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Official letter from Dutch society of plastic surgery

By November 12 2021No Comments

The safety of breast implants

Articles on the safety of breast implants appear regularly in the media. Last week (20 September 2021), a publication by researcher Henry Dijkman was published, stating that not only breast implants with liquid gel can release silicone particles (molecules), but that this also applies to solid breast implants. The television program Radar, among others, paid attention to this and some media even concluded that all implants would be dangerous. Such reports cause concern. Patients who are considering breast reconstruction after breast cancer or women who have taken implants for cosmetic reasons wonder whether this is safe and what health risks they run. The NVPC, the professional association for plastic surgeons, understands these concerns and wants to inform women as well as possible. In this article we address a number of frequently asked questions and respond to Dijkman’s research on the basis of currently known scientific insights and literature.

What did Dijkman study?

Dijkman’s study shows that migration of silicone molecules inside, inside and outside the capsule also occurs with so-called cohesive gel implants. The study describes that the researchers searched the database of the pathology department of the Radboudumc for data on patients with breast implants where the 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. Inside and just outside the capsule, silicone particles could be detected in the vast majority. 46 women had prostheses with a cohesive gel (which has been the standard for breast implants since 1996) and 343 had old-fashioned implants, which are much more fluid (and leakage more common). In both groups an equal number of silicone particles were found in the tissue immediately surrounding the prosthesis.

What does the NVPC think of the research?

The NVPC and plastic surgeons are critical of Dijkman’s study because it is not a representative sample. This is because the study only looked at the capsules that were sent for examination at the Radboud (389 over a period of 34 years, while approximately 19,000 implants are placed annually). Moreover, during an operation, capsules are only sent in if something special is going on, such as a severe thickening of the capsule or someone with complaints. It is also not known how many implants were broken or intact when they were removed, what the health background of the women involved was, or whether they smoked, for example. All this gives a distorted picture of the extent of the problem. Patients who have no complaints and whose capsules were not sent in were not included in this study. It is therefore impossible to say how often and how much silicone particles are released by cohesive implants. This reaction was also shared with JAMA, where Dijkman’s study was published.

Should I be worried now?

The question then remains whether and how harmful this is to health. However, whether the presence of silicone particles also causes (health) complaints and what the chances are of this has not been investigated. The research only looked at the presence of these particles in the hairstyles investigated. The conclusions in the media are therefore rather unsubtle. For decades, large groups of women with breast implants have been followed and compared to women without breast implants. These studies have not found clear differences in complaints between the groups with and without implants. The presence of silicone in breast tissue is also nothing new: this has been stated for many years in the NVPC surgical information leaflet on silicone breast implants, which plastic surgeons use to inform their patients. In fact, there are several studies that show the presence of silicone particles in blood and even in breast tissue, even in women without breast implants. This is probably due to the consumption of food and drinks that also contain these particles.

Are implants safe or not?

For as long as silicone breast implants have been in use (since 1962), research has been carried out to determine whether they are harmful to health. So far, so-called large cohort studies (comparing women with and without implants) have not been able to demonstrate any danger to public health. In America, the use of silicone breast implants for cosmetic treatment was banned by the FDA (the US public health authority) in 1992 in order to conduct more research. In 2006, after 14 years of investigation, the FDA concluded that there was no evidence that silicone breast implants were unsafe and allowed their use again. The Dutch IGJ (Inspectorate for Health Care and Youth) also states that there are no reasons to ban the use of silicone breast implants. Read more about the safety of implants on the website of the IGJ.

Misunderstood complaints

At the same time, there are women with breast implants who have complaints for which no clear cause can be found. This group often feels very misunderstood. Although much research is being done into what is known as breast implant illness (BII), BII is not (yet) a recognized disease. It is thought that the risk of developing symptoms is less than 1 percent. Symptoms described with BII are atypical and include fatigue, forgetfulness, hair loss, muscle pain, brain fog, etc. This makes it very difficult to investigate; the complaints are so general and wide-ranging that they can have many causes unrelated to breast prostheses. A study published this year by the Maastricht UMC showed that these complaints occurred just as often in women with silicone implants as in women without.

More research

We take all complaints and studies very seriously and we follow all developments closely. The NVPC also advocates more research into the safety of breast implants and is involved in several (multiyear) studies together with the RIVM and the NIVEL. These studies focus, among other things, on the question of whether women with silicone breast implants are more likely to have symptoms than women without, and which women may be at greater risk of these symptoms. In other words, can we find risk factors that predict complaints? These may include factors in the patients themselves such as smoking, allergic predisposition, already having an autoimmune disorder or prosthetic factors such as a broken prosthesis, age of the prosthesis (length of time they have been in the body). For the time being, the NVPC sees no reason to adjust its views and advice. Women with breast prostheses, who nevertheless have concerns or think they have complaints due to their breast implants, can always make an appointment with their plastic surgeon for further examination.