MENTOR MemoryShape Breast Implant 3341009Recalls & reported problems
Mentor Texas L.P. · Tall Height, Moderate Plus Profile Silicone Gel-Filled Breast Implant, 205cc |Textured|Contour|Silicone| · Class 3 · Implant
All models of MENTOR MemoryShape Breast Implant (65)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00081317005032), received between Apr 2, 2025 and Apr 2, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Rupture” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Rupture1
Patient problems
- Capsular Contracture2
- Pain1
- Swollen Lymph Nodes/Glands1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 2, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 205CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED RIGHT SIDED BAKER GRADE III CAPSULAR CONTRACTURE, LEFT SIDED RUPTURE, LEFT SIDED LYMPHADENOPATHY, AND LEFT SIDED PAIN POST PROCEDURE. SHE WAS HAVING NECK PAIN WITH SWOLLEN LYMPH NODES. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2025.
Patient problems: Capsular Contracture; Pain; Swollen Lymph Nodes/Glands
MAUDE report 21753274 ↗InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 205CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED RIGHT SIDED BAKER GRADE III CAPSULAR CONTRACTURE, LEFT SIDED RUPTURE, LEFT SIDED LYMPHADENOPATHY, AND LEFT SIDED PAIN POST PROCEDURE. SHE WAS HAVING NECK PAIN WITH SWOLLEN LYMPH NODES. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2025.
Patient problems: Capsular Contracture
MAUDE report 21753272 ↗
Other Prosthesis, breast, noninflatable, internal, silicone gel-filled devices
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- MENTOR MemoryGel Breast Implant 3504004BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,012 reports
- MENTOR MemoryGel Breast Implant 3504504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,754 reports
- MENTOR MemoryGel Breast Implant 3503001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,752 reports
- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
- MENTOR MemoryGel Breast Implant 3504501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,690 reports
- MENTOR MemoryGel Breast Implant 3503251BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,684 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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