U.S. FDA Approves New MemoryGel BOOST Breast Implant by Mentor

by Surgical Times

Mentor Worldwide LLC announced early Thursday, January 13, that the U.S. FDA has approved its MemoryGel BOOST Breast Implant for breast augmentation in women at least 22 years old, and for women of all ages undergoing breast reconstruction.

The new implants will be commercially available for surgeons in the United States in early 2022.

Nearly 400,000 women undergo breast implant surgeries each year in the U.S., according to the American Society of Plastic Surgeons. Selecting an implant is a personal decision and critical part of the journey. Each patient’s preferences and goals are unique, and that means providing surgeons with a wide range of sizes and profiles to enhance their ability to individualize a patient’s results. While there are many options currently available, surgeons cite the need for an implant with increased form stability to help shape the breast, without sacrificing the soft, natural feel that patients desire.      

“Our commitment to innovation is driven, first and foremost, by the needs of our customers and patients, and providing them with the highest quality products to achieve their desired outcome,” said Lori Tierney, Worldwide President, Mentor Worldwide LLC. “With this pivotal addition to our MemoryGel portfolio, we are thrilled to provide a meaningful range of options to meet surgeon objectives and patient preferences, beyond what is currently available in the breast aesthetics market.”

According to a recent survey involving 297 respondents, patients and surgeons preferred the new implant as feeling more like a natural breast versus another leading brand. The new implant provides the natural feel patients desire with increased form stability to shape the breast.

MemoryGel BOOST brings together Mentor’s proprietary highly cohesive gel, an innovative implant shell design and precision fill ratio, the combination of which provides an implant with increased form stability to shape the breast. 

“Through science-based design and innovation, we are able to offer both increased form stability and a natural feel in the same product,” said Krasimira Hristov, Director of R&D, Mentor Worldwide LLC. “The MemoryGel BOOST Breast Implant is truly a unique innovation that satisfies an unmet need and expands the MemoryGel product line.”

For more than 30 years, Mentor has been trusted and respected by surgeons and their patients, with over seven million women worldwide choosing Mentor Breast Implants for their breast augmentation and breast reconstruction journeys. Mentor also offers the industry’s most comprehensive enhanced warranty, and all Mentor Breast Implants are backed by the Mentor Promise Protection Plan, which provides free automatic coverage for patients who qualify.

US law restricts this device to sale by or on the order of a physician. The sale and distribution of Mentor Breast Implant Devices are restricted to users and/or user facilities that provide information to patients about the risks and benefits of the device prior to its use in the form and manner specified in approved labeling to be provided by Mentor Worldwide LLC.

Warning

  • Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery.
  • Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This cancer occurs more commonly in patients with textured breast implants than smooth implants, although rates are not well defined. Some patients have died from BIA-ALCL.
  • Patients receiving breast implants have reported a variety of systemic symptoms such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement.

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, and 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 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 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. 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 MemoryGel Implants: Important Information for Augmentation Patients about MENTOR MemoryGel Breast Implants. For MemoryShape Implants: Patient Educational Brochure – Breast Augmentation 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 sale and distribution of Mentor Breast Implant Devices are restricted to users and/or user facilities that provide information to patients about the risks and benefits of the device prior to its use in the form and manner specified in approved labeling to be provided by Mentor Worldwide LLC.

198878-220106. © Mentor Worldwide LLC 2022. Source: Johnson & Johnson Medical Devices Companies

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