Product Insert Data Sheet MENTOR MEMORYGEL - FDA 2025

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The US Food and Drug Administration (FDA) has reviewed the materials used in the manufacture of MENTOR Implants and determined that the implants are safe and effective.
Projection, Fullness Firmness MemoryGel, Xtra Implants provide increased projection, fullness and firmness when compared to MemoryGel Implants.
Mentor has initiated a voluntary Medical Device Recall (removal) regarding specific lots of MENTOR Smooth Round Saline Diaphragm Valve (DV) Implants which have expiration dates from January 01, 2025 to September 30, 2025.
There are two types of FDA-approved implants: saline-filled (saltwater solution) and silicone gel-filled. Both have a silicone outer shell and vary in size, shell thickness, shell surface texture, and shape (contour).
These lawsuits include claims that the new silicone implants cause skin rashes, fatigue, and autoimmune system responses. Other claims state that heavy metals are used to manufacture the implants, and can end up in the bloodstream and cause serious illnesses.
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(December 2, 2024) Mentor Worldwide LLC, the number one global brand in aesthetics, and part of Johnson Johnson MedTech, today announced the U.S. Food and Drug Administration (FDA) approved MENTOR MemoryGel Enhance Implants for primary and revision reconstruction surgery in post-mastectomy