MemoryGel Silicone Gel-Filled Breast Implants

• • Terminated Z-2326-2016 FDA Class II ·initiated 1 Jul 2016

  The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.

Full name

Mentor Memorygel Silicone Gel-Filled Breast Implants

Trade Name

Memorygel Silicone Gel -Filled Breast Implants

Generic Name

Prosthesis, breast, noninflatable, internal, silicone gel-filled

PMA Number

P030053 ↗

FDA Product Code

FTR

Device Class

Class III

Regulation

21 CFR Part 878.3540

Advisory Committee

General, Plastic Surgery

FDA Decision

APPR Approved

• MENTOR CPX4, Tall Height Breast Tissue Expander, Suture Tabs, Textured

  Class III

  CE/MDR

• MENTOR CPX4, Medium Height Breast Tissue Expander, Suture Tabs, Textured

  Class III

  CE/MDR

• MENTOR CPX4, Medium Height Breast Tissue Expander, Textured

  Class III

  CE/MDR

• MENTOR CPX4, Tall Height Breast Tissue Expander, Textured

  Class III

  CE/MDR

• MENTOR CPX4, Low Height Breast Tissue Expander, Textured

  Class III

  CE/MDR

• MENTOR CPX4, Low Height Breast Tissue Expander, Suture Tabs, Textured

  Class III

  CE/MDR

See all devices from Mentor Corp. →

• What are the primary uses for the MemoryGel Silicone Gel-Filled Breast Implants, and who qualifies for them?

  The MemoryGel Silicone Gel-Filled Breast Implants are intended for **breast augmentation in women aged 22 or older** to increase breast size or correct/revise prior augmentation results. They are also approved for **breast reconstruction in women of any age** following tissue removal due to cancer, trauma, or congenital abnormalities, including revision surgeries to improve reconstruction outcomes. The device is not intended for cosmetic purposes in patients under 22.

• Are these implants single-use or reusable, and how should they be stored?

  The MemoryGel Silicone Gel-Filled Breast Implants are **sterile and intended for single-use only**. They must be stored according to sterile surgical protocols to maintain device integrity and patient safety. Improper storage could compromise sterility, so follow manufacturer guidelines for packaging and environmental conditions.

• What regulatory pathway does this device follow, and how does that affect its availability?

  This device follows the **FDA Pre-Market Approval (PMA) pathway**, authorized under PMA Number **P030053**. This means it has undergone rigorous clinical evaluation and approval before commercial distribution. Availability is restricted to **qualified healthcare professionals** in controlled surgical settings, as it is classified as a **Class III** device under FDA regulations.

• Do these implants come in multiple sizes, and how would a clinician determine the appropriate size for a patient?

  Yes, the MemoryGel Silicone Gel-Filled Breast Implants are available in **multiple sizes** (specific dimensions are listed in the FEI numbers provided). The appropriate size is determined by the surgeon based on patient anatomy, desired outcome, and clinical assessment—factors like breast tissue quality, patient body type, and aesthetic goals influence selection. Consult the manufacturer’s sizing guides for detailed reference.

• Can these implants be used in revision surgeries, and if so, what scenarios are they approved for?

  Yes, these implants are explicitly approved for **revision surgeries** to correct or improve outcomes of prior breast augmentation or reconstruction procedures. This includes addressing complications like capsular contracture, implant malposition, or patient dissatisfaction with initial results. The approval covers both **augmentation revisions** (for women ≥22) and **reconstruction revisions** (for any age).