Silicone breast implants: correlation between implant ruptures, magnetic resonance spectroscopically estimated silicone presence in the liver, antibody status and clinical symptoms

D. T. Sharpe

Plastic Surgery Unit, Bradford Royal Infirmary, 9 Duckworth Lane, Bradford BD9 6RJ, UK

The controversy regarding the potential harmful effects of silicone from breast implants has been raging for over 10 yr. During this period this has led to a great number of medical papers, many of which had political, social and legal bias. Indeed at the height of the controversy, despite being peer reviewed, many papers were published that came from two clearly identifiable camps. On the one hand the rheumatologist with a legal vested interest and Food and Drugs Administration (FDA) employees anxious to justify their position, and on the other hand plastic surgeons backed by breast implant manufacturers with a clearly financial vested interest.

At last, however, we are beginning to see papers which are soundly based on epidemiological studies of enormous size [1] and studies based on the life expectancy of the modern breast implant [2].

It is still quite difficult, however, to sort out the truly neutral paper from the biased cohort of patients assembled via attorneys with claimed medical injuries. Equally plastic surgeons and implant manufacturers in the past have been guilty of bland assumptions of no harm based on little more than anecdotal evidence and poor audit of results.

A clear pattern is beginning to emerge. First of all, there is no clear silicone-induced connective tissue disorder associated with breast implants and this has been established by independent agencies such as the American Medical Association, the Independent Review Group, the Institute of Medicine and Judge Pointer's Scientific Panel.

Local complications and symptoms due to capsular contracture, localized silicone leakage and the deficiencies of the implant shell causing palpable irregularities have become the main issues. Rheumatologists, I am sure, will agree that there is a group of women, typically of the age range of Gaubitz's paper [5], who suffer from vague aches and pains, lethargy and depression, that has coincidentally become associated with the presence of breast implants, which has given rise to the concept that silicone gel can cause a multiplicity of symptoms. The scientific evidence for the connection is such that silicone gel could be regarded as just as likely to protect against these symptoms as responsible for causing them, yet the very vagueness of these symptoms should not necessarily be a reason to dismiss them. An investigator should be ever vigilant to ensure that silicone itself, or the associated factors of its implantation into the body, does not indeed cause some pathology of sort.

Gaubitz's paper [5] is notable in that it demonstrates quite clearly that silicone does leak from breast implants, that 54% of women having ruptured implants have detectable silicone in the liver, as well as finding it in the livers of 22% of patients who did not have a ruptured implant. Control patients, who for many years have had renal dialysis using silicone tubes, did not appear to show evidence of deposition in the liver. The mechanism whereby this silicone is transmitted is not due to the soluble nature of silicone, which is hydrophobic, but to the phagocytic engulfment of minute droplets of silicone in and around the breast capsule which are transported via the natural lymphatics and bloodstream to the liver where death of the macrophage leaves a minute droplet of silicone. Over time this accumulation can clearly be demonstrated by stimulated echo acquisition mode (STEAM) magnetic resonance (MR) spectroscopy.

The paper [5] also shows that antinuclear antibody (ANA) positivity is no indication of ongoing autoimmune process in women with silicone breast implants, as the rate of ANA positivity was comparable in the control group of breast cancer patients and those with hormone substitution. Twenty-four patients (26.6%) had MR documented implant rupture. MRI scan is the investigation of choice for determining the intact status of silicone gel breast implants [3]. However, the average age of implants investigated was over 9 yr, and this means that the majority of these would belong to a second generation of implants, i.e. those with a thinner shell which have a much higher incidence of rupture compared with the modern third generation implants with a low incidence of rupture [4]. There is, however, no evidence that the modern third generation of implants does not still leak significant amounts of silicone and one cannot assume that, were the study to be performed on patients with modern implants at a time equivalent to 9 yr following implantation, that a similar incidence of hepatic silicone would not be found.

However, the main conclusion of Gaubitz's paper [5] is in my opinion valid in that it finds no difference between the incidence of hepatic silicone in both ruptured or non-ruptured implants. Fifty per cent of the patients who underwent the implantation of breast implants were post-mastectomy patients and in this case the implants were placed under the muscle and are more subject to trauma and a much higher incidence of rupture [4]. This would also account for the patients with nodules and wrinkling localized close to the silicone breast implant as the absence of breast tissue overlying the implant makes these findings more easy to detect [4]. The high incidence of complaints of arthralgias, myalgias and tingling and numbness of the fingers which appeared in the questionnaires of the 90 patients of this study may be accounted for by the fact that nearly 40% of the women were members of an association of ‘silicone damaged women’. This must indicate a degree of selection bias as in the UK the membership of similar groups is of the order of a thousand compared to a total population with implants of approximately 250 000. I would be a lot more comfortable in assessing the validity of Gaubitz's paper [5] if I knew precisely which criteria were used for patient selection, and whether patients were selected from a large cohort of breast reconstruction and augmentation patients taken at random.

Overall the paper is reassuring to those of us still using silicone gel breast implants as it shows that the obvious psychological and self-esteem benefits of the use of silicone breast implants in post-mastectomy patients and those wishing for augmentation are not counter-balanced by a significant morbidity of patients suffering from the effects of silicone damage. It does, however, point to the need for establishing the true benefits to patients of breast reconstruction and augmentation in each case, so that these can be properly juxtaposed against potential harm and long-term effects. No one should have breast implants as a fashion accessory, equally the ability to rebuild and enhance the sexuality of disadvantaged women is a choice that must remain open in a free society.

References

  1. Hennekens CH, Lee IM, Cook NR et al. Self-reported breast implants and connective-tissue diseases in female health professionals. J Am Med Assoc1996;275:616–21.[Abstract]
  2. Peters W, Smith D, Lugowski S. Failure properties of 352 explanted silicone gel breast implants. Can J Plast Surg1996;4:55–8.
  3. Dobke MK, Middleton MS. Clinical impact of breast implant magnetic resonance imaging. Ann Plast Surg1994;33:241–6.[ISI][Medline]
  4. Collis N, Sharpe DT. Silicone gel-filled breast implant integrity: a retrospective review of 478 consecutively explanted implants. Plast Reconstr Surg2000; 105:1979–85; discussion 1986–9.[ISI][Medline]
  5. Gaubitz M, Jackisch C, Domschke W, Heindel W, Pfleiderer B. Silicone breast implants: correlation between implant ruptures, magnetic resonance spectroscopically estimated silicone presence in the liver, antibody status and clinical symptoms. Rheumatology2002;41:129–35.[Abstract/Free Full Text]




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