MENTOR MemoryShape Breast Implant 3341205Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00081317005322), received between Jun 5, 2019 and Sep 3, 2026 — classified as 54 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 330CC MENTOR MEMORYSHAPE BREAST IMPLANT AND HAD A REDOMSTRATED BIOPSY CLIP WITHIN THE LOWER INNER QUADRAN ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24621088 ↗
• InjurySep 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 330CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED 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 23024207 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYSHAPE MM+ AND EXPERIENCED BILATERAL PTOSIS, BILATERAL BREAST PAIN, AND RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI/MAMMOGRAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 22689428 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 330CC GEL BREAST PROSTHESES DEVELOPED SIGNIFICANT PAIN UNDER THE ARMPITS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION IN (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22379120 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT IMT 330CC GEL BREAST PROSTHESES; DEVELOPED SIGNIFICANT PAIN UNDER THE ARMPITS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION IN (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22379119 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 42-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 330CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 2) ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21930758 ↗
• InjuryMar 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 42-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 330CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN ULTRASOUND. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Granuloma

  MAUDE report 21532002 ↗
• InjuryJan 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 41-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 330CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED DURING OFFICE VISIT. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21173535 ↗
• InjuryNov 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 330CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE WITH NO TRAUMA POST PROCEDURE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20730620 ↗
• InjuryNov 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 330CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE WITH NO TRAUMA POST PROCEDURE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20730619 ↗
• InjuryNov 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 330CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20730063 ↗
• InjuryNov 19, 2024Gel Leak; Material Rupture; Gel Leak; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 330CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3 ON THE LEFT AND 4 ON THE RIGHT). AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 20727026 ↗
• InjuryNov 19, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 330CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3 ON THE LEFT AND 4 ON THE RIGHT). AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 20725891 ↗
• InjuryJul 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH 330CC MENTOR MEMORYSHAPE BREAST IMPLANT ON THE LEFT SIDE, AND WITH 255CC MENTOR MEMORYSHAPE BREAST IMPLANT ON THE RIGHT SIDE AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURES AND BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN POSTOPERATIVELY. 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-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 19803466 ↗
• InjuryMay 23, 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 STUDY UNDERWENT A BREAST AUGMENTATION SURGERY WITH 330CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING BILATERAL BREAST PAIN. THE PATIENT¿S FIFTH-YEAR FOLLOW-UP WAS COMPLETED WHERE THE PATIENT REPORTED ISSUES WITH RIPPLING/WRINKLING, BUT THE SIDE OF COMPLICATION WAS NOT DISCLOSED. THE RELATIONSHIP TO THE DEVICE WAS NOT PROVIDED AT THE TIME OF THIS REVIEW. IN ADDITION, IT WAS REPORTED THAT THE PATIENT REPORTED JOINT PAIN, RASHES, AND ANXIETY. AT THE TIME OF THIS REPORT, MENTOR HAS NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT IMPLANT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Wrinkling

  MAUDE report 19387729 ↗
• InjuryMay 23, 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 STUDY UNDERWENT A BREAST AUGMENTATION SURGERY WITH 330CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING BILATERAL BREAST PAIN. THE PATIENT¿S FIFTH-YEAR FOLLOW-UP WAS COMPLETED WHERE THE PATIENT REPORTED ISSUES WITH RIPPLING/WRINKLING, BUT THE SIDE OF COMPLICATION WAS NOT DISCLOSED. THE RELATIONSHIP TO THE DEVICE WAS NOT PROVIDED AT THE TIME OF THIS REVIEW. IN ADDITION, IT WAS REPORTED THAT THE PATIENT REPORTED JOINT PAIN, RASHES, AND ANXIETY. AT THE TIME OF THIS REPORT, MENTOR HAS NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT IMPLANT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19387728 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 330CC GEL BREAST PROSTHESES DEVELOPED WRINKLING POST IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. INFORMATION ABOUT TWO DEVICES WAS REPORTED: LEFT DEVICE: MENTOR MEMORYSHAPE BREAST IMPLANT 330CC GEL BREAST PROSTHESIS, CATALOG # 3341205, LOT #9428151, SERIAL #(B)(6) RIGHT DEVICE: MENTOR MEMORYSHAPE BREAST IMPLANT 330CC GEL BREAST PROSTHESIS, CATALOG # 3341205, LOT #9428151-050, SERIAL #(B)(6) IT WAS NOT SPECIFIED ON WHICH BREAST THE WRINKLING DEVELOPED (LEFT BREAST, RIGHT BREAST, OR BILATERAL). IF CLARIFICATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Wrinkling

  MAUDE report 19385843 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 330CC GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING CHRONIC LOW BACK PAIN, CHRONIC NECK PAIN, JOINT PAIN, MUSCLE PAIN, SLEEP DISORDERS, MUSCLE CRAMPS, FINGERS BECOMING NUMB AND PALE, DRY EYES, AND DRY MOUTH. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. 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 RIGHT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18489245 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 330CC GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING CHRONIC LOW BACK PAIN, CHRONIC NECK PAIN, JOINT PAIN, MUSCLE PAIN, SLEEP DISORDERS, MUSCLE CRAMPS, FINGERS BECOMING NUMB AND PALE, DRY EYES, AND DRY MOUTH. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18489215 ↗
• InjuryNov 15, 2023Migration; Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 330CC GEL BREAST PROSTHESES DEVELOPED RIPPLING ON BOTH BREASTS POST IMPLANTATION. THE PATIENT LOST 15 POUNDS AND NOTICED RIPPLING ON HER BREASTS. ADDITIONALLY, IT WAS REPORTED THAT BOTH BREAST PROSTHESES ROTATED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED MENTOR GEL BREAST PROSTHESES ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 18142844 ↗
• InjuryNov 15, 2023Migration; Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 330CC GEL BREAST PROSTHESES DEVELOPED RIPPLING ON BOTH BREASTS POST IMPLANTATION. THE PATIENT LOST 15 POUNDS AND NOTICED RIPPLING ON HER BREASTS. ADDITIONALLY, IT WAS REPORTED THAT BOTH BREAST PROSTHESES ROTATED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED MENTOR GEL BREAST PROSTHESES ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 18142842 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT INVOLVED IN A STUDY UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 330CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY FOR AN UNDISCLOSED REASON. THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH UNDISCLOSED IMPLANTS ON AN UNDISCLOSED DATE. THE DATE OF EVENT WAS NOT PROVIDED TO MENTOR. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-09623 FOR THE CONTRALATERAL EVENT.

  Patient problems: Breast Discomfort/Pain; Insufficient Information; Wrinkling

  MAUDE report 17557956 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT INVOLVED IN A STUDY UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 330CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY FOR AN UNDISCLOSED REASON. THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH UNDISCLOSED IMPLANTS ON AN UNDISCLOSED DATE. THE DATE OF EVENT WAS NOT PROVIDED TO MENTOR. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-09621 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement; Insufficient Information; Wrinkling

  MAUDE report 17557954 ↗
• InjuryMay 1, 2023Migration; Migration

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 300CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL DEVICE MIGRATIONS AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16844777 ↗