MENTOR MemoryShape Breast ImplantRecalls & reported problems across all models
Mentor Texas L.P. · 65 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,595
- Deaths reported
- 0
- Injuries reported
- 1,588
- Recalls
- 0
We found 65 models of MENTOR MemoryShape Breast Implant by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 1,595 adverse event reports in the FDA's MAUDE database, received between Mar 20, 2018 and Sep 29, 2026 — classified as 1,588 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (406 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MENTOR MemoryShape Breast Implant problems
Device problems
- Adverse Event Without Identified Device or Use Problem1,128
- Material Rupture406
- Migration104
- Appropriate Device Problem Term/Code Not Available21
- Off-Label Use7
- Gel Leak6
- Material Discolored5
- Device Contamination with Chemical or Other Material3
Patient problems
- Capsular Contracture465
- Deformity/ Disfigurement378
- No Code Available286
- Wrinkling241
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available152
- Breast Discomfort/Pain113
- Seroma112
- Pain86
MENTOR MemoryShape Breast Implant models
65 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR MemoryShape Breast Implant 3341452Prosthesis, breast, noninflatable, internal, silicone gel-filled98 reports
- MENTOR MemoryShape Breast Implant 3341302Prosthesis, breast, noninflatable, internal, silicone gel-filled95 reports
- MENTOR MemoryShape Breast Implant 3341402Prosthesis, breast, noninflatable, internal, silicone gel-filled91 reports
- MENTOR MemoryShape Breast Implant 3341252Prosthesis, breast, noninflatable, internal, silicone gel-filled80 reports
- MENTOR MemoryShape Breast Implant 3341255Prosthesis, breast, noninflatable, internal, silicone gel-filled75 reports
- MENTOR MemoryShape Breast Implant 3341352Prosthesis, breast, noninflatable, internal, silicone gel-filled62 reports
- MENTOR MemoryShape Breast Implant 3341202Prosthesis, breast, noninflatable, internal, silicone gel-filled60 reports
- MENTOR MemoryShape Breast Implant 3341259Prosthesis, breast, noninflatable, internal, silicone gel-filled57 reports
- MENTOR MemoryShape Breast Implant 3341305Prosthesis, breast, noninflatable, internal, silicone gel-filled57 reports
- MENTOR MemoryShape Breast Implant 3341205Prosthesis, breast, noninflatable, internal, silicone gel-filled54 reports
- MENTOR MemoryShape Breast Implant 3541208Prosthesis, breast, noninflatable, internal, silicone gel-filled50 reports
- MENTOR MemoryShape Breast Implant 3341155Prosthesis, breast, noninflatable, internal, silicone gel-filled46 reports
- MENTOR MemoryShape Breast Implant 3341355Prosthesis, breast, noninflatable, internal, silicone gel-filled46 reports
- MENTOR MemoryShape Breast Implant 3541308Prosthesis, breast, noninflatable, internal, silicone gel-filled44 reports
- MENTOR MemoryShape Breast Implant 3341209Prosthesis, breast, noninflatable, internal, silicone gel-filled41 reports
- MENTOR MemoryShape Breast Implant 3341152Prosthesis, breast, noninflatable, internal, silicone gel-filled32 reports
- MENTOR MemoryShape Breast Implant 3341409Prosthesis, breast, noninflatable, internal, silicone gel-filled31 reports
- MENTOR MemoryShape Breast Implant 3541358Prosthesis, breast, noninflatable, internal, silicone gel-filled31 reports
- MENTOR MemoryShape Breast Implant 3341309Prosthesis, breast, noninflatable, internal, silicone gel-filled29 reports
- MENTOR MemoryShape Breast Implant 3541408Prosthesis, breast, noninflatable, internal, silicone gel-filled29 reports
- MENTOR MemoryShape Breast Implant 3341102Prosthesis, breast, noninflatable, internal, silicone gel-filled28 reports
- MENTOR MemoryShape Breast Implant 3541258Prosthesis, breast, noninflatable, internal, silicone gel-filled28 reports
- MENTOR MemoryShape Breast Implant 3341359Prosthesis, breast, noninflatable, internal, silicone gel-filled25 reports
- MENTOR MemoryShape Breast Implant 3341105Prosthesis, breast, noninflatable, internal, silicone gel-filled24 reports
- MENTOR MemoryShape Breast Implant 3541158Prosthesis, breast, noninflatable, internal, silicone gel-filled24 reports
- MENTOR MemoryShape Breast Implant 3341404Prosthesis, breast, noninflatable, internal, silicone gel-filled22 reports
- MENTOR MemoryShape Breast Implant 3341354Prosthesis, breast, noninflatable, internal, silicone gel-filled20 reports
- MENTOR MemoryShape Breast Implant 3541708Prosthesis, breast, noninflatable, internal, silicone gel-filled18 reports
- MENTOR MemoryShape Breast Implant 3341405Prosthesis, breast, noninflatable, internal, silicone gel-filled17 reports
- MENTOR MemoryShape Breast Implant 3341254Prosthesis, breast, noninflatable, internal, silicone gel-filled17 reports
- MENTOR MemoryShape Breast Implant 3341505Prosthesis, breast, noninflatable, internal, silicone gel-filled16 reports
- MENTOR MemoryShape Breast Implant 3341109Prosthesis, breast, noninflatable, internal, silicone gel-filled15 reports
- MENTOR MemoryShape Breast Implant 3541458Prosthesis, breast, noninflatable, internal, silicone gel-filled15 reports
- MENTOR MemoryShape Breast Implant 3341454Prosthesis, breast, noninflatable, internal, silicone gel-filled15 reports
- MENTOR MemoryShape Breast Implant 3541508Prosthesis, breast, noninflatable, internal, silicone gel-filled14 reports
- MENTOR MemoryShape Breast Implant 3541608Prosthesis, breast, noninflatable, internal, silicone gel-filled14 reports
- MENTOR MemoryShape Breast Implant 3341304Prosthesis, breast, noninflatable, internal, silicone gel-filled14 reports
- MENTOR MemoryShape Breast Implant 3341455Prosthesis, breast, noninflatable, internal, silicone gel-filled13 reports
- MENTOR MemoryShape Breast Implant 3341159Prosthesis, breast, noninflatable, internal, silicone gel-filled12 reports
- MENTOR MemoryShape Breast Implant 3341055Prosthesis, breast, noninflatable, internal, silicone gel-filled12 reports
- MENTOR MemoryShape Breast Implant 3341459Prosthesis, breast, noninflatable, internal, silicone gel-filled11 reports
- MENTOR MemoryShape Breast Implant 3341154Prosthesis, breast, noninflatable, internal, silicone gel-filled11 reports
- MENTOR MemoryShape Breast Implant 3341052Prosthesis, breast, noninflatable, internal, silicone gel-filled9 reports
- MENTOR MemoryShape Breast Implant 3341607Prosthesis, breast, noninflatable, internal, silicone gel-filled8 reports
- MENTOR MemoryShape Breast Implant 3341059Prosthesis, breast, noninflatable, internal, silicone gel-filled8 reports
- MENTOR MemoryShape Breast Implant 3341107Prosthesis, breast, noninflatable, internal, silicone gel-filled7 reports
- MENTOR MemoryShape Breast Implant 3341307Prosthesis, breast, noninflatable, internal, silicone gel-filled7 reports
- MENTOR MemoryShape Breast Implant 3341002Prosthesis, breast, noninflatable, internal, silicone gel-filled7 reports
- MENTOR MemoryShape Breast Implant 3541108Prosthesis, breast, noninflatable, internal, silicone gel-filled7 reports
- MENTOR MemoryShape Breast Implant 3341257Prosthesis, breast, noninflatable, internal, silicone gel-filled6 reports
- MENTOR MemoryShape Breast Implant 3341509Prosthesis, breast, noninflatable, internal, silicone gel-filled6 reports
- MENTOR MemoryShape Breast Implant 3341204Prosthesis, breast, noninflatable, internal, silicone gel-filled6 reports
- MENTOR MemoryShape Breast Implant 3341207Prosthesis, breast, noninflatable, internal, silicone gel-filled5 reports
- MENTOR MemoryShape Breast Implant 3341507Prosthesis, breast, noninflatable, internal, silicone gel-filled5 reports
- MENTOR MemoryShape Breast Implant 3341357Prosthesis, breast, noninflatable, internal, silicone gel-filled3 reports
- MENTOR MemoryShape Breast Implant 3341407Prosthesis, breast, noninflatable, internal, silicone gel-filled3 reports
- MENTOR MemoryShape Breast Implant 3341157Prosthesis, breast, noninflatable, internal, silicone gel-filled2 reports
- MENTOR MemoryShape Breast Implant 3341457Prosthesis, breast, noninflatable, internal, silicone gel-filled2 reports
- MENTOR MemoryShape Breast Implant 3341009Prosthesis, breast, noninflatable, internal, silicone gel-filled2 reports
- MENTOR MemoryShape Breast Implant 3341005Prosthesis, breast, noninflatable, internal, silicone gel-filled2 reports
- MENTOR MemoryShape Breast Implant 3541008Prosthesis, breast, noninflatable, internal, silicone gel-filled2 reports
- MENTOR MemoryShape Breast Implant 3541058Prosthesis, breast, noninflatable, internal, silicone gel-filled2 reports
- MENTOR MemoryShape Breast Implant 3341057Prosthesis, breast, noninflatable, internal, silicone gel-filled1 report
- MENTOR MemoryShape Breast Implant 3341004Prosthesis, breast, noninflatable, internal, silicone gel-filled1 report
- MENTOR MemoryShape Breast Implant 3341104Prosthesis, breast, noninflatable, internal, silicone gel-filled1 report
Recent MENTOR MemoryShape Breast Implant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Material Rupture
It was reported that a 53-year-old Caucasian female patient underwent a primary breast augmentation with a 250cc MENTOR MemoryShape Breast Implant and 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 50936773 ↗InjurySep 29, 2026Migration
It was reported that a patient underwent a Primary Breast Reconstruction Surgery with implantation of a 350cc MENTOR MemoryShape Breast Implant prosthesis. Post-operatively, the patient experienced a hard right breast and the implant migrated up towards the collar bone. Mammogram Imaging was scheduled. 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: Capsular Contracture
MAUDE report 50932977 ↗InjurySep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925216 ↗InjurySep 24, 2026Material Rupture
Patient problems: Capsular Contracture
MAUDE report 50889259 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50889258 ↗InjurySep 16, 2026Material Rupture
It was reported that a patient involved in a clinical study underwent a Breast Augmentation Revision Surgery with implantation of a 355cc MENTOR MemoryShape Breast Implant prosthesis. Post-operatively, the patient reported having fallen and afterwards having pain. Computerized Tomography Imaging was performed and identified a ruptured right implant. In addition, a nodule on the margin of the right implant was observed and recommended for further correlation with Mammogram and/or Ultrasound. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.The date of event and implantation were provided to Mentor as a best estimate.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: Breast Discomfort/Pain; Breast Mass
MAUDE report 50792302 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
This event is associated with the Glow clinical trial (Subject ID: (b)(6).It was reported that a female patient underwent a breast surgery with a 255cc MENTOR MemoryShape Breast Implant and experienced cutaneous contour deformity (wrinkling) on the right side post-operatively. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.
Patient problems: Wrinkling
MAUDE report 50717884 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50656385 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50656382 ↗InjurySep 3, 2026Material Rupture
It was reported that a patient underwent primary breast augmentation with two 330cc MENTOR MemoryShape Breast Implants. Post-operatively, the patient was diagnosed, via physical examination and MRI, with right breast implant rupture. 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 50594324 ↗InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient who underwent a breast augmentation revision procedure with a MENTOR MemoryShape Breast Implant gel breast prosthesis developed Baker Grade III capsular contracture in her right breast post implantation. The capsular contracture was diagnosed via a physical exam. As a result, the patient is scheduled to undergo explantation.
Patient problems: Capsular Contracture
MAUDE report 50418398 ↗InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent a Primary Breast Augmentation Surgery with implantation of a 245cc MENTOR MemoryShape Breast Implant prosthesis. Post-operatively, the patient received Ultrasound and Magnetic Resonance Imaging for a left breast mass involving the left axilla. Imaging identified a ruptured left implant and a left axillary silicone granuloma. However, pre-operative diagnosis from a medical professional stated as bilateral rupture. As a result, the patient underwent bilateral exchange with Mentor gel implants on (b)(6) 2026. The left implant was confirmed ruptured and the right implant was observed without abnormalities. This report is for the right breast prosthesis.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50242926 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient implanted with two MENTOR MemoryShape Breast Implants experienced symptoms including excessive sleep, extreme fatigue, brain fog, memory loss, cognitive disfunction, hair loss, dry eye, mouth, vision problems, difficulty swallowing, choking, difficulty breathing, digestive issues, food intolerance, temperature intolerance, anxiety, depression, frequent urination, vertigo, dizziness, rippling, thin skin, tightening of skin, inflamed rash, heavy weight on chest, and pain post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50118589 ↗InjuryMay 28, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 685CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 25325401 ↗InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 420CC MENTOR MEMORYSHAPE BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST THAT WAS NOT PRODUCING ENOUGH MILK. 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: Unspecified Reproductive System or Breast Problem
MAUDE report 25207355 ↗
Other Mentor Texas L.P. products
- MENTOR MemoryGel Breast Implants368 models · 56,155 reports
- MENTOR MemoryGel Breast Implant211 models · 49,379 reports
- MENTOR Smooth Round Moderate Profile20 models · 14,918 reports · 1 recall
- MENTOR Smooth Round Moderate Plus Profile22 models · 6,091 reports · 1 recall
- MENTOR MemoryGel Xtra Breast Implant88 models · 5,679 reports
- MENTOR Smooth Round High Profile17 models · 4,098 reports · 1 recall
- MENTOR SILTEX Round Moderate Profile13 models · 2,160 reports
- MENTOR MemoryGel BOOST Breast Implant53 models · 1,078 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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