The spread of “silicone disease” is becoming increasingly common. On this subject, please find the joint publication of the Brazilian Society of Plastic Surgery and the Brazilian Society of Rheumatology here:

“Medical Societies Unite to Clear Up Myths About ASIA Syndrome

São Paulo, March 2021

The Brazilian Society of Plastic Surgery (SBCP) and the Brazilian Society of Rheumatology (SBR) are launching the ‘Myths and Truths Campaign’, which aims to promote a safe environment for patients to seek correct information about the syndrome. The societies will also hold a live stream on March 24 to answer people’s questions on the subject.

With the aim of informing the public about the real issues surrounding silicone implants, the Brazilian Society of Plastic Surgery (SBCP) and the Brazilian Society of Rheumatology (SBR) are launching the Myths and Truths campaign. The initiative provides access to reliable information on Silicone Disease, as it is known on social media, and on ASIA Syndrome and its manifestations. In the last year, Google searches for these diseases have increased by 350%. In relation to this, searches for silicone explants increased by 170%. Because it is relatively new, ASIA and Silicone Disease have been the subject of countless fake news stories that have alarmed and generated excessive anxiety and, often, the search for surgical procedures as a preventative measure, based on facts without any scientific source. The SBCP campaign is available on the hot site www.doencadosilicone.org.br and on the institutions’ social networks.

“It’s important to note that silicone disease and ASIA syndrome are not the same thing. Silicone disease is a term given by patients themselves to describe a set of symptoms they attribute to the use of the implant, also known as Breast Implant Illness (BII). Symptoms include fatigue, depression, poor bowel function, joint pain, etc. Because it is a newly described condition, this association between silicone and the development of symptoms that simulate immunological diseases is still being studied to ascertain the causal relationship. The WHO (World Health Organization) does not yet recognize this term as a real disease. In addition, no tests have yet been identified to prove the condition, making it difficult to differentiate it from the usual symptoms of stress. Although it is often used to encompass ASIA Syndrome, they are different conditions and in BII we can’t characterize an immunological disease as such,” explains Dr. Marcela Cammarota, SBCP’s Communications Director.

The Syndrome

ASIA Syndrome (adjuvant-induced autoimmune-inflammatory syndrome) was described in 2011 by Yehuda Schoenfeld and consists of the development of autoimmune diseases in genetically predisposed individuals as a result of exposure to adjuvants (substances foreign to the body that provoke an immune reaction). These substances have been described for some years and some of them are: infectious fragments, hormones, aluminum and recently scalene, an oil obtained from shark tissue and used in the anti-influenza vaccines available in the country.

Despite being a very rare condition, silicone has been considered to be one of these substances that can trigger an immunological reaction and manifestations similar to those of some rheumatic diseases, the most common symptoms being chronic fatigue, joint and muscle pain, dry mouth and eye and some neurological manifestations. The presence of autoantibodies against silicon and certain specific HLA, which are responsible for presenting antigens to the immune system, can indicate the development of the disease.

Although these are extremely rare conditions in patients who have undergone breast implant procedures, the campaign aims to provide a safe environment for exchanging information and combating fake news. “The Myths and Truths Campaign aims to clear up all doubts based on scientific evidence and medical research carried out in recent years,” explains Dr. Dênis Calazans, President of the SBCP. The action is based on simple and direct language for better understanding of the content, which mixes cards and informative videos with specialists in the fields of plastic surgery and rheumatology. The campaign presents content on symptoms, diagnoses and treatments for the syndrome in a lively and interactive way. The campaign features videos by experts on the disease and an educational eBook to share.

ASIA syndrome and BII are not the same thing!

ASIA syndrome: this is short for “adjuvant-induced autoimmune syndrome”, and the silicone in breast implants can act as an adjuvant. There is no laboratory or imaging test that can diagnose the syndrome. Diagnosis is made by fulfilling major and minor clinical criteria. The relationship between breast implants and ASIA syndrome or rheumatic diseases is still inconclusive.

Breast Implant Illness (BII): loosely translated as silicone disease, it is not to be confused with ASIA Syndrome. BII is not a disease recognized by the medical profession. It is a cluster of symptoms reported by patients (fatigue, hair loss, anxiety, depression, photosensitivity, insomnia), without laboratory or radiological changes. It is associated with all makes and models of breast prosthesis and can occur between 3 days and 30 years after implantation.”

On this subject, please find the publication of the Brazilian Society of Mastology :

Reproduction of text found in the link: https://www.sbmastologia.com.br/nota-oficial-sobre-proteses-mamarias-2/

The American company Allergan made the decision to recall three types of breast prostheses in all the markets where it operates, including Brazil, after the Food and Drug Administration (FDA) and the US Health Authority ordered the products to be discontinued on American soil. The reason is that these products have been linked to 573 cases of anaplastic large cell lymphoma worldwide, which are linked to the use of breast implants. Therefore, the Brazilian Society of Mastology agrees with the FDA’s decision and has issued the following guidance:

• Inform the patient about the risk of developing the disease and the risks and benefits of the different types of implants.
• The main symptoms reported by patients with this neoplasm were swelling and fluid accumulation around the implant.
• Consider the possibility of BIA-ALCL when treating a patient with late onset peri-implant changes. Some of the signs described are: seroma, mass or hardening adjacent to the breast implant.
• Such patients should be evaluated and if these signs occur, fresh seroma fluid and representative parts of the prosthesis capsule should be sent for pathology tests to rule out BIA-ALCL. Diagnostic evaluation should include cytological assessment of the seroma fluid or mass with Wright Giemsa-stained smears and immunohistochemistry / flow cytometry on cell block for differentiation markers (CD30) and Anaplastic Lymphoma Kinase (ALK).
• The recall of Biocell brand implants is intended for hospital professionals and institutions so that these devices are not implanted and are returned to Allergan.
• The devices covered by the recall are the Biocell brand products listed below: Natrelle saline-filled breast implants, Natrelle silicone-filled breast implants, Natrelle Inspira 410 highly cohesive anatomically shaped silicone-filled breast implants. The recall also includes the expanders used before breast augmentation or reconstruction, which are: Natrelle 133 Plus tissue expander and Natrelle 133 tissue expander with suture tabs.
• If a neoplasm is suspected or confirmed, it is important for the professional to develop an individualized treatment plan, taking into account current clinical practice guidelines, such as those of the Plastic Surgery Foundation of the National Comprehensive Cancer Network (NCCN) AND to report all cases of BIA-ALCL to MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Lastly, the Brazilian Society of Mastology reiterates its commitment to vigilance and constant monitoring of any information that may directly or indirectly affect the health and safety of patients.

Antônio Luiz Frasson
President”