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.
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