4 July 1998, Regensburg
European Committee on Quality Assurance & Medical Devices in Plastic Surgery

1. Silicon is a widely used  and essential material in every day life. At the moment, no better alternative material is available. Implants and medical devices made from silicone are used in other fields of medicine and surgery as well. The use of these are essential not only for aesthetics, but also for survival.
2. Recent scientific studies show that silione-gel filled implants do not cause breast cancer or any other malignant diseases.
3. The available scientific, clinical, immunological and epidemiological data show that silicone-gel filled implants do not cause any type of autoimmune or connective tissue diseases.
4. There is no scientific evidence that silicone allergy, silicone intoxication, atypical disease or a new silicone disease exist. There is a normal foreign body reaction after every implant, but this is not an immune disease.
5. Silicone implants do not adversely affect pregnancy, breast feeding or the health of the breastfed child.
6. Patients with breast implants should have regular follow-up and, if necessary, imaging of the breasts.
7. Laboratory tests for detecting silicone have no clinical value.  No specific antibodies against silicone have been detected.
8. EQUAM believes there is a need for a harmonized EU standard regarding silicone implants. EQUAM is urging EU members to concur on this issue.
9. EQUAM calls for continuous clinical and basic scientific research to provide more accurate information on and support further development of breast implants and new technologies.
10. Objective media reports contribute to the reassurance of patients. EQUAM will continue to provide updated information about implants and new technologies in plastic surgery to the media.