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European Conference on breast silicone-gel implants. A review of their use in Europe in 1993, Paris, 6 February 1993
The Breast,
1993) 2,262
0 1993 Longman Group UK Ltd
I Conference report European Conference on breast silicone-gel implants. A review of their use in Europe in 1993, Paris, 6 February 1993 J-Y. Petit Institute Gustave Roussy, Villejuif, France
The representives of nine countries (UK, Germany, Belgium, Holland, Sweden, Italy, Spain, USA and France) met on Saturday 6 February after the EUSOMA meeting on Breast Screening in Paris to review our knowledge of silicone gel implants and to compare their use in the main European countries. The scientific reports presented during the first part of this meeting have enabled us to come to the following conclusions:
the placement of an implant was presented by Dr Clough form the Fondation Curie. The review demonstrated, as did an expert committee report requested by the Ministry a few months earlier, that if a risk exists, it is extremely low. The presence of a silicone implant was associated with the existence of an immune-related disorder (the most frequent being scleroderma) in less than 50 cases in a population of 2 million women with a breast implant. Even if investigations reveal a further few cases, it is impossible to affirm in a definitive manner that these immune-related disorders are due to the presence of silicone gel. The recent discovery of ‘anti-silicone’ antibodies might contribute further evidence in this field. Prospective trials are needed to demonstrate whether these antibodies are markers of immune-related disorders. Variations in the level of these antibodies also need to be verified in a control population without an implant.
1. The carcinogenic risk of placement of silicone gel implants in the human body can be considered nonexistent. Two recent studies have confirmed this statement : one published in June 1992 in the New England Journal of Medicine by a Canadian team involved several thousand women who had undergone mammaplasty with a prosthesis. The incidence of breast cancers in this population was significantly lower than that observed by the authors in the general population. The second study, which appeared in the same journal on 4 March 1993, was conducted at the Institut Gustave Roussy. A team in this Institut demonstrated that a group of 146 women having undergone breast implantation for reconstruction with a silicone-gel implant more than 10 years earlier (between 10 and 15 years) overall fared better than a control group of women treated during the same period for a similar type of cancer, but without a breast implant. The rates of local recurrence, metastasis and mortality were two-fold higher in the control group than among breast implant recipients. 2. Today, technical progress achieved in screening mammography as well as an improvement in interpretation due to a better understanding of mammograms of breasts which contain an implant, allow us to ensure follow-up of patients and perform satisfactory screening of breast lesions in spite of implants behind the gland. It is however recommended that this surveillance be undertaken by specialized teams which possess high performance modem techniques such as digitilized mammography. In addition, this technique permits the study of the quality of products used to manufacture the implant. 3. A review of the risks of immune reactions linked to
Experts from different European countries took stock of the situation in their respective countries. Silicone-gel implants are authorized in all the European countries except France and Italy where only ‘double-lumen’ implants are allowed. These implants have a dual covering and contain silicone gel in the inner sac and saline solution in the outer bag. Dr R. Hester, from Atlanta, delivered the concluding remarks by recalling the position of the USA. Siliconegel implants are not banned for breast reconstruction purposes, nor for women for whom augmentation mammoplasty is not being performed for the first time. In all cases and in all countries where the use of implants is permitted, plastic surgeons are being encouraged to use certain investigation and follow-up protocols which, in future, will allow a better surveillance of the outcome of these patients and thus, provide better information on the natural history of these implants. Overall, the discussions that took place during this seminar appeared to be extremely fruitful and all the participants plan to meet again in Berlin in June 1993 to continue to exchange thoughts on the subject. Several suggested setting up a centralized registry of patients so that the statistical power of our studies can be increased. 262
1993) 2,262
0 1993 Longman Group UK Ltd
I Conference report European Conference on breast silicone-gel implants. A review of their use in Europe in 1993, Paris, 6 February 1993 J-Y. Petit Institute Gustave Roussy, Villejuif, France
The representives of nine countries (UK, Germany, Belgium, Holland, Sweden, Italy, Spain, USA and France) met on Saturday 6 February after the EUSOMA meeting on Breast Screening in Paris to review our knowledge of silicone gel implants and to compare their use in the main European countries. The scientific reports presented during the first part of this meeting have enabled us to come to the following conclusions:
the placement of an implant was presented by Dr Clough form the Fondation Curie. The review demonstrated, as did an expert committee report requested by the Ministry a few months earlier, that if a risk exists, it is extremely low. The presence of a silicone implant was associated with the existence of an immune-related disorder (the most frequent being scleroderma) in less than 50 cases in a population of 2 million women with a breast implant. Even if investigations reveal a further few cases, it is impossible to affirm in a definitive manner that these immune-related disorders are due to the presence of silicone gel. The recent discovery of ‘anti-silicone’ antibodies might contribute further evidence in this field. Prospective trials are needed to demonstrate whether these antibodies are markers of immune-related disorders. Variations in the level of these antibodies also need to be verified in a control population without an implant.
1. The carcinogenic risk of placement of silicone gel implants in the human body can be considered nonexistent. Two recent studies have confirmed this statement : one published in June 1992 in the New England Journal of Medicine by a Canadian team involved several thousand women who had undergone mammaplasty with a prosthesis. The incidence of breast cancers in this population was significantly lower than that observed by the authors in the general population. The second study, which appeared in the same journal on 4 March 1993, was conducted at the Institut Gustave Roussy. A team in this Institut demonstrated that a group of 146 women having undergone breast implantation for reconstruction with a silicone-gel implant more than 10 years earlier (between 10 and 15 years) overall fared better than a control group of women treated during the same period for a similar type of cancer, but without a breast implant. The rates of local recurrence, metastasis and mortality were two-fold higher in the control group than among breast implant recipients. 2. Today, technical progress achieved in screening mammography as well as an improvement in interpretation due to a better understanding of mammograms of breasts which contain an implant, allow us to ensure follow-up of patients and perform satisfactory screening of breast lesions in spite of implants behind the gland. It is however recommended that this surveillance be undertaken by specialized teams which possess high performance modem techniques such as digitilized mammography. In addition, this technique permits the study of the quality of products used to manufacture the implant. 3. A review of the risks of immune reactions linked to
Experts from different European countries took stock of the situation in their respective countries. Silicone-gel implants are authorized in all the European countries except France and Italy where only ‘double-lumen’ implants are allowed. These implants have a dual covering and contain silicone gel in the inner sac and saline solution in the outer bag. Dr R. Hester, from Atlanta, delivered the concluding remarks by recalling the position of the USA. Siliconegel implants are not banned for breast reconstruction purposes, nor for women for whom augmentation mammoplasty is not being performed for the first time. In all cases and in all countries where the use of implants is permitted, plastic surgeons are being encouraged to use certain investigation and follow-up protocols which, in future, will allow a better surveillance of the outcome of these patients and thus, provide better information on the natural history of these implants. Overall, the discussions that took place during this seminar appeared to be extremely fruitful and all the participants plan to meet again in Berlin in June 1993 to continue to exchange thoughts on the subject. Several suggested setting up a centralized registry of patients so that the statistical power of our studies can be increased. 262