Print this page! print this page
 

PERTHESE® TX, MX, T3

Cohesive Silicone Gel-filled Breast Implant

Tri-laminated Micro-Textured surface


 

SAFETY
  • The PERTHESE® breast implant is a sterile gel-filled implant made with a trilaminar silicone envelope. The silicone envelope consists of an internal and external layer made with a high mechanical resistance medical grade silicone elastomer and an intermediate barrier layer to significantly reduce gel bleed. The envelope is filled with a soft transparent silicone gel, very close to the normal breast consistency. The elongation of the shell is greater than 500%. These implants form an extremely soft and resilient structure, limiting gel migration to a minimum.
  • The PERTHESE® mammary prostheses is manufactured and packaged under the ISO9001/EN 46001 quality standards applicable to medical devices. Quality controls are performed at all stages of the production.
  • Each implant carries the manufacturer's identification, the serial number and the volume (in cc) engraved on the patch.
  • The PERTHESE® breast implant is provided sterile within a rigid double blister package in order to ensure security and convenience. The prosthesis is sterilized by ethylene oxide.
  • The base of PERTHESE® AX anatomic mammary implants has five positioning blocks helping to hand-position in the space.
 

PERTHESE® TX REFERENCE DATA

Low profile gel-filled textured breast implant


   References Volume cc Diameter

Projection
  TX 100
TX 125
TX 150
TX 170
TX 185
TX 200
TX 220
TX 240
TX 260
TX 280
TX 300
TX 325
TX 350		 100
125
150
170
185
200
220
240
260
280
300
325
350		 9,1
9,7
10,2
10,8
11,1
11,4
11,8
12,2
12,3
12,5
12,8
13,1
13,5 		2,2
2,4
2,6
2,7
2,8
2,9
2,9
3,0
3,1
3,2
3,2
3,3
3,4
 

PERTHESE® MX REFERENCE DATA

Moderate profile gel-filled textured breast implant


   References Volume cc Diameter Projection
  MX 100
MX 125
MX 150
MX 175
MX 200
MX 225
MX 250
MX 275
MX 300
MX 325
MX 350
MX 375
MX 400
MX 450
MX 500
MX 550
MX 600
MX 650
MX 700
MX 808		 100
125
150
175
200
225
250
275
300
325
350
375
400
450
500
550
600
650
700
800		 8,7
9,2
9,9
10,4
11,0
11,5
12,0
12,2
12,5
12,8
13,0
13,2
13,5
13,9
14,2
14,5
14,9
15,2
15,6
16,1		 2,8
3,0
3,2
3,3
3,4
3,5
3,6
3,7
3,8
4,0
4,2
4,4
4,5
4,6
5,0
5,2
5,4
5,5
5,6
6,0
 

PERTHESE® 540 T3 REFERENCE DATA

High profile gel-filled textured breast implant


   References Volume cc Diameter Projection
  540-075
540-100
540-125
540-150
540-175
540-200
540-230
540-260
540-300
540-250
540-400
540-440
540-500		 75
100
125
150
175
200
230
260
300
350
400
440
500		 8,1
8,3
9,1
9,3
9,9
10,1
10,4
11,0
11,2
11,9
12,1
12,7
13,2		 2,3
2,5
2,9
3,2
3,6
3,8
4,0
4,3
4,5
4,8
4,9
5,3
5,4
 

* Measurements are obtained by placing the pre-filled unit on a concave shape surface.

Please note: individual implant dimensions may vary slightly in products of this type. Not all units will conform exactly to the above dimensions.

* DO NOT UNDER FILL THIS IMPLANT.

 

INDICATIONS – CONTRAINDICATIONS
  • Contour reconstruction and size augmentation following a subcutaneous mastectomy for benign disease as for example chronic cystic mastitis, or for augmentation or reconstruction for correction of defects following radical mastectomy procedures.
  • Unilateral or bilateral mammary augmentation or reconstruction to surgically correct various congenital or acquired anomalies such as amastia, aplasia, hypomastia, hypoplasia or for cosmetic purposes.

It is the surgeon’s sole responsibility to determine criteria for the patient selection

PERTHESE® mammary prostheses should not be implanted in patients with:

  • a general or localized infection of the mammary sphere.
  • a history of auto-immune disease
  • an ongoing pregnancy.
 

PRECAUTIONS FOR USE
Precautions for use should be considered by the surgeon prior to the use of a PERTHESE® mammary prosthesis:
  • No evaluating breast cancer at the time of implantation, even if a breast reconstruction can be considered in the case of a controlled metastatic syndrome, the prerequisite being to well balance the benefits to the patient with the consequences of the surgical procedure and its non-interference with the required carcinologic treatments.
  • If the patient exhibits a lack of skin it is the sole responsibility of the surgeon to decide the use of an expansion technique or a tissue graft.
  • Patient is not willing to accept the possibility of multiple surgeries for revision, which could be related to a lack of understanding, or inappropriate motivation, or to a history of repeated failures following cosmetic augmentations or subcutaneous mastectomy.
  • On a general point of view, the health condition of the patient should be considered in view of the type of surgical procedure and the required anesthesia. Each patient must be evaluated by the surgeon to balance the risk/benefit to the patient.
 
"The product quality" (PDF, 324 KB)
 
WARRANTY
Pérouse Plastie introduces a new Quality Insurance Program which includes:
  • In case of rupture of the implant, free replacement with an identical product during 15 years from the date of its implantation
  • In case of capsular contracture Baker III and IV in augmentation surgery, free replacement product with an identical product during a period of 10 years from the date of its date of implantation.

Please ask us for the full text and conditions of the warranty: info@hojmed.com

PEROUSE PLASTIE warrants that reasonable care in selection of materials and methods of manufacture were used in fabrication of these products.
PÉROUSE PLASTIE shall not be liable for any incidental or consequential loss, damage, or expense, directly or indirectly arising from the use of these products.

The foregoing warranties, as conditioned and limited, are in lieu of and exclude all other warranties not expressly set forth herein, whether express or implied by operation of law or otherwise.

PEROUSE PLASTIE neither assumes nor authorizes any other person to assume for it any other or additional liability or responsibility in connection with these products.
PEROUSE PLASTIE intends that these products should be used only by physicians having appropriate training in plastic and reconstructive surgery techniques.

PERTHESE® is a registered Trademark of PEROUSE PLASTIE. Made in France by PEROUSE PLASTIE.

© Höjmed AB – 2006

info@hojmed.com