MENTOR MemoryGel Breast Implant 3508004BCRecalls & reported problems
Mentor Texas L.P. · Smooth Round High Profile Gel-Filled Breast Implant, 800cc |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 is a silicone gel-filled implant placed in the breast. Of its 471 reports, many describe the implant shell rupturing, while others mention hardening of scar tissue around the implant, a changed breast shape, and pain. The reports include 461 injuries and no deaths. No recalls name this device.
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
- 481
- Deaths reported
- 0
- Injuries reported
- 471
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 481 adverse event reports that list this exact device (DI 00081317000587), received between Feb 15, 2018 and Sep 29, 2026 — classified as 471 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (271 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 Rupture271
- Adverse Event Without Identified Device or Use Problem199
- Migration24
- Appropriate Device Problem Term/Code Not Available16
- Use of Device Problem4
- Material Discolored2
- No Apparent Adverse Event2
- Peeled/Delaminated2
Patient problems
- Capsular Contracture171
- Deformity/ Disfigurement155
- No Code Available87
- Breast Discomfort/Pain41
- No Clinical Signs, Symptoms or Conditions26
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available24
- Pain14
- Crushing Injury9
Recent adverse event reports
The 25 most recent of 481 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Material Rupture
It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of an 800cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient was involved in a motor vehicle accident. Subsequently, Ultrasound Imaging confirmed a ruptured left implant with the right implant suspicious of rupture. As a result, the patient was scheduled for bilateral implant exchange on (b)(6) 2026.This report is for the left breast prosthesis.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936310 ↗InjurySep 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936308 ↗InjurySep 29, 2026Material Rupture
It was reported that a patient underwent a Breast Augmentation Surgery with implantation of an 800cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient experienced a swollen, firm, and painful left breast. A ruptured right implant was identified using Ultrasound and Computerized Tomography Imaging. She was diagnosed with left breast Baker Grade II Capsular Contracture during a physical exam. As a result, the patient underwent bilateral exchange with Mentor gel implants on (b)(6)2026.
Patient problems: Capsular Contracture; Local Reaction
MAUDE report 50936076 ↗InjurySep 17, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810888 ↗InjurySep 17, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810879 ↗InjurySep 17, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810279 ↗InjurySep 17, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810274 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient with MENTOR MemoryGel Breast Implants experienced capsular contracture Baker Grade II on the right 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: Capsular Contracture
MAUDE report 50775039 ↗InjurySep 10, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721623 ↗InjurySep 10, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721622 ↗InjurySep 8, 2026Material Rupture; Adverse Event Without Identified Device or Use Problem
It was reported that a 34-year-old Caucasian female patient underwent revision breast augmentation with 750cc MENTOR MemoryGel Breast Implant on the left side, and with 800cc MENTOR MemoryGel Breast Implant on the right side and experienced bilateral breast implant ruptures postoperatively; diagnosed in the office and via ultrasound. The patient has consulted with the healthcare professional. As a result, the devices were explanted on (b)(6), 2026.This MedWatch report is for the patient¿s right-sided device.
Patient problems: Breast Mass; No Clinical Signs, Symptoms or Conditions; Ptosis
MAUDE report 50671101 ↗InjurySep 1, 2026Material Rupture
It was reported that a patient underwent a primary breast augmentation procedure with a MENTOR MemoryGel Breast Implant gel breast prosthesis that ruptured post implantation. Rupture of the patient¿s left breast prosthesis was diagnosed via MRI. 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 50548255 ↗InjuryJul 27, 2026Material Rupture
It was reported that a patient underwent breast augmentation revision with two 800cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient developed left breast capsular contracture (baker grade III). As a result, the patient underwent breast implant removal and replacement surgery on (b)(6) 2026. During the surgery, the left breast implant was discovered to be ruptured and the right breast implant also had a tear along the posterior patch area. The replacement devices were two Mentor gel implants.This Medwatch form is for the right breast prosthesis.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50031784 ↗InjuryJun 3, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN 800CC 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 25377225 ↗InjuryMay 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 25319483 ↗InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL SUSPECTED RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. UPON EXPLANTATION, THE LEFT BREAST PROSTHESIS WAS FOUND TO BE INTACT. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Insufficient Information
MAUDE report 25203678 ↗InjuryApr 22, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES 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 24957021 ↗InjuryApr 22, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 800 CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES 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 24957018 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF AN 800CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED THE IMPLANTS WERE PROTRUDING, HAD INDENTS ON HER BREASTS, AND PAIN IN THE ARMPITS. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS YET TO BE CONDUCTED. 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; Pain
MAUDE report 24802394 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF AN 800CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED THE IMPLANTS WERE PROTRUDING, HAD INDENTS ON HER BREASTS, AND PAIN IN THE ARMPITS. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS YET TO BE CONDUCTED. 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; Pain
MAUDE report 24802391 ↗MalfunctionMar 11, 2026Material Rupture
IT WAS REPORTED THAT AN 800CC MENTOR MEMORYGEL BREAST IMPLANT WAS FOUND TO BE RUPTURED PRIOR AN OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY ANY PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24575554 ↗InjuryMar 6, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF AN 800CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT IMPLANT 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: Deformity/ Disfigurement
MAUDE report 24537277 ↗InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE II 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: Capsular Contracture
MAUDE report 24444878 ↗InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem; Migration
IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III 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: Capsular Contracture
MAUDE report 24337127 ↗InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROTHESIS IMPLANTATION SURGERY WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADES UNSPECIFIED). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 24318988 ↗
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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