Our Response to the Radar Broadcast on Breast Implants

Recent media reports have appeared regarding the safety of breast implants. This issue has been receiving a great deal of attention lately, and we understand that you may have questions. If you are considering breast augmentation, you may be wondering whether it is safe and advisable. And if you have already had breast augmentation, you will want to know whether you are now at a health risk. We understand these concerns and would like to inform you as thoroughly as possible, elaborating on this based on the currently available scientific literature. What is happening? On Monday 20 September, the television programme Radar covered a recently published study by Henry Dijkman. The researchers conclude that all breast implants, regardless of the type of gel they are made from, can release silicone particles. The article describes how the researchers searched the database of the pathology department at Radboud UMC for data on patients with breast implants whose capsules had been removed and examined over the past 34 years (from 1986 to the present). In total, the capsules of 389 women were examined. Silicone particles could be detected in and just outside the capsule in a large majority. 46 women had implants with cohesive gel (a type of wine gummy implant, the standard for breast implants since 1996) and 343 had older-style implants that are much more liquid (in which leakage occurs more frequently). Equal numbers of silicone particles were found in the tissue immediately surrounding the implant in both groups. Is this concerning? The media has drawn the conclusion that it has now been proven that all implants are harmful. However, this conclusion needs to be put into perspective. As far back as 1999, a study (1) demonstrated that silicone particles could also be detected in the blood, serum, and even breast tissue of women without breast implants. This is most likely due to the consumption of food and drinks that also contain these particles. Furthermore, large groups of women with breast implants have been followed for decades and compared with women without breast implants in so-called "cohort" studies (3). These studies find no clear differences in symptoms between the groups with and without implants (2). This is an important finding, especially since implants are very common and have been used and studied for 60 years. Furthermore, the group studied by Dijkman is not simply a random sample from the general population. The study only examined capsules that were sent in for investigation. Capsules are only sent for investigation during surgery when something unusual is present, such as severe thickening of the capsule or a patient experiencing symptoms. This gives a distorted picture of the extent of the problem. All patients who have no symptoms and whose capsules were not sent in for examination remain invisible in such a study. In simple terms: it is impossible to say how often silicone particles are released; this study is not a random sample but concerns a group of women in whom there was a reason to examine the capsules. The researchers themselves also indicate that they do not know whether the women with cohesive gel implants had older-style implants in the past. In simple terms: it is impossible to say whether the silicone particles found actually originate from the cohesive gel implants. Should you be concerned? As described above, this study only examined the presence of silicone particles in the studied capsules. Whether these particles actually cause symptoms and what the likelihood of this is has not been investigated. To date, large studies have found no difference in symptoms between women with and without breast implants. The above does not alter the fact that there are indeed women with breast implants who experience symptoms for which no clear cause can be found. This group often feels very misunderstood. Research indicates that after removal of the implants, symptoms reduce in more than half of these patients within the first 6 months following the procedure. Longer-term results are still being studied. We take this extremely seriously and follow all developments closely. Our professional association, the Dutch Association of Plastic Surgery (NVPC), also devotes considerable attention to disseminating accurate and clear information in close consultation with the government and the Healthcare and Youth Inspectorate (IGJ). For further information, please also see the website of the NVPC: https://www.nvpc.nl/nieuws_detail.php?nieuws_id=445. Are implants safe or not? Ever since silicone breast implants have been in use (from 1962), research has been conducted into whether they are harmful to health. To date, even the large cohort studies have been unable to demonstrate any danger to public health. In America in 1992, the FDA (the American public health authority) banned the use of silicone breast implants for cosmetic indications in order to conduct further research. After 14 years of research, the FDA concluded in 2006 that there were no indications that silicone breast implants were unsafe, and their use was once again permitted. The Dutch Healthcare and Youth Inspectorate (IGJ) also states that there are no reasons to restrict the use of silicone breast implants. For further information, please also see their website: https://www.igj.nl/onderwerpen/borstimplantaten/veiligheid-van-borstimplantaten; https://www.igj.nl/onderwerpen/borstimplantaten/borstimplantaten-en-ziekten. Also read this article by a journalist with breast implants who is trying to find her way through the jungle of information: https://www.groene.nl/artikel/kies-je-inderdaad-voor-een-tijdbom. What about leakage? Leakage can occur when the outer casing of the implant, the 'shell', ruptures. This can be caused by sudden severe pressure, such as in an accident, or by gradual wear of the material, such as with folding or capsular contracture. The silicone content then exits the shell but remains within the capsule; this is called an intracapsular rupture. From there, the silicone content can also migrate outside the capsule; this is called an extracapsular rupture. The risk of this is considerably greater with older-style liquid silicone implants and less so with cohesive gel implants. How often an implant rupture occurs varies by implant type, and studies report varying figures. In general terms, it can be said that the longer an implant has been in the body, the greater the risk of rupture. There appears to be a turning point around 10 years; most studies suggest that approximately 10% of the examined implants show a rupture at that point. This is one of the reasons why it is advised to have implants checked, replaced, or removed around this time. What about sweating or "gel-bleed"? This refers to the release of silicone particles from an intact shell. The silicone gel consists of chains held together by cross-linking. There are also small "low molecular weight molecules" that are not fixed within these chains and can move freely through the implant, including through the wall of the implant. Many manufacturers state that current gels contain few low molecular weight molecules and that there is a protective barrier in the surrounding shell, which would minimise gel-bleed. The extent to which different types of implants exhibit gel-bleed is the subject of ongoing research. How common are symptoms exactly? Despite extensive research into breast implant illness (BII), it is not (yet) a recognised disease. It is suspected that the risk of developing symptoms is less than 1 per cent. Symptoms described in BII are atypical complaints such as fatigue, forgetfulness, hair loss, muscle pain, brain fog, etc. This makes it very difficult to study; the symptoms are so generic and broad that they can have all sorts of causes unrelated to breast implants (4). A study from Maastricht UMC was published this year in which these symptoms occurred just as frequently in women with silicone implants as in women without silicone implants (2). It is therefore difficult to determine and remains the subject of ongoing research. Alternatives Read more on our website about the pros and cons of various alternatives: /blog/alternatieven-borstimplantaten/ Update RIVM 17 November 2021 Following the publication of Dijkman et al. in JAMA Network Open in September 2021, the Ministry of Health, Welfare and Sport (VWS) asked the RIVM whether this publication leads to new insights regarding the quality and safety of silicone breast implants. The RIVM's response can be found on the RIVM website. In summary, according to the State Secretary, the RIVM concludes in its response that the study has not produced new insights. Firstly, the RIVM notes that migration of silicone from breast implants to the surrounding tissue and lymph nodes is already a widely recognised phenomenon and that various measures have been taken to reduce the amount of migration, the State Secretary writes. The RIVM also notes, according to the State Secretary, that it has long been known that local complications can arise with breast implants. This is a risk that is already included in manufacturers' instructions for use and the surgical package insert drawn up by plastic surgeons. Furthermore, as the authors themselves state, the study demonstrates no association between having breast implants and the development of systemic symptoms, according to the State Secretary. In Summary We fully understand that you may be concerned by media reports and unsure what is true and what is not. With this explanation, we aim to provide greater clarity on the matter. We attach great importance to everyone feeling heard and wish to be as transparent as possible. At Blooming, health is also our top priority. Should you still have questions after reading this and the text on the NVPC website, we will of course be happy to answer them. Send your question to info@bloomingpc.nl or call 023-5444974 to schedule a call-back appointment with one of our plastic surgeons if you would like to speak with someone in person. References: 1) Silicon Assays in Women with and without Silicone Gel Implants - a review. Peters W; Ann Plast Surg 1999; 43; 324-330 2) The Prevalence of Self-Reported Health Complaints and Health-Related Quality of Life in Women With Breast Implants, Misere et al, Aesth Surg J 2021, 41(6), 661-668 3) Silicone Breast Implants; a cohort study of complaints, complications and explantations between 2003 and 2015. Pool SMW et al ; J Plast Reconstr Aesth Surg. 2018; 71(11): 1563-1569. 4) "Silicone Related Symptoms" are common in patients with fibromyalgia: no evidence of a new disease; Wolfe F, J Rheumatol, 1999, 26(5); 11761-1175. 5) Long-Term Safety of Textured and Smooth Breast Implants, Bradley Calobrace M et al, Aesthet Surg J, 2017, 38 (1); 38-48.