Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized Recalled by Mentor Texas, LP. Due to Due to a manufacturing issue, Implant may have...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mentor Texas, LP. directly.
Affected Products
MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available with SILTEX Textured or smooth surface shells. Each implant is supplied sterile with a disposable fill tube and reflux valve.
Quantity: 28,348 implants
Why Was This Recalled?
Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mentor Texas, LP.
Mentor Texas, LP. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report