EQUAM

EQUAM Consensus Declaration on Breast Implants

EUROPEAN COMMITTEE ON QUALITY ASSURANCE AND MEDICAL DEVICES IN PLASTIC SURGERY
4 July 1998, Regensburg

1. Silicon is widely used and essential material in our daily life today. Currently, there is no better alternative available. Silicon-based implants and medical devices are used in various areas of medicine and surgery, which are often essential not only for well-being but also for survival.
2. Continuous studies show that silicone gel-filled implants do not cause breast cancer or any other malignant diseases.
3. Available scientific – clinical, immunological, epidemiological – research data convincingly prove that silicone gel-filled implants do not cause any autoimmune or connective tissue diseases.
4. There is no scientific evidence for the existence of conditions such as “silicone allergy”, “silicone intoxication”, “atypical silicone disease” or a “new silicone disease”. A normal foreign body reaction occurs after implantation, but this is not an autoimmune disease.
5. Silicone implants do not adversely affect pregnancy, breastfeeding, or the health of the breastfed child.
6. Patients with breast implants require regular check-ups and, if necessary, breast imaging is required.
7. Laboratory tests that detect silicone have no clinical value. Specific silicone-antibodies were not detected.
8. According to EQUAM, there is a great need for a uniform, specific EU standard for silicone breast implants. EQUAM urges agreement among the European states in this regard.
9. EQUAM advocates for ongoing clinical and basic research for the further development of breast implants, as well as for new technologies in plastic surgery.
10. Objective media releases contribute to reassuring patients. EQUAM continuously provides the latest data on implants and new technologies in the field of plastic surgery.”

www.iquam.org

www.ipraf.org/committees/equam.html