Mentor Worldwide LLC

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Mentor Worldwide LLC Overview

Mentor Worldwide LLC is a wholly-owned subsidiary of Johnson & Johnson MedTech and the only U.S.-based manufacturer of silicone breast implants. Founded in 1969 and headquartered in Santa Barbara, California, the company designs, manufactures and markets breast implants, tissue expanders and body-contouring devices for both aesthetic augmentation and post-mastectomy reconstruction. The acquisition by Johnson & Johnson was completed in January 2009 for approximately US $1.1 billion cash.

Core Business & Key Technologies

Mentor’s core business is structured around three strategic pillars:

Breast Aesthetics – round and anatomical silicone implants (MemoryGel®, MemoryShape®), saline implants (SPECTRUM®) and the newly FDA-approved MemoryGel Enhance™ with expanded volume range (930 cc–1,445 cc).
Breast Reconstruction – CPX®4 and Spectrum® tissue expanders, Contour Profile® adjustable expanders, and the ATHENA 10-year clinical study supporting safety and efficacy.
Body Contouring – Power-Assisted Lipoplasty (PAL®) systems and post-surgical compression garments.

Proprietary technologies include Siltex® textured shell, cohesive MemoryGel™ silicone and patented self-sealing valves that reduce gel bleed to < 1 %.

Market Position & Flagship Products

Mentor is one of the top-two global players in the US $3.4 billion breast-implant market, alongside Allergan (AbbVie). Flagship products include:

MemoryGel BOOST™ – FDA-approved in 2022 for both augmentation and reconstruction; features increased projection and cohesive gel.
MemoryGel Enhance™ – the largest-volume silicone implant approved by FDA (December 2024) for primary and revision reconstruction, supported by 3-year ATHENA data.
SPECTRUM® Adjustable Saline Implants – allow intra-operative or post-operative volume adjustment without additional surgery.

Global footprint spans > 80 countries; > 5 million Mentor implants have been placed since inception, with > 350,000 in 2023 alone.

Recent Milestones & Regulatory Updates

Dec 2024 – FDA approval of MemoryGel Enhance™ for post-mastectomy reconstruction, expanding the largest silicone implant range to 1,445 cc.
Jan 2025 – CE-Mark renewal for MemoryGel® Xtra round implants, enabling continued European sales under the new EU MDR.
Q2 2025 – NMPA registration dossier submitted for MemoryGel BOOST™ in China (CMDE review ongoing).

Additionally, Mentor is advancing the next-generation cohesive gel (MemoryGel XtraSoft™) with pre-clinical trials demonstrating 30 % softer feel and improved shape retention.