MENTOR MemoryGel Xtra Breast Implant SMHX150Recalls & reported problems
Mentor Texas L.P. · Smooth Moderate High Profile Xtra, 150 cc |Smooth|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
- 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 10081317027758), received between Feb 19, 2026 and Apr 21, 2026 — classified as 2 injuries.
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
Patient problems
- Breast Discomfort/Pain1
- Capsular Contracture1
- Paresthesia1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 38-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 240CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE LEFT SIDE AND WITH 150CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE RIGHT SIDE AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. ON (B)(6) 2026, MENTOR BECAME AWARE THAT THE PATIENT SUFFERED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2026. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.
Patient problems: Capsular Contracture
MAUDE report 24948400 ↗InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem
A FEMALE PATIENT WITH A HISTORY OF PRIMARY BREAST AUGMENTATION USING MENTOR MEMORYGEL XTRA SILICONE PROSTHESES (150 CC) PRESENTED WITH LEFT SIDED PARESTHESIA AND PERSISTENT BREAST PAIN FOLLOWING THE PROCEDURE. SHE REPORTED CONSTANT BURNING PAIN OF THE LEFT BREAST FOR APPROXIMATELY 6¿9 MONTHS AFTER A SCAR REVISION IN (B)(6) 2024. MULTIPLE INTERVENTIONS WERE ATTEMPTED AT ANOTHER CLINIC, BUT THE PATIENT REMAINED SYMPTOMATIC AND SOUGHT A SECOND OPINION WITH ANOTHER DR FOR EXPLANTATION. THERE WAS NO EVIDENCE OF CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT IMPLANT REMOVAL ON (B)(6) 2026.
Patient problems: Breast Discomfort/Pain; Paresthesia
MAUDE report 24390941 ↗
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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