MENTOR MemoryGel Breast Implant 3505504BCRecalls & reported problems
Mentor Texas L.P. · Smooth Round High Profile Gel-Filled Breast Implant, 550cc |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 Mentor MemoryGel breast implant has 1,245 adverse event reports, with no deaths and 1,226 injuries. Many reports describe the implant rupturing, and others mention hardening of the scar tissue around it, changes in breast shape, pain, and the implant shifting out of place. Some patients had the implant removed after a rupture. No recalls name this device. Reports in the last 12 months (70) are fewer than in the 12 months before (155).
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
- 1,250
- Deaths reported
- 0
- Injuries reported
- 1,231
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,250 adverse event reports that list this exact device (DI 00081317000549), received between Apr 11, 2018 and Sep 28, 2026 — classified as 1,231 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (552 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 Problem686
- Material Rupture552
- Migration57
- Appropriate Device Problem Term/Code Not Available25
- Material Deformation5
- Use of Device Problem4
- Device Contamination with Chemical or Other Material2
- Insufficient Device Problem Information2
Patient problems
- Capsular Contracture604
- Deformity/ Disfigurement379
- No Code Available209
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available54
- Breast Discomfort/Pain44
- Pain43
- No Clinical Signs, Symptoms or Conditions24
- Wrinkling23
Recent adverse event reports
The 25 most recent of 1,250 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Material Rupture
Patient problems: Capsular Contracture
MAUDE report 50926038 ↗InjurySep 23, 2026Material Rupture
It was reported that a patient implanted with two 550cc MENTOR MemoryGel Breast Implant experienced bilateral ruptures post-operatively. As a result, the patient underwent explantation on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870649 ↗InjurySep 23, 2026Material Rupture
It was reported that a patient implanted with two 550cc MENTOR MemoryGel Breast Implant experienced bilateral ruptures post-operatively. As a result, the patient underwent explantation on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870646 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
During the 8 Year Follow-up visit the patient reported breastfeeding issues. At this time, Mentor has received very limited information regarding this event, based on the information provided in EDC (iMedidata) the patient suffered lactation disorder. At the time of this report, Mentor received no information regarding explantation or an expected explantation date.Should additional information become available, this case will be re-assessed and notes will be updated. This report relates to the left side.
Patient problems: Unspecified Reproductive System or Breast Problem
MAUDE report 50807804 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
During the 8 Year Follow-up visit the patient reported breastfeeding issues. At this time, Mentor has received very limited information regarding this event, based on the information provided in EDC (iMedidata) the patient suffered lactation disorder. At the time of this report, Mentor received no information regarding explantation or an expected explantation date.Should additional information become available, this case will be re-assessed and notes will be updated. This report relates to the right side.
Patient problems: Unspecified Reproductive System or Breast Problem
MAUDE report 50807326 ↗InjurySep 16, 2026Material Rupture
It was reported that a 48-year-old Caucasian female patient underwent a primary breast augmentation with a 550cc (Left) MENTOR MemoryGel Breast Implant and a 450cc (Right) MENTOR MemoryGel Breast Implant and experienced bilateral rupture post-operatively, which was diagnosed with a Magnetic Resonance Imaging. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.This report is for the left side device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792746 ↗InjurySep 16, 2026Material Rupture
It was reported that a patient underwent an unspecified breast surgery with a MENTOR MemoryGel Breast Implant gel breast prosthesis that ruptured post implantation. Rupture of the patient¿s right breast prosthesis was reported. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791543 ↗InjurySep 10, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718483 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient implanted with a 550cc MENTOR MemoryGel Breast Implant experienced capsular contracture Baker Grade 4 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: Capsular Contracture
MAUDE report 50671917 ↗InjurySep 2, 2026Material Rupture
A female patient who underwent an unspecified Breast surgery with MENTOR MemoryGel, 550cc silicone implant experienced bilateral silent ruptures postoperative. The issue was confirmed through MRI examination. As a result, the patient scheduled for removal surgery on (b)(6), 2026. This report relates to the right prosthesis.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50570629 ↗InjuryAug 3, 2026Material Rupture
It was reported that a patient implanted with two 550cc MENTOR MemoryGel Breast Implant experienced bilateral ruptures post-operatively. As a result, the patient underwent explantation on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50117060 ↗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 right breast prosthesis was reported. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50009242 ↗InjuryJul 27, 2026Material Rupture
It was reported that a patient underwent primary breast augmentation with two 550cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient was diagnosed, via ultrasound, with left breast implant rupture with thin echogenic fluid. As a result, the patient underwent breast implant removal and replacement surgery on (b)(6) 2026. During the surgery, the patient was also diagnosed with bilateral breast ptosis, bilateral waterfall deformity, left breast capsular contracture (baker grade IV), left breast implant lateral displacement, right breast implant rupture, and thickened right breast anterior capsule. The replacement devices were two Mentor gel implants. This Medwatch form is for the right breast prosthesis.
Patient problems: Capsular Contracture
MAUDE report 50003075 ↗InjuryMay 21, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA CT SCAN, 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 25240579 ↗InjuryMay 19, 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 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 25221288 ↗InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem
A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL, 550CC SILICONE IMPLANTS DEVELOPED LEFT SIDED BREAST PAIN AFTER THE PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Breast Discomfort/Pain
MAUDE report 25162300 ↗InjuryMay 11, 2026Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. THE PATIENT MENTIONED THE BREAST BEING ASYMMETRICAL AND BEING "QUITE SAGGY". AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 25143016 ↗InjuryMay 11, 2026Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. THE PATIENT MENTIONED THE BREAST BEING ASYMMETRICAL AND BEING "QUITE SAGGY". AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 25143009 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL¿S 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 25038367 ↗InjuryApr 28, 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 EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 25018723 ↗InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 475CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING SICKNESS, FEELING COLD, DISCOLORED, STRINGY CLEAR PHLEGM, AND A CHEMICAL TASTE IN THE MOUTH. SHE BELIEVED THERE WAS A SLOW LEAK OF THE IMPLANTS; HOWEVER MAGNETIC RESONANCE IMAGING WAS CONDUCTED AND DID NOT SUPPORT LEAKAGE. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24899013 ↗InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH AN UNSPECIFIED MENTOR GEL BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 24821746 ↗InjuryApr 2, 2026Material Rupture
IT WAS REPORTED THAT A 57-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 550CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026, AND REPLACED WITH A 550CC MENTOR MEMORYGEL BREAST IMPLANT.
Patient problems: Deformity/ Disfigurement
MAUDE report 24769918 ↗InjuryApr 1, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 550CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT ALLEGED THE DEFLATION WAS THE RESULT OF AN ACCIDENT ON ALL-TERRAIN VEHICLE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24758346 ↗InjuryMar 31, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES. DURING EXPLANT SURGERY, RUPTURE OF BOTH THE LEFT AND RIGHT BREAST PROSTHESES WAS OBSERVED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2026-00147 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 24745973 ↗
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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