MENTOR MemoryGel Xtra Breast Implant TMPX240Recalls & reported problems
Mentor Texas L.P. · SILTEX Moderate Plus Profile Xtra Silicone Gel-Filled Breast Implant, 240cc |Textured|Round|Silicone| · Class 3 · Implant
All models of MENTOR MemoryGel Breast Implants (368) · MENTOR MemoryGel Xtra Breast Implant (88)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00081317025436), received between Mar 23, 2020 and Oct 16, 2023 — classified as 2 injuries, 1 malfunction.
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
- Breast Discomfort/Pain2
- Capsular Contracture2
- Deformity/ Disfigurement2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 53-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL XTRA, 240CC SILICONE BREAST IMPLANT, EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE UNKNOWN GRADE, AND BILATERAL BREAST PAIN POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REMOVAL ON (B)(6) 2023. THIS REPORT RELATES TO THE LEFT SIDE.
Patient problems: Breast Discomfort/Pain; Capsular Contracture; Deformity/ Disfigurement
MAUDE report 17939262 ↗InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL XTRA, 240CC SILICONE BREAST IMPLANT, EXPERIENCED RIGHT-SIDED CAPSULAR CONTRACTURE UNKNOWN GRADE POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Breast Discomfort/Pain; Capsular Contracture; Deformity/ Disfigurement
MAUDE report 14279854 ↗MalfunctionMar 23, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT A 240CC TEXTURED MENTOR MEMORYGEL XTRA BREAST IMPLANT BEING USED FOR A PRIMARY BREAST AUGMENTATION WAS FOUND TO BE RUPTURED INTRAOPERATIVELY. THE SURGEON DISCOVERED THE RUPTURE DURING SURGERY. AS A RESULT, THE RUPTURED IMPLANT WAS REPLACED WITH LIKE DEVICE, CATALOG # TMPX240, SERIAL # (B)(4) ON (B)(6) 2020. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR SURGICAL DELAYS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9869705 ↗
Other Prosthesis, breast, noninflatable, internal, silicone gel-filled devices
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- 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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