MENTOR MemoryShape Breast Implant 3341209Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00081317005070), received between May 1, 2019 and Sep 29, 2026 — classified as 41 injuries.

The most frequently reported specific device problem is “Material Rupture” (8 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 41 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJan 29, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA ULTRASOUND AND MRI. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT GEL BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE 2ND OF THE PATIENT¿S TWO BREAST PROSTHESES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24214845 ↗
• InjuryJan 29, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA ULTRASOUND AND MRI. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT GEL BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE 1ST OF THE PATIENT¿S TWO BREAST PROSTHESES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24214838 ↗
• InjuryJun 16, 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 SURGERY WITH IMPLANTATION OF A 350CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING BILATERAL BREAST PAIN AND WAS CONCERNED REGARDING IMPLANT RECALL. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS WERE NOT PERFORMED PER THE PATIENT'S REQUEST.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22214313 ↗
• InjuryJun 16, 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 SURGERY WITH IMPLANTATION OF A 350CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING BILATERAL BREAST PAIN AND WAS CONCERNED REGARDING IMPLANT RECALL. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS WERE NOT PERFORMED PER THE PATIENT'S REQUEST.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22214306 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 35-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED A BILATERAL BREAST PTOSIS POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A RUPTURE ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024, AND REPLACED WITH 390CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS (CATALOG NUMBER SMPB390). THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20920671 ↗
• InjuryDec 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 35-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED A BILATERAL BREAST PTOSIS POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A RUPTURE ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024 AND REPLACED WITH 390CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS (CATALOG NUMBER: SMPB390). THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20918909 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT INVOLVED IN A CLINICAL TRIAL UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH A 395CC MENTOR MEMORYSHAPE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED WRINKLING IN HER LEFT BREAST WITH BREAST PAIN, WHICH REQUIRED FAT GRAFTING. ADDITIONALLY, THE PATIENT EXPERIENCED BILATERAL ANISOMASTIA. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE PATIENT WAS PART OF A POST APPROVAL STUDY. THE LEFT SIDED ISSUES WERE REPORTED INITIALLY UNDER 1645337-2022-15726. ON OCTOBER 1, 2024 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20494200 ↗
• InjuryMay 24, 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 WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 350CC AND EXPERIENCED BREAST RIPPLING (SIDE UNKNOWN) 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. THE IMPLANT INFORMATION WAS PROVIDED FOR BOTH BREAST PROSTHESES; HOWEVER, IT IS UNCLEAR WHICH IS THE IMPACTED PRODUCT. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE CORRECT COMPLAINT DEVICE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Wrinkling

  MAUDE report 19392242 ↗
• InjuryApr 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH 350CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE OF HER LEFT PROSTHESIS, WHICH WAS CONFIRMED VIA ULTRASOUND AND COMPLICATED BY GRANULOMA FORMATION IN THE LEFT AXILLA. SMALL CYSTS WERE OBSERVED IN THE UPPER OUTER QUADRANT OF THE RIGHT BREAST AND THE RETRO AREOLAR REGION OF THE LEFT BREAST. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED IMPLANT SITE CALCIFICATION OF THE LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 355CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-04362 FOR THE CONTRALATERAL EVENT.

  Patient problems: Calcium Deposits/Calcification; Cyst(s); Deformity/ Disfigurement; Granuloma

  MAUDE report 19083840 ↗
• InjuryApr 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 PRIMARY BREAST AUGMENTATION SURGERY WITH 350CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RUPTURE OF HER LEFT PROSTHESIS, WHICH WAS CONFIRMED VIA ULTRASOUND AND COMPLICATED BY GRANULOMA FORMATION IN THE LEFT AXILLA. SMALL CYSTS WERE OBSERVED IN THE UPPER OUTER QUADRANT OF THE RIGHT BREAST AND THE RETRO AREOLAR REGION OF THE LEFT BREAST. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED IMPLANT SITE CALCIFICATION OF THE LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 355CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-04361 FOR THE CONTRALATERAL EVENT.

  Patient problems: Cyst(s)

  MAUDE report 19083837 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 350CC MENTOR MEMORY SHAPE BREAST IMPLANT EXPERIENCED BILATERAL BREAST PAIN POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2024. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 18999226 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 350CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED BILATERAL BREAST PAIN POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 18997987 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORY SHAPE BREAST IMPLANT 270CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORY SHAPE BREAST IMPLANT 350CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED PAIN IN BOTH OF HER BREASTS POST IMPLANTATION. 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: Breast Discomfort/Pain

  MAUDE report 18084292 ↗
• InjuryMar 10, 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 A BREAST RECONSTRUCTION WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 350CC AND EXPERIENCED BREAST CANCER WHICH METASTASIZED TO THE RIGHT LUNG POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Cancer; Cancer

  MAUDE report 16524670 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A BREAST SURGERY WITH A 350CC MENTOR MEMORYSHAPE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BREAST PAIN ON AN UNDISCLOSED SIDE. AT THE TIME OF THIS REPORT, THE PATIENT HAS NOT CONSULTED WITH A MEDICAL PROFESSIONAL, NOR HAS MENTOR RECEIVED INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE LOT AND SERIAL NUMBERS WERE PROVIDED FOR BOTH IMPLANTED DEVICES, BUT THE IMPACTED SIDE WAS NOT DISCLOSED TO MENTOR. THE LEFT SIDE WAS IDENTIFIED AS SERIAL NUMBER: (B)(4) AND THE RIGHT SIDE WAS IDENTIFIED AS SERIAL NUMBER: (B)(4). BOTH DEVICES HAVE THE SAME LOT AND CATALOG NUMBER. AS SUCH, THE SERIAL NUMBER FOR EACH DEVICE HAS BEEN POPULATED IN THE SERIAL NUMBER FIELD. 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.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 15878303 ↗
• InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 67-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 350CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND SUFFERED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III). THE BREASTS HAVE PAIN AND ARE SITTING HIGH. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15858380 ↗
• InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 67-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 350CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND SUFFERED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III). THE BREASTS HAVE PAIN AND ARE SITTING HIGH. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Local Reaction

  MAUDE report 15858373 ↗
• InjuryJul 21, 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 FEMALE PATIENT UNDERWENT REVISION-AUGMENTATION SURGERY WITH MENTOR GLOW STUDY GEL DEVICES ON (B)(6) 2017. ON (B)(6) 2018, THE PATIENT EXPERIENCED RIGHT SIDE BREAST CANCER, WHICH REQUIRED LUMPECTOMY WITH RADIATION ON (B)(6) 2018.

  Patient problems: Cancer; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15079278 ↗
• InjuryApr 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT, UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, VIA MAMMOGRAM, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST IMPLANT RUPTURE AND SILICONE IN HER LYMPH NODES AND ARMPIT. PRIOR TO THE MAMMOGRAM, THE PATIENT INITIALLY NOTICED A LUMP IN HER RIGHT BREAST AND SWOLLEN LYMPH NODES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT ON (B)(6) 2022. THE LEFT IMPLANT WAS IDENTIFIED TO BE RUPTURED ALSO. THE REPLACEMENT DEVICES WERE: (RIGHT) 545CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: SMPX545 LOT: 9555950 SN: (B)(4) AND (LEFT) 545CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: SMPX545 LOT: 9555950 SN: (B)(4). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS. RUPTURE ON THE RIGHT BREAST IMPLANT HAS BEEN REPORTED UNDER MRN: 1645337-2022-00933.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14088088 ↗
• InjuryJan 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT, UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, VIA MAMMOGRAM, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST IMPLANT RUPTURE AND SILICONE IN HER LYMPH NODES AND ARMPIT. PRIOR TO THE MAMMOGRAM, THE PATIENT INITIALLY NOTICED A LUMP IN HER RIGHT BREAST AND SWOLLEN LYMPH NODES. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR IMPLANT REMOVAL ON (B)(6).

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 13371341 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE MEN-15-003 CLINICAL TRIAL, PARTICIPANT (B)(6). IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 270CC (LEFT) AND 350CC (RIGHT) MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED DISSATISFACTION WITH THE PROCEDURE OUTCOME POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

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

  MAUDE report 13111858 ↗
• InjuryDec 14, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 350CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED SPONTANEOUS RIGHT SIDED RUPTURED WITH DISCOMFORT AND LYMPHADENOPATHY POST PROCEDURE. THE ISSUES WERE DIAGNOSED THROUGH ULTRASOUND. SILICONE UPTAKE INTO THE RIGHT AXILLARY LYMPH NODES WAS FOUND. AS A RESULT, AN EXPLANT IS PLANNED FOR (B)(6) 2021.

  Patient problems: Breast Discomfort/Pain; Swollen Lymph Nodes/Glands

  MAUDE report 13003296 ↗
• InjuryDec 2, 2021Adverse 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 WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 350CC GEL BREAST PROSTHESIS DEVELOPED CELLULITIS IN HER LEFT BREAST POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED A SEROMA IN HER LEFT BREAST THAT REQUIRED PLACEMENT OF A DRAIN. LASTLY, IT WAS REPORTED THE DEVICE EXTRUDED FROM THE PATIENT¿S BREAST. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESIS ON (B)(6) 2020. PATHOLOGY REPORTS INDICATED NO MALIGNANCY.

  Patient problems: Pocket Erosion; Post Operative Wound Infection; Seroma

  MAUDE report 12921199 ↗
• InjuryJun 17, 2021Migration; Migration

  THIS EVENT IS ASSOCIATED WITH THE (B)(4) CLINICAL TRIAL, PARTICIPANT (B)(6). IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 350CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED A DEVICE MIGRATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH REQUIRED SURGICAL INTERVENTION TO HAVE THE IMPLANT REPOSITIONED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12019152 ↗