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Devices Product Launch

 News Release - April 28, 2017

MENTOR(R) Launches MENTORPromise Protection Plan

Company offers the industry's most comprehensive product warranty program for breast implant surgery patients

SAN DIEGO, April 28, 2017 -- (Healthcare Sales & Marketing Network) -- Mentor Worldwide LLC, a global leader in breast aesthetics, today announced at The American Society for Aesthetic Plastic Surgery (ASAPS) meeting the new MENTORPromise Protection Plan - the industry's most comprehensive warranty program - for all MENTOR® breast implants sold in the U.S. All MENTOR® breast implant recipients are automatically enrolled in the MENTORPromise Protection base plan, and the company offers an enhanced version of the plan for an additional fee.

The warranty program provides even more protection than the company's current industry-leading plan, by offering the highest level of financial assistance for the broadest range of needs, including a lifetime guarantee for product replacement and 10-year financial assistance coverage.

"When you have a warranty program as strong as the MENTORPromise Protection Plan, it makes choosing MENTOR® products an easy decision," said Dr. Aldo Guerra,* MD, Fellow of the American College of Surgeons (FACS). "Mentor's confidence in their products reassures me that I am working with quality products, and that is exactly what my patients want."

MENTOR® is announcing this new warranty program following the U.S. Food and Drug Administration's approval of MENTOR® MemoryGel® Xtra Breast Implants, designed for extra fullness and projection in women undergoing breast reconstruction, augmentation or revision surgery. This extension to the company's top-selling global brand of breast implants will be covered under the MENTORPromise Protection Plan.

"We understand the importance of developing products that not only make our patients feel confident, but also give them and their surgeons the extra peace of mind that comes with choosing MENTOR® products," said Warren Foust, Vice President, MENTOR® US Sales and Marketing. "This warranty program reinforces the confidence we have in the quality of our products and our commitment to our customers and their patients."

MENTOR® will be featuring the MENTORPromise Protection Plan at its booth at the ASAPS meeting. Please visit www.mentorwwllc.com for full warranty details.

About Mentor Worldwide LLC

Mentor Worldwide LLC, part of Johnson & Johnson Medical Devices Companies, is a leading supplier of breast implants in the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow breast surgery patients to improve their quality of life. The company is focused on two strategic areas: breast reconstruction and breast augmentation. MENTOR® is the only manufacturer whose silicone breast implants are made in the U.S.A.

For more information about MENTOR® visit: www.mentorwwllc.com

Important Safety Information:

The MENTOR® Collection of Breast Implants are 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.

Breast implants are not lifetime devices and breast implantation may not be a one-time surgery.

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. 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.

The most common complications for breast reconstruction with MENTOR® Saline-filled Breast Implants include reoperation, implant removal, capsular contracture, breast pain, and implant deflation.

Detailed information regarding the risks and benefits associated with MENTOR® Breast Implants is provided in several educational brochures. For MemoryGel® Implants: Important Information for Reconstruction Patients about MENTOR® MemoryGel® Breast Implants. For MemoryShape® Implants: Patient Educational Brochure – Breast Reconstruction with MENTOR® MemoryShape® Breast Implants and Quick Facts about Breast Augmentation & Reconstruction with MENTOR® MemoryShape® Breast Implants. For MENTOR® Saline-filled 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.

The CONTOUR PROFILE® Breast Tissue Expander can be utilized 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. CONTOUR PROFILE® Expanders should not be used in patients where an MRI may be needed. 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. Detailed information about indications, contraindications, warnings, and precautions associated with the use of CONTOUR PROFILE® Expanders are provided in the Product Insert Data Sheet available online at www.mentorwwllc.com.


Source: Mentor Worldwide

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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