Mentor Announces FDA Approval for MemoryGel® Xtra Silicone Gel-Filled Breast Implants

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New addition to ARTOURATM Breast Tissue Expander Line also cleared

Irvine, Calif., April 26, 2017 -- Mentor Worldwide LLC, a global leader in breast aesthetics, today announced that it has received approval from the U.S. Food & Drug Administration (FDA) to market MemoryGel® Xtra silicone gel-filled breast implants in the U.S. The new addition to the company’s top-selling global brand of breast implants offers extra fullness and projection to women undergoing breast reconstruction, augmentation or revision surgery.

“I look forward to being able to provide women with this new style of implant to consider, as they evaluate the options associated with breast implant surgery,” said Dr. Louis Strock,* American Board of Plastic Surgery, Diplomate. “MENTOR®MemoryGel®implants, with their soft, natural feel, have been a great fit for many of my patients throughout the years. Each enhancement to the MemoryGel product line has been thoughtfully designed with patients in mind.”

MENTOR® MemoryGel® Xtra implants will soon be available to customers in the U.S.

ARTOURA™ Breast Tissue Expander with a Smooth Shell
The company also announced a new addition to its ARTOURA™ Breast Tissue Expander line, an expander with a smooth shell that will be available throughout the U.S. This product widens options for reconstructive surgeries and provides an alternative for surgeons who may prefer a smooth expander.

The MENTOR® ARTOURA Breast Tissue Expander is the only expander with Dynamic Control Technology™ designed to provide a precise, controlled expansion. The reliable, contoured MENTOR® ARTOURA™ Breast Tissue Expander simplifies expander selection and provides a more seamless transition to final implant selection.

“Since its launch in 2015, the MENTOR® ARTOURA™ expander platform has proven to be a welcome innovation in breast tissue expander technology,” said Dr. Salvatore J. Pacella,* Division Head, Plastic Surgery Scripps Clinic and Green Hospital in La Jolla, California. “Having a new smooth shell configuration, in addition to the existing SILTEX® textured shell, gives me the ability to select an appropriately surfaced expander for my patients, which has previously not been available.  I’ve continued to add the smooth-shelled ARTOURA™ Expander into my practice and have been very pleased with the performance of the device, particularly with the final aesthetic result after expander-to-implant exchange.”

The ARTOURA™ Expander is available in two projections and achieves a full profile at a range of fill volumes which enables a match with corresponding MemoryShape® and MemoryGel® Breast Implant options.
 

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.

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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.
 

* Dr. Strock and Dr. Pacella are paid consultants to Mentor Worldwide LLC.