Silicone Implants
Silicone breast implants have been in use for over 40 years now and have changed greatly in design and safety over this time.
There are many different manufacturers of silicone implants whose products are used in the UK without restriction. They must be CE-marked. There are over 10000 breast augmentation operations per year in the UK, and these are dominated by the use of silicone implants in over 80% of cases.
Women who udergoe breast augmentation with silicone implants whould have appropriate advice as recommended by the Department of Health. As cosmetic surgery is an intervention that is to cause a change as opposed to treat a disease, it is vitally important to have accurate and detailed information before making any decisions on surgery.
Independent Expert Groups working on behalf of the Department of Health have now investigated the risks associated with silicone gel breast implants. The Independent Review Group concluded that the risks were no greater than for other implants, such as hip joints. The latest update summarises the key issues.
Known potential complications
The consultation with your breast surgeon should detail relevant potential complications. Every medical intervention carries some risk.
Capsular contraction forms around some implants and can alter the aesthetic appearance and cause discomfort when it is pronounced. There are reasons why capsulation may be more common in some patients, and with the use of some types of implants over others and these should be explored with your Breast Surgeon.
Loss of nipple sensitivity occurs is some individuals and seems to be more common with large augmentations.
Implant rupture used to be much more common with an increase in occurence over time. It is certainly less common now with the modern design of implants and as long as a high cohesive silicone implant is used (as opposed to runny gel) there is less risk of silicone migration if rupture occurs. In a recent publication that reviewed women with modern high cohesive silicone impants that had been in place for 10 years, MRI was able to detect silent ruptures in under 10% of patients who were usually free of symptoms. However reoperation must always be considered likely in a patient's lifetime after breast augmentation- it should not be assumed that breast implants will last indefinitely. Silicone oils can "bleed" through the silicone implant's outer elastomer shell. This occurs less commonly with high cohesive implants and with manufactures who design implants with a barrier layer.
The systematic reviews have explored the research on autoimmune diseases and have reached a consensus conclusion that there is no evidence of a causal link between the implantation of silicones and connective tissue disease.
Systematic reviews:
1) UK Department of Health review, 1992. This review by the Independent Expert Advisory Group concluded that there was no evidence of an increased incidence of connective tissue disease associated with silicone gel breast implants.
2) UK Department of Health review, 1994. The Medical Devices Agency, which is now called the MHRA (Medicines and Healthcare products Regulatory Agency) concluded that results from clinical or scientific studies did not demonstrate an increase in the incidence of connective tissue disease in implanted patients, compared with the unimplanted population as a whole.
3) Independent Review Group (IRG), 1997. The IRG reviewed the evidence relating to the possible health effects associated with silicone gel breast implants and examined the issues relating to pre-operative patient information. The IRG concluded that silicone gel breast implants are not associated with any greater health risk than other surgical implants, and that silicone induces a conventional biological response, rather than an unusual toxic reaction. The group also made a number of recommendations regarding the provision of information to, and the follow-up of patients. Their report was published in July 1998 and is available on the IRG website at www.silicone-review.gov.uk. The IRG met again in April 2004 and felt the conclusions reached in 1998 remained unchanged.
4) The Committee on Carcinogenicity, carried out a review on behalf of the Department of Health between 1989 and 1990 and concluded, that the possibility that silicone gel implants would induce local tumours in humans was remote.
5) The IRG report also stated that "analyses of large groups of women both with and without breast implants have shown that there is a slightly reduced incidence of breast cancer in women with breast implants. Studies looking at the incidence of other cancers have failed to demonstrate a statistically significant increase among women with breast implants.”
Systematic reviews carried out in other countries
Other detailed independent scientific reviews have been carried out in the USA (US National Science Panel, 1997-8, and Institute of Medicine, 1999), Canada (Canadian Expert Advisory Committee review, 1992), France (ANDEM, 1996), and the Scientific Technical Opinions Assessment (STOA) report commissioned in Europe. The conclusions reached were the same as the UK reviews that there is no evidence of a causal link between the implantation of silicones and connective tissue disease.
Other types of Implants
Many different substances have been used for breast augmentation. Many are now of historical interest, some have been previously used and now abandoned, whislt a few remain in current useage.
Saline Implants
Saline-filled breast implants consist of an outer silicone elastomer layer which is called the shell. This contains the saline solution (salt water). This type of implant was popularised in the USA during the period of the silicone implant ban. Since the refinement and further development of silicone implants the saline implant has diminished. However this product can be used and the specific disadvantages and advantages should be explored with your breast surgeon. Rupture of a saline implant is noticeable by the sudden decrease in size of one breast, caused by the escape of the saline which is absorbed in the surrounding tissue.
Polyurethane-coated breast implants
These implants are available in the UK. They consist of a silicone elastomer shell filled with silicone gel. The shell is coated with a polyurethane foam which gradually breaks down. These implants were banned in the UK in 1991, following concerns about the possible carcinogenic risk from the polyurethane product, but further review conculded that the risk was very small and in April 2005, the manufacturer of one type of polyurethane-coated breast implant reintroduced them to the UK. The possible advantages and disadvantages of this type of implant can be discussed with your breast surgeon.
Hydrogel and Trilucent implants
Both types have been withdrawn and are unavailable for use in the UK. If a patient has a concern that she may have one of these implant types still, she should be reviewed by a Breast Surgeon.