Better Breasts

Local complications and known risks

Complications, such as capsular contraction or loss of sensitivity, have long been known to be associated with breast implantation, although good information on the incidence of such problems is lacking. The possibility of these complications should be fully explained to patients by their surgeon before surgery.

There is also a possibility of rupture of the implant, which will normally necessitate reoperation. Some early implants are known to have remained intact for over 30 years, but the actual lifespan varies greatly with the circumstances; it should not be assumed that breast implants will last indefinitely.

The technique of "closed capsulotomy" which has been used to relieve capsular contracture, is known to increase the chance of rupture and is not recommended by manufacturers. Silicone gel can be released into tissue on rupture of implants and silicone oils can "bleed" through the silicone elastomer shell.

Speculated risk: autoimmune disorders

In response to concerns raised over the last fifteen years over the safety of breast implants, particularly regarding the possibility of long-term immunological effects, a number of reviews have been carried out by MHRA and independent bodies. These systematic reviews 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:

UK Department of Health review, 1992
This review by the Independent Expert Advisory Group (IEAG), set up by the UK Department of Health, concluded that there was no evidence of an increased incidence of connective tissue disease associated with silicone gel breast implants. They did, however, recommend that a registry of implanted patients should be set up because of the general anxieties raised. Their report was published in 1993 and is available in full.

UK Department of Health review, 1994

A second analysis, reviewing scientific papers written on the possible link between silicone gel breast implants and connective tissue diseases, was prepared and published by the Medical Devices Agency (now MHRA). The review 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. The report was published in 1994 and is available in full.

Independent Review Group (IRG)

The IRG was set up by the Chief Medical Officer in 1997 to review the evidence relating to the possible health effects associated with silicone gel breast implants and to examine 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 website contains further information and more detailed discussion of certain aspects of the review. It also contains references to the literature considered by the IRG, the minutes of the IRG meetings held since December 1998 and the IRG’s analyses of scientific papers published after the IRG report. The IRG held their last meeting in April 2004 when they concluded that there was no reason to change any of the conclusions reached in 1998. The group will meet again if significant new evidence on the safety of silicone gel breast implants comes to light.

Systematic reviews carried out in other countries

Similar reviews have been carried out by groups outside of the UK including Canada (Canadian Expert Advisory Committee review, 1992), France (ANDEM, 1996), USA (US National Science Panel, 1997-8, and Institute of Medicine, 1999), and the Scientific Technical Opinions Assessment (STOA) report commissioned by the European Parliament. A clear consensus emerged from these independent scientific reviews that there is no evidence of a causal link between the implantation of silicones and connective tissue disease.