Health risks of silicone breast implants

The present advisory report, produced at the request of the Minister of Health, Welfare and Sport, has been drawn up by the Committee on Silicone Implants of the Health Council of the Netherlands.

Between one and two million women world-wide have silicone breast implants. Approximately 80 per cent of them have undergone implantation for the purposes of breast enhancement, while the remaining 20 per cent have done so following the removal of breast tissue due to breast cancer or other conditions. The first reports about a (possible) connection between silicone breast implants and autoimmune diseases appeared in the 1980s. Due to the concern aroused by these reports and the uncertainty over the safety of implants, the US Food and Drug Administration (FDA) decided in 1992 to impose restrictions on the use of implants in the United States. This ruling, combined with the legal dispute that erupted in the United States between (lawyers of) women with implants and implant manufacturers, led to an increased polarisation of opinion on the safety of implants.

There are estimated to be between 25,000 and 30,000 breast implantees in the Netherlands. Among them are women with severe health problems which they attribute to their implants.

Based on the scientific literature, the Committee concludes that there is unlikely to be a connection between silicone breast implants and autoimmune diseases. These disorders are just as prevalent in women without implants. The Committee expects that it is not possible to set up further epidemiological research into autoimmune diseases that adds anything to the knowledge that is already available on this subject.

Some researchers report an increased autoimmune reactivity in implantees. The Committee regards autoimmune reactivity as a normal phenomenon and autoimmune disease as the degeneration of this phenomenon. The Committee is at present uncertain as to what value should be attached to the above reports. It expects that research with a long follow-up and involving larger groups of implantees with an increased autoimmune reactivity may provide a definitive answer to this question.

The Committee has found no indications of an increased risk of cancer in women with breast implants, nor of a delay in the detection of breast cancer. Because it is not possible to inspect all of an implantee’s breast tissue using standard mammography, the Committee supports the Dutch Radiological Society (NVvR) initiative which aims to optimise the screening of implantees. In view of the fact that the majority of implantees are young women, the Committee attaches particular importance to long-term screening of women with implants.

The percentage of damaged implants that are revealed by research into local complications is high. The fact is, however, that the results from this type of research are generally distorted by selection during the formation of trial groups. The Committee advocates a nation-wide registration and careful follow-up of all implantees, the aim being to identify damage to implants at the earliest possible stage. This may also provide more reliable data about implant failure and its consequences.

The Committee views the formation of fibrous capsules and capsular contracture as normal reactions to the placement of the implant. Nevertheless, it considers capsular contracture, in particular, to be important, since this phenomenon frequently necessitates reoperation. Here too, the proposed registration and follow-up of implantees will provide more accurate data. Further research is required into the cause of capsular contracture. This may give rise to potential prophylactic treatments for implantees.

The Committee considers it essential that potential silicone breast implantees should be furnished with adequate information. Individuals can only decide on whether or not to undergo breast implantation after they have been fully informed. It is not only the established potential side effects and risks that need to be discussed during this information process, but also — with care being taken to mention the shortage of scientific evidence — those side effects which are unproven, but have nevertheless been experienced by some patients and attributed to silicone implants. The Committee notes that the information leaflets which it has examined do not systematically consider all of the aspects which it regards as important.

The scientific literature does not demonstrate any connection between breast implants and the severe health problems which some implantees associate with them. Nevertheless, the Committee advocates the adoption of a serious approach with regard to implantees who are experiencing problems, which must be aimed both at alleviating the problems and discovering what has caused them.