MENTOR MemoryShape Breast Implant 3341152Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00081317005193), received between Mar 20, 2018 and Dec 30, 2025 — classified as 31 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (7 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 345CC GEL BREAST PROSTHESIS THAT MIGRATED POST IMPLANTATION. THE RIGHT BREAST POCKET IS UNDER THE IMPLANT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23926745 ↗
• InjuryAug 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 345CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING LEFT BREAST PAIN WITH LUMPS AND BELIEVES THE IMPLANT IS RUPTURED. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS YET TO BE COMPLETED. 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: Breast Discomfort/Pain; Wrinkling

  MAUDE report 22835553 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 51 YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 345CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED IMPLANT SITE CALCIFICATIONS ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 440CC MENTOR MEMORYGEL BOOST BREAST IMPLANT (CATALOG NUMBER SHPB440).

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 22778190 ↗
• InjuryJul 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III ON THE LEFT AND BAKER GRADE IV ON THE RIGHT). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. IT WAS NOT SPECIFIED WHICH BREAST SIDE THE REPORTED IMPLANTS BELONGS TO, SO BOTH WILL BE REPORTED WITH NO ASSIGNED BREAST FOR NOW UNTIL CLARIFICATION IS RECEIVED.

  Patient problems: Capsular Contracture

  MAUDE report 22490743 ↗
• InjuryMay 20, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 345CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A MAMMOGRAM. IT WAS REPORTED THAT THE PATIENT WAS IN A CAR ACCIDENT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Calcium Deposits/Calcification; Crushing Injury; Deformity/ Disfigurement

  MAUDE report 22054845 ↗
• InjuryFeb 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 390CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS OBSERVED DURING AN IMPLANT EXCHANGE SURGERY ON (B)(6) 2025. THE PATIENT HAD BOTH BREAST PROSTHESES EXPLANTED AND THEY WERE REPLACED WITH ALLERGAN GEL BREAST PROSTHESES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21316051 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT, AS PART OF A CLINICAL STUDY, BREAST RECONSTRUCTION WITH A (RIGHT) 345CC MENTOR MEMORYSHAPE BREAST IMPLANT AND (LEFT) 495CC MENTOR MEMORYSHAPE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST ASYMMETRY AND BILATERAL BREAST WRINKLING. AS A RESULT, THE PATIENT UNDERWENT LEFT BREAST FAT GRAFTING AND RIGHT BREAST IMPLANT REMOVAL AND REPLACEMENT ON (B)(6) 2022. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 16791895 ↗
• InjuryOct 19, 2022Adverse 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 PRIMARY BREAST RECONSTRUCTION WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 330CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A 3341152 MENTOR MEMORYSHAPE BREAST IMPLANT 345CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED ASYMMETRY OF THE BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYSHAPE BREAST IMPLANT 300CC GEL BREAST PROSTHESES ON (B)(6) 2018. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15633930 ↗
• InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 73-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A 345CC MENTOR MEMORYSHAPE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A WOUND INFECTION AND A HEMATOMA ON THE LEFT SIDE, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022.

  Patient problems: Hematoma; Post Operative Wound Infection

  MAUDE report 15545000 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 55-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 345CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE 3). THE PATIENT ALSO HAS BILATERAL BREAST DISCOMFORT, RIPPLING, VERY SLIGHT DOUBLE BUBBLE CREASE, AND IMPLANT DISPLACEMENT. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2022. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15496172 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 55-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 345CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE 3). THE PATIENT ALSO HAS BILATERAL BREAST DISCOMFORT, RIPPLING, VERY SLIGHT DOUBLE BUBBLE CREASE, AND IMPLANT DISPLACEMENT. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2022. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15496100 ↗
• InjuryAug 29, 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 AUGMENTATION WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 345CC AND EXPERIENCED BREAST PAIN 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: Breast Discomfort/Pain

  MAUDE report 15314182 ↗
• InjuryAug 25, 2022Migration; Migration

  IT WAS REPORTED THAT A 50-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 260CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYSHAPE BREAST IMPLANT 345CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED LUMPS AND UNSPECIFIED DEFORMITIES ON BOTH BREASTS POST IMPLANTATION. ADDITIONALLY, THE PATIENT SUFFERED FROM BILATERAL BREAST PAIN. IT WAS ALSO REPORTED THAT THE PATIENT¿S RIGHT BREAST PROSTHESIS FLIPPED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH ALLERGAN GEL BREAST PROSTHESES ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Breast Mass

  MAUDE report 15294641 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 36-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH A 345CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED PAIN AND DISCOMFORT ON HER RIGHT SIDE POSTOPERATIVELY. IT WAS CONFIRMED THAT THERE WAS NO OTHER COMPLICATION. MAMMOGRAM AND ULTRASOUND SCANS WERE TAKEN. THE PATIENT IS SCHEDULED FOR IMPLANT EXCHANGE SURGERY ON (B)(6) 2022.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 15157669 ↗
• InjuryApr 5, 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 345CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED ANISOMASTIA ON THE LEFTSIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14016699 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 345CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED RIGHT-SIDED LATE ONSET SEROMA, SURGICAL INTERVENTION, AND SUSPECTED ANAPLASTIC LARGE-CELL LYMPHOMA (ALCL) POSTOPERATIVELY. ON (B)(6) 2021, THE PATIENT STARTED TO EXPERIENCE SYMPTOMS OF INTERMITTENT SWELLING AND REDNESS IN HER RIGHT BREAST. THE BREAST WOULD OCCASIONALLY BECOME RED AND SWOLLEN AND SPONTANEOUSLY RESOLVE. MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED TO EVALUATE THE BREAST IMPLANTS FOR 5-YEAR SCREENING. BASED ON THE FINDINGS OF THE MRI, IT WAS RECOMMENDED THAT ULTRASOUND-GUIDED ASPIRATION BE PERFORMED OF THE AREA IN QUESTION. ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION OF THE RIGHT PERI-IMPLANT FLUID TOOK PLACE ON (B)(6) 2021. A TOTAL OF 5ML OF CLEAR, STRAW-COLORED YELLOW FLUID WAS ASPIRATED. POST-ASPIRATION ULTRASOUND SHOWED THE AMOUNT OF PERI-IMPLANT FLUID TO BE DECREASED. THERE WERE NO COMPLICATIONS. THE FLUID WAS SENT TO CYTOLOGY FOR ANALYSIS FOR CD30 AND TO RULE OUT BIA-ALCL. THE CYTOLOGY REPORT OF THE RIGHT BREAST FLUID INDICATED THAT THE CYTOLOGICAL EVALUATION AND CELL BLOCK SHOW RARE LARGE LYMPHOCYTE, IN BACKGROUND

  Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL); Local Reaction; Seroma

  MAUDE report 12901385 ↗
• InjuryOct 4, 2021Migration; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 345CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT WAS SUFFERING FROM BILATERAL BREAST PAIN, NUMBNESS, SWELLING, BURNING SENSATION, AND THE BREASTS WERE HOT TO THE TOUCH. LASTLY, THE PATIENT EXPERIENCED MOVEMENT OF HER BREAST PROSTHESES WHILE LYING DOWN. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Local Reaction; Paresthesia

  MAUDE report 12569463 ↗
• InjuryOct 4, 2021Migration; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 345CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT WAS SUFFERING FROM BILATERAL BREAST PAIN, NUMBNESS, SWELLING, BURNING SENSATION, AND THE BREASTS WERE HOT TO THE TOUCH. LASTLY, THE PATIENT EXPERIENCED MOVEMENT OF HER BREAST PROSTHESES WHILE LYING DOWN. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Local Reaction; Paresthesia

  MAUDE report 12569421 ↗
• InjuryJun 18, 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 MENTOR MEMORYSHAPE BREAST IMPLANT 345CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT A CAPSULECTOMY ON (B)(6) 2017. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 12025432 ↗
• InjuryMar 12, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 345CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED A LOCAL REACTION AND A SUSPECTED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2020.

  Patient problems: Local Reaction

  MAUDE report 11475477 ↗
• InjuryNov 19, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION SURGERY WITH A 345CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED RIGHT SIDED BREAST PAIN AND RUPTURE POST PROCEDURE. PATIENT STATED THAT SHE HAS DISCOMFORT WHEN SHE WORKS OUT AND IMPLANT IS ROTATED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Pain

  MAUDE report 10872715 ↗
• InjuryNov 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 345CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available

  MAUDE report 10856891 ↗
• InjuryOct 22, 2020Migration; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD NON-HISPANIC FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 345CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL DEVICE MIGRATION POST-OPERATIVELY. THE PATIENT REPORTED THAT THE IMPLANTS WERE SHIFTING UPSIDE DOWN AND SIDEWAYS. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH 375CC MENTOR MEMORYGEL BREAST IMPLANTS, CATALOG # 3503754BC, LEFT LOT-SERIAL # (B)(4) AND RIGHT LOT-SERIAL # (B)(4) ON (B)(6) 2017. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: No Code Available

  MAUDE report 10722607 ↗
• InjuryOct 22, 2020Migration; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD NON-HISPANIC FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 345CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL DEVICE MIGRATION POST-OPERATIVELY. THE PATIENT REPORTED THAT THE IMPLANTS WERE SHIFTING UPSIDE DOWN AND SIDEWAYS. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH 375CC MENTOR MEMORYGEL BREAST IMPLANTS, CATALOG # 3503754BC, LEFT LOT-SERIAL # (B)(4) AND RIGHT LOT-SERIAL # (B)(4) ON (B)(6) 2017. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

  Patient problems: No Code Available

  MAUDE report 10722604 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYSHAPE BREAST IMPLANT 345CC AND EXPERIENCED IMPAIRED HEALING ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 10284248 ↗