Empowering Breast Surgeons and Patients for Over 30 Years.

innovations

Not All Innovations Are Equal

At Mentor, we believe that innovation should be driven by what patients need and should be backed by solid research, high design and thorough testing. It takes some time to develop and launch safe, impactful innovations that significantly and positively affect patient outcomes.

This is why we stand by our proven portfolio of meaningful innovations. We are committed to earning and keeping your trust by offering new product innovations as they are needed and valued by your patients.

Safety Information and Resources

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References

* Based on worldwide market share. Data as of June 2017.
1. Based on warranty comparisons of the following breast implants: Allergan Natrelle, EuroSilicone & Nagor, Arion, Polytech, Motiva, Sebbin.
2. Summary of the Safety and Effectiveness of Mentor’s MemoryGel® Silicone Gel-Filled Implants in Patients who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. 10-Year Core Gel Final Clinical Study Report. April 2013.
3. Mentor Worldwide, LLC. MemoryShape™ Post-Approval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report. 02 June 2015.
4. Bielefeld, B. A Prospective Clinical Study of Mentor Corporation Saline-filled MammaryProsthesis, Siltex® Saline-filled Mammary Prosthesis, and Siltex® Saline-filled Post-operatively Adjustable Mammary Prosthesis (SpectrumTM) for Augmentation Mammoplasty and Reconstruction Mammoplasty. Nov 10, 1999.
5. Bondurant, S., Ernster, V., and Herdman, R. Safety of Silicone Implants. Washington, DC: National Academy Press. 1999.
6. Mentor Worldwide LLC. Mentor Worldwide Sales Data
7. Mentor Worldwide LLC. PROC400623

Important Safety Information

MENTOR® Breast Implants are indicated for breast augmentation, in women who are at least 18 years old, or 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 breast(s) who have not received adequate treatment for those conditions or who are pregnant or nursing.

There are risks associated with breast implant surgery. Breast implants are not lifetime devices and breast implantation is not necessarily a one-time surgery. The most common complications with MENTOR® MemoryGel™ Breast Implants include re-operation, implant removal, capsular contracture, asymmetry, and breast pain. A lower risk of complication is implant rupture, which is most often silent. The health consequences of a ruptured silicone gel-filled breast implant have not been fully established. Screenings such as mammography, MRI, or ultrasound are recommended after initial implant surgery to assist in detecting implant rupture.

The most common complications with MENTOR® Saline-Filled Implants include re-operation, implant removal, capsular contracture, wrinkling, deflation, asymmetry, and breast pain.

MENTOR® CPX™4 Breast Tissue Expanders can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures.

These expanders are intended for temporary subcutaneous or submuscular implantation.*

CONTOUR PROFILE™ Tissue Expanders are devices that contain magnetic injection domes and are NOT MRI compatible. Do not use the CONTOUR PROFILE™ Tissue Expander in patients where an MRI may be needed. DO NOT use the CONTOUR PROFILE™ Tissue Expander in patients that have a previously implanted device that could be affected by a magnetic field. The device could be moved by the MRI causing pain or displacement, potentially resulting in a revision surgery. 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 or where severe surgical reduction of the area has previously been performed.

Your patient needs to be informed and understand the risks and benefits of breast implants, and provided with an opportunity to consult with you prior to deciding on surgery.

For detailed indications, contraindications, warning and precautions associated with the use of all MENTOR® Implantable Devices, please refer to the Product Insert Data Sheet provided with each product, or review the Important Safety Information provided at https://www.jnjmedicaldevices.com/en-EMEA/mentor.

 

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Last Modified: 1/13/20

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