MENTOR MemoryShape Breast Implant 3341354Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00081317024255), received between May 31, 2019 and Mar 20, 2023 — classified as 20 injuries.

The most frequently reported specific device problem is “Material Rupture” (2 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AUGMENTATION SURGERY WITH MENTOR GLOW STUDY GEL DEVICES ON (B)(6) 2019. INFECTION, (RIGHT SIDE, IMPLANT SERIAL NUMBER: (B)(4). DOI: (B)(6) 2019, DOE: (B)(6) 2019. ON (B)(6) 2019, SHE PRESENTED WITH INFECTION, WHICH REQUIRED IMPLANT REMOVAL ON (B)(6) 2019. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS SEVERE IN SEVERITY, SERIOUS, POSSIBLY RELATED TO THE DEVICE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16574322 ↗
• InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT ENROLLED IN A CLINICAL TRIAL UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH 610CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED WRINKLING IN BOTH OF HER BREASTS, WHICH REQUIRED FAT GRAFTING AND A POCKET ADJUSTMENT ON (B)(6) 2020. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-15411 FOR THE CONTRALATERAL EVENT.

  Patient problems: Wrinkling

  MAUDE report 16068082 ↗
• InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT ENROLLED IN A CLINICAL TRIAL UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH 610CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED WRINKLING IN BOTH OF HER BREASTS, WHICH REQUIRED FAT GRAFTING AND A POCKET ADJUSTMENT ON (B)(6) 2020. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-15410 FOR THE CONTRALATERAL EVENT.

  Patient problems: Wrinkling

  MAUDE report 16068077 ↗
• InjuryDec 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HISPANIC FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 610CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED DELAYED WOUND HEALING ASSOCIATED WITH THE LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2021. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-15235 FOR THE CONTRALATERAL EVENT AND MANUFACTURING REPORT NUMBER 1645337-2021-04129 FOR THE PREVIOUS LEFT-SIDED EVENT.

  Patient problems: Impaired Healing

  MAUDE report 16040001 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 610CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT REPORTED CHRONIC PAIN AND THAT THE BREAST LOOKED SMALLER THAN THE OTHER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 14657275 ↗
• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADVERSE EVENT # 2. ASYMMETRY, (LEFT SIDE, IMPLANT SERIAL NUMBER: (B)(4) DOI: (B)(6) 2020, DOE: (B)(6) 2020). ON (B)(6) 2020, SHE PRESENTED WITH ASYMMETRY, WHICH REQUIRED MEDICAL DEVICE REMOVAL ON (B)(6) 2020. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, SERIOUS, POSSIBLY RELATED TO THE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13453395 ↗
• InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO UNDERWENT AN UNSPECIFIED SURGERY WITH AN UNKNOWN MENTOR PROSTHESIS EXPERIENCED LEFT SIDED WOUND INFECTION POST PROCEDURE. AS A RESULT, THE IMPLANT WAS EXPLANTED ON (B)(6) 2021. NOTE: THE TYPE OF DEVICE INVOLVED IS UNKNOWN, AND THE GEL PROCODE/COMMON DEVICE NAME ARE BEING USED FOR SUBMISSION PURPOSES ONLY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF CLARIFYING INFORMATION IS RECEIVED.

  Patient problems: Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions; Post Operative Wound Infection

  MAUDE report 12221727 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYSHAPE 610CC SILICONE PROSTHESIS EXPERIENCED LEFT SIDED SEROMA, AND WOUND INFECTION POST PROCEDURE. AS A RESULT, THE IMPLANT WAS EXPLANTED ON (B)(6) 2021. ON (B)(6) 2021, PATIENT HAD SURGERY TO ADDRESS A POST-EXPLANT INFECTION AND HAS NEW DEVICE INSERTED WITH CAT#: 3341354, SN#: (B)(4).

  Patient problems: Post Operative Wound Infection; Seroma

  MAUDE report 12108781 ↗
• InjuryJun 24, 2021Adverse 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 BREAST RECONSTRUCTION WITH A 610CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE LEFT-SIDED CUTANEOUS CONTOUR DEFORMITY AND ANISOMASTIA. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A 680CC MENTOR MEMORYSHAPE BREAST IMPLANT (LEFT CATALOG #: 3341404, LEFT SERIAL #: (B)(4)) ON (B)(6) 2020. DURING THE REVISION, FAT GRAFTING WAS ALSO PERFORMED TO TREAT THE CUTANEOUS CONTOUR DEFORMITY. THE PATIENT¿S DOB WAS ESTIATMED AS (B)(6) BASED ON AVAILABLE INFORMATION.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 12064320 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH MENTOR MEMORYSHAPE BREAST IMPLANT 610CC BREAST IMPLANT AND SUFFERED FROM A BILATERAL WOUND INFECTION. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2020. THIS MEDWATCH IS FOR THE LEFT SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Post Operative Wound Infection

  MAUDE report 11791079 ↗
• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE (B)(6) CLINICAL TRIAL, PARTICIPANT (B)(6). IT WAS REPORTED THAT A HISPANIC FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 610CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED IMPAIRED HEALING ON THE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED REQUIRED SURGICAL INTERVENTION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A 510CC MENTOR MEMORYSHAPE BREAST IMPLANT ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement; Impaired Healing; Wrinkling

  MAUDE report 11770701 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE WHO UNDERWENT UNSPECIFIED BREAST RECONSTRUCTION SURGERY WITH A 275CC MENTOR MEMORYSHAPE, 610CC BREAST IMPLANT EXPERIENCED LEFT SIDED INFECTION POST PROCEDURE. ON (B)(6) 2021 INCISION DRAINAGE ASPIRATION WAS PERFORMED ON THE LEFT SIDE AND REMOVAL OF THE LEFT IMPLANT.

  Patient problems: Deformity/ Disfigurement; Post Operative Wound Infection

  MAUDE report 11754049 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE (B)(6) CLINICAL TRIAL, PARTICIPANT (B)(6). IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH TWO 610CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BILATERAL INFECTIONS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 11749781 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE (B)(6) CLINICAL TRIAL, PARTICIPANT (B)(6). IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH TWO 610CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BILATERAL INFECTIONS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 11749778 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH TWO 610CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESES (LEFT: REVISION, RIGHT: PRIMARY) AND EXPERIENCED BILATERAL CUTANEOUS CONTOUR DEFORMITY, LEFT-SIDED RUPTURE, AND RIGHT-SIDED SURGICAL INTERVENTION POSTOPERATIVELY. ON (B)(6) 2020, THE PATIENT HAD A CONSULTATION WITH A HEALTHCARE PROFESSIONAL, AND THE DIAGNOSIS WAS CONFIRMED VIA PHYSICAL EXAMINATION. DURING THE CONSULTATION, THE PATIENT¿S PHYSICIAN STATED THAT A BODY SCAN PERFORMED ON UNSPECIFIED DATE INDICATED LEFT-SIDED RUPTURE. IN ADDITION, THE PHYSICIAN STATED THAT THE PATIENT EXPERIENCED LEFT-SIDED RADIATION FIBROSIS AND LIPODYSTROPHY, AND BILATERAL EXCESS SKIN. AS A RESULT, THE PATIENT UNDERWENT A SURGICAL INTERVENTION FOR THE EXCESS SKIN ON HER RIGHT BREAST AND REMOVAL AND REPLACEMENT WITH A 595CC MENTOR GEL BREAST IMPLANT FOR HER LEFT BREAST ON (B)(6) 2020. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

  Patient problems: No Code Available; Wrinkling

  MAUDE report 10796382 ↗
• InjuryOct 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A REVISION BREAST RECONSTRUCTION WITH A 610CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE LEFT-SIDED RUPTURE AND CUTANEOUS CONTOUR DEFORMITY. A HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT EXPERIENCED RADIATION FIBROSIS, EXCESS SKIN, AND LIPODYSTROPHY. THE PATIENT HAD A CONSULTATION WITH A HEALTHCARE PROFESSIONAL, AND THE DIAGNOSIS WAS CONFIRMED VIA PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL REMOVAL AND REPLACEMENT WITH UNSPECIFIED MENTOR GEL BREAST IMPLANTS ON (B)(6) 2020.

  Patient problems: No Code Available; Wrinkling

  MAUDE report 10671167 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST IMPLANTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 610CC AND WITH AN UNSPECIFIED GEL MENTOR BREAST IMPLANT (THE SIDES ARE UNKNOWN) AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE II ON THE LEFT SIDE AND BAKER GRADE IV ON THE RIGHT SIDE AND FEELING CHRONIC FATIGUE. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2019.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9707252 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 610CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED WOUND INFECTION. THE DIAGNOSIS WAS CONFIRMED BY PHYSICIAN UPON EXAMINATION. AS A RESULT, THE PATIENT'S IMPACTED PRODUCT WAS EXPLANTED ON (B)(6) 2019 AND REPLACED BY A LIKE DEVICE (CATALOG NUMBER 3341354, SERIAL NUMBER (B)(4)). THE PATIENT HAD ALSO BEEN PRESCRIBED ANTIBIOTICS. TREATMENT OF THE INFECTION IS STILL ONGOING. NO DEVICE ISSUE, SUCH AS RUPTURE, WAS REPORTED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9339624 ↗
• InjuryJul 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 610CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED RIGHT SIDED INFECTION POST PROCEDURE. THE RIGHT BREAST REQUIRED FLUID TO BE DRAINED, AS THE PHYSICIAN SUSPECTED IT WAS INFECTED. AS A RESULT, THE DEVICE WAS REMOVED WITHOUT REPLACEMENT ON (B)(6) 2019.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8833909 ↗
• InjuryMay 31, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 610CC GEL BREAST PROSTHESIS THAT RUPTURED AFTER IMPLANTATION. THE PATIENT FIRST NOTICED LEAKAGE FROM HER RIGHT BREAST PROSTHESIS AND CALLED A PHYSICIAN FOR ADVICE. THE PHYSICIAN CONFIRMED THE LEAK AND PRESCRIBED ANTIBIOTICS. IN ADDITION, THE PATIENT DEVELOPED EDEMA IN HER RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 610CC GEL BREAST PROSTHESIS ON (B)(6) 2019. RUPTURE OF THE RIGHT BREAST PROSTHESIS WAS CONFIRMED BY THE PHYSICIAN DURING EXPLANTATION SURGERY.

  Patient problems: Local Reaction; No Code Available

  MAUDE report 8658848 ↗