Get useful, helpful and relevant health + wellness information. Women 'should be warned' of breast implant illness, Safety concerns raised over breast implants, Human error to blame for train crash - Greek PM, At the crash site of 'no hope' - BBC reporter in Greece. 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https://www.ncbi.nlm.nih.gov/pubmed/?term=A+nationwide+study+of+connective+tissue+disease+and+other+rheumatic+conditions+among+Danish+women+with+long-term+cosmetic+breast+implantation, https://www.ncbi.nlm.nih.gov/pubmed/?term=Self-reported+musculoskeletal+symptoms+among+Danish+women+with+cosmetic+breast+implants, https://www.ncbi.nlm.nih.gov/pubmed/?term=Potential+risk+factors+for+undifferentiated+connective+tissue+disease+among+women%3A+implanted+medical+devices, https://www.ncbi.nlm.nih.gov/pubmed/20943932, www.accessdata.fda.gov/cdrh_docs/pdf3/p030053b.pdf on 28 July 2015, https://www.ncbi.nlm.nih.gov/pubmed/20195108, https://www.ncbi.nlm.nih.gov/pubmed/11480483, https://hpr-rps.hres.ca/reg-content/summary-basis-decision-medical-device-detailOne.php?lang=en&linkID=SBD00412, Alzheimers, Dementia & Other Disabilities, Early Puberty & Problems in Sexual Development, Capsular contracture (the painful tightening of the scar tissue around the implant), Micro-leakage (sweating or bleeding of silicone outside the shell), Interference with the accuracy of mammography. In January 2011, the FDA announced that women with breast implants seem to be more likely to develop ALCL (anaplastic large cell lymphoma), a rare cancer of the immune system. Women with breast implants had a 35% higher rate of arthritis, which was not statistically significant (relative risk: 1.35). FDA required that patient booklets provided by implant manufacturers must warn about that; For example, Allergans booklet states: Caution: Notify your doctor if you have any of the following conditions, as the risks of breast implant surgery may be higher: Autoimmune Diseases (for example, lupus and scleroderma).7 Unfortunately, patients report they are not given the booklets or the warning prior to surgery, the FDA does not include that warning on its website, and in our preliminary analysis, 6% of the women in our study reported that they had been diagnosed with an autoimmune diseasepriorto getting implants. Some recently published systematic reviews investigating BII and breast implant safety have shed some light on the matter. In addition, certain textured breast implants, most often used in breast reconstruction procedures, were voluntarily recalled by their manufacturer in the summer of 2019, at the prompting of the FDA, after they were linked with a rare type of non-Hodgkins lymphoma called anaplastic large cell lymphoma (ALCL), a cancer that affects cells that work as part of the bodys immune system. The authors conclude that there is inconclusive evidence to make a claim between breast implants and long-term health outcomes. This shortcoming is exacerbated when the studies include women who have had breast implants for relatively short periods of time, since the womens symptoms are likely to be apparent for years before a diagnosis is made. Leakage: Numerous studies have shown silicone leaked into the scar capsules surrounding breast implants, even for implants that were not ruptured. Efforts were made to confirm diagnoses using medical records, but that was not always possible. The hope is that such studies will help researchers answer questions and find solutions. However, another article in the journal Plastic and Reconstructive Surgery called for researchers to enroll people with BII-like symptoms in their studies. The cosmetic outcome is also sometimes disappointing, with breasts looking or feeling unnatural or asymmetrical. Only women who were hospitalized with classic connective-tissue disease or with other and ill-defined rheumatic conditions were diagnosed. FDA. Nevertheless, the FDA did not question the integrity of the data and maintained in their report that silicone implants were safe and effective.13, FDA states on its website that the 10-year studies of 40,000 women that FDA required of each of the two implant companies were never completed.16 FDA reports that their Advisory Panel that met in 2011 recommended that the 10-year studies be replaced by a systematic literature review as well as re-designed studies that have more efficient methodologies to assess rare complications. On its website, FDA explains that In response, FDA entered into collaboration with the American Society of Plastic Surgeons (ASPS), the Plastic Surgeons Foundation (PSF), breast implant manufacturers and patient advocate groups, to establish the National Breast Implant Registry (NBIR) and the PROFILE Registry (established to collect data on potential cases of breast-implant associated anaplastic large cell lymphoma (BIA-ALCL)). 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