In the USA there are only 3 FDA approved prosthesis brands: Sientra-Silimed, Allergan and Mentor.
The FDA is the U.S. government agency responsible for the regulation of food, drugs, cosmetics and medical devices.
The indications for use advised by the FDA are:
- Primary augmentation mammoplasty to increase breast size as well as revision surgery to correct or improve the result of an augmentation mammoplasty (secondary surgery).
- Breast reconstruction after breast cancer, severe malformation or reconstructive surgery to correct and improve the result of breast reconstruction.
Contraindications are:
- Woman with an active infection at the time of surgery.
- Woman with active breast cancer.
- Pregnant or breastfeeding women.
Within the studies, it has been seen that patients who underwent primary augmentation mammoplasty were women between 26-39 years old and married, 2nd place for single women and 3rd place for divorced women. Reconstructive breast surgery took place in women around 46 years of age and married, with 2nd and 3rd place being repeated for single and divorced women.
Most patients increased their bra size by 1-2 cups, and only 8-10% wanted to increase their bra size by more than 2 cups.
Regarding breastfeeding, 8% of the patients operated with Silimed and Mentor had some kind of difficulty with breastfeeding while with Allergan this figure has increased to 18%.
No evidence of either genotoxicity or carcinogenicity has been reported for any of the FDA-approved brands of prostheses tested in this study.
COMPLICATION RATE AT 3 YEARS
|
Primary augmentation mammoplasty |
Silimed-Sientra
1,115 patients |
Allergan
455 patients |
Mentor
551 patients |
| Capsular contracture III-IV |
6,00% |
13,20% | 8,10% |
| Hematoma | 0,80% | 1,60% | 2,60% |
| Rippling | 0,50% | 0,70% | 0,70% |
| Infection | 0,70% | 0,50% | 1,50% |
| Implant rupture | 2,50% | 2,70% | 0,50% |
| Unsightly scars | 0,60% | 3,70% | 6,70% |
Several studies in the literature have analyzed the prevalence of silicone gel implant rupture. This rate is estimated at less than 10% at 10 years, the most frequent being intracapsular rupture.
After augmentation mammoplasty, approximately 92-94% of patients felt more attractive and feminine, and approximately 85% of patients reported that having augmentation mammoplasty made them feel better about themselves.
