SIRG minutes - 2 April 2004

Silicone Gel Breast Implants: Independent Review Group
Meeting of 2nd April 2004 Hannibal House, Elephant and Castle, London

Present:
     Professor R Sturrock (Chair) (RS)
     Professor A Cooke (AC)
     Professor V Harpwood (VH)
     Dr I Kimber (IK)
     Professor D London (DL)
     Mr T Milward (TM)
     Ms K Murphy (KM)
     Ms N Ratcliffe (NR)
     Professor A Silman (AS)

Apologies:
     Professor A Silman (AS)
     Professor R Walker (RW)

Secretariat:
     Dr S Bourne
     Miss K Hopkins
     Dr S Ludgate
     Mr M Ridgway
     Mr J Tinkler

MHRA
     Dr S Costigan (item 7 only)

Other
     Alison Clements (AC1: item 5 only)
     Penny Wood (PW; item 5 only)
     June Warden (JW; item 5 only)

1. Welcome
The Chairman welcomed members of the Group.

2. Minutes of the last meeting [SIRG(04)02]
The minutes of the last meeting (held on the 22 November 2002) were agreed as a correct record of the meeting. It was noted that all action points are on the present agenda. No additional action points were identified.

3. Matters arising
There were no matters arising that were not on the agenda for the present meeting.

4. Update on the recommendations from the Independent Review Group report [SIRG(04)03]
The Secretariat introduced this agenda item. It was noted that there had been a general plateau in progress since the last meeting. Each recommendation was then individually discussed.

Recommendation 1. Department of Health (DH) information booklet was published in October 2000, then revised and reissued in April 2002. It is available from MHRA and on the DH website. MHRA received occasional requests for this booklet. No further action is planned.

Recommendation 2. It was reported that this recommendation has proved difficult to progress further because of advertising standards.

Recommendation 3. It was reported that Clinical Guidelines for breast implant surgery have been developed. They are now being implemented and promoted by BAPS and BAAPS. The Secretariat informed the Group that these guidelines had only recently been finalised as the process was prolonged by professional body consultation. A final version of the guidelines will be circulated to members of the Group by the Secretariat and a copy placed on the IRG website.

Recommendation 4. It was noted that best practice guidelines were addressed in the Clinical Guidelines discussed under Recommendation 3. It was reported that there has been reluctance to develop a specific form for breast implants, and this recommendation has been partly superseded by the UKBIR (UK Breast Implant Registry, formerly known as the National Breast Implant Registry (NBIR)) form. There was some discussion on this matter between the group and it was noted that the UKBIR form seems to be used in cases where the potential for litigation exists.

Recommendation 5. It was noted that the Commission for Health Improvement (CHI) became the Healthcare Commission on 1st April 2004. The work of the IRG fed into the Care Standards Act. It was noted that some clinics closed down as a direct result of the Act.

Recommendation 6. It was reiterated that compulsory registration with the UKBIR is not possible. The new consent form, which requires the signatures of both the surgeon and the patient, was introduced in March 2002. The new form appears to have had an adverse effect on number of registrations received, as it has been difficult to get all the signatures required. The form has now been changed so that it does not specifically need a surgeon's signature. It was agreed that this recommendation has been progressed as well as can be expected, although there was some discussion that DH may have been overcautious in its application of the Data Protection Act.

Recommendation 7. The Secretariat informed the Group that mHRA had published a "Current Issues - Breast Implants" document in September 2003, which included advice to clinicians on reporting adverse events to MHRA. It was noted that it had been distributed through the Professional Bodies and was also available on the MHRA website.

Recommendation 8. It was noted that the pilot study, which has been using data from the UKBIR will be reporting its preliminary findings later in the meeting.

Recommendation 9. It was reported that a paper on mammography was added to the IRG web site in October 2002. It was also noted that newer technology may have some relevance in the long term.

There were no further comments or questions on the recommendations from the IRG report. It was agreed that the table listing the IRG recommendations and progress made with them will be updated and placed on the IRG website.

5. Report on research - Sue Moss [SIRG(04)33]
The Chairman introduced Alison Clements (AC1) who then presented the findings of a feasibility study for using the UKBIR to study outcomes associated with silicone gel breast implants. The group had looked at a wealth of data and reported finding discrepancies between the questionnaire responses of women and the information recorded in their hospital notes. It was noted that in the NHS there is no regular review structure for patients with breast implants, although women who had undergone breast reconstruction following mastectomy were followed up in cancer clinics. The main points from this presentation were that:

• many women do not seek help when problems become apparent, although it was noted that this could be for a number of reasons;
• there is still a lack of awareness of expectations following implantation amongst women for example with respect to the lifetime of the implant or the need for further surgery. However it was stated that the women interviewed in this study were implanted before recommendations of the IRG were implemented, particularly those about provision of information and advice to women considering breast implants.
• the problems seem to be moving away from silicone health related issues, but that this does not mean that other (psychological) issues should be ignored.

The Group discussed the study findings at length. Some concern was expressed that the population of women used in the study was selective. The Group was also concerned that the study had found that some women would not seek breast cancer examination if they had to tell the radiologist that they had a breast implant. This was considered in the light of difficulty experienced by some surgeons in getting patients back for follow-up appointments. It was noted that a contributory factor could be public perception of breast implants.

The Group concluded that this study contains important information and agreed that it should be written up for publication. The Department of Health and MHRA will discuss with researchers on how to conclude this study and report their findings.

6. Scientific papers [SIRG (04)05 to SIRG (04)32]
Members presented summaries of their findings from the papers they had reviewed, which included recently published or submitted scientific papers. Details of the reviews and the papers can be found in the annex to these minutes.

7. Platinum toxicity review - [SIRG(04)34(summary) SIRG(04)41(full review)]
The Chairman outlined the background to this paper which was produced, at the IRG's request, in response to questions raised during the Open Day. The report was introduced by its principal author, Dr Sandra Costigan, an MHRA toxicologist. The Chairman and members agreed that it was an excellent report and that the information was reassuring. Specifically, it provided valuable information concerning the chemical nature and toxicity of the relevant platinum compounds, estimated exposure to them and accurately assessed the resulting risk. Members outlined and endorsed the content of the report, concluding that the platinum compounds used were relatively benign and that there was no concern over immunotoxicity. The worst case estimate for exposure was several orders of magnitude lower than that expected to cause harm to health. The IRG concluded that the presence of platinum compounds in breast implants does not represent a risk to human health.

A discussion followed on how this information should be disseminated and it was agreed that this should be via the IRG website. In view of the detailed technical nature of much of the information contained in the full report it was noted that this would have to remain restricted. The IRG agreed that the summary report provided by MHRA, together with a record of the preceding discussion would form a suitable basis for a publication on the website.

8. Analysis of adverse events [SIRG(04)35]
An overview of the adverse events reported to MHRA involving silicone gel breast implants was presented. It was noted that there are interrogation of large numbers of records can be difficult because the MHRA database is designed to suit all problems with all medical devices. However some changes are in progress that will allow easier capture of information relevant to breast implant incident reports. It was noted that recently there has been a plateau in the number of reports received and that the majority of reports now come from breast implant manufacturers through Vigilance reporting, with less incidents being reported by members of the public and implanting centres. The IRG discussed some details of the reports and the way that data is stored. The Chairman concluded that this is a situation that MHRA will continue to monitor.

9. Regulatory issues
a) Reclassification of breast implants in Europe [SIRG(04)36]
With effect from 1st September 2003, breast implants have been reclassified from medium/high risk (Class IIb) to high risk (Class III) under the Medical Devices Directive (93/42/EEC). Breast implants placed on the market for the first time will now be more stringently assessed before being CE marked and will require pre-market clinical data. Manufacturers of models of breast implants that are already available in Europe had until March 2004 to comply with these new requirements.

b) European National Measures relating to breast implants [SIRG(04)37]
A MEDDEV document was produced by the European Commission in February 2003 outlining specific measures to ensure the safety of breast implants. This document goes further than the Standard. The Group agreed that this is a very useful document and that much of it is based on the recommendations of the IRG. The Group also discussed whether clarification is required on whether or not registration of breast implants is compulsory.

c) FDA decision on use of silicone breast implants in USA [SIRG(04)38]
The Secretariat updated the Group on the FDA decision to retain the ban on silicone breast implants in the US. The expert panel vote was split 9 to 6 in favour of rescinding the ban on silicone gel breast implants, but the FDA ruled that the existing ban should remain. It was noted that the FDA came under pressure from women's groups, amongst others, who believe that silicone breast implants should not be returned to the market.

10. Correspondence from interested parties
a) Communications from a Member of the Public and her MP [SIRG(04)39]
The Secretariat informed the Group that MHRA has communicated with a member of the public and her MP on a number of occasions regarding her concerns. It was noted that this member of the public has quite a high public profile and has appeared on television programmes. She also runs a website with details of her own case and the experiences of other women.

b) Other [SIRG(04)40]
Requests for copies of the 1998 report of the Independent Review Group are still being received. 274 copies have been requested and distributed since the last IRG meeting.

IRG members and the Secretariat confirmed that no other related correspondence has been received since the last meeting.

11. The future of the IRG
The Chairman proposed that this would be the last meeting of the IRG. He stated that it is clear from the papers reviewed and from the lack of correspondence received by the Group that there are no continuing issues. The Secretariat and Chairman confirmed that Ministers have been informed and that the Department of Health is content for the Group to disband as long as they can reconvene in the future if the need arises. The Group agreed with the Chairman's proposal that this should be the last scheduled meeting of the IRG.

12. Website
The Secretariat informed the Group that the IRG website is still live, however it was noted that some of the links on the website were not working correctly. These problems are attributable to changes being made to the Department of Health website.

The future of the website was discussed in the light of Agenda Item 11. The Group agreed that the website would be updated with the minutes (and annex) of this meeting as well as remaining papers such as that for the platinum study and clinical practice guidelines. After these updates the website would remain live but no further changes would be made, unless any critical issues came to light or the Group reconvened.

13. Any other business
The Chairman gave a summary of the Groups activities over the last 7 years and thanked the members and Secretariat for their work. The meeting concluded.

April 2004: Annex:
Recently published literature : summaries provided by IRG members

Silicone Gel Breast Implants and Connective Tissue Disease - a Comprehensive Review. EranBar Meir, Michael Eherenfeld & Yehuda Shoenfeld. Cutting Edge Reports from http://www.rheuma21st.com [SIRG(04)05]
Epidemiology data presented does not support a significant association with autoimmune disease and silicone. The authors quote from their own work, which is unpublished and reference Tenenbaum's work, which has been previously reviewed by the IRG. The authors conclude that there is an immunogenic link in some women, thus women should avoid silicone gel breast implants if they have a family history of autoimmune disease. However, this conclusion is justified by the data presented. It was noted that there is a theoretical possibility for silicone to bind some MHC types although there is currently insufficient data to test this hypothesis. It was commented that there is some emerging data concerning fibromyalgia, but overall this paper does not add anything new to the debate and is based on unpublished work. Furthermore, the link between the antipolymer antibody and silicone is tenuous. Moreover, nickel is not a good precedent for an immunogenic link study.

Suicide Among Women with Cosmetic Breast Implants: A Review of the Epidemiological Evidence. Joseph K McLaughlin, Loren Hipworth, Robert E Tarone. Journal of Long Term Effects of Medical Implants 13(6)445-450 (2003) [SIRG(04)06]
This is a US review of evidence that mortality rates due to suicide are higher in women who have had cosmetic breast implants. There is good evidence that there is a significant increase (based on 95% confidence levels) in suicide risk in women with implants when compared with the general population. This is based on four key scientific papers from studies carried out in US, Sweden, Finland and Denmark. These show between a 2- and 3-fold increase in suicide risk. However, increased incidence of suicide is the only effect that can be supported by current evidence; current research cannot determine the causation link with any degree of certainty. So, for example, there might be an increased prevalence of underlying psychiatric disorders in women seeking breast augmentation. There is some evidence to show that women who undergo cosmetic breast implantations are different from women that do not (i.e. more likely to smoke, higher alcohol intakes etc), and these might influence suicide rates. But characteristics of women with implants are not consistent and the authors critique some of the evidence (low response rates, self-selection, etc).

The authors call for urgent studies of causation; stressing the importance of more research looking at the psychiatric status of women who chose to have breast implants. These studies are going to be difficult to conduct in practice, and this is acknowledged by the authors. Access to data is a huge problem (raising issues around the availability of such data in the first place and then the problems concerning consent, confidentiality and privacy of sensitive information). Countries such as those in Scandinavia were pinpointed as where unique nationwide data registries exist to make this possible. The situation in the UK is not discussed. However the implications for the UK, particularly those relating to Data Protection law and access to relevant data (i.e. psychiatric, hospital discharge, family history etc) could be a problem.

Epidemiology of Silicone-gel breast implants. Lori Brown. Epidemiology vol 13 no 13 s34-s39 [SIRG(04)07]
This is a very brief overview of the current literature on the risk, particularly of connective tissue disease, following silicone-gel breast implantation. The review concludes, consistent with the results of several other reviews, that silicone-gel breast implants neither increase or decrease the risk of either auto-immune disease or breast cancer but there was need for further work on rates of rupture.

Silicate Antibodies in Danish women with Silicone breast implants. B Jansen et al. Rheumatology 2003;42:1032-1035 [SIRG(04)08]
It is recognised that antibodies can be detected in the serum of women with silicone breast implants. These antibodies to silicone might indicate the body's response to implanted silicone but the question of importance remains is do they also increase the likelihood of physical illness? To address this question 186 women from a Danish population-based implant registry and appropriate controls (women who were receiving other breast surgery or no breast surgery) were then stratified into those with or without evidence of musculoskeletal and/or related syndromes. In brief there was no evidence of an association between the presence of symptoms and the presence of silicate antibodies in women who had received a breast implant. Furthermore, there is no evidence the level of antibodies was higher in women who had received the silicone gel implant compared to those who had not. The authors emphasise that it is possible to raise antibodies to silicone from other sources of silicone, either from medical devices or indeed other environmental exposures including food stuffs, water and talc. The authors conclude that the clinical significance of these antibodies in women with implants is questionable.

Long-term exposure to silicone breast implants does not induce antipolymer antibodies. Wim H De Jong et al. Biomaterials 25(2004) 1095-1103 [SIRG(04)09]
&
Study to determine the presence of antipolymer antibodies in a group of Dutch women with silicone breast implants. W H De Jong et al. Rheumatology 2002;20:151-160 [SIRG(04)13]
Both of these articles were carried out by the same research group and looked at a large group of women identified from the implant Registry. The researchers studied validity of anti-polymer antibody assay that is based on a tenuous link between this antibody and silicone. The authors had tried very hard to establish any link and the study has been well executed however a link was not found. This is an important study particularly in the context of the work of Tenenbaum.

Incidence of Silicone Breast Implant Rupture. Lisbet R et al. Arch Surg 2003;138:801-806 [SIRG(04)10]
This is a helpful and well-designed study adding to the information on the incidence of rupture in silicone gel-filled breast implants.

In 1999, 271 women randomly chosen from a larger cohort underwent a baseline MRI scan of their implants with a second MRI scan being performed in 2001. They estimated that for modern third generation implants, 98% are rupture-free at five years and 83 to 85% are rupture-free at ten years. Double-lumen implants had a significantly lower rupture risk than single-lumen ones. They conclude that the risk of implant rupture increases with implant age. It is not clear from the article whether "intra-capsular rupture" or "possible rupture" was confirmed by explantation or was purely judged on examination of the MRI scans.

Regulating human implant technologies in Europe - understanding the new era in medical device regulation. Julie Kent, Alex Faulkner. Health, Risk and Society, Vol 4, No. 2, 2002. 189-209 [SIRG(04)11]
This article focused on the withdrawal of two types of implant - the capital hip implant and the Trilucent breast implant - in the broader context of European regulation of medical devices.

Most of the article is descriptive and historical but the analytical contention of the authors is that risks are socially derived and that this in turn requires analysis of the politics of knowledge, here defined as "the recognition that competing rationalities of scientific and social rationality shape regulatory processes". After providing an overview of the way in which regulation has developed in the European context, the authors conclude that commercial interests frequently dominate regulatory policy in the EU and that generally regulation of medical devices is weak but there are moves towards a more consumer orientated perspective on regulation.

The article is sociological in approach and discusses various academic approaches to the determination of risk. It recommends a more comparative approach to regulation across European states to identify degrees of policy convergence and divergence. The authors state that the difference between the two forms of implant was that the hip implant was not regarded as a public health policy issue at European level.

In summary, the article is predominantly descriptive, and simply reconceptualises what is already known about the regulation of implants, offering few new insights into the issues surrounding regulation of the two medical devices under discussion.

Lay experts and the politics of breast implants. Julie Kent. Public Understanding of Science. 12 (2003) 403-421 [SIRG(04)12]
The author of this article approaches the subject of breast implants in the US and the UK from a gender prospective and reformulates in terms of the politics of knowledge, as in the article discussed above, the familiar arguments about the use of scientific expertise to undermine women's accounts of their experiences of their bodies and illness. She argues that the distinction between lay and expert accounts has been shown to be an oversimplification of the issues. The argument is that the women with implants have been doubly disadvantaged in the policy debate as both consumers and women. The disadvantage stems in part from the fact that women are seen as psychologically weak and incapable of rational debate.

The article is essentially descriptive and provides an overview of the existing literature but offers little by way of fresh insights or evidence. There is little reference to or analysis of the scientific research, particularly the epidemiological studies that underpin the stance taken by many governments, only criticism of the way in which it has been used in the debate. The author appears to disparage scientific experts in order to further her arguments in support of women's own experiences of their suffering. The article is lacking in rigorous legal and scientific analysis and makes the rather specious point that because some expert opinion has been increasingly challenged, lay knowledge should be given greater prominence. While it is of course accepted that experts can be fallible, this does not of itself support the stance taken by the author, who has not explored the experiences of transsexuals in relation to breast implants. Many of the examples of scientific incompetence selected by the author, such as BSE and organ retention, are surely not susceptible to gendered analysis in any event. The choice of instances of scientific fallibility does not assist the author's case. Ultimately, she fails to distinguish between sound scientific studies of breast implants, and more cursory expert evaluations in other areas of science, simply in order to support her ideological stance.

Rupture of a Silicone Gel Mammary Prosthesis and Amyloidosis: A Case Report. Ufuk Emekli et al. Aesthetic Plastic Surgery. 26:383-387,2002 [SIRG(04)14]
This is a case report of a 45 year old woman who had silicone gel-filled breast implants inserted nineteen years ago with an untreated rupture of the implants occurring five years ago, who developed secondary or reactive (AA type) renal amyloidosis.

The authors point out that secondary amyloidosis is associated with chronic infective diseases such as osteomyelitis and tuberculosis. They report the case without stating whether they feel there is a link between the untreated rupture and the amyloidosis.

Counterfactual Thinking and Quality of Life Among Women With Silicone Breast Implants. Patricia A Parker, Michael S Middleton, James A Kulik. Journal of Behavioural Medicine, Vol 25, No 4 August 2002 pg 317-335 [SIRG(04)15]
This paper looks at the relationship between counterfactual thinking (defined as thoughts about how one's situation might have turned out differently i.e. 'what if…') and psychosocial adjustment and quality-of-life. The paper was of a sample population of 74 women with silicone breast implants. A potential methodological challenge with this sample is that all women were already concerned about the safety of the implants or were experiencing problems. All had sought an MRI scan to assess the implants (in fact, this is how they had been recruited in the first place). This could introduce bias into the findings. 46% had had them removed, 56% were intact. 61% were involved in Class Action, 15% in private litigation and 24% in no litigation - again, variables that may introduce bias. Perhaps not overly surprisingly given this sample of women was that counterfactual thinking was significantly associated with more psychosocial adjustment difficulties, more perceived implant related problems and poorer quality-of-life in the physical domain. The authors congratulate themselves on providing additional insight into this population of women - and providing insight into the adjustment process for other women. No causal links can be made from this study between counterfactual thinking and poorer adjustment and health problems. On a more positive note, the study does add value by identifying physical/psychological distress in this population of women and the need for possible intervention.

Spread silicone to inguinal lymph nodes from a leaking testicular prosthesis: a cause for chronic fatigue? Doherty A P et al. BJU International (2000) 86, 1090 [SIRG(04)16]
A 32 year old man with a silicone gel-filled testicular implant inserted aged 11 presented with symptoms of chronic lethargy typical of ME. He had consulted the Internet and found that patients with silicone prostheses often complained of similar symptoms to his. He requested that his prosthesis be changed for a newer variety as he was concerned that the silicone gel may have leaked. At replacement of the implant (the article doesn't state whether it was ruptured or not) silicone was found in the fibrous tissue of the capsule and in local fleshy inguinal lymph nodes. The authors postulate that the free silicone caused the lethargy.

Biodurability of Retrieved Silicone Gel Breast Implant. Harold J Brandon et al. Plastic Reconstructive Surgery. 2003 2295-2306 [SIRG(04)17]
The authors have investigated the measurements of the mechanical and chemical properties of various types of silicone gel-filled implants and compared them with a control of unimplanted implants.

Their conclusion is that mechanical and chemical degradation of the implant shells following implantation is not the primary mechanism in implant failure. Amongst other mechanisms, they suggest are stresses on the implant shell caused by the surgeon when implanting the prosthesis. This may be a significant cause of weakening the shell.

Safety Concerns about breast implants persist. Roy Moynihan BMJ Vol 327 Oct 2003 p947 [SIRG(04)18]
The author reports that the FDA's panel vote the end the 10 year moratorium on silicone implants by a majority of nine to six. The panel was relying on research involving 940 women using an implant made by a company called Inamed. The study in question found that after 3 years a fifth of the group had already had repeat surgery, although only one percent had experienced a rupture. Various pressure groups are arguing that the panel underestimated safety concerns and that complication rates continue to rise over time. The national Women's Health Network has drawn attention to data in the most recent study indicating that women were suffering from a range of symptoms including muscle pain an fatigue only two years after having implants. These pressure groups are urging the FDA only to allow silicone implants for reconstruction as opposed to enlargement.

Histological analysis of silicone breast implant capsules and correlation with capsular contracture. Wulf Siggelkow et al. Biomaterials 24 (2003) 1101-1109 [SIRG(04)19]
The aim of the study was to compare the long term histological changes occurring around breast implants to clinical data including the Baker score for the degree of capsular contracture.

Capsules from 53 silicone breast implants from 43 patients were examined histologically for the presence of cellular inflammation, silicone leakage, calcification and pseudo-epithelial layer at implant interface. Capsular thickness was determined. 23 implants were smooth surfaced, and 30 textured. 17 had been in situ <1year, 18 1-10 years and 18 >10 years. 27 patients had severe capsular contracture (Baker score 3 or 4), with a much higher frequency with smooth implants, increasing patient age and implant duration. The capsule thickness was greater with increased implant duration and older age at implantation. The extent of synovial like metaplasia decreased with time. The extent of inflammation varied but did not correlate with capsule thickness or implant duration. Greater capsular thickness was associated with a greater presence of silicone in the capsules, but there was no correlation between amount of silicone and Baker score. Capsular thickness correlated to capsule contracture, with both relating to implant duration. They also concluded that the amount of capsular contracture was related to any evidence of inflammation.

Leakage and silicone lymphadenopathy with cohesive breast implant. H Shaaban, S Jmor. The British Association of Plastic Surgeons (2003) 56, 518-520 [SIRG(04)20]
Twelve months after a 44 year old lady had had cohesive gel implants inserted, she presented with an enlarged lymph node in her left axilla. A fine needle aspiration biopsy revealed silicone in the lymph gland and an MRI scan revealed that the left implant had ruptured. Histology of the whole 4cm diameter node showed that it was entirely replaced by silicone particles.

This case raises concerns that the commonly held view that cohesive gel does not migrate and is less likely to leak is not necessarily an accurate view.

Silicon, Silicone and breast implants. Jae Hong Lee, Diana Zuckerman. Paediatrics 2002 Nov. 110(05): 1030 [SIRG(04)21]
This is a letter that addresses confusion about whether reports address silicon or silicone. Authors question statement by paediatricians on breast feeding (silicon in breast milk). Paediatricians are talking about silicon not silicone and it is therefore not relevant to silicone breast implants. Furthermore, the sample size was too small for analysis to be valid.

Self reported diseases and symptoms by rupture among unselected Danish women with cosmetic silicone breast implants. Lisbet R Holmich et al. Plastic and Reconstructive Surgery, Feb 2003 Vol 111 No 2 [SIRG(04)22]
This paper compared self-reported diseases and symptoms and presence of anti nuclear antibodies. No association was found between the presence of anti-nuclear antibodies and silicone gel breast implants apart from excess capsular contracture.

Silicone Implants, Granulomas and chronic infection: a causal relationship? Eric David Austad, Rod J Rohrich. Vol 111 No3/Correspondence [SIRG(04)23]
This letter is a plea to Plastic Surgeons to send silicone granulomas for culture to try and establish if there is any link between silicone granulomas and chronic infection.

This is a worthwhile request to try and clarify whether chronic low grade infection causes silicone granulomas or makes any contribution to capsule contracture.

Incidence of Breast and other cancers among Finnish women with cosmetic breast implants, 1970-1999. Journal of long term effects of Medical Implants, 12(04), 271-279 (2002) [SIRG(04)24]
These authors used the Finnish National datasets to further investigate the question as to whether silicone breast implants are associated with an increased risk of breast and other cancers. The authors compared cancer risk in women receiving an implant in the 30 year period 1970-1999 with the national rates from the Finnish National Cancer Register. There were 2,171 Finnish women who had received an implant during this time period. In general terms the overall cancer incidence was virtually the same as that expected, indeed there is a marginal reduction observed (standardised ratio 0.9, 95% confidence interval = 0.6 - 1.3). Interestingly there was a halving in the incidence of breast cancer (SIR 0.5, 0.2-1.0). The reason for this reduction is not known and it may be due to the selection of women who received a breast implant being at lower risk of breast cancer. The overall numbers of cases of cancer were quite small in this study and thus while there is overall reassurance for some rare sights of cancers it would be necessary to study a vastly larger group of women to either prove a protective or risk effect. These conclusions are consistent with other studies.

Silicone breast implants do not cause rheumatic diseases, but can they influence them? Daniel J Wallace. Arthritis Rheum. Nov;44(11):2477-84.(2001) [SIRG(04)25]
This was a letter examining whether the removal of the breast implants has any affect on the natural progression of rheumatic disease. In 26 patients removal had no effect, in 3 complete serological and clinical remission was seen. It is therefore suggested that removal could affect disease progression, but the evidence is anecdotal. Although it was not considered whether merely having an operation, whether implants were removed or not, could affect disease progression. [Editorial at SIRG(04)30].

Determination of siloxanes, silicon and platinum in tissues of women with silicone gel-filled implants. Daniella Flassbeck et al. Anal Bianal Chem. (2003) 375: 356-362 [SIRG(04)26]
3 subjects and 3 controls were included in this study. This is the first demonstration of platinum and siloxanes leaking into local tissue. Noted that sophisticated analytical techniques can detect small amounts of silicone leakage.

Comments on "Determination of low molecular weight silicones in plasma and blood of women after exposure to silicone breast implants by GC/MS. A.Lee Smith. Anal Chem Vol 74 No 5 March 2001 [SIRG(04)27]
This is a commentary on a paper similar to SIRG(04)26 by a scientist from Dow Corning, who believes that the detection of the leakage cannot be proven. The analysis is flawed as detection of low molecular weight silicones cannot be proved and good controls are needed and contamination has to be removed.

Silicone breast implants what researchers know about SBIs and CTD. Barbara Arthur, Patricia A Janssen. Awhonn Lifelines Vol 4 issue 5 pg 28-32 [SIRG(04)28]
This is a review article by two Canadian nursing specialists. The article is slightly partisan. The authors seem to be slightly disappointed that a distinct association has not been established between silicone gel breast implants and connective tissue disorders. Although this article is not inaccurate, it is perhaps written for a more general audience.

Rupture of silicone gel breast implants and symptoms of pain and fatigue. Vermeulen RC, Scholth HR. J. Rheumatol 2003 Oct; 30(10):2263-7 [SIRG(04)29]
Previous studies have suggested that silicone gel breast implants can rupture, sometimes this may be symptomatic, other times it might only be detected using imaging. One health consequence that has been postulated following silicone-gel breast implant rupture is symptoms related to chronic fatigue and pain. In this investigation, a retrospective questionnaire of 500 female readers of a Dutch silicone implant support group were investigated, asking about symptoms and whether they had or had not had any implants. Of the 176 women who gave data, 131 said that they had been told that their implant was ruptured and 45 said it was intact. Those women who reported a rupture implant, had a higher fatigue score and were more likely to score positive on a whole variety of symptoms including poor memory, chronic fatigue, multi-joint pain and post exertional malaise. It is however very difficult to interpret these findings firstly because the study was retrospective, secondly because the women were aware of their breast implant status which might have influenced the findings and thirdly the respondents to the questionnaire were members of a silicone implant support group and may not be fully representative of a whole population of women receiving implant.

Where there's smoke there's fire: The silicone breast implant controversy continues to flicker: a new disease that needs to be defined. Frank B Vasey et al. The Journal of Rheumatology. 2003 Oct (10) 2092-4 [SIRG(04)30]
Editorial - Symptoms have been seen in women with ruptured implants. The article recommends that a group is set up to review these symptoms. The author does not appear to be aware of the IRG. The article lists symptoms that have already been reviewed by the IRG. The data used are not valid and the author is not justified in recommending the removal of breast implants. This reviewer is not objective and has a history on this subject. the IRG. The group agreed that it is too late to submit a reply or raise correspondence. Questions were raised about whether this editorial has been peer reviewed.

Is Granulomatous thyroiditis a complication of breast implants? Ally P H Prebani et al. Endocrine Pathology. Vol 13 No 13 2002 293-243? [SIRG(04)31]
Case report of 51 year old woman with past history of breast implants for 20 years removed before presentation with 2 year history of thyroid nodule and arthralgia. No evidence of autoantibodies. The thyroid showed focal granulomatous inflammation with occult (<4mm) papillary carcinomas. Lengthy discussion but no direct evidence to link implants with the thyroiditis apart from temporal association.

Comparative examination of complaints of patients with breast cancer with and without silicone implants. Imke Berner et al. Obstetrics and Gynaecology and Reproductive Biology. 102 (2002) 61-66 [SIRG(04)32]
Used a standardised questionnaire and applied it to 96 women with breast cancer (32 with silicone implants, 64 without) to assess frequency of arthralgia/myalgia, dermatological, ophthalmological, oropharyngeal changes, complaints in extremities. Implants were monitored by MRI and presence of Raynaud's phenomenon was determined where appropriate.

There was no difference in the frequency of arthralgia/myalgia in the two groups and no correlation between silicone implants and "chronic fatigue syndrome". There was a positive correlation (p = 0.02) between implant rupture and numbness/tingling in extremities but it was concluded that many of the symptoms occurring related to age regardless of silicone implant or underlying disease.

Silicone breast implants still available in the UK. Clare Dyer. BMJ Vol 327; 25 Oct 2003
In this news report Clare Dyer briefly summarises the legal position concerning breast implants in the UK and mentions the findings of the IRG. This is a short article in which she states that the IRG did identify chronic low-grade infection as a possible explanation for some symptoms, but repeats the findings of the IRG that "implants carry no increased risk of connective tissue disease or of an abnormal inflammatory response".