MENTOR MemoryGel Breast Implant 3503251BCRecalls & reported problems
Mentor Texas L.P. · Smooth Round Moderate Plus Profile Gel-Filled Breast Implant, 325cc |Smooth|Round|Silicone| · 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 is the Mentor MemoryGel breast implant, a silicone gel-filled implant. The 1,678 reports often describe the implant rupturing, and many mention hardening of the scar tissue around the implant, changes in breast shape, and pain. The records include no deaths, 1,653 injuries and 25 malfunctions, and no recalls name this device. Reports fell to 96 in the last 12 months from 183 in the 12 months 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
- 1,684
- Deaths reported
- 0
- Injuries reported
- 1,659
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,684 adverse event reports that list this exact device (DI 00081317000297), received between Apr 17, 2018 and Sep 29, 2026 — classified as 1,659 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (818 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
- Adverse Event Without Identified Device or Use Problem857
- Material Rupture818
- Migration52
- Appropriate Device Problem Term/Code Not Available21
- Gel Leak14
- Material Discolored10
- Off-Label Use6
- Use of Device Problem6
Patient problems
- Capsular Contracture804
- Deformity/ Disfigurement482
- No Code Available344
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available78
- Pain59
- Breast Discomfort/Pain53
- No Clinical Signs, Symptoms or Conditions45
- Wrinkling25
Recent adverse event reports
The 25 most recent of 1,684 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926785 ↗InjurySep 25, 2026Material Rupture
It was reported that a patient with MENTOR MemoryGel Breast Implants experienced capsular contracture Baker Grade unknown along with rupture on the left side post-operatively, which was confirmed during a physical exam. As a result, the patient underwent device removal and replacement.
Patient problems: Capsular Contracture
MAUDE report 50898711 ↗InjurySep 23, 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. As a result, the patient has been scheduled for breast implant removal surgery on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871426 ↗InjurySep 23, 2026Material Rupture
It was reported that a patient implanted with a 325cc MENTOR MemoryGel Breast Implant experienced a rupture on the right side post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869602 ↗InjurySep 22, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859143 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient with MENTOR MemoryGel Breast Implants experienced capsular contracture Baker Grade III 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 explantation or an expected explantation date.
Patient problems: Capsular Contracture
MAUDE report 50856832 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a female patient underwent a breast augmentation revision with a 325cc MENTOR MemoryGel Breast Implant and experienced inflammation/irritation/swelling on the left side post-operatively. As a result, the patient underwent explantation on (b)(6) 2026, and replaced with a 325cc MENTOR MemoryGel Breast Implant.
Patient problems: Local Reaction
MAUDE report 50855740 ↗InjurySep 21, 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 underwent bilateral exchange with Mentor gel implants on(b)(6)2026 for an elective size exchange surgery. However, during the surgery, both explanted devices were found to be ruptured. There were no reported procedural delays or patient consequences/harms due to the findings. This report is for the left breast prosthesis.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841263 ↗InjurySep 21, 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. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.Follow-ups have been conducted, and no additional information has been received. If more information becomes available, Mentor will submit a supplemental report accordingly.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840545 ↗InjurySep 21, 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. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.Follow-ups have been conducted, and no additional information has been received. If more information becomes available, Mentor will submit a supplemental report accordingly.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840544 ↗InjurySep 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827894 ↗InjurySep 17, 2026Material Rupture
Patient problems: Crushing Injury; No Clinical Signs, Symptoms or Conditions
MAUDE report 50808842 ↗InjurySep 17, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808841 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of a 325cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient was diagnosed with right breast Baker Grade III Capsular Contracture during a physical exam as the breast was firm, elevated, and distorted. As a result, the patient underwent right-sided exchange with a Mentor gel implant on (b)(6) 2026.
Patient problems: Capsular Contracture
MAUDE report 50793517 ↗InjurySep 16, 2026Material Rupture
It was reported that a patient underwent breast augmentation revision with a 325cc MENTOR MemoryGel Breast Implant on the left breast. Post-operatively, the patient was diagnosed with left breast implant rupture. As a result, the patient underwent breast implant removal and replacement surgery on(b)(6)2026. The replacement device was a Mentor gel implant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791161 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient implanted with TWO MENTOR MemoryGel Breast Implant experienced bilateral capsular contracture Baker Grade 4 post-operatively. As a result, the patient underwent explantation on (b)(6), 2026.
Patient problems: Capsular Contracture
MAUDE report 50775550 ↗InjurySep 9, 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 a ruptured right implant during a physical exam. Magnetic Resonance Imaging was also conducted. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.Follow-ups are being conducted. If more information becomes available, Mentor will submit a supplemental report accordingly.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695885 ↗InjurySep 8, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50658961 ↗InjuryAug 3, 2026Material Rupture
It was reported that a patient underwent a primary breast augmentation procedure with an unspecified Mentor gel breast prosthesis that ruptured post implantation. Rupture of the patient¿s left breast prosthesis was reported. Additionally, the patient developed capsular contracture (Baker Grade unknown) in her left breast. The issues were diagnosed via a CT scan and during an office visit. As a result, the patient underwent explantation.
Patient problems: Capsular Contracture
MAUDE report 50124330 ↗InjuryJul 27, 2026Material Rupture
It was reported that a patient underwent a breast augmentation revision procedure with a MENTOR MemoryGel Breast Implant gel breast prosthesis that ruptured post implantation. Rupture of the patient¿s left breast prosthesis was reported. As a result, the patient underwent bilateral explantation and replacement with MENTOR MemoryGel Xtra Breast Implant gel breast prostheses.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50015478 ↗InjuryJun 11, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE AND SUFFERED POSSIBLE BILATERAL BREAST IMPLANT RUPTURES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 25480761 ↗InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV 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 EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Capsular Contracture
MAUDE report 25458538 ↗InjuryJun 3, 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. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 25375195 ↗InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Capsular Contracture
MAUDE report 25319224 ↗InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNSPECIFIED DATE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 25257126 ↗
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 3503751BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,671 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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