MENTOR® CPX4 Breast Tissue Expander

Used in breast reconstruction, MENTOR® CPX®4 Breast Tissue Expander, available in smooth or SILTEX® Shell Surface, is designed to expand primarily in the lower pole of the breast, so the resulting pocket will accommodate the implant and slope like a natural looking breast. It also has an integrated “injection dome” that allows surgeons to add saline solution to the expander and gradually stretch the breast tissue over several months.**

cpx4 implant

Features & Benefits

Intraoperative

MENTOR® CPX®4 Expander has a soft and flexible BufferZone® Self-Sealing Patch designed to help ease insertion and removal. Added suture tabs for flexibility and fixation to stabilize pocket placement and help control aesthetic outcome.

During the Expansion

BufferZone® Self-Sealing Patch and posterior Dacron® Patch focus device expansion towards the lower pole of the breast. More pliant BufferZone® Patch and smoother injection dome are designed for enhanced patient comfort and to drive lower pole expansion to mimic the shape of the natural breast. Greater target area and stronger magnet (within the expander) facilitates the location of the injection dome.**+

Continuing Our Commitment to Safety and Reliability

CPX®4 Breast Tissue Expanders maintain key features fundamental to the MENTOR® Tissue Expander Portfolio to continue our legacy of safety and reliability: Smooth and SILTEX® Surface; Suture Tabs; Dacron® Patch; BufferZone® Self-Sealing Patch.1-4*+§ CPX®4 Breast Tissue Expanders include an internal injection dome, which contains a magnet (Reference the Important Safety Information below for relevant contraindications and warnings).

Product Resources

For more information, read a MENTOR® CPX®4 Breast Tissue Expander Brochure.

  The Most Comprehensive Breast Reconstruction Portfolio

CPX® 4 PLUS Smooth, Low Height, Breast Tissue Expanders

Base Width(cm)

Height(cm)

Projection(cm)

Label Fill Volume(cc)

Catalog #

11.4

8.1

6.1

250

SCPX-114LH

12.7

9.4

6.5

350

SCPX-127LH

14.0

10.2

7.1

450

SCPX-140LH

15.0

10.9

7.4

550

SCPX-150LH

15.7

11.2

7.9

650

SCPX-157LH

16.5

11.9

8.1

750

SCPX-165LH

 

CPX® 4 PLUS Smooth, Medium Height, Breast Tissue Expanders

Base Width(cm)

Height(cm)

Projection(cm)

Label Fill Volume(cc)

Catalog #

10.7

9.3

6.2

275

SCPX-107MH

11.7

10.0

6.6

350

SCPX-117MH

12.7

10.8

7.0

450

SCPX-127MH

13.5

11.7

7.4

550

SCPX-135MH

14.6

12.6

7.6

650

SCPX-146MH

15.6

13.3

8.0

800

SCPX-156MH

 

CPX® 4 PLUS Smooth, Tall Height, Breast Tissue Expanders

Base Width(cm)

Height(cm)

Projection(cm)

Label Fill Volume(cc)

Catalog #

10.1

10.7

5.6

250

SCPX-101TH

11.3

11.8

6.0

350

SCPX-113TH

12.3

12.9

6.5

450

SCPX-123TH

13.2

13.8

6.9

550

SCPX-132TH

14.0

14.6

7.3

650

SCPX-140TH

14.6

15.3

7.6

750

SCPX-146TH

15.4

15.9

7.9

850

SCPX-154TH

 

CPX®4 Low Height, Breast Tissue Expander, Style 8100

Catalog #

Vol.

Width

Height

Proj.

3548111

250 cc

11.4 cm

8.1 cm

6.1 cm

3548112

350 cc

12.7 cm

9.4 cm

6.5cm

3548113

450 cc

14 cm

10.2 cm

7.1cm

3548114

550 cc

15 cm

10.9 cm

7.4 cm

3548115

650 cc

15.7 cm

11.2 cm

7.9 cm

3548116

750 cc

16.5 cm

11.9 cm

8.1 cm

CPX®4 Medium Height, Breast Tissue Expander, Style 8200

Catalog #

Vol.

Width

Height

Proj.

3548211

275 cc

10.7 cm

9.3 cm

6.2 cm

3548212

350 cc

11.7 cm

10 cm

6.6 cm

3548213

450 cc

12.7 cm

10.8 cm

7 cm

3548214

550 cc

13.5 cm

11.7 cm

7.4 cm

3548215

650 cc

14.6 cm

12.6 cm

7.6 cm

3548216

800 cc

15.6 cm

13.3 cm

8 cm

CPX®4 Tall Height, Breast Tissue Expander, Style 8300

Catalog #

Vol.

Width

Height

Proj.

3548311

250 cc

10.1 cm

10.7 cm

5.6 cm

3548312

350 cc

11.3 cm

11.8 cm

6 cm

3548313

450 cc

12.3 cm

12.9 cm

6.5 cm

3548314

550 cc

13.2 cm

13.8 cm

6.9 cm

3548315

650 cc

14 cm

14.6 cm

7.3 cm

3548316

750 cc

14.6 cm

15.3 cm

7.6 cm

3548317

850 cc

15.4 cm

15.9 cm

7.9 cm

CPX®4 SILTEX® with Suture Tabs, Low Height, Breast Tissue Expander, Style 9100

Catalog #

Vol.

Width

Height

Proj.

3549111

250 cc

11.4 cm

8.1 cm

6.1 cm

3549112

350 cc

12.7 cm

9.4 cm

6.5 cm

3549113

450 cc

14 cm

10.2 cm

7.1 cm

3549114

550 cc

15 cm

10.9 cm

7.4 cm

3549115

650 cc

15.7 cm

11.2 cm

7.9 cm

3549116

750 cc

16.5 cm

11.9 cm

8.1 cm

CPX®4 SILTEX® with Suture Tabs, Medium Height, Breast Tissue Expander, Style 9200

Catalog #

Vol.

Width

Height

Proj.

3549211

275 cc

10.7 cm

9.3 cm

6.2 cm

3549212

350 cc

11.7 cm

10 cm

6.6 cm

3549213

450 cc

12.7 cm

10.8 cm

7 cm

3549214

550 cc

13.5 cm

11.7 cm

7.4 cm

3549215

650 cc

14.6 cm

12.6 cm

7.6 cm

3549216

800 cc

15.6 cm

13.3 cm

8 cm

CPX®4 SILTEX® with Suture Tabs, Tall Height, Breast Tissue Expander, Style 9300

Catalog #

Vol.

Width

Height

Proj.

3549311

250 cc

10.1 cm

10.7 cm

5.6 cm

3549312

350 cc

11.3 cm

11.8 cm

6 cm

3549313

450 cc

12.3 cm

12.9 cm

6.5 cm

3549314

550 cc

13.2 cm

13.8 cm

6.9 cm

3549315

650 cc

14 cm

14.6 cm

7.3 cm

3549316

750 cc

14.6 cm

15.3 cm

7.6 cm

3549317

850 cc

15.4 cm

15.9 cm

7.9 cm

CPX®4 Smooth, Low Height, Breast Tissue Expander with Suture Tabs, Style 9100

Catalog #

Vol.

Width

Height

Proj.

3509111

250 cc

11.4 cm

8.1 cm

6.1 cm

3509112

350 cc

12.7 cm

9.4 cm

6.5 cm

3509113

450 cc

14.0 cm

10.2 cm

7.1 cm

3509114

550 cc

15.0 cm

10.9 cm

7.4 cm

3509115

650 cc

15.7 cm

11.2 cm

7.9 cm

3509116

750 cc

16.5 cm

11.9 cm

8.1 cm

CPX®4 Smooth, Medium Height, Breast Tissue Expander with Suture Tabs, Style 9200

Catalog #

Vol.

Width

Height

Proj.

3509211

275 cc

10.7 cm

9.3 cm

6.2 cm

3509212

350 cc

11.7 cm

10.0 cm

6.6 cm

3509213

450 cc

12.7 cm

10.8 cm

7.0 cm

3509214

550 cc

13.5 cm

11.7 cm

7.4 cm

3509215

650 cc

14.6 cm

12.6 cm

7.6 cm

3509216

800 cc

15.6 cm

13.3 cm

8.0 cm

CPX®4 Smooth, Tall Height, Breast Tissue Expander with Suture Tabs, Style 9300

Catalog #

Vol.

Width

Height

Proj.

3509311

250 cc

10.1 cm

10.7 cm

5.6 cm

3509312

350 cc

11.3 cm

11.8 cm

6.0 cm

3509313

450 cc

12.3 cm

12.9 cm

6.5 cm

3509314

550 cc

13.2 cm

13.8 cm

6.9 cm

3509315

650 cc

14.0 cm

14.6 cm

7.3 cm

3509316

750 cc

14.6 cm

15.3 cm

7.9 cm

3509317

850 cc

15.4 cm

15.9 cm

8.1 cm

Accessories

Aseptic Transfer System

Carton contains four sterile kits. Each kit contains the following:

Description

Catalog #

Aseptic Transfer System

350-8400

 

Includes:
•    60 cc syringe (sterile, disposable)
•    Piercing spike
•    48” tubing (saline container to syringe)
•    Dual check valve
•    10” tubing (syringe to implant fill tube)
•    Luer connector (attaches to implant fill tube)

Injection Port Detector

Description

Catalog #

CENTERSCOPE® Magnetic Detection Device

350-4402

 

Miscellaneous 

Description

Catalog #

Check Valve

200464-001

21-Gauge Winged Infusion Set

7B3050


Product Catalog

Product Catalog

Important Information for Your Patients to Consider

Product Insert Data Sheets

References

1. Ethicon Shape and Strain study, 2012
2. Design Requirements Matrix, CPX4, 2017
3. Tissue Expander VOC Research, 2011
4. Internal memo on magnet strength, 2012
5. Mentor Design Verification Report, CPX4
6. Mentor Design Validation Report, CPX4
7. Connelly, N et al. Nomenclature of Inorganic Chemistry: IUPAC Recommendations 2005. ®International Union of Pure and Applied Chemistry, 2005. RSC Publishing.
8. 100316549 3D Benchtop Imaging of Artoura and Allergan Completion Report.
9. Allergan Natrelle® 133 Plus Tissue Expander 510k.
10. Atlan M et al. Breast implant surface texture impacts host tissue response. J Mech Behav Biomed Mater. 2018 Dec;88:377-385.
11. Mentor Worldwide, LLC, Internal Memo - Surface Area November 6, 2012

**The third-party trademarks used herein are trademarks of their respective owners. 

*ARTOURA™ Breast Tissue Expander compared to Allergan 133MV-13 and 133MX-13 in a benchtop study under simulated compression
+CPX®4 Smooth and ARTOURA™ provide more suture tab options than competitors.
§Proprietary BufferZone® Self-Sealing Patch

Important Safety Information

The MENTOR® Collection of Breast Implants are indicated for breast augmentation - in women who are at least 22 years old for MENTOR® MemoryGel® Breast Implants or MENTOR® MemoryShape® Breast Implants, and at least 18 years old for MENTOR® Saline Breast Implants. MENTOR® Breast Implants are also indicated for breast reconstruction.

Breast implant surgery should not be performed in women:

  • With active infection anywhere in their body
  • With existing cancer or pre-cancer of their breasts who have not received adequate treatment for those conditions
  • Who are currently pregnant or nursing

Safety and effectiveness have not been established in patients with autoimmune diseases (for example lupus and scleroderma), a weakened immune system, conditions that interfere with wound healing and blood clotting, or reduced blood supply to breast tissue. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery.

There are risks associated with breast implant surgery. You should be aware that breast implants are not lifetime devices and breast implantation may not be a one-time surgery. You may need additional unplanned surgeries on your breasts because of complications or unacceptable cosmetic outcomes. Many of the changes to your breast following implantation are irreversible (cannot be undone) and breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production. Consult your physician for a full discussion of risks and benefits to determine whether this procedure is right for you. The success of this procedure depends on many factors, including your physical condition and your body’s ability to tolerate the procedure. Use care in the selection of your doctors and hospital, based on their skill and experience.

Breast implants are not lifetime devices and breast implantation may not be a one-time surgery. The most common complications for breast augmentation with MemoryGel® Implants include any reoperation, capsular contracture, nipple sensation changes, and implant removal with or without replacement. The most common complications with MemoryShape® Implants for breast augmentation include reoperation for any reason, implant removal with or without replacement, and ptosis. The most common complications for breast reconstruction with MENTOR® MemoryGel® Breast Implants include any reoperation, implant removal with or without replacement, and capsular contracture. The most common complications with MENTOR® MemoryShape® Breast Implants for breast reconstruction include reoperation for any reason, implant removal with or without replacement, and capsular contracture. The most common complications for breast reconstruction with MENTOR® Saline-filled Breast Implants include re-operation, implant removal, capsular contracture, breast pain, and implant deflation A lower risk of complication is rupture. The health consequences of a ruptured silicone gel breast implant have not been fully established. MRI screenings are recommended three years after initial implant surgery and then every two years after to detect silent rupture. Breast implants are also associated with the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), an uncommon type of lymphoma. An individual’s risk of developing BIA-ALCL with MENTOR® Breast Implants is low based on the incidence of worldwide cases. .

Detailed information regarding the risks and benefits associated with MENTOR® Breast Implants is provided in several educational brochures for both augmentation and reconstruction:

  • For Augmentation: Important Information for Augmentation Patients about MENTOR® MemoryGel® Breast Implants. Patient Educational Brochure – Breast Augmentation with MENTOR® MemoryShape® Breast Implants and Quick Facts about Breast Augmentation & Reconstruction with MENTOR® MemoryShape® Breast Implants.
  • For Reconstruction: Important Information for Reconstruction Patients about MENTOR® MemoryGel® Breast Implants. Patient Educational Brochure – Breast Reconstruction with MENTOR® MemoryShape® Breast Implants and Quick Facts about Breast Augmentation & Reconstruction with MENTOR® MemoryShape® Breast Implants.
  • Saline-Filled Breast Implants: Making an Informed Decision. These brochures are available from your surgeon or visit www.mentorwwllc.com. It is important that you read and understand these brochures when considering MENTOR® Breast Implants.

ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® Breast Tissue Expanders are used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® Tissue Expanders contain a magnet within the internal injection domes and are NOT MRI compatible. The device could be moved by the MRI causing pain or displacement, potentially resulting in a revision surgery. DO NOT use the ARTOURA® Breast Tissue Expander and CONTOUR PROFILE® Tissue Expander in patients that have a previously implanted device such as pacemakers, drug infusion devices, artificial sensing devices, etc. that could be affected by a magnetic field. Mentor has not tested the effects of radiation therapy with ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® Expander devices. The incidence of extrusion of the expander has been shown to increase when the expander has been placed in injured areas: scarred, heavily irradiated or burned tissue, crushed bone areas, where severe surgical reduction of the area has previously been performed; and where steroids are used in the surgical pocket. Detailed information about indications, contraindications, warnings, and precautions associated with the use of ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® Expanders are provided in the Instructions for Use (IFU) available online at www.mentorwwllc.com

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