MENTOR MemoryGel Breast Implant 3547007Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00081317000761), received between Mar 20, 2018 and Aug 2, 2023 — classified as 32 injuries.

The most frequently reported specific device problem is “Material Rupture” (26 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.

• InjuryAug 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 55-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 700CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED SYMPTOMATIC RUPTURE, CAPSULAR CONTRACTURE GRADE UNKNOWN, AND LEFT SIDED SILENT RUPTURE POST PROCEDURE. THE ISSUE OF RUPTURE WAS CONFIRMED BY CT-SCAN. AS A RESULT, PATIENT UNDERWENT RIGHT SIDED CAPSULOTOMY AND BILATERAL IMPLANT REPLACEMENTS AS FOLLOW: LEFT CATALOG NUMBER SMHX430, SERIAL NUMBER (B)(6), AND RIGHT CATALOG NUMBER SMHX430, RIGHT SERIAL NUMBER (B)(6) ON (B)(6) 2023. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17446574 ↗
• InjuryAug 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 55-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 700CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED SYMPTOMATIC RUPTURE, CAPSULAR CONTRACTURE GRADE UNKNOWN, AND LEFT SIDED SILENT RUPTURE POST PROCEDURE. THE ISSUE OF RUPTURE WAS CONFIRMED BY CT-SCAN. AS A RESULT, PATIENT UNDERWENT RIGHT SIDED CAPSULOTOMY AND BILATERAL IMPLANT REPLACEMENTS AS FOLLOW: LEFT CATALOG NUMBER SMHX430, SERIAL NUMBER (B)(6), AND RIGHT CATALOG NUMBER SMHX430, RIGHT SERIAL NUMBER (B)(6) ON (B)(6) 2023. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 17443843 ↗
• InjuryJun 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 700CC MENTOR GEL IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. THE RUPTURES WERE CONFIRMED THROUGH MAGNETIC RESONANCE IMAGING. AS A RESULT, EXPLANT WITHOUT REPLACEMENT IS PLANNED. THE RIGHT SIDED RUPTURE WAS REPORTED INITIALLY UNDER 1645337-2023-05136. ON MAY 16, 2023 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE LET PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17066573 ↗
• InjuryMay 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH AN UNKNOWN MENTOR GEL IMPLANT EXPERIENCED SPONTANEOUS RIGHT SIDED RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16856397 ↗
• InjuryFeb 2, 2023Adverse 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 SURGERY WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Capsular Contracture

  MAUDE report 16286173 ↗
• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 42-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED BAKER GRADE III CAPSULAR CONTRACTURE OF THE RIGHT BREAST, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 16278830 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 61-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 700CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE II AND RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 16215868 ↗
• InjuryJan 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 700CC AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE II AND RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 16215864 ↗
• InjurySep 17, 2021Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED SPONTANEOUS RIGHT BILATERAL RUPTURE ACCOMPANIED BY A DEFORMED NIPPLE POST PROCEDURE. ADDITIONALLY BAKER GRADE IV CAPSULAR CONTRACTURE WAS PRESENT. THE RUPTURE WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION AND ULTRASOUND. AS A RESULT, EXPLANT AND REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2021. THE RIGHT SIDED RUPTURE WAS REPORTED INITIALLY UNDER 1645337-2021-07418 ON JUNE 30, 2021. ON AUGUST 24, 2021 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 12492835 ↗
• InjurySep 13, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE POSTOPERATIVELY DIAGNOSED AT THE DOCTOR'S OFFICE. AS A RESULT, THE DEVICES WILL BE EXPLANTED ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12460290 ↗
• InjurySep 13, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE POSTOPERATIVELY DIAGNOSED AT THE DOCTOR'S OFFICE. AS A RESULT, THE DEVICES WILL BE EXPLANTED ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12460285 ↗
• InjuryJun 30, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED SPONTANEOUS RIGHT SIDED RUPTURE ACCOMPANIED BY A DEFORMED NIPPLE POST PROCEDURE. THE RUPTURE WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION AND ULTRASOUND. AS A RESULT, AN EXPLANT IS PLANNED FOR (B)(6) 2021.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 12097395 ↗
• InjuryApr 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE BREAST AUGMENTATION REVISION WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED SPONTANEOUS BILATERAL BREAST IMPLANT RUPTURES, POST-PROCEDURE. THE RUPTURES WERE DIAGNOSED VIA AN MRI. AS A RESULT, THE PATIENT UNDERWENT BILATERAL CAPSULORRHAPHY, BILATERAL REMOVAL AND THEN BILATERAL REPLACEMENT ON (B)(6) 2021. THE CAPSULES WERE DESCRIBED TO BE ABNORMAL AND WERE SENT TO PATHOLOGY. THE REPLACEMENT DEVICES WERE THE FOLLOWING: (RIGHT) 800CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE CATALOG: 3502800 LOT: 9550486 SN: (B)(4) AND (LEFT) 800CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE CATALOG: 3502800 LOT: 9550486 SN: (B)(4). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS. COMPLICATIONS ON THE RIGHT BREAST/IMPLANT WAS REPORTED UNDER MRN: 1645337-2021-03145.

  Patient problems: Local Reaction

  MAUDE report 11742635 ↗
• InjuryMar 24, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE BREAST AUGMENTATION REVISION WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED SPONTANEOUS RIGHT BREAST IMPLANT RUPTURE, POST-PROCEDURE. THE RUPTURE WAS DIAGNOSED VIA AN MRI. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND THEN BILATERAL REPLACEMENT ON (B)(6) 2021, WITH THE FOLLOWING DEVICES: (RIGHT) 800CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE CATALOG: 3502800, LOT: 9550486, SN: (B)(4) AND (LEFT) 800CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE CATALOG: 3502800, LOT: 9550486, SN: (B)(4).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11566354 ↗
• InjuryJun 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 700CC AND SUFFERED FROM AUTOIMMUNE DISORDER (GUILLAIN-BARRE SYNDROME ) , BILATERAL RUPTURE AND MELANOMA, BREAST PAIN ON THE RIGHT BREAST IMPLANT, CAPSULAR CONTRACTURE ON THE LEFT IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 425CC ON (B)(6) 2013. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

  Patient problems: Autoimmune Reaction; Cancer; Capsular Contracture; No Code Available

  MAUDE report 10215635 ↗
• InjuryJun 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 700CC AND SUFFERED FROM GENERALIZED ILLNESS SYMPTOMS, BILATERAL RUPTURE AND BREAST PAIN ON THE RIGHT BREAST IMPLANT, CAPSULAR CONTRACTURE ON THE LEFT IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 425CC ON (B)(6) 2013. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: Autoimmune Reaction; Cancer; No Code Available; Pain

  MAUDE report 10215507 ↗
• 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 FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 700CC AND SUFFERED FROM GENERALIZED ILLNESS AND BREAST PAIN. THE PATIENT EXPERIENCED:¿ FATIGUE, BRAIN FOG, MEMORY LOSS, MUSCLE JOINT PAIN, HAIR LOSS, DRY SKIN, PRE-MATURE AGING, WEIGHT PROBLEMS, INFLAMMATION, RASHES ON BODY, INSOMNIA, POOR SLEEP, VERTIGO, NAUSEA, GASTRAL PROBLEMS, PAIN IN STOMACH, NIGHT SWEAT, INTOLERANT TO HOT AND COLD, HEADACHES, SLOW MUSCLE RECOVERY, HEART PALPATION, ANXIETY, SWOLLEN LYMPH NODES, INFECTIONS, GALL BLADDER PROBLEMS, DEPRESSION, BODY ACHING, BRUISING EASILY, TAKES LONG TO HEAL, RESPIRATORY PROBLEMS, UNABLE TO BREATH, PAIN IN CHEST, METALLIC TASTE, EAR RINGING, DEHYDRATION, TINGLING IN ARMS AND LEGS, ARTHRITIC PAIN, STABBING/ACHING SENSATION, STABBING PAIN, FEELS LIKE SHE IS DYING¿. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: Capsular Contracture; No Code Available; Pain

  MAUDE report 9857643 ↗
• 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 FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 700CC AND SUFFERED FROM GENERALIZED ILLNESS AND BREAST PAIN. THE PATIENT EXPERIENCED: ¿FATIGUE, BRAIN FOG, MEMORY LOSS, MUSCLE JOINT PAIN, HAIR LOSS, DRY SKIN, PRE-MATURE AGING, WEIGHT PROBLEMS, INFLAMMATION, RASHES ON BODY, INSOMNIA, POOR SLEEP, VERTIGO, NAUSEA, GASTRAL PROBLEMS, PAIN IN STOMACH, NIGHT SWEAT, INTOLERANT TO HOT AND COLD, HEADACHES, SLOW MUSCLE RECOVERY, HEART PALPATION, ANXIETY, SWOLLEN LYMPH NODES, INFECTIONS, GALL BLADDER PROBLEMS, DEPRESSION, BODY ACHING, BRUISING EASILY, TAKES LONG TO HEAL, RESPIRATORY PROBLEMS, UNABLE TO BREATH, PAIN IN CHEST, METALLIC TASTE, EAR RINGING, DEHYDRATION, TINGLING IN ARMS AND LEGS, ARTHRITIC PAIN, STABBING/ ACHING SENSATION, STABBING PAIN, FEELS LIKE SHE IS DYING¿.AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

  Patient problems: Capsular Contracture; No Code Available; Pain

  MAUDE report 9857637 ↗
• InjuryMar 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 700CC GEL BREAST PROSTHESES THAT BOTH RUPTURED AFTER IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED BY ULTRASOUND AND BY MRI. IN ADDITION, THE PATIENT SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING FEELING ILL, FEVER, AND CHILLS. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED RIGHT BREAST SWELLING AND PAIN. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: No Code Available; Pain

  MAUDE report 9803216 ↗
• InjuryMar 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 700CC GEL BREAST PROSTHESES THAT BOTH RUPTURED AFTER IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED BY ULTRASOUND AND BY MRI. IN ADDITION, THE PATIENT SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING FEELING ILL, FEVER, AND CHILLS. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED RIGHT BREAST SWELLING AND PAIN. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 9803214 ↗
• InjuryFeb 3, 2020Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; 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 REVISION WITH A 700CC TEXTURED MENTOR MEMORYGEL BREAST IMPLANTS HAS EXPERIENCED POSTOPERATIVE LEFT-SIDED RUPTURE AND UNEXPLAINED SYSTEMIC SYMPTOM OF HAIR LOSS. PATIENT REPORTED THAT THE LEFT IMPLANT IS GETTING SMALLER, IT¿S MISSHAPEN AND HAS A DENT ON THE BREAST, AND SHE BELIEVED THIS IS DUE TO RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. A DISCREPANCY HAS BEEN NOTED FOR THE REPORTED IMPLANTATION DATE AND MANUFACTURING DATE OF THE SUSPECT MEDICAL DEVICES. MULTIPLE ATTEMPTS FOR FOLLOW UP WAS MADE, AND PATIENT RESPONDED WITH CONFIRMATION FOR THE YEAR OF IMPLANTATION, AND STATED SHE HAS NO ADDITIONAL INFORMATION UNTIL THE DEVICES ARE EXPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS APPLICABLE. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

  Patient problems: Autoimmune Disorder; No Code Available

  MAUDE report 9662224 ↗
• InjuryFeb 3, 2020Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A 700CC TEXTURED MENTOR MEMORYGEL BREAST IMPLANTS HAS EXPERIENCED POSTOPERATIVE LEFT-SIDED RUPTURE AND UNEXPLAINED SYSTEMIC SYMPTOM OF HAIR LOSS. PATIENT REPORTED THAT THE LEFT IMPLANT IS GETTING SMALLER, IT¿S MISSHAPEN AND HAS A DENT ON THE BREAST, AND SHE BELIEVED THIS IS DUE TO RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. A DISCREPANCY HAS BEEN NOTED FOR THE REPORTED IMPLANTATION DATE AND MANUFACTURING DATE OF THE SUSPECT MEDICAL DEVICES. MULTIPLE ATTEMPTS FOR FOLLOW UP WAS MADE, AND PATIENT RESPONDED WITH CONFIRMATION FOR THE YEAR OF IMPLANTATION, AND STATED SHE HAS NO ADDITIONAL INFORMATION UNTIL THE DEVICES ARE EXPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS APPLICABLE. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: Autoimmune Disorder; No Code Available

  MAUDE report 9662115 ↗
• InjuryAug 9, 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 WHO UNDERWENT EXPLANTATION OF MENTOR GEL IMPLANTS ON (B)(6) 2019 DEVELOPED, POST OPERATIVE UNACCEPTABLE COSMETIC APPEARANCE DUE TO HEMATOMA CAUSED BY A PIECE OF THE IMPLANT THAT WAS LEFT INSIDE HER FROM SURGERY THAT WAS DIAGNOSED DURING EXPLORATORY SURGERY ON (B)(6) 2019 FOR CAPSULAR CONTRACTURE (REFERENCE MANUFACTURER¿S REPORT NUMBER 1645337-2018-07661). NO DEVICE IS CURRENTLY IMPLANTED.

  Patient problems: Hematoma; No Code Available

  MAUDE report 8881432 ↗
• InjuryJun 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST IMPLANT SURGERY PROCEDURE WITH MENTOR MEDICAL DEVICES (GEL SILTEX MOD-RND 700CC DATE OF IMPLANT (B)(6) 2002) NOTED THE SWELLING IN THE LEFT BREAST IN EARLY MAY WITH AN INCREASE APPROXIMATELY 5 DAYS PRIOR TO HER PHYSICIAN OFFICE VISIT (B)(6) 2019. THE LEFT BREAST WAS MASSIVELY SWOLLEN BY HER SURGERY (B)(6) 2019. 750CC PLUS OF SEROMA WAS EVACUATED FROM THE BREAST DURING SURGERY. THE FLUID WAS SENT FOR CYTOLOGY AND A BIOPSY OF THE CAPSULE WAS ALSO SENT. THESE WERE BOTH NEGATIVE FOR ALCL. ISSUE WAS DIAGNOSED AT AN OFFICE VISIT ON (B)(6) 2019. SURGERY WAS PERFORMED ON (B)(6) 2019. THE PROCEDURE WAS EVACUATION LEFT BREAST SEROMA, BILATERAL REMOVAL RUPTURED GEL IMPLANTS, AND BILATERAL IMPLANT EXCHANGE. REPLACEMENT DEVICES USED WERE CATALOG # 3507004BC, SN (B)(4) FOR THE RIGHT SIDE AND CATALOG # 3507004BC, SN (B)(4) WAS USED FOR THE LEFT SIDE. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: No Code Available

  MAUDE report 8709553 ↗
• InjuryJun 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST IMPLANT SURGERY PROCEDURE WITH MENTOR MEDICAL DEVICES (GEL SILTEX MOD-RND 700CC DATE OF IMPLANT (B)(6) 2002) NOTED THE SWELLING IN THE LEFT BREAST IN EARLY MAY WITH AN INCREASE APPROXIMATELY 5 DAYS PRIOR TO HER PHYSICIAN OFFICE VISIT (B)(6) 2019. THE LEFT BREAST WAS MASSIVELY SWOLLEN BY HER SURGERY (B)(6) 2019. 750CC PLUS OF SEROMA WAS EVACUATED FROM THE BREAST DURING SURGERY. THE FLUID WAS SENT FOR CYTOLOGY AND A BIOPSY OF THE CAPSULE WAS ALSO SENT. THESE WERE BOTH NEGATIVE FOR ALCL. ISSUE WAS DIAGNOSED AT AN OFFICE VISIT ON (B)(6) 2019. SURGERY WAS PERFORMED ON (B)(6) 2019. THE PROCEDURE WAS EVACUATION LEFT BREAST SEROMA, BILATERAL REMOVAL RUPTURED GEL IMPLANTS, AND BILATERAL IMPLANT EXCHANGE. REPLACEMENT DEVICES USED WERE CATALOG# 3507004BC, SN (B)(4) FOR THE RIGHT SIDE AND CATALOG # 3507004BC, SN (B)(4) WAS USED FOR THE LEFT SIDE. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: No Code Available; Seroma

  MAUDE report 8709550 ↗