About Complications with Breast Implants

At Blooming Plastische Chirurgie, we value transparency about the possible complications that may arise after a procedure. In the case of breast augmentations with implants, some concerning reports are currently circulating. In this article, we explain a number of terms mentioned in these reports. Currently, 1 in 30 women in the Netherlands has breast implants. Women have these placed for aesthetic improvement or as part of breast reconstruction following breast cancer. Breast implants have been used for medical purposes since the 1960s. In so-called "cohort studies" in which women with and without breast implants were asked to complete a health questionnaire at various points in time, no significant differences in health complaints have been found. This does not mean that no complaints can arise after a breast augmentation with implants, but it does mean that this applies to a small percentage. Any foreign body that is implanted can cause complaints — think, for example, of a hip prosthesis. Below we provide a brief description of the terms used to describe complications with breast implants. Leakage Leakage can occur if an implant tears or a rupture occurs. In general, this affects 8.7% of prostheses within 10 years, with the filling usually remaining within the capsule. There is no evidence that this is harmful to the body, but it is one of the reasons why we advise having implants exchanged or removed after more than 10 years. Gel bleed With gel bleed, the "sweating" of an implant is meant. An implant can release silicone molecules. This occurs because so-called "low molecular weight molecules" are present in the gel that are not bound to the cross-linking silicone chains and can move freely through the gel and also through the shell (the envelope or outer casing of the prosthesis). Many manufacturers claim that current gels contain few low molecular weight molecules and that there is a protective layer in the gel, which would mean that gel bleed is no longer an issue. To what extent this is accurate is not entirely clear. It is quite possible that prostheses do release low molecular weight molecules. That sounds alarming, but must be put into perspective. We also ingest silicones daily through the food and drinks we consume. The body is more or less capable of eliminating silicone particles. BIA-ALCL (large-cell anaplastic lymphoma) ALCL stands for Anaplastic Large-Cell Lymphoma. With regard to breast implants, one often refers to 'breast implant-associated ALCL' or 'BIA-ALCL'. This is a rare form of lymphoma — a type of cancer related to the immune system. In the breast, it most commonly takes the form of fluid accumulation, known as seroma. It can also present as a lump. It often develops some time after the placement of the breast implant, ranging from a few months to many years (often 8 to 10 years) after implantation. Worldwide, ALCL has been diagnosed in 933 women with textured prostheses. The majority of those diagnosed with BIA-ALCL can be cured with treatment. A recent assessment by the RIVM has shown that cases of BIA-ALCL occur primarily with Allergan Biocell implants. These implants have not been commercially available in the Netherlands or the rest of Europe since December 2018. The RIVM considers it plausible that Biocell implants carry a higher risk of BIA-ALCL than other breast implants. At Blooming, we primarily place Motiva implants. These fall into the category of smooth prostheses. No cases of ALCL have been identified with smooth implants. A recent article refers to the comparison using micromorts — the risk of 1 in a million that a person faces of dying — to illustrate the risk of BIA-ALCL. Drinking 0.5 ml of wine or walking 28 km carries a death risk of 1 micromort. The risk of dying from BIA-ALCL for women with breast implants is 0.4 micromort. Breast implant illness (BII) The clinical picture described in women with the alleged Breast Implant Illness (BII) encompasses many atypical complaints such as fatigue, forgetfulness, hair loss, muscle pain, and others. Despite extensive research into BII, it is not (yet) a recognised condition. However, 65% of women who have had their breast implants removed report that their complaints have diminished. It is suspected that the risk of developing complaints as reported with BII is less than 1 per cent. In the United States in 2019, according to the ASAPS, approximately 34,000 implants were removed, of which 2,900 were removed due to suspected symptoms related to BII. With 600,000 implants placed annually, 5% are removed each year, and of those, fewer than 10% are removed due to complaints related to BII. The risk in the United States therefore appears to be 10% of 5% and thus less than 1%. ASIA syndrome The ASIA syndrome (Autoimmune/inflammatory Syndrome Induced by Adjuvants) refers to a collection of autoimmune-related complaints that arise following the introduction of a foreign substance or material — such as a vaccination, a piercing, or a (silicone) implant. The ASIA syndrome was documented by Israeli immunologist Yehuda Shoenfeld as a pattern of complaints. In the case of breast implant illness, this pattern does not cover the full picture. The ASIA syndrome implies that the immune system is involved, and this has not (yet) been scientifically established. Clients who wish to undergo breast augmentation and in whom multiple allergies or an autoimmune disease are identified during the consultation may have an immune system that responds less well to breast implants. These individuals may therefore have a somewhat higher risk of developing complaints and should carefully consider whether the risks of breast augmentation in their case outweigh the benefits. If you experience symptoms that may be associated with immune system conditions, we advise you to discuss this with your plastic surgeon, internist, or immunologist. Both the Dutch Healthcare and Youth Inspectorate and the American FDA see no reason to ban breast implants, as there is (as yet) no scientific evidence that they pose health risks. Both parties have no financial interest in breast implants and are independent. At Blooming Plastische Chirurgie, safety and transparency are our top priorities. If we had any genuine doubt about the overall safety of breast prostheses, we would of course not offer breast implants to our clients. Every operation carries certain risks, which we discuss during a personal consultation. Should you have any questions following this article, we would be happy to answer them. Send your question to info@bloomingpc.nl. Source: Long-Term Safety of Textured and Smooth Breast Implants https://pubmed.ncbi.nlm.nih.gov/29040370/ Surgical leaflet for silicone breast implants NVPC