On September 26, 2024, our breast implants received approval from the stringent U.S. Food and Drug Administration (FDA), a very rare recognition for their safety and effectiveness.
Dr. Nelissen was one of the pioneers in the Benelux region in using these advanced implants.
Designed specifically for women and their lifestyles, these implants offer a natural feel and movement thanks to the viscoelastic material (similar to real breast tissue) and the safe, patented SmoothSilk surface (low inflammation surface).
Since their introduction in 2010 (15 years ago), nearly four million implants have been distributed worldwide among plastic and reconstructive surgeons in over 85 countries, supported by over 100 clinical studies and publications.
Comprehensive safety study of breast implants
This approval marks the first new FDA approval for breast implants since 2013 and is the result of the strictest study of breast implants ever conducted according to FDA guidelines. Furthermore, the FDA imposes strict follow-up regarding further safety studies of these breast implants, including risks of capsular contracture and rupture.
The study shows that our breast implants are not only safe but also achieve exceptional results, with less than one percent (1%) experiencing capsular contracture and rupture in primary breast augmentations.
The Kaplan-Meier risk figures for the occurrence of complications in the primary augmentation cohort after three years, with a 95% confidence interval, were as follows:
- Capsular contracture: 0,5%
- Rupture, confirmed or presumed: 0,6%
- Breast pain: 0,7%
- Infection: 0,9%
- Reoperation including implant size change: 6,1%
- Complication including reoperation: 8,4%
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