SIRG minutes - 23 May 2002

Silicone Gel Breast Implants: Independent Review Group Meeting
23 May 2002, Hannibal House, Elephant and Castle, London

Present:
     Professor R Sturrock (Chairman)
     Professor A Cooke
     Professor I Kimber
     Professor D London
     Ms K Murphy
     MS N Ratcliff
     Professor R Walker

     Professor A Silman (teleconference agenda item 8 only)

Apologies:
     Mrs V Harpwood
     Mr T Milward

Secretariat:
     Dr A Austin
     Mr G A Crosbie
     DR S Ludgate
     Ms L Robery
     Mr J Tinkler

1. Welcome
The Chairman welcomed members of the Group and introduced Professor Cooke, who gave the Group a brief overview of her background and experience in immunology and rheumatology.

2. Minutes of the last meeting
The draft minutes [SIRG(02)02] of the previous meeting, held on the 6 December 2001, were reviewed and were accepted.

3. Matters arising
There were no other matters arising that were not already on the agenda.

4. Declarations of interest
The proposed "declaration of interest" form [SIRG(02)] was discussed. The Group agreed that a list of IRG members should be placed on the website along with a short resume and a declaration of interests for each member. Any declaration of interests should be declared at the beginning of each meeting.

5. Membership of the IRG
Immunologist - Prof Cooke had joined the IRG in this capacity.

The contents of a letter from DR Judy Evans [SIRG (02)45] was noted.

6. Update on progress on IRG recommendations
Recommendation 1 - The revised version of the Department of Health's patient information booklet was published in April 2002.

Recommendation 2 - The IRG noted that Care Standards Act was now in place.

Recommendation 3 - The final draft of the Royal College of Surgeons; clinical guidelines for surgeons carrying out breast implant surgery was reviewed. The IRG made several comments which the secretariat will pass on passed to Mr Brough (Chair of the drafting committee).

Recommendation 4 - The IRG noted that the issue of consent to surgery was now being considered as a general issue across the whole of the NHS.

Recommendation 5 - The IRG noted that the recommendations made by the IRG in 1998 were important in the decision to create Care Standards Act. The Act has now been enacted and the National Care Standards Commission as part of CHI will be taking this forward.

Recommendation 6 - The IRG noted that new consent forms from the National Breast Implant Registry (NBIR) were now in use. The new forms record womens' consent to be contacted directly for research purposes. The old form did not do this and for this reason all research using this group of women will need to obtain the consent of women participating by making contact through the surgeon, via the NBIR.

Recommendation 7 - The IRG noted that MDA was drafting a specific adverse incident report form and poster with the aim of encouraging clinicians to report of adverse events involving breast implants to MDA.

Recommendation 8 - The secretariat reported that the pilot study to look at the early complications of breast implant surgery and analyze the feasibility of carrying out a national study based on data held by the NBIR, had been delayed due to problems with the company originally contracted to carry out the research. This research will now proceed with a new consortium.
With regard to studies of chronic low grade infection, the secretariat reported that a group had not been identified who were willing to take this work forward.
It was noted that any research proposal would need to compete with proposals from other areas of health research.

Recommendation 9 - The group noted the breast implant and mammography text would be included on the IRG website as soon as access had been reestablished (see agenda 14 below).

7. Scientific papers
Members present summarized their findings from the papers they had reviewed, which included recently published or submitted scientific papers. Details of the reviews of published papers can be found in the annex to these minutes.

8. Review of papers relating to chronic fatigue like symptoms published since the publication of the IRG report in 1998
The 2001 published article by Lori Brown, "Silicone gel breast implant rupture, extracapsular silicone and health status in a population of women" (J Rheumatol 2001; 28:996-103) suggested an association between the presence of extracapsular silicone and self-reported, physician diagnosed fibromyalgia. A teleconference discussion of this paper was held with Lori Brown and Gene Pennell. The IRG agreed to prepare a review of this and other relevant papers, for publication on the IRG website.

9. Breast implants and cancer
The 2001 published article by Briton LA, "Cancer Risk at Sites Other Than Breast Following Augmentation Mammoplasty" (AA Epidemiol 2001;11 248-256) suggested an increased risk of brain cancer. The IRG agreed to prepare a review of this paper and others relating to brain cancer to be placed on the IRG's website.

10. Platinum toxicity review
The secretariat reported that work on this matter was progressing. The secretariat were in the process of obtaining information on the platinum compounds present in the silicones used in the manufacture of breast implants.

11. DH's booklet for women considering breast implants
The IRG noted that the revised booklet had been published had been published in April 2002.

12. MDA's breast implant update
The IRG noted that MDA's device updated on breast implants would be available from 27 May 2002. The update is designed to give clinicians and members of the public up to date information on safety issues relating to silicone gel, Trilucent and Hydrogel breast implants.

13. Correspondence
The Group noted items of correspondence circulated, in particular a large number of emails from Margo Cameron. IRG members who represented consumer interests agreed to review these and other correspondence and prepare a report for the group's consideration at the next meeting.

14. Any other business
Information supplied by the IRG. The Group noted that 126 copies of the IRG reports had been distributed in the last 6 months. They also noted that (on average) the IRG website is accessed over 2000 times a week.
IRG website. The Group noted that the IRG website service provider was being changed. This had resulted in an interruption in the secretariat's ability to update the website. This service will be restored in the near future.

15. Date of next meeting
It was agreed that the next meeting will take place on 22 November 2002(full day).

MAY 2002: Annex 1 : Recently published literature : Summaries provided by IRG members

Rheumatic manifestations in Danish women with silicone breast implants Jensen-B et al.: Clinical Rheumatology 2001, VOL: 20 (05), P: 345-52. SIRG(02)06
This study compared the musculoskeletal complaints of women with breast reduction, silicone breast implants and women with no surgery in relation to a prior history of 'muscular rheumatism'. Patients were identified from the Danish National Hospital Register.

The study demonstrated that a prior history of rheumatic complaints will lead to an increased musculoskeletal symptomatology in all the groups of patients studied. There was no difference in musculoskeletal reporting between the breast implant and breast reduction patients.

The authors emphasise that a prior history of rheumatic complaints should be recorded when evaluating the effects of breast implant surgery on musculoskeletal symptoms. Interestingly they noted that women who had breast reduction and breast implant surgery were higher users of the health care system than the general population.

Health Outcomes in Offspring of Danish Mothers with Cosmetic Breast Implants, Kjoller K et alAnnals of Plastic Surgery 2002 vol48p 238-245 SIRG(02)54
These authors had previously published on a study showing that children born to mothers with a breast implant had an increased occurrence of oesophageal problems. However, such an increase is also observed in women who had had breast reduction surgery and was also observed in the children born to the same women prior to their breast implant operation. The authors had concluded from that original study that if there was an association between breast implant and oesophageal disorders in the offspring, then this was a reflection of some confounding factor rather than due to the implant itself. In this current study they have extended these observations by including more women, including those recruited from private plastic surgery clinics, and they have also expanded their follow up to include more pregnancies on the original set of women.

This study now compares the results from 2,854 children born to women with breast implants and 5,805 children born to women who had had other breast surgery. The results interestingly showed higher rates of oesophageal disorders in children in the implanted mothers, but only in those where the pregnancy occurred before the implant. In general terms, there is a significant excess (approximately 2), compared to national expectations, of congenital malformations of the digestive organ but this was seen in both the women who had had a breast implant as well as those women who had had other breast surgery. These results are consistent with the previous findings that any increase in congenital abnormality in women with breast implant surgery is not different from women who have had other forms of breast surgery and, given the increase prior to surgery, would not suggest that the implants were themselves responsible.

Silicone breast implants: correlation between implant ruptures, magnetic resonance spectroscopically estimated silicone presence in the liver, antibody status and clinical symptoms Rheumatology 2002 41: 129-135 and Editorial 123-124 SIRG(02)55
This paper set out to investigate whether there is a relationship between leakage of silicone from an implant and the occurrence of symptoms, particularly of connective tissue disease. The authors recruited 90 consecutive patients who presumably had had an implant and had not necessarily been selected for continuing health problems. Two aspects of leakage were investigated. Firstly, an MR scan was used to assess the integrity of the implant and secondly, magnetic resonance spectroscopy (MRS) was used to determine whether there was any evidence of silicone occurring in the liver. The women were assessed for aspects of connective tissue disease and the occurrence of these features were compared (1) between women with and without an MRI detected rupture and (2) women with and without evidence of silicone in their liver.

Results:
There were structural defects in 27% of the 90 women who had had an implant, and in half of these, silicone was apparent in the liver. Interestingly, silicone was also apparent in the liver in 23% of women whose MR scan suggested the implant was intact.

A comparison of 14 symptoms showed no evidence of an association between either implant rupture or the presence of silicone in the liver. The authors conclude that even though there is a relatively high proportion of women with evidence of silicone being found outside the breast, this phenomenon was not associated with an increased reporting of symptoms of musculoskeletal and connective tissue disease. An accompanying editorial by David Sharpe, Consultant Plastic Surgeon, concurred with the conclusions above that likewise questioned the selection process for the women who were studied.

Do silicone breast implants cause rheumatic disorders? A Systematric review for a court appointed national science panel. Tugwell-P et al.: Arthritis and rheumatism (Arthritis-Rheum) 2001 Nov, VOL: 44 (11), P:2477-84, Refs: 54. SIRG(02)09
This special article in Arthritis and Rheumatism details the activities of a National Science Panel set up by an American court to investigate the scientific evidence for a link between silicone breast implants and connective tissue diseases.
The paper describes how the panel reviewed the available literature and came to the conclusion that no evidence could be found of an association between silicone breast implants and connective tissue diseases.

Breast implant research: where we have been, where we are, where we need to go. Young VL & Watson ME: Clinic in plastic surgery 2001 July 28(3) p451-83 SIRG(02)10
This publication is essentially a review article describing the history of silicone breast implantation, the medical controversies associated with them and the factors leading to implant rupture. It also speculates regarding the design factors required for developing better implants.

Serologic evaluations of women exposed to breast implants. Karlson-EW, Lee-IM, Cook-NR,Buring-JE Hennekens-CH, Block-KJ. The Journal of Rheumatology 2001 Vol 28(7) p1523-30 SIRG(02)11
This is an interesting study published in the Journal of Rheumatology, which investigates the evidence for a disturbance of the immune system in women who have had a breast implant. The authors did not distinguish between the type of implant used i.e. silicone or saline filled. Subjects were chosen from the Womens' Health Study (WHS) and the comparator groups were women without breast implants and women with insulin dependent diabetes. Blood samples were tested for a wide range of autoantibodies and no major differences were detected between the three groups. The only finding specific to the breast implant group was of isolated low C3 and C4 levels. The clinical significance of this finding was unclear as it did not correlate with positivity for other antibody tests such as ANA positivity.

MR Imaging of extracapsular silicone from Breast implants: diagnostic pitfalls. Berg-Wendie-A et al.: AJR. American Journal of Roentegenology 2002 Feb, VOL: 178 (2), P: 465-72. SIRG(02)07
Three experienced observers reviewed MR images in 359 women with silicone gel breast implants. Rupture was identified in 55% of 687 implants with extracapsular silicone found in 12%.

Conclusion
"Extracapsular rupture is usually manifest as local spread of silicone in the breast and is not well depicted on fast spin-echo T2-weighted images. Water-suppressed inversion-recovery T2-weighted images are often needed to identify extracapsular silicone. Distinction of the bulge in the fibrous capsule from herniation through the capsule remains problematic".

Comment
This audit does not add anything significant to the problems of diagnosing silicone gel implant rupture and makes no comments about intra-capsular rupture which is a far more difficult diagnosis to make with the MRI scan.

Variability in the properties of silicone gel breast implants. Brandon-H-J et al.: Plastic and Reconstructive 2001 Aep 1, VOL: 108 (3), P: 647-55 SIRG(02)08
This article from the Washington University School of Medicine is a scientific laboratory investigation into the mechanical and chemical properties of two types of Dow Corning silicone gel implants (Silastic I and Silastic II).

The Silastic II is a third generation low bleed implant. The article doesn't state whether Silastic I is first or second generation.

This is a useful reference work to the physical properties of silicone gel implants, pointing out that there are considerable physical and chemical differences between different types of silicone implants but also between different batch numbers within a single type.

There is a reassuring comment at the end "The strength of all the Silastic I and Silastic II controls we tested exceeded the specifications of both the American Society for Testing and Materials and the manufacturer."

The implants were obtained from Dow Corning's inventory (presumably their reference collection) and none of them had been implanted. The research was partly funded by the Dow Corning Corporation.

Bioavailability of octamethylcyclotetrasiloxane (D(4)) after exposure to silicones by inhalation and implantation Luu-HM and Hutter-JC. Environmental Health Perspectives 2001 Nov Vol109(11) p1095-101 SIRG(02)44
D4 is a low molecular weight siloxane that has been shown - at high doses - to cause lung, liver and developmental effects in rodents

Human exposure to D4 derives from a range of personal care products and also potentially from breast implants. D4 is used in the manufacture of polydimethylsiloxane (PDMS) polymer and remains in the polymer as a contaminant.

This paper reveals that the highly lipohilic D4 is accumulated in fatty tissues and that with increasing exposure the level of excretion remains about the same due probably to saturation of elimination processes.

These data provide a basis for determining the possibility of adverse health effects in humans.