Product Insert Data Sheet MENTOR MEMORYGEL FDA Form
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People also ask
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What brand of breast implants are being recalled?
Breast Implant and Tissue Expanders in July 2019 U.S. Recall BRAND/MODELFDA PREMARKET APPROVALNatrelle Biocelle Textured Soft Touch Silicone-Filled Breast ImplantsP020056Natrelle 133 Tissue Expanders with suture tabsK102806Natrelle 133 Plus Tissue ExpandersK1433545 more rows -
What are the issues with Mentor memory gel implants?
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, sensation changes, and implant removal with or without replacement. -
Is there a recall on Mentor memory gel implants?
Mentor has initiated a voluntary Medical Device Recall (removal) regarding specific lots of MENTOR® Smooth Round Saline Diaphragm Valve (DV) Breast Implants which have expiration dates from January 01, 2025 to September 30, 2025. -
Are mentor implants FDA approved?
U.S. FDA Approves New MENTOR® MemoryGel BOOST™ Breast Implant | Johnson & Johnson. -
What are the FDA recommendations for breast implant surveillance?
Even if you have no symptoms, you should have your first ultrasound or MRI at 5-6 years after your initial implant surgery and then every 2-3 years thereafter. If you have symptoms at any time or uncertain ultrasound results for breast implant rupture, an MRI is recommended. -
Which Mentor implants were recalled?
Device Recall MENTOR MemoryGel Sizer MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer. -
Is Mentor memory gel saline or silicone?
Mentor Silicone Gel-Filled Breast Implants are devices with shells constructed from silicone elastomer. The shell is filled with MemoryGel®, Mentor's proprietary formulation of silicone gel. -
How can I find out if my implants are recalled?
Check their breast implants in the list of recalled products on the FDA's website. Contact Allergan to determine whether the company has information about the patient's breast implants.
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