Breast Implants - Description of the device

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Our breast implants — Description of the device —

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CEREFORM ® breast implants are implantable, long term, silicone elastomer medical devices pre-filled with silicone gel. These prostheses are sold sterile after ethylene oxide sterilisation. They are for one patient only, single use.

CEREFORM ® breast implants are placed in a double packaging that ensures a dual microbiological barrier guaranteeing sterility until implantation. The cardboard box provides additional protection to the double packaging to deliver the product in the best possible conditions.

The traceability of each implant is assured by a unique identification number etched on its patch. The accompanying documents also carry this number and all the characteristics related to the implant

CEREFORM ® breast implants are manufactured with the latest generation of medical grade silicones which guarantee the necessary properties in order to be in conformity with the regulation requirements in force. An integrated barrier layer strongly limits silicone gel bleeding through the shell. Moreover, the specific formulation of the silicone gel makes the implant very similar to a natural breast. CEREFORM ® breast implants do not contain any phtalates.

> CEREFORM ® breast implants exist in two shapes:

- The round shape gives volume to the upper part of the breast and uplifts the bust. It is particularly well suited to women that already have formed breasts.
- The anatomical shape gently follows the bust contour without a rupture between the upper breast and the thorax. It is ideal for very slim figures and women with small or no breasts.

> Depending on their shape, CEREFORM ® breast implants are available with two different surfaces:

- The smooth surface, available in the round shape, for easy implantation and removal.
- The intermediate texture, available in the round and anatomical shapes, for the best cell colonisation and a reduced risk of the appearance of retractile capsular contracture, whilst preserving ease of implantation and removal.

All these implants are available in different sizes. To select the best suiting reference, CEREPLAS ® has developed a range of sizers identical to that of the implants. Refer to the literature for further information.