4 July 1998, Regensburg
EUROPEAN COMMITTEE ON QUALITY ASSURANCE AND MEDICAL DEVICES IN PLASTIC SURGERY
- Silicone is a widely used and an essential material in every day life, at present. We have no better alternative material available as yet. In all fields of medicine and surgery, implants and medical devices made of silicone are essential not only for well-being, but often for survival.
- Updated studies continue to show that silicone gel-filled implants do not cause cancer nor other malignant disease.
- There are conclusive scientific – clinical, immunological, epidemiological – data, that silicone gel-filled breast implants do not cause any auto-immune or connective tissue diseases.
- There is no scientific evidence that such things as silicone allergy, silicone intoxication, atypical disease, or a 'new silicone disease', exist. There is a normal foreign body reaction to every implant, but this is not immune disease. *
- Silicone implants do not adversely affect pregnancy nor breast-feeding nor the health of breast-fed children.
- Patients with breast implants need regular follow-up and - if indicated - appropriate imaging of the breasts.
- Laboratory tests for the detection of silicone are of no clinical value. No specific antibodies against silicone have been detected.
- EQUAM is of the opinion that there is a great need for a functioning harmonized, specific EU-standard for breast implants. EQUAM urges the European countries to reach a consensus in this matter soon.
- EQUAM calls for continuous clinical and basic research to further improve breast implants and new technologies in plastic surgery.
- Objective media reports contribute to the reassurance of patients.
EQUAM will provide updated information about implants and new technologies in plastic surgery to the media.