A prospective study of 708 form-stable silicone gel breast implants.

[BACKGROUND] Form-stable silicone gel breast implants represent the fifth generation of silicone gel augmentation devices. Additional crosslinking between the silicone molecules allows these implants to retain their shape, especially in the vertical position.

[OBJECTIVE] The authors evaluate the efficacy of Silimed form-stable silicone gel breast implants.

[METHODS] A total of 355 patients (708 implants) were enrolled prospectively over a 60-month period. Data were collected on patient demographics, implant factors, complications, and revisions. Chi-square analysis and Fisher's exact test were implemented to compare groups with respect to differences in complication and revision rates.

[RESULTS] The overall tissue-related complication rate was 8.2% per patient, or 4.1% per breast. The overall implant-related cosmetic complication rate was 2.5% per patient, or 1.3% per implant. The overall implant-related complication rate, which was represented by the capsular contracture (CC) rate, was 1.4% per patient and 0.7% per implant. There were no complications in any of the reconstruction patients. There were no deep vein thromboses, pulmonary emboli, myocardial infarctions, or deaths among the patients in this study. In addition, there were no instances of flap necrosis, hematoma, or loss of implant integrity. The overall complication rate was 9.6% per patient, or 4.8% per implant. The overall tissue-related revision rate was 5.4% per patient, with the most common tissue-related reason for revision being unacceptable scarring. The overall implant-related cosmetic revision rate was 7.6% per patient, with the most common reason for revision in this category being size change. The overall implant-related revision rate was 1.1% per patient and was solely due to CC.

[CONCLUSIONS] This study demonstrates that form-stable silicone gel breast implants are safe and have a complication profile similar to other models of silicone breast implants, with a lower CC rate and a decreased incidence of wrinkling compared to fourth-generation silicone gel implants (as well as other published studies of fifth-generation implants).