ingredient of most meshes be one too?

Your Editor, Jane Akre talked to Professor Tervaert about his findings.

 

Macrophages at work, Stonybrook Medicine

Q: Maybe you could tell me when you started seeing mesh implanted women, how many and what are you telling them? And with hernia patients too?

I saw 40 patients in the last several years, eight were men and 32 were women. The symptoms were basically the same as seen in patients with ASIA (Autoimmune/Autoinflammatory Syndrome) as has been described for silicone breast implants.

Mainly patients are very tired, even when they wake up and generally if they have an extra day where they have to be active, the next day they have to lay in bed to recover.  It’s called post – exertional malaise (PEM). They have pain in their muscles and joints and generally widespread pain. Frequently in these patients a diagnosis of Fibromyalgia or Chronic Fatigue Syndrome is made.

In addition, they often have fever or feverish feelings like menopause flushes, night sweats. Another important symptom is sicca or dry eyes and dry mouth.  And that can result in burning eyes and inflammation whereas dry mouth can result in gum disease, problems with swallowing, and enlarged salivary glands.  Also we see general cognitive impairment with problems finding words and concentration problems and forgetting things.

Those are the six symptoms I encounter most and are comparable with ASIA as seen in silicone disease (breast implant patients).

In addition, they sometimes have not well understood neurological symptoms which are stroke-like or Multiple Sclerosis-like. Patients might develop a numb leg or a temporary paralysis of the leg. Also Raynaud’s phenomenon (numb fingers in the cold with tripahsic discoloration such as white, blue and red) is frequently found. They also may have irritable bowel syndrome (IBS) or at least abdominal pain because the mesh itself is painful, so pain is an important characteristic.

It’s also important that 8 out of 10 patients have allergies that were pre-existing, so before the mesh implant already present. Allergies generally become much more severe after mesh implantation.

Dental work, Erik Christensen, WikiCommons

 

Q: What about dental symptoms such as losing teeth? A lot of women complaint about that.

Dental is related to gum disease. If you produce less saliva your teeth are not in good shape.  Saliva is very important as an antibacterial mechanism to keep your teeth in good health.

Q: Could all of these symptoms in so many be simply coincidental?

That’s an important question. Because we see a specific combination of symptoms in patients with ASIA, we think it is more than coincidental. Of course, opponents of the idea say it’s coincidental.  So that’s why we need more research into this.

One of my PhD students actually did some research on silicone breast implants complaints and she found that compared to the normal population, this combination of symptoms was three times more often present in breast implant patients, suggesting there is an adjuvant mechanism operative and that these symptoms probably are not coincidental. Before we can say we can exclude it as coincidental, we should do more studies in patients who got a mesh implant as well.

 

Q: What is going on in the body of both hernia mesh and pelvic mesh patients?

These symptoms are probably not coincidental because we also see other symptoms of adjuvant disease, which is the occurrence of well-defined autoimmune diseases, which I found in my population in 45%, and finally also immunodeficiency. We postulate that the immune system cannot make enough antibodies anymore because the immune system is so tired it cannot at a sufficient level.   So, what is the adjuvant mechanism? Adjuvant means the immune system is helped by a certain chemical or in this case by a foreign body. It means the immune system is constantly activated.

Adjuvants were discovered in the beginning of the 20th century.  They have played an important role to make vaccines.  Without that generally peptides of a dead bacteria do not induce sufficient immune response so they need a helping chemical, mostly aluminum salts these days to activate the immune system. Not only aluminum, but also silicones are a known activator of the immune system, as well as most microbes.

Biofilm around mesh

Also there is research that demonstrated that foreign bodies implanted in animals act as an adjuvant. Is it the foreign body reaction or is it the biofilm which is around most of these foreign bodies and that contain bacteria that is responsible for the adjuvant activity?  We don’t know. The hypothesis is that these foreign bodies, like mesh, induce the adjuvant activity.  But whether the microbes in the biofilm play a role as well, we don’t know. It is clear, however, that there is an adjuvant activity, resulting in an activated immune system causing symptoms such as feverish feelings, fatigue, myalgia and cognition problems. So that is basically the hypothesis.

Q: The body is smart- it senses something is wrong and it’s responding to it?  

Yes, immediately if you implant, the body reacts. That’s a little bit problematic because officially these things were put on the on the market as if they were inert and non-toxic but they are immediately recognized with a foreign body reaction. The foreign body reaction starts with all kinds of proteins and histamines. Subsequently, all kinds of white blood cells – specifically macrophages are attracted to the foreign body. Finally these macrophages turn into giant cells giving the typical foreign body inflammatory reaction. Everybody agrees on that. There is not a lot of research needed. Industry tries to avoid this foreign body reaction but to my knowledge that is not possible. So, there is a foreign body reaction with those inflammatory cells around the mesh.
 

Q: What would your large population mesh study look line? 

Mesh explant, St. Michaels Hospital, CTV Mesh Misery

These are the questions that need to be asked and answered:

Among the patients with mesh implants, so more of them have complaints than observed in the normal population?

Do we see more autoimmune diseases in patients with mesh than in the normal population?

The third question is can we demonstrate, with a good animal model, that autoimmunity can be induced?

For silicone breast implants these studies have been produced.  Similar studies in mesh implants should be performed. Hopefully, there is a little less reluctance to approve this whole concept of adjuvant disease in patients with mesh. In breast implants, the concept is not yet widely accepted. Unfortunately, breast implant studies always trigger non-evidence based opinions.

Finally, it is my dream to develop a genetic to predict which patient will suffer from mesh complications. How the immune system reacts is in your genes. What we’d develop now is a screening tool with a questionnaire to patients. But it would be great if we could predict this using just a little bit of DNA.

Q: Breast implants are still on the market though.

In the Netherlands, the breast implant victims sued the inspector of health and wanted them to get silicone breast implants off the market.  They were not successful but we should focus on the fact that we can predict better who is going to be ill.

Getting silicone breast implants and the mesh off the market it too difficult because the options as an alternative are not that well established yet.

Q: Describe the allergies you are referring to?

Generally allergies were hay fever, house dust allergy, dog and cat allergies, allergies to nickel, those are the main allergies among my patients who had an overreacting immune system.

Q: Could we call them “high reactors”?

You could translate that as a quickly over-reacting immune system.

Vitamin D Walgreens

Q: Was there any immune suppression therapy or vitamins or diet that could address that?

We don’t know, but we know that allergies generally become less severe if Vitamin D levels are in the normal range. If you have a low Vitamin D your allergy is more severe.

There have been some studies where allergies are treated with Vitamin D supplementation. .   And we have proven if you measure several factors of the immune system, such as hyper-reactivity, it can be down-regulated by high doses of Vitamin D.

So, Vitamin D seems to be the safe therapy that could be given to patients and also as a pre-treatment.  Generally, a Vitamin D dose of 800-1000 IU (International Units) is sufficient, though recently some advocate 2,000 IU.

In studies we performed, to down-regulate the immune system, to down-regulate the hyper-reactivity of the immune system, we used 10,000 to 15,000 IU per day.

Q: What did you see when people were treated with that?

We saw better regulation of the immune system.

One of my PhD students actually became the principal investigator in a large study, not yet published, but has been presented in abstract, where the patient with MS (multiple sclerosis) not only gets their standard therapy, interferon beta, but also 15,000 mg of Vitamin D a day. And what they found is that at the end, the patient with high dose of Vitamin D had fewer lesions in the brains. That’s really considered to be an effective therapy.

Q: Did people feel better? 

That’s another issue, I’m not sure in this study but generally there are many studies showing high dose Vitamin D is an alternative method to reduce widespread pain, and fatigue.   So there are all kinds of reasons to treat these patients with high does Vitamin D.

Q: Any Vitamin D?

It has to be Vitamin D 3!   Most of it is Vitamin D 3 today.

Q: Should a warning about pre-existing allergies be in IFU (instructions for use) with a mesh implant?

Because of the similarities with silicone breast implants, I’m convinced that that is the way to go. From studies in breast implant patients, we already concluded we should warn every person that wants silicone breast implants, if they have a prominent history of allergies – they shouldn’t do it.

In The Netherlands, for breast implants there is already a warning about allergies.  Two years ago, a warning was sent out to all plastic surgeons that any patient with a history of allergies should not be a candidate for a breast implant.

That didn’t happen in the U.S.

Polypropylene raw resin pellets

Q: What role might the chemical additives to mesh play in sparking a reaction?

I’m not an expert in biomaterials, the hypothesis I put forward is that polypropylene (PP) itself induced a foreign body reaction and subsequently acts as an adjuvant. So, I don’t need other explanations yet.  A similar study with silicone breast implants, silicone is causing adjuvant activity, but the biofilms may contribute, I don’t know.

Q: Is it fair to say PP is not an ideal material for implant and is not biocompatible?

It’s fair to say it’s recognized by your immune system there is no discussion about that everybody knows.  If you remove those meshes that have been placed in hernia patients, and we did it with some patients and then examined the mesh, a massive foreign body reaction to the mesh was seen in the explanted mesh.

Q: Yes only a percentage have reactions?

Yes, but we don’t know which percentage. In silicone breast implants, we estimate that about 15 to 20% of the population will get symptoms of ASIA.

Q: That’s what we’re finding in mesh up to 30% of the population is reacting. 

So that would be in line, yes. ###

LEARN MORE:

Camb Times- Kath Sansom Interview, June 12, 2018 
http://www.cambstimes.co.uk/news/leading-canadian-professor-talks-on-links-between-surgical-mesh-and-auto-immune-diseases-1-5557890