MENTOR MemoryShape Breast Implant 3341352Recalls & reported problems
Mentor Texas L.P. · Medium Height, High Profile Silicone Gel-Filled Breast Implant, 555cc |Textured|Contour|Silicone| · Class 3 · Implant
All models of MENTOR MemoryShape Breast Implant (65)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Mentor MemoryShape silicone gel-filled breast implant is used for breast augmentation and reconstruction. The 62 reports mostly describe implants rupturing after surgery, sometimes found only on imaging, along with the implant shifting, and patients experiencing tightening scar tissue around the implant, wrinkling or contour changes in the breast, and wound infections. All 62 reports involve injuries, with no deaths mentioned. 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
- 62
- Deaths reported
- 0
- Injuries reported
- 62
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00081317005230), received between May 7, 2019 and Mar 19, 2026 — classified as 62 injuries.
The most frequently reported specific device problem is “Material Rupture” (17 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 Problem44
- Material Rupture17
- Migration6
- Appropriate Device Problem Term/Code Not Available2
- No Apparent Adverse Event1
- Off-Label Use1
Patient problems
- Capsular Contracture13
- No Code Available12
- Wrinkling12
- Deformity/ Disfigurement9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Cancer6
- Local Reaction6
- Post Operative Wound Infection6
Recent adverse event reports
The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2026Material Rupture
IT WAS REPORTED THAT A 80-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A 555CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT MENTIONED THAT THE BREAST WAS DROPPY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 24641911 ↗InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH 555CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL CUTANEOUS CONTOUR DEFORMITY POST PROCEDURE. THERE IS WRINKLING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS PATIENT IS PART OF A POST APPROVAL STUDY.
Patient problems: Wrinkling
MAUDE report 23994735 ↗InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH 555CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL CUTANEOUS CONTOUR DEFORMITY POST PROCEDURE. THERE IS WRINKLING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS PATIENT IS PART OF A POST APPROVAL STUDY.
Patient problems: Wrinkling
MAUDE report 23994730 ↗InjurySep 11, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED 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: Deformity/ Disfigurement
MAUDE report 23030728 ↗InjuryMar 4, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYSHAPE 555 CC SILICONE PROSTHESIS EXPERIENCED A RIGHT-SIDED SILENT RUPTURE, WHICH WAS IDENTIFIED ON A CTA SCAN DATED (B)(6) 2024. AS A RESULT OF THIS COMPLICATION, THE PATIENT IS SCHEDULED FOR REMOVAL SURGERY WITHOUT REPLACEMENT ON (B)(6) 2025.
Patient problems: Capsular Contracture; Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions
MAUDE report 21516369 ↗InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT INVOLVED IN A CLINICAL TRIAL UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 555CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST CANCER. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS SEVERE IN SEVERITY, SERIOUS, AND POSSIBLY RELATED TO THE DEVICE. THE PATIENT HAS AN APPOINTMENT WITH ONCOLOGY. THE EVENT IS STILL ONGOING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Breast Cancer
MAUDE report 20667542 ↗InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS FILE WAS CREATED TO DOCUMENT THE IMEDIDATA CSEN ALERT 6Y POST-OP CANCER DETAILS. [ADVERSE EVENT REVIEW CLINICAL NOTE AND PATIENT CODING VERIFICATION]: CODING WAS REVIEWED BY A CLINICIAN ON JUN-3-2024 PER (B)(4) WITH THE AVAILABLE INFORMATION ABOUT THE REPORTABLE EVENT. DURING THE 5 YEAR FOLLOW-UP VISIT THE PATIENT REPORTED DISSATISFACTION WITH PROCEDURE OUTCOME. AT THIS TIME, MENTOR HAS RECEIVED VERY LIMITED INFORMATION REGARDING THIS EVENT, BASED ON THE INFORMATION PROVIDED IN EDC (IMEDIDATA) THE PATIENT SUFFERED BREAST RIPPLING (WRINKLING).
Patient problems: Wrinkling
MAUDE report 19484590 ↗InjuryDec 18, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 555CC GEL BREAST PROSTHESIS THAT POSSIBLY RUPTURED POST IMPLANTATION. POSSIBLE 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: Deformity/ Disfigurement
MAUDE report 18347438 ↗InjuryNov 22, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 555CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND BILATERAL RUPTURE SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2023-13904 FOR CONTRALATERAL SIDE.
Patient problems: Capsular Contracture
MAUDE report 18193254 ↗InjuryNov 22, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 555CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND BILATERAL RUPTURE SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER (B)(4) FOR CONTRALATERAL SIDE.
Patient problems: Capsular Contracture
MAUDE report 18193083 ↗InjuryOct 12, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 555CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT AND A MILDLY ENLARGED LEFT AXILLARY LYMPH NODE WITH POSSIBLE SILICONE UPTAKE USING MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH UNDISCLOSED MENTOR SALINE IMPLANTS ON (B)(6) 2023.
Patient problems: Granuloma
MAUDE report 17922490 ↗InjuryJul 13, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYSHAPE, 555CC SILICONE PROSTHESIS EXPERIENCED RIGHT-SIDED SILENT RUPTURE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 17318773 ↗InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 555CC GEL BREAST PROSTHESIS DEVELOPED WRINKLING AND ASYMMETRY IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 620CC GEL BREAST PROSTHESIS ON (B)(6) 2022.
Patient problems: Deformity/ Disfigurement; Wrinkling
MAUDE report 16088186 ↗InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 620CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED ASYMMETRY ON THE LEFT SIDE POST-OPERATIVELY, WHICH REQUIRED EXPLANTATION AND REPLACEMENT WITH A 555CC MENTOR MEMORYSHAPE BREAST IMPLANT ON (B)(6) 2017. THE PATIENT THEN EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING JOINT STIFFNESS, JOINT PAIN, SKIN REDNESS ON BOTH CHEEKS, TIGHT SKIN, SKIN RASH, DRY EYES, DRY MOUTH, AND HAIR LOSS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE OF THE REPLACEMENT IMPLANT. THIS REPORT IS FOR THE SECOND OF TWO DEVICES.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Wrinkling
MAUDE report 16053201 ↗InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST AUGMENTATION WITH A MENTOR MEMORYSHAPE, 555CC SILICONE BREAST IMPLANT, EXPERIENCED BILATERAL NEOPLASM MALIGNANT POSTOPERATIVE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. NO FURTHER INFORMATION WAS PROVIDED REGARDING THIS CASE. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED, AND NOTES WILL BE UPDATED.THIS REPORT RELATES TO THE LEFT PROSTHESIS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cancer
MAUDE report 15764661 ↗InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST AUGMENTATION WITH A MENTOR MEMORYSHAPE, 555CC SILICONE BREAST IMPLANT, EXPERIENCED BILATERAL NEOPLASM MALIGNANT POSTOPERATIVE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. NO FURTHER INFORMATION WAS PROVIDED REGARDING THIS CASE. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED, AND NOTES WILL BE UPDATED.THIS REPORT RELATES TO THE RIGHT PROSTHESIS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cancer
MAUDE report 15764618 ↗InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL. IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION SURGERY WITH A 555CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED LEFT SIDED HYPERTROPHIC SCAR POST PROCEDURE. PATIENT UNDERWENT A SMALL REVISION TO AREA WHERE HER NIPPLE USED TO BE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Scar Tissue
MAUDE report 15636064 ↗InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 68-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 555CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH OF HER BREASTS POST IMPLANTATION. IT WAS REPORTED THAT THE PATIENT SUFFERED FROM BILATERAL ITCHINESS, INFLAMMATION, HEAVY FEELING, AND SLIGHT STINGING SENSATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture; Local Reaction
MAUDE report 15251189 ↗InjuryAug 3, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH 555CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.
Patient problems: Deformity/ Disfigurement
MAUDE report 15161400 ↗InjuryJul 13, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 555CC GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING ITCHING, BURNING SENSATION, SENSITIVE TO TOUCH, BRUISING, STOMACH ISSUES, AND FATIGUE. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. ADDITIONALLY, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH OF HER BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture
MAUDE report 15009451 ↗InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 555CC GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING ITCHING, BURNING SENSATION, SENSITIVE TO TOUCH, BRUISING, STOMACH ISSUES, AND FATIGUE. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. ADDITIONALLY, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH OF HER BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture
MAUDE report 15009439 ↗InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 555CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL BREAST PAIN POST PROCEDURE. 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: Breast Discomfort/Pain
MAUDE report 13654666 ↗InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 555CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL BREAST PAIN POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Breast Discomfort/Pain
MAUDE report 13654654 ↗InjuryFeb 15, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH TWO 555CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST IMPLANT RUPTURE, RIGHT BREAST PAIN, AND FLUID IN THE LEFT BREAST IMPLANT. THE PATIENT HAD THE FLUID REMOVED ON AN UNSPECIFIED DATE WITH AN UNSPECIFIED PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Breast Discomfort/Pain
MAUDE report 13536307 ↗InjuryFeb 15, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH TWO 555CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST IMPLANT RUPTURE, RIGHT BREAST PAIN, AND FLUID IN THE LEFT BREAST IMPLANT. THE PATIENT HAD THE FLUID REMOVED ON AN UNSPECIFIED DATE WITH AN UNSPECIFIED PROCEDURE. 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: Local Reaction
MAUDE report 13536292 ↗
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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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