MENTOR MemoryShape Breast Implant 3341102Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00081317005186), received between Apr 30, 2019 and May 6, 2026 — classified as 28 injuries.

The most frequently reported specific device problem is “Material Rupture” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 67-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 300CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED A BREAST MASS ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT FELT A "CAVE IN AND LUMP". AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Breast Mass

  MAUDE report 25094534 ↗
• 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 22490744 ↗
• InjuryJul 10, 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 PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL PTOSIS ALONG WITH RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. THE PATIENT WAS INVOLVED IN A CAR ACCIDENT WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025.THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22470962 ↗
• InjuryJun 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. THE PATIENT WAS INVOLVED IN A CAR ACCIDENT WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025.

  Patient problems: Crushing Injury; Deformity/ Disfigurement

  MAUDE report 22123315 ↗
• InjuryJun 12, 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 REVISION SURGERY WITH IMPLANTATION OF A 300CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS INVOLVED IN A CAR ACCIDENT. SUBSEQUENTLY, SHE WAS DIAGNOSED WITH A LEFT BREAST SEROMA BY A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Seroma; Wrinkling

  MAUDE report 19520898 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL, SUBJECT ID: (B)(6). ADVERSE EVENT #1 & #2: WRINKLING (LEFT SERIAL NUMBER: (B)(6) AND RIGHT SERIAL NUMBER: (B)(6) ON (B)(6) 2021, THE PATIENT REPORTED EXPERIENCING BILATERAL WRINKLING. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD/MODERATE IN SEVERITY, HOWEVER, THE RELATIONSHIP TO THE DEVICE AND THE SURGICAL PROCEDURE WAS NOT PROVIDED AT THE TIME OF THIS REVIEW. THIS EVENT IS STILL ONGOING. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Wrinkling

  MAUDE report 19355724 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL, SUBJECT ID: (B)(6). ADVERSE EVENT #1 & #2: WRINKLING (LEFT SERIAL NUMBER: (B)(6) AND RIGHT SERIAL NUMBER: (B)(6)). ON (B)(6) 2021, THE PATIENT REPORTED EXPERIENCING BILATERAL WRINKLING. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD/MODERATE IN SEVERITY, HOWEVER, THE RELATIONSHIP TO THE DEVICE AND THE SURGICAL PROCEDURE WAS NOT PROVIDED AT THE TIME OF THIS REVIEW. THIS EVENT IS STILL ONGOING. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Wrinkling

  MAUDE report 19355695 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 300CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED RIGHT SIDED RUPTURE, RIGHT SIDED GRANULOMA, AND BILATERAL PTOSIS POST PROCEDURE. SILICONE WAS FOUND IN A RIGHT AXILLARY LYMPH NODE. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH 275CC MENTOR MEMORYGEL BREAST IMPLANTS WAS PERFORMED ON (B)(6) 2023. THE RIGHT SIDED RUPTURE WAS REPORTED INITIALLY UNDER 1645337-2023-04837 ON (B)(6) 2023. ON JUNE 26, 2023 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17346275 ↗
• InjuryApr 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 300CC MENTORMEMORYSHAPE BREAST IMPLANT EXPERIENCED 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; Granuloma

  MAUDE report 16812236 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 41-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 300CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED DELAYED WOUND HEALING OF THE RIGHT PERI AREOLAR INCISION WHICH THEN SUBSEQUENTLY REQUIRED A FAT GRAFTING PROCEDURE DUE TO AN UNDISCLOSED REASON. CURRENTLY, BOTH IMPLANTS HAVE ROTATED FROM THEIR ORIGINAL POSITIONS AND SHE WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE OF THE LEFT BREAST. 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. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-03765 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 16652094 ↗
• InjuryFeb 15, 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 SURGERY WITH IMPLANTATION OF A 300CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A BREAST MASS/CYST ASSOCIATED WITH THE LEFT BREAST. SURGICAL INTERVENTION WAS PERFORMED IN WHICH A BIOPSY WAS PERFORMED.

  Patient problems: Cyst(s)

  MAUDE report 16380874 ↗
• InjuryJan 24, 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 PRIMARY BREAST RECONSTRUCTION WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 330CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYSHAPE BREAST IMPLANT 345CC GEL BREAST PROSTHESIS (RIGHT DEVICE) DEVELOPED ASYMMETRY OF THE BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION OF THE RIGHT BREAST PROSTHESIS AND IT WAS REPLACED WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 300CC GEL BREAST PROSTHESIS GEL BREAST PROSTHESIS ON (B)(6) 2018. IT WAS LATER REPORTED THAT THE PATIENT DEVELOPED BREAST ASYMMETRY AGAIN. ADDITIONALLY, THE PATIENT DEVELOPED WRINKLING ON BOTH BREASTS. THE PATIENT ALSO DEVELOPED ANXIETY ABOUT HER TEXTURED BREAST IMPLANTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL XTRA BREAST IMPLANT 380CC GEL BREAST PROSTHESIS AND A MENTOR MEMORYGEL XTRA BREAST IMPLANT 355CC GEL BREAST PROSTHESIS ON (B)(6) 2019. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S SECOND RIGHT BREAST PROSTHESIS THAT WAS IMPLANTED ON (B)(6) 2018. REFER TO MANUFACTURER REPORT NUMBER 1645337-2022-12582 FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS THAT WAS IMPLANTED ON (B

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 16236957 ↗
• InjuryApr 7, 2022Material 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 300CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS NOTICED DURING AN IMPLANT EXCHANGE SURGERY ON (B)(6) 2022. THE PATIENT HAD BOTH BREAST PROSTHESES REMOVED AND THEY WERE REPLACED WITH MENTOR MEMORYGEL BREAST IMPLANT 230CC GEL BREAST PROSTHESES ON THAT DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14048392 ↗
• InjuryDec 1, 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 UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED FLUID BUILD UP, AND LOCAL REACTION ON HER RIGHT SIDE POSTOPERATIVELY. SURGICAL INTERVENTION WAS PERFORMED REMOVE THE FLUID. THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT SURGERY ON (B)(6) 2021.

  Patient problems: Local Reaction

  MAUDE report 12913380 ↗
• InjuryAug 6, 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 IRANIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 300CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE 3 POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 12291064 ↗
• InjuryApr 6, 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 HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 300CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED LEFT SIDE CAPSULAR CONTRACTURE; BAKER GRADE III. ON MARCH 25, 2021, MENTOR BECAME AWARE THAT PATIENT ALSO EXPERIENCED RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE III. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2021. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 11618474 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 300CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED LEFT SIDE CAPSULAR CONTRACTURE; BAKER GRADE III. ON (B)(6) 2021, MENTOR BECAME AWARE THAT PATIENT ALSO EXPERIENCED RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE III. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2021. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture; Hematoma

  MAUDE report 11618466 ↗
• InjuryApr 8, 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 PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 300CC GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING FATIGUE, BRAIN FOG, AND SHOOTING RANDOM PAIN IN HER CHEST. THE PATIENT REPORTED THAT HER IMPLANTS ARE MAKING HER SICK AND SHE FEELS LIKE SHE HAS BREAST IMPLANT ILLNESS. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 9934245 ↗
• InjuryApr 8, 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 PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 300CC GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING FATIGUE, BRAIN FOG, AND SHOOTING RANDOM PAIN IN HER CHEST. THE PATIENT REPORTED THAT HER IMPLANTS ARE MAKING HER SICK AND SHE FEELS LIKE SHE HAS BREAST IMPLANT ILLNESS. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 9934225 ↗
• InjuryMar 19, 2020Migration; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH 300CC GEL MENTOR MEMORYSHAPE BREAST IMPLANT HAS EXPERIENCED POSTOPERATIVE BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE III ON LEFT AND GRADE II-III ON RIGHT, AND LEFT-SIDED IMPLANT MIGRATION. PATIENT REPORTED THAT BREASTS ARE EXTREMELY HARD, LEFT SIDE IS HIGH, NIPPLE IS DOWN, AND LEFT IMPLANT HAS ROTATED OR SHIFTED OUT OF THE POCKET. IN ADDITION, PATIENT ALSO UNDERWENT BREAST BIOPSY WITH BENIGN FINDINGS. CAPSULAR CONTRACTURE WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9857840 ↗
• InjuryMar 19, 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 WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH 300CC GEL MENTOR MEMORYSHAPE BREAST IMPLANT HAS EXPERIENCED POSTOPERATIVE BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE III ON LEFT AND GRADE II-III ON RIGHT, AND LEFT-SIDED IMPLANT MIGRATION. PATIENT REPORTED THAT BREASTS ARE EXTREMELY HARD, LEFT SIDE IS HIGH, NIPPLE IS DOWN, AND LEFT IMPLANT HAS ROTATED OR SHIFTED OUT OF THE POCKET. IN ADDITION, PATIENT ALSO UNDERWENT BREAST BIOPSY WITH BENIGN FINDINGS. CAPSULAR CONTRACTURE WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9857837 ↗
• InjurySep 4, 2019Adverse 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 PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYSHAPE 300CC SILICONE BREAST IMPLANTS WHICH THE REPORT INDICATES THAT PATIENT HAS SYMPTOMS OF ANXIETY, HEART PALPITATION AND BRAIN FOG BILATERALLY AFTER IMPLANTATION. THE ISSUE HAS NOT BEEN CONFIRMED BY THE PHYSICIAN. AS A RESULT PATIENT HAD THE DEVICES REMOVED ON (B)(6) 2019. THIS REPORT IS FOR THE LEFT SIDE.

  Patient problems: No Code Available

  MAUDE report 8960706 ↗
• InjurySep 4, 2019Adverse 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 PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYSHAPE 300CC SILICONE BREAST IMPLANTS WHICH THE REPORT INDICATES THAT PATIENT HAS SYMPTOMS OF ANXIETY, HEART PALPITATION AND BRAIN FOG BILATERALLY AFTER IMPLANTATION. THE ISSUE HAS NOT BEEN CONFIRMED BY THE PHYSICIAN. AS A RESULT PATIENT HAD THE DEVICES REMOVED ON (B)(6) 2019. THIS REPORT IS FOR THE RIGHT SIDE.

  Patient problems: No Code Available

  MAUDE report 8960686 ↗
• InjuryAug 23, 2019Adverse 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 AUGMENTATION WITH MENTOR MEMORYSHAPE BREAST IMPLANT 300CC AND EXPERIENCED PAIN ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Pain; Wrinkling

  MAUDE report 8928455 ↗
• InjuryAug 1, 2019Adverse 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 UNSPECIFIED BREAST SURGERY WITH 300CC MENTOR MEMORYSHAPE BREAST IMPLANT AND WAS PRESENTED WITH RIGHT SIDE LATE ONSET SEROMA. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Seroma

  MAUDE report 8851729 ↗