— Informations Techniques —
For full openness, CEREPLAS wishes to give more details about the technical and clinical characteristics about its CEREFORM® breast implants range pre-filled with silicone gel.
The complete automatization of the manufacturing process of the breast implants envelopes:
Automatization of raw material filtration, viscosity measures, raw material loading, filling, immersion of the molds for both envelope and barrier layers (between 14 and 16 immersions depending on the implant profile),
crosslinking process, etc… allow us to present a product of optimum quality.
These several totally automatized steps offer a higher repeatability and therefore avoid human interventions and error risks.
To our knowledge, only one other competing company has put into place an automatized manufacturing process.
Concerning clinical data, no premature rupture, linked to the wear and tear of the implant has been noticed during the 5-year follow-up available.
The total number of identified complications during 2011 on a worldwide basis is the following:
- 0.06% gel fracture rate at the moment of the implantation i.e. 36 gel fractures.
This fracture is detected while putting the implant in during the operation. The implant is immediately changed and there is therefore no impact on the patient;
- 0.03% folds rate i.e. 15 folds;
- 0.03% rupture rate due the instruments used inside the theater, i.e. 17 implant ruptures linked to the operation.
After close analysis of the causes, the identified ruptures are linked to the contact of the implant with surgical instrument during the procedure (scalpel, retractor, etc.);
- 0.05% implant rotation rate de l'implant, i.e. 29 rotations;
- 0.01% infection rate, i.e. 2 infections;
- 0.01% capsular contracture rate, i.e. 8 capsular contractures;
- No abrasion or seroma has been identified during 2011.
This data has been gathered thanks to quality declarations made to the AFSSAPS by French surgeons, declarations made to our sales team by our distributors and sales people, the analysis of our clinical follow-up data, product returns analysis, etc.
This list of complications is included in our instruction manual and should be discussed during pre-operative consults.
For all information, feel free to contact us: export@cereplas.com
