MENTOR MemoryGel Breast Implant 3507325BCRecalls & reported problems
Mentor Texas L.P. · Smooth Round Moderate Profile Gel-Filled Breast Implant, 325cc · Class 3 · Implant
All models of MENTOR MemoryGel Breast Implants (368) · MENTOR MemoryGel Breast Implant (211)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This MENTOR MemoryGel breast implant is a silicone gel-filled implant. Most of its 455 reports describe implants that rupture, and others mention gel leaking, implants shifting, breast deformity, and hardening of the scar tissue around the implant, often followed by removal and replacement surgery. The reports list 453 injuries, no deaths and 2 malfunctions, and no recalls name this device. Reports fell to 19 in the most recent year from 38 in the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 464
- Deaths reported
- 0
- Injuries reported
- 462
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 464 adverse event reports that list this exact device (DI 00081317000105), received between Apr 27, 2018 and Sep 30, 2026 — classified as 462 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (368 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
- Material Rupture368
- Adverse Event Without Identified Device or Use Problem96
- Appropriate Device Problem Term/Code Not Available11
- Gel Leak5
- Migration5
- No Apparent Adverse Event2
- Material Discolored1
- Off-Label Use1
Patient problems
- Deformity/ Disfigurement187
- Capsular Contracture148
- No Code Available133
- Pain23
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available14
- Breast Discomfort/Pain13
- No Clinical Signs, Symptoms or Conditions11
- Breast Mass6
Recent adverse event reports
The 25 most recent of 464 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Material Rupture
It was reported that a female patient underwent unspecified breast augmentation with MENTOR MemoryGel, 325cc silicone implants. The patient subsequently presented with right-sided capsular contracture grade III, symptomatic rupture and left sided silent rupture. Rupture were discovered during surgery. As a result, the patient underwent bilateral replacements with unspecified Mentor Gel on (b)(6)2026. This report relates to the left side.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948113 ↗InjurySep 29, 2026Material Rupture
It was reported that a patient with MENTOR MemoryGel Breast Implants experienced bilateral rupture post-operatively, which was confirmed during a physical exam. As a result, the patient is scheduled for removal on (b)(6) 2026.This report is for the right breast prosthesis.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935903 ↗InjurySep 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935902 ↗InjurySep 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826452 ↗InjurySep 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826147 ↗InjurySep 18, 2026Gel Leak
It was reported that a female patient underwent Breast Augmentation Primary with MENTOR MemoryGel, 325cc Silicone implants, subsequently the patient experienced left sided gel bleed. The report indicated that Lymph nodes were not examined. The surgical pathology shows: Pericapsular tissue with fibrosis and florid histiocytic response. Associated foreign body giant cell reaction and focal acute inflammation. As a result, the patient underwent removal surgery on (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822738 ↗InjurySep 16, 2026Material Rupture
It was reported that a patient with MENTOR MemoryGel Breast Implants experienced rupture on the right side post-operatively, which was confirmed during a physical exam. As a result, the patient underwent device removal and replacement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789104 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient with MENTOR MemoryGel Breast Implants experienced bilateral capsular contracture Baker Grade unknown and rupture on the left side post-operatively, which was confirmed during a physical exam. As a result, the patient underwent device removal and replacement.This report is for the right breast prosthesis.
Patient problems: Capsular Contracture
MAUDE report 50734834 ↗InjurySep 8, 2026Material Rupture
It was reported that a patient with MENTOR MemoryGel Breast Implants experienced rupture on the left side post-operatively, which was confirmed during a physical exam. At the time of this report, Mentor has received no information regarding explanation or an expected explanation date.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671252 ↗InjuryAug 19, 2026Material Rupture
It was reported that a 48-year-old Caucasian female patient underwent a primary breast augmentation with a 325cc MENTOR MemoryGel Breast Implant and experienced a rupture on the right side post-operatively, which was diagnosed MRI. As a result, the patient underwent explantation on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50333426 ↗InjuryMay 17, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 325CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH LEFT BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 25196182 ↗InjuryApr 30, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 25048384 ↗InjuryApr 24, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 325CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED IMPLANTS BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR SALINE IMPLANTS ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24987560 ↗InjuryApr 24, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 325CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED IMPLANTS BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR SALINE IMPLANTS ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24987436 ↗InjuryApr 1, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE II ALONG WITH BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 24753764 ↗InjuryMar 30, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 325CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADES IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. DURING THE REMOVAL SURGERY, BOTH IMPLANTS WERE FOUND TO BE RUPTURED. THE REPLACEMENT DEVICES WERE TWO NEW MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 24723203 ↗InjuryMar 30, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 325CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADES IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. DURING THE REMOVAL SURGERY, BOTH IMPLANTS WERE FOUND TO BE RUPTURED. THE REPLACEMENT DEVICES WERE TWO NEW MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 24722267 ↗InjuryMar 25, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 325CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24690700 ↗InjuryFeb 25, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA MAMMOGRAM AND MRI. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION.
Patient problems: Deformity/ Disfigurement
MAUDE report 24449194 ↗InjuryFeb 19, 2026Material Rupture
IT WAS REPORTED THAT A 40-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 24392675 ↗InjuryFeb 4, 2026Material Rupture
A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL , 325CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED SILENT RUPTURE POST OPERATION. THE RUPTURE WAS DISCOVERED DURING THE SURGERY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENTS PER FOLLOWING: L) REF: (B)(4), SN: (B)(6), R) REF: (B)(4), SN: (B)(6), ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24260371 ↗InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem; Migration
IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 350CC (LEFT) MENTOR MEMORYGEL BREAST IMPLANT AND 325CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE EXPLANTATION ON (B)(6) 2026. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.
Patient problems: Capsular Contracture
MAUDE report 24039996 ↗InjuryJan 7, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 23994444 ↗InjuryDec 26, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 325CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 23900856 ↗InjuryDec 8, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WITH A MENTOR MEMORYGEL BREAST IMPLANT (L) AND AN UNSPECIFIED MENTOR GEL BREAST IMPLANT (R) EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 23748351 ↗
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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