Silicone gel breast implants

Guyen J M, Lairy G, Fleurette F
Record ID 31996008433
Authors' objectives:

To assess the local and systemic complications attributed to silicone gel breast implants which have been used for reconstruction and cosmetic enhancement of the breast since the early 1960s. Given these potential risks, the use of silicone breast implant was forbidden in France.

Authors' results and conclusions: Based on a critical appraisal of the literature, we answered the following questions: 1) Concerning the incidence of local complications: capsular contracture occurs at 4 years in 10% of cases; rupture occurs at 10 years in 15% of cases; low bleeding occurs at 10 years in 17% of cases. But the incidence of local complications are not known (no published studies) for the new breast implants (filled with silicone gel or other products) that are coming up in the market. 2)Concerning the association between silicone breast implant and connective tissue disease, we found 12 epidemiologic studies. Only three were of high quality. Two of them did not find an association. The third one found a relative risk for any connective tissue disease of 1.24 (CI, 1.08 to 1.41). This finding is in favour of a small increased risk.
Authors' recommendations: Concerning the implanted women, we recommend to not perform systematic explantation, but to inform the women of these findings and to assure a clinical evaluation of incidence of local complications. Other output or dissemination activity: The French Ministry of Health is about to reinforce market approval conditions in order to re-allow silicone breast implants.
Authors' methods: Review
Project Status: Completed
URL for project:
Year Published: 1996
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: France
MeSH Terms
  • Breast Implants
  • Connective Tissue Diseases
  • Contracture
  • Rupture
  • Silicon Compounds
  • Mammaplasty
Organisation Name: L'Agence Nationale d'Accreditation d'Evaluation en Santé
Contact Address: 2 avenue du Stade de France, 93218 Saint-Denis La Plaine Cedex, France. Tel: +33 01 55 93 71 88; Fax: +33 01 55 93 74 35;
Contact Name:
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Copyright: Agence Nationale pour le Developpement de l'Evaluation Medicale
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