MENTOR MemoryShape Breast Implant 3541008Recalls & reported problems
Mentor Texas L.P. · Medium Height, Moderate Profile Silicone Gel-Filled Breast Implant, 155cc |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 00081317005414), received between Jun 24, 2024 and Jun 24, 2024 — 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 Problem2
- Material Rupture1
Patient problems
- Capsular Contracture2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 155CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BAKER GRADE II CAPSULAR CONTRACTURE, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 19600420 ↗InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 155CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BAKER GRADE II CAPSULAR CONTRACTURE, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 19600306 ↗
Other Prosthesis, breast, noninflatable, internal, silicone gel-filled devices
- MENTOR MemoryGel Breast Implant 3503501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,167 reports
- MENTOR MemoryGel Breast Implant 3504001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,130 reports
- 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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