MENTOR MemoryGel BOOST Breast Implant SHPB200Recalls & reported problems
Mentor Texas L.P. · Smooth High Profile, 200cc |Smooth|Round|Silicone| · Class 3 · Implant
All models of MENTOR MemoryGel Breast Implants (368) · MENTOR MemoryGel BOOST Breast Implant (53)
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 00081317027003), received between Oct 20, 2025 and Oct 20, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (2 reports).
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
- Migration2
Patient problems
- Breast Discomfort/Pain1
- Capsular Contracture1
- Deformity/ Disfigurement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 20, 2025Migration; Migration
IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 200CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS AND EXPERIENCED BILATERAL DEVICE MIGRATION POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE LEFT SIDE AND BREAST ASYMMETRY WITH PAIN ON THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 FOR THE LEFT BREAST AND REPLACED WITH A 225CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG NUMBER 3502254BC) WITH LOT NUMBER 9984802. THE PATIENT DID HAVE SURGICAL INTERVENTION ON THE RIGHT SIDE BUT THE BREAST PROSTHESIS WAS NOT REMOVED. THIS REPORT IS FOR THE LEFT SIDE DEVICE.
Patient problems: Capsular Contracture
MAUDE report 23343013 ↗InjuryOct 20, 2025Migration; Migration
IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 200CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS AND EXPERIENCED BILATERAL DEVICE MIGRATION POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE LEFT SIDE AND BREAST ASYMMETRY WITH PAIN ON THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 FOR THE LEFT BREAST AND REPLACED WITH A 225CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG NUMBER 3502254BC) WITH LOT NUMBER 9984802. THE PATIENT DID HAVE SURGICAL INTERVENTION ON THE RIGHT SIDE BUT THE BREAST PROSTHESIS WAS NOT REMOVED. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.
Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement
MAUDE report 23343007 ↗
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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