The article has been automatically translated into English by Google Translate from Russian and has not been edited.

Silicone or life: the dark side of breast implants

'20.06.2019'

ForumDaily Woman

In social networks from time to time you can stumble upon a discussion of “breast implant disease” (breast implant ilness, BII): women who have recently or recently undergone surgery to enlarge or reconstruct the breast discuss fatigue, muscle and joint pain, sleep disturbances and other symptoms. As evidence of the connection of these problems with implants, they refer to the so-called ASIA syndrome, according to the first letters of the English name “autoimmune syndrome caused by adjuvants”. Together with experts Wonderzine We understand whether this syndrome actually exists and whether it is necessary to be afraid of silicone implants.

Фото: Depositphotos

Schonfeld syndrome

In 2011, an article by Israeli scientist Yehuda Schönfeld and his colleagues about a new syndrome called ASIA appeared in the Journal of Autoimmunity; The authors combined several different conditions into it - in particular, the so-called silicosis (toxic effect of silicone), macrophage myofasciitis (also called syndrome of the diseased building) and post-vaccination syndrome. As the authors describe, all of these conditions are characterized by muscle pain or weakness, pain in the joints, chronic fatigue, sleep and memory disorders, dry mouth, and later more precise autoimmune processes can join. Another common characteristic is the prior exposure to an adjuvant, that is, an additive component of a vaccine (primarily aluminum), a silicone implant, or a substance present in the environment, particularly in building materials.

You can see that most of the ASIA syndrome publications come from Schönfeld and his colleagues, and the original 2011 article of the year was published in a journal, the editor-in-chief of which is Schoenfeld himself. The professor is also known for giving lectures at St. Petersburg State University on the future of the therapy of autoimmune diseases - “molecules based on worms”, which makes one think about the scientific validity of his statements. According to the candidate of medical sciences, a member of the European Academy of Allergologists and Clinical Immunologists (EAACI), an immunologist Umar Khasanov, the syndrome is very controversial, and its manifestations are so non-specific that, if desired, this diagnosis can be done to anyone, as it is still with non-existent vegetative-vascular dystonia. “Even the people who advocate the rejection of vaccination are no longer talking about the dangers of vaccine adjuvants, but perhaps another wave of horror stories is approaching,” the doctor continues.

Denials quickly appeared in the scientific community: for example, in the Practical Journal of Allergology and Clinical Immunology (JACI In Practice) an article titled “Evidence refuting the existence of ASIA syndrome” was published. Since Schonfeld claims that aluminum in vaccines is capable of causing autoimmune diseases, allergologists should be especially worried about this: during allergen-specific immunotherapy (ASIT), they use preparations containing much more aluminum. During such a course of treatment, the patient can receive about 350 mg of aluminum in five years - many times more than from triple vaccination against hepatitis B virus (750 μg). So, for people who have gone through ASIT, the risk of autoimmune diseases does not increase, but decreases - and this is a powerful argument against the existence of ASIA syndrome. Many studies have been carried out on the connection of vaccine adjuvants with autoimmune diseases, including diabetes mellitus, multiple sclerosis, and systemic lupus erythematosus. In all cases, this relationship was absent.

The criteria on the basis of which it is proposed to make an ASIA diagnosis raise many questions, they are so broad that they cannot be accurate. The first of these is the effect of a vaccine or other foreign substance at any point in time during life, which is applicable to the entire world population. Fatigue, muscle pain, sleep problems, or increased body temperature occur throughout the life of the 25 – 100% of the population. Another diagnostic criterion is the disappearance of symptoms after removal of a foreign substance from the body, but in the case of the same vaccines, this is simply impossible. The authors of the refuted article consistently explain why none of the criteria is clear enough to speak about the existence of the syndrome (by the way, in addition to ASIA, it is also called Schönfeld syndrome).

On the subject: Breast implants ruined life: a resident of Latvia for years did not know what happened to her until she went to America

The ASIA syndrome is not in the International Classification of Diseases, and in the United States, where a system of compensation for vaccine-induced adverse events exists, one application associated with this diagnosis is known. She was not satisfied for a simple reason: the existence of the syndrome has not been proven. Apparently, Schonfeld is trying to convince the public that “after” and “as a result” are one and the same, and this is not difficult considering how many people believe in effects, such as electromagnetic storms.

Official denials have also appeared on the websites of some clinics - doctors fear that people will refuse vaccination because of fear of complications. This can lead to increased mortality from preventable diseases, including cervical cancer. The authors of the article in JACI offer international organizations, including the WHO and the International Association of Immunological Communities, to assemble an independent expert panel that would study the ASIA diagnostic criteria and make an official statement.

The popular science blog Sceptical Raptor, the author of which is actively fighting pseudoscience, explains that Schönfeld syndrome is another invention of anti-vaccination agents. The author conducts an entire investigation: in addition to the poor quality of the research to which Schonfeld refers, a number of his works were funded by the Dwoskin Foundation, she also supports other authors whose published works about the dangers of vaccines have been withdrawn. The founder of another institute, also sponsoring the work of Schönfeld, once called vaccines "holocaust poison for the brain and the immune system of our children."

Фото: Depositphotos

Siliconosis

Schonfeld syndrome does not hold water due to vague criteria and anti-vaccination attitude - but what about one of its components, the so-called silicosis, which is supposedly caused by silicone implants? Some reports of reactions to silicone implants describe local rather than systemic reactions - even if the same ASIA syndrome is mentioned in the title. In other cases, the authors claim silicone-induced autoimmune diseases, but they cannot prove this connection — for example, in a publication that deals with only three patients, one after the removal of implants did not improve, and the rest refused to remove them. In another case, after analyzing the data for thirty years, it turned out that complaints had diminished in 27 of 54 women who had removed implants. It should be noted that we are talking about the reduction of subjective complaints, and in women with actually diagnosed autoimmune diseases, the objective indicators (test results) did not change.

Siliconosis, a condition caused by the migration of silicone particles in the body, was described in the mid-nineties. Initially, it was about the toxicity of liquid silicone, but one author of one of the publications said that it could develop after prosthetics with silicone implants. Another publication, 1994, states that silicone is not inert: in the twenty-five previous years, there have been cases where the silicone particles migrated to the lymph nodes or nervous tissue. Then, in 1991, implants were withdrawn from the US market and banned for a while. Over time, much evidence of their safety has accumulated, and they have been re-approved by the FDA. To date, the agency's position is as follows: implants are generally safe, but they involve certain risks; Before deciding on an operation, it is important to understand that it is unlikely to give life-long results, be aware of the composition of the prosthesis and its quality, and be aware of the likelihood of complications.

In March 2019, the FDA held a major hearing with the participation of researchers, plastic surgeons, implant manufacturers, and women who consider themselves affected by "breast implant disease." In May, an official statement appeared on the FDA website, which states: “We receive reports from patients about fears that their implants are associated with such immune system reactions as chronic fatigue, cognitive impairment, pain in joints and muscles. Although the FDA has no evidence that implants can cause these symptoms, it is known that in some women they disappear after the removal of prostheses; Some patients and doctors call this condition a disease of the breast implants. We believe that women considering the possibility of surgery should be aware of this. ” The agency plans to raise the awareness of patients and the medical community so that decisions are made on the basis of the fullest possible knowledge.

According to Dmitry Melnikov, Candidate of Medical Sciences, plastic surgeon, deputy national secretary of the ISAPS (International Society of Plastic, Reconstructive and Aesthetic Surgeons), after removal of implants for any reason, they are sent for histological examination and are not detected on the surface of silicone particles. Implant rupture is theoretically possible, a defect at the level of a manufacturing defect, but this is rare, and in any case such cases are not associated with autoimmune processes. Irina Babina, a rheumatologist at the Rassvet clinic, notes that implants are constantly being improved and special attention is paid to their immunological inertness; Although a fibrous capsule is often formed around the implant, which can be considered the body's response to a foreign body, it is not a systemic autoimmune process. It is important that the implants are of good quality and selected individually.

On the subject: How breast implants ruined my life: personal experience

In the global market, you may encounter poor quality or fake implants. The best way to protect yourself is to look for a clinic and a doctor with a good reputation, to know that they work with proven suppliers, not to trust the offers to put “exactly the same” implants at half the price. In an attempt to save money, you can run into unqualified health care workers: in Australia last year, almost 250 patients from the Cosmetic Institute network went to court for complications after breast augmentation. The network of clinics offered surgery cheaply and in installments - for 20 dollars per week; as it turned out, non-plastic surgeons were engaged in operations at all. Another scary case from Australia is an operation performed at home and without the presence of an anesthesiologist; as a result of the proceedings, the damage to the patient was estimated at more than 200 thousand dollars.

Spanish plastic surgeons say that they face the consequences of using low-quality prostheses when they are approached by patients after “surgical tourism”. It is not clear which countries we are talking about, but because of the low standards in terms of materials and procedures, people sometimes return without even having a medical discharge. True, several years ago, the scandal broke out in Europe: it turned out that the French company PIP had supplied implants filled with technical silicone to the market for many years - it is ten times cheaper than medical and not approved for use in humans. It is estimated that from 1991 to 2011 year, these prostheses received from 300 to 400 thousands of patients. The frequency of implant ruptures and inflammation reached 10%, and PIPs were withdrawn from the market in the EU. Lawsuits are still ongoing: it turned out that the organization that checks the quality of materials has become a victim of fraud on the part of PIP. The European Commission continues to collect data on the effects of operations, organized by the World Association for Implant Victims PIP, which helps women get compensation.

Фото: Depositphotos

What about lymphoma?

In February, the FDA published a report on the association of implants with a type of lymphoma. The disease was called anaplastic large cell lymphoma associated with breast implants (BIA-ALCL). The agency also issued a letter for health workers about how to discuss the risk of this disease with patients and about its identification. The risk of this lymphoma is estimated as 1: 30 000, although according to Australian data, among women with polyurethane and textured silicone implants, it can reach 1: 1000. Almost immediately after this, textured implants were banned in France.

BIA-ALCL is a tumor that was first described not by oncologists, but by plastic surgeons. It is detected locally, in the capsule around the implant, does not metastasize and is cured by removing both prostheses and capsules. In almost all cases, lymphoma was associated with textured, rather than smooth, implants - however, this does not mean that all patients with textured implants should urgently remove them. An official ISAPS statement stated that in the absence of symptoms, neither removal of implants nor any additional examinations are required. It also says that at the moment there are no data that would lead to the abandonment of textured implants, and for some patients they fit better than smooth ones. Another thing is that at the consultation the doctor should tell about all possible risks, allowing you to make an informed decision.

Galina K. from Moscow tells about her experience.

“After the birth of the child, my breasts stopped satisfied with me, I wanted to like myself and feel confident. In 2006, I decided to have a breast lift, but the surgeon at the consultation convinced me that as a result of mastopexy I would get a breast of the first size and all with scars. He offered to go the other way - to put implants, talked about their quality and lifetime warranty. I agreed. Immediately after the operation, my hormonal background was disturbed, the cycle was lost, acne appeared that did not go away even after six months, it was often hard to breathe. Then there were severe migraines and fainting with a sharp change in weather. A year after the operation, my hands began to go numb, I could not lie on my back because I felt sick and dizzy. Then I lost a lot of weight, stomach problems appeared, the skin began to dry a lot. By 2014, I was diagnosed with a variety of diagnoses, from gastroduodenitis to irritable bowel syndrome.

Over the years, I went around all the traditional doctors, went through all the examinations, tried Chinese medicine, massages and so on. It didn't get any better. Gradually, I began to spend most of my time in bed. Already in the morning, an hour after waking up, I felt tired and wanted to sleep. I stopped planning anything because I didn’t know if I could carry out my plans or it would be bad for me.

In 2017, I turned to a psychotherapist. The doctor did not see any signs of depression in me, but I asked for antidepressants to be prescribed to me, because I heard that they are good for problems with intestines. I drank antidepressants for about six months. Health did not improve at all, but after they were canceled, the menstrual cycle was disrupted. In 2018, the gynecologist-endocrinologist diagnosed me with premature ovarian failure, assuring me that it is hereditary and antidepressants have nothing to do with it.

By the spring of 2019, I had tenosynovitis and inflammations in the ligaments of the neck, shoulder, hip, ankles, constant back pain, migraines, pressure jumps, intolerance to many products, allergies, chronic problems with the stomach, gall bladder and intestines, joint pain, pain in the muscles, hair loss, chronic fatigue, violations of the level of sex hormones and much more. The rheumatologist confirmed many systemic disorders, but could not make an unequivocal diagnosis.

At some point, for the first time in all these years, I wondered if all this could not be a reaction to implants. On the same day I found a group on breast implants on Facebook, read the symptoms and found almost all of them in my room. I had a hope that I had already forgotten. I realized that over the years with implants I did not even have time to feel them: I waited for my life with a new breast to become bright and rich, but instead from the very first months I plunged into the struggle for health. Since March, 2019, I consulted four plastic surgeons, was a rheumatologist. Surgeons are not opposed to removing implants, "if it becomes easier for me this way." The rheumatologist, when she learned that I had implants, said that I was not the first with similar symptoms and, of course, it is better to remove them. Science is still collecting evidence, and it takes time and data to recognize the disease of breast implants.

I hope to have my breasts operated on in the near future and I realize that I don't care what they look like. When I realized that because of the desire to please others, I had spent so many years in suffering and illness, something turned over in me. Now I don't care what others think. The body is perfect when it is healthy, without health it will not be possible to enjoy life ”.

Фото: Depositphotos

The power of social networks

Groups on Facebook with discussions on “breast implant disease” are covered in a separate 2017 article of the year in the Journal of Plastic and Reconstructive Surgery. The authors note that the relationship of implants with autoimmune and other systemic diseases has not been proven, and the patient’s diagnosis is made independently, seeking removal of implants, and with precise requirements, for example, about the complete removal of the fibrous capsule. Members of the group often express dissatisfaction with the communication with doctors and actively thank for the support of their fellows, calling each other breasties (pun: the bestie is the best friend and the breast is the breast). According to the authors of the publication, it is important to go towards patients and agree to remove prostheses, but explain that at the moment it is not known about their relationship with autoimmune processes.

In a study of the state of one hundred patients who removed implants, it turned out that those who were diagnosed with an autoimmune disease did not improve. Among women with complaints, but without confirmed rheumatic or autoimmune diseases, both physical and psychological symptoms disappeared after explantation. Manifestations of patients may be caused by psychological problems; in particular, the level of anxiety in the survey participants was the same as in people diagnosed with anxiety disorder. The high level of anxiety could be partly due to the reasons why women initially wanted to enlarge their breasts or change their shape - for example, with low self-esteem, the survey says. It is clear that psychological discomfort can be reinforced by insufficient attention on the part of doctors, when it seems to the patient that her requests are ignored. Support in social networks contrasts sharply with this - and it becomes easier to convince yourself that the problems associated with implants.

Another publication 2019 of the year details the lack of evidence for the linkage of systemic diseases with implants - and the poor quality of research, where such a link was demonstrated. Nevertheless, the authors do not exclude that the complex interaction of implant materials, the immune system, genetic and other parameters in individual patients could theoretically lead to systemic symptoms. It may take decades to complete a description of a new disease, and you need to start with a thorough data collection, for which registers will be needed. They are in a small number of countries, the International Collaboration of Registers (ICOBRA) is founded. According to Dmitry Melnikov, work is underway to create such a register in Russia.

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