From time to time you can stumble upon a discussion on social media Breast implant ilness (BII): Women who have had or recently had breast augmentation or reconstruction surgery discuss fatigue, muscle and joint pain, sleep disturbance, and other symptoms. They cite the so-called ASIA-syndrome, as the first letters of the English name “Adjuvant-Induced Autoimmune Syndrome” as proof of the link between these problems and implants. Together with the experts, we figure out whether this syndrome really exists and whether it is necessary to be afraid of silicone implants.
In 2011, the Journal of Autoimmunity published an article by Israeli scientist Yehuda Schoenfeld and his colleagues about a new syndrome called ASIA; the authors combined several different conditions into it - in particular, the so-called siliconosis (toxic effects of silicone), macrophage myofasciitis (also called sick building syndrome) and post-vaccination syndrome. As the authors describe, all these conditions are characterized by muscle pain or weakness, joint pain, chronic fatigue, sleep and memory disorders, dry mouth, and later, more distinct autoimmune processes can join. Another common characteristic is prior exposure to an adjuvant, that is, an additive component of a vaccine (primarily aluminum), a silicone implant, or a substance found in the environment, in particular in building materials.
It can be seen that most of the publications on ASIA syndrome come from Schoenfeld and his colleagues, and the original 2011 article was published in a journal whose editor-in-chief is Schoenfeld himself. The professor is also known for giving at St. Petersburg State University a course of lectures on the future of therapy for 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 Allergists and Clinical Immunologists (EAACI), an immunologist Umar Khasanov, the syndrome is very controversial, and its manifestations are so nonspecific that anyone can attract this diagnosis if they want, as it still happens with a nonexistent vegetative-vascular dystonia. “Even people who advocate refusal to vaccinate are no longer talking about the dangers of vaccine adjuvants, but perhaps another wave of horror stories is approaching,” the doctor continues.
The criteria on the basis of which it is proposed to diagnose ASIA raise many questions, they are so broad that they cannot be accurate.
Denials quickly appeared in the scientific community: for example, an article was published in the Practical Journal of Allergology and Clinical Immunology (JACI In Practice) entitled "Evidence refuting the existence of ASIA syndrome." Since Schoenfeld claims that aluminum in vaccines can cause autoimmune diseases, this should be of particular concern to allergists: during allergen-specific immunotherapy (ASIT), they use drugs containing much more aluminum. In the course of such a course of treatment, a patient can receive about 350 mg of aluminum in five years - many times more than three times hepatitis B virus vaccination (750 μg). So, in people who have undergone ASIT, the risk of autoimmune diseases does not increase, but decreases - and this is a powerful argument against the existence of ASIA syndrome. There have been many studies of the relationship between vaccine adjuvants and autoimmune diseases, including diabetes mellitus, multiple sclerosis, and systemic lupus erythematosus. In all cases, this connection was absent.
The criteria on the basis of which it is proposed to diagnose ASIA raise many questions, they are so broad that they cannot be precise. The first is exposure to a vaccine or other foreign substance at any point in time during life, which applies to the entire global population. Fatigue, muscle pain, sleep problems, or fever occur in 25–100% of the population throughout their lives. Another diagnostic criterion is the disappearance of symptoms after the removal of a foreign substance from the body, but in the case of the same vaccines, this is simply impossible. The authors of the refuting article consistently explain why none of the criteria is clear enough to really talk about the existence of the syndrome (by the way, in addition to ASIA, it is also called Schoenfeld's syndrome).
ASIA is not listed in the International Classification of Diseases, and in the United States, which has a vaccine-induced adverse event compensation system, there is one known claim associated with this diagnosis. She was not satisfied for a simple reason: the existence of the syndrome has not been proven. Apparently, Schoenfeld is trying to convince the public that "after" and "after" are one and the same, and this is not difficult given how many people believe in the effects of, for example, electromagnetic storms.
Official denials have also appeared on the websites of some clinics - doctors fear that people will refuse vaccinations for fear of complications. This can lead to higher deaths from preventable diseases, including cervical cancer. The authors of the article in JACI invite international organizations, including WHO and the International Union 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 actively fights against pseudoscience, explains that Schoenfeld's syndrome is just another invention of anti-vaccinators. The author conducts a whole investigation: in addition to the low quality of research, which Schönfeld refers to, a number of his works were funded by the Dwoskin Foundation, she also supports other authors whose published works on the dangers of vaccines have been withdrawn. The founder of another institute, also sponsoring Schönfeld's work, once called vaccines "the poison of the holocaust for the brains and immune systems of our children."
Schoenfeld's Syndrome does not hold water due to its vague criteria and anti-vaccination stance - but what about one of its components, so-called siliconosis, which is believed to be 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 autoimmune diseases caused by silicone, but they cannot prove this connection - for example, in a publication where we are talking about only three patients, in one, after removing the implants, the condition did not improve, and the rest refused to remove them. In another case, after analyzing data over thirty years, it turned out that complaints had decreased in 27 of 54 women who had their implants removed. It is worth noting that we are talking about a decrease in subjective complaints, and in women with really diagnosed autoimmune diseases, 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 stated that it can develop after prosthetics with silicone implants. Another 1994 publication claims that silicone is not inert: in the previous twenty-five years, there have been cases where silicone particles have migrated into lymph nodes or nerve tissue.Then, in 1991, the implants were withdrawn from the American market and banned for some time. Over time, much evidence of their safety has accumulated and they have been re-approved by the FDA. Today the position of the agency is as follows: implants are generally safe, but certain risks are associated with their use; before deciding on an operation, it is important to understand that it is unlikely to give lifelong results, to know about the composition of the prosthesis and its quality, to be aware of the likelihood of complications.
Last year in Australia, nearly 250 patients from The Cosmetic Institute went to court for complications from breast augmentation.
In March 2019, the FDA held a major hearing involving researchers, plastic surgeons, implant manufacturers and women who claim to be suffering from "breast implant disease." In May, the FDA posted a statement on its website that said: “We are receiving reports from patients about concerns that their implants are associated with immune system reactions such as chronic fatigue, cognitive impairment, and joint and muscle pain. Although the FDA does not have evidence that implants can cause these symptoms, it is known that in some women they disappear after the dentures are removed; some patients and doctors refer to this condition as breast implant disease. We believe that women considering surgery should be aware of this.” The agency plans to raise awareness among patients and the medical community so that decisions are made based on the fullest possible knowledge.
According to Dmitry Melnikov, candidate of medical sciences, plastic surgeon, deputy national secretary of ISAPS (International Society of Plastic, Reconstructive and Aesthetic Surgeons), after removal of implants, for any reason, they are sent for histological examination, and no silicone particles are found on the surface. Theoretically, an implant rupture, a defect at the level of a factory defect, is possible, 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, this is not a systemic autoimmune process. It is important that the implants are of good quality and are selected individually.
In the global market, you can come across substandard 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 trusted suppliers, not to trust offers to supply "exactly the same" implants at half the price. In an attempt to save money, you can run into unskilled health workers: last year in Australia, almost 250 patients of The Cosmetic Institute network went to court in connection with complications after breast augmentation. The network of clinics offered the operation inexpensively and in installments - at $ 20 a week; as it turned out, plastic surgeons were not involved in the 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 caused to the patient was estimated at more than 200 thousand dollars.
Spanish plastic surgeons note that they face the consequences of using low-quality prostheses when patients come to them after "surgical tourism". It is not clear which countries are in question, but due to low standards for materials and procedures, people sometimes return without even a medical record. True, a few years ago a scandal erupted in Europe as well: it turned out that the French company PIP had been supplying implants filled with technical silicone to the market for many years - it is ten times cheaper than medical silicone and is not approved for use in humans. It is believed that from 1991 to 2011, these prostheses received from 300 to 400 thousand patients. The incidence of implant rupture and inflammation was as high as 10%, and PIPs were withdrawn from the EU market. The lawsuits are still ongoing: for example, it turned out that the organization that checks the quality of the materials has also become a victim of fraud on the part of PIP.The European Commission continues to collect data on the impact of surgery, and the PIP World Implant Victims Association is organized to help women obtain compensation.
What About Lymphoma?
In February, the FDA published a report on the link between implants and a type of lymphoma. The disease was termed breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The agency also issued a letter to healthcare providers on how to talk to patients about the risk of this disease and how to identify it. The risk of this lymphoma is estimated at 1:30 000, although Australian data indicate that it can be as high as 1 in 1000 among women with polyurethane and textured silicone implants. Almost immediately thereafter, textured implants were banned in France.
BIA-ALCL is a tumor first described not by oncologists, but by plastic surgeons. It is detected locally, in the capsule around the implant, does not metastasize and can be cured by removing both prostheses and capsules. In almost all cases, the lymphoma was associated with textured, rather than smooth, implants - however, this does not mean that all patients with textured implants should be urgently removed. ISAPS said in an official statement that in the absence of symptoms, neither implant removal nor any additional examinations are required. It also says that at the moment there is no data that would force to abandon textured implants, and for some patients they are better suited to smooth ones. Another thing is that at the consultation, the doctor should talk about all possible risks, allowing him to make an informed decision.
After the birth of the child, my breasts ceased to suit 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 have bypassed all traditional doctors, passed all examinations, tried Chinese medicine, massages, and more. It didn't get 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 if I would feel bad.
In 2017, I turned to a psychotherapist. The doctor did not see any signs of depression in me, but I asked to prescribe antidepressants for me, because I heard that they are good at helping with intestinal problems. I drank antidepressants for about six months. Health did not improve at all, but after their abolition, the menstrual cycle was disrupted. In 2018, a gynecologist-endocrinologist diagnosed me with premature ovarian failure, assuring me that it was hereditary and had nothing to do with antidepressants.
By the spring of 2019, I had tenosynovitis and inflammation in the ligaments of the neck, shoulder, hip, ankles, persistent back pain, migraines, pressure surges, intolerance to many foods, allergies, chronic problems with the stomach, gall bladder and intestines, joint pain, pain in muscles, hair loss, chronic fatigue, disorders of the level of sex hormones and much more.The rheumatologist confirmed many systemic disorders, but could not make a definite diagnosis.
At some point, for the first time in all these years, I wondered if all this could be a reaction to implants. On the same day, I found a Facebook group dedicated to breast implant disease, read the symptoms and found almost all of them at home. I had a hope that I had already forgotten. I realized that over the years with the implants, I did not even have time to feel them: I expected that my life with the new breast would become bright and eventful, and instead, from the very first months, I plunged into the struggle for health. Since March 2019, I have consulted four plastic surgeons and a rheumatologist. Surgeons do not mind removing the implants, "if it becomes easier for me." The rheumatologist, when she found out that I had implants, said that I was not the first with similar symptoms and, of course, it would be better to remove them. Science is still gathering evidence, and it takes time and data to recognize breast implant disease.
I hope to have my breasts operated on in the near future and realize that I don't really 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 is impossible to enjoy life.
The power of social media
A separate 2017 article in the Journal of Plastic and Reconstructive Surgery is devoted to Facebook groups discussing “breast implant disease”. The authors note that the connection of implants with autoimmune and other systemic diseases has not been proven, and the patients make the diagnosis themselves, applying for the removal of implants, and with clear requirements, for example, complete removal of the fibrous capsule. Members of the group often express dissatisfaction with communication with doctors and actively thank for the support of their colleagues, calling each other breasties (pun: bestie - best friend and breast - breast). According to the authors of the publication, it is important to meet the patients halfway and agree to the removal of prostheses, but at the same time explain that at the moment it is not known about their connection with autoimmune processes.
In a study of 100 patients who had implants removed, it was found that those who were actually diagnosed with an autoimmune disease did not improve. Among women with complaints but no confirmed rheumatic or autoimmune diseases, both physical and psychological symptoms disappeared after explantation. Manifestations that bother patients can be caused by psychological problems; in particular, the level of anxiety in the survey participants was the same as in people with a diagnosed anxiety disorder. The high level of anxiety could be partly due to reasons why women initially wanted to enlarge their breasts or change their shape - for example, with low self-esteem, according to the survey. It is clear that psychological discomfort can be reinforced by insufficient attention on the part of doctors, when the patient feels that her requests are being ignored. Social media support is in stark contrast to this - and it becomes easier to convince yourself that the problems are due to implants.
Another 2019 publication details the lack of evidence of a link between systemic diseases and implants - and the low quality of studies where such a link has been demonstrated. Nevertheless, the authors do not exclude that the complex interaction of implant materials, the immune system, genetic and other parameters in individual patients can theoretically lead to systemic symptoms. It can take decades to fully describe a new disease, and start with careful data collection, which will require registers. They exist in a small number of countries, and the International Collaboration of Registers (ICOBRA) was founded.According to Dmitry Melnikov, work is underway to create such a register in Russia.
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