MENTOR MemoryGel Breast Implant 3507700BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00081317000181), received between Dec 18, 2018 and Jun 13, 2024 — classified as 34 injuries.

The most frequently reported specific device problem is “Material Rupture” (27 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 34 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 60-YEAR-OLD FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 600CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT SIDE, AND WITH 700CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT SIDE AND BILATERAL BREAST IMPLANT RUPTURES WERE FOUND DURING BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3507001BC; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3506001BC; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2024. MENTOR IS AWARE THAT THE DATE OF IMPLANT (B)(6) 2001 IS PRIOR TO THE MANUFACTURING DATE (11/1/2002) OF LOT 254113. PER RESPONSE RECEIVED, THE PATIENT GUESSED ON THE DATE OF IMPLANT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19529333 ↗
• InjuryDec 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 700CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA A CT SCAN. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18360420 ↗
• InjuryOct 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH AN UNSPECIFIED MENTOR GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS REPORTED. ADDITIONALLY, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER RIGHT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANT 685CC GEL BREAST PROSTHESES ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 18004554 ↗
• InjuryAug 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 63-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH SPONTANEOUS LEFT BREAST PAIN AND LEFT BREAST IMPLANT RUPTURE. THE BREAST HAD SOME TWINGES, SMALLER THAN THE RIGHT, AND FELT WEIRD. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023.

  Patient problems: Breast Discomfort/Pain; Paresthesia

  MAUDE report 17578524 ↗
• InjuryJul 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 47-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 700CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT A BREAST REVISION SURGERY FOR AN UNDISCLOSED REASON. DURING THIS PROCEDURE, A RUPTURED LEFT BREAST IMPLANT WAS DISCOVERED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 375CC (LEFT-SIDED) AND 320CC (RIGHT-SIDED) MENTOR MEMORYGEL BREAST IMPLANTS. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE RUPTURE. THE DATE OF IMPLANTATION WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. 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: Deformity/ Disfigurement

  MAUDE report 17264005 ↗
• InjuryDec 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 700CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION (BAKER GRADE III IN LEFT BREAST, BAKER GRADE IV IN RIGHT BREAST). AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 700CC GEL BREAST PROSTHESES ON (B)(6) 2022. DURING EXPLANT SURGERY, IT WAS OBSERVED THAT BOTH REMOVED BREAST PROSTHESES HAD RUPTURED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15997519 ↗
• InjuryDec 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 700CC GEL BREAST PROSTHESES DEVELOPED CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION (BAKER GRADE III IN LEFT BREAST, BAKER GRADE IV IN RIGHT BREAST). AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 700CC GEL BREAST PROSTHESES ON (B)(6) 2022. DURING EXPLANT SURGERY, IT WAS OBSERVED THAT BOTH REMOVED BREAST PROSTHESES HAD RUPTURED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15997515 ↗
• InjuryOct 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 47-YEAR-OLD, HISPANIC AND PACIFIC ISLANDER FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 700CC SILICONE BREAST PROSTHESIS DEVELOPED LEFT-SIDED CAPSULAR CONTRACTURE GRADE IV AND BILATERAL SYMPTOMATIC RUPTURE POSTOPERATIVELY. THE ISSUE WAS DISCOVERED DURING SURGERY. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH SIENTRA IMPLANTS ON AUGUST 31, 2022. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15591305 ↗
• InjuryOct 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 47-YEAR-OLD, HISPANIC AND PACIFIC ISLANDER FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 700CC SILICONE BREAST PROSTHESIS DEVELOPED BILATERAL CAPSULAR CONTRACTURE GRADE IV AND BILATERAL SYMPTOMATIC RUPTURE POSTOPERATIVELY. THE ISSUE WAS DISCOVERED DURING SURGERY. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH SIENTRA IMPLANTS ON (B)(6) 2022. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15591297 ↗
• InjurySep 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 50-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON THE LEFT SIDE POST-OPERATIVELY COMPLICATED BY GRANULOMA FORMATION IN THE LEFT AXILLA REGION. THE PATIENT¿S DIAGNOSIS WAS DIAGNOSED WITH A MAMMOGRAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Granuloma

  MAUDE report 15456878 ↗
• InjurySep 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 73-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 680CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 700CC GEL BREAST PROSTHESIS (RIGHT DEVICE) THAT BOTH RUPTURED POST IMPLANTATION. IT WAS OBSERVED THAT THE PATIENT¿S BREASTS HAD A DIFFERENT TEXTURE AND SHAPE. ADDITIONALLY, THE PATIENT DEVELOPED BILATERAL BREAST PAIN POST IMPLANTATION. BILATERAL RUPTURE WAS LATER DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Cyst(s); Deformity/ Disfigurement

  MAUDE report 15442925 ↗
• InjuryApr 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION, AS PART OF A CLINICAL STUDY, WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT ON (B)(6) 2022. DURING SURGERY, IT WAS DISCOVERED THAT THE RIGHT BREAST IMPLANT WAS ALSO RUPTURED. SUBSEQUENTLY, THE IMPLANTS WERE REPLACED WITH TWO 750CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG: 3507501BC). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS. LEFT BREAST IMPLANT RUPTURE WAS REPORTED UNDER MRN: 1645337-2022-02799.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14059855 ↗
• InjuryMar 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION, AS PART OF A CLINICAL STUDY, WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT IMPLANT REMOVAL AND REPLACEMENT WITH A 750CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG: 3507501BC) ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13771860 ↗
• InjuryDec 9, 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 BREAST RECONSTRUCTION PRIMARY WITH A (B)(6) BREAST IMPLANT (B)(4) (R) AND AN UNSPECIFIED MENTOR GEL BREAST IMPLANT (L) AND EXPERIENCED A BURNING SENSATION BILATERALLY AND BILATERAL CAPSULAR CONTRACTURE BAKER GRADE 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. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Paresthesia

  MAUDE report 12972736 ↗
• InjuryNov 23, 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) YEAR-OLD AFRICAN AMERICAN/NATIVE AMERICAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 550CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2021. THE LEFT SIDED RUPTURE WAS REPORTED INITIALLY UNDER 1645337-2020-08062 ON JUNE 30, 2020. THE DEVICE THOUGHT TO BE CONCOMITANT WAS RETURNED AND REPORTED UNDER 1645337-2020-08062 ON OCTOBER 27, 2021. ON OCTOBER 28, 2021, MENTOR RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE RETURNED WAS IN FACT THE RIGHT SIDED DEVICE. THE ADDITIONAL INFORMATION CLARIFIED THAT THE EXPLANT WAS BEING PERFORMED DUE TO LEFT SIDED RUPTURE, HOWEVER, UPON EXPLANT, THE RIGHT SIDE WAS ALSO FOUND TO BE DAMAGED, AND THAT THE RIGHT IMPLANT WAS RETURNED TO MENTOR. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12865985 ↗
• InjuryApr 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD NON-HISPANIC FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL IMPLANT RUPTURE, LEFT-SIDED CAPSULAR CONTRACTURE (UNKNOWN GRADE) AND LEFT-SIDED LOCAL REACTION POSTOPERATIVELY. THE PATIENT REPORTED COMPLICATIONS OF PAIN, BILATERAL LUMPS, AND THAT THE LEFT SIDE IS SWOLLEN NEAR THE ARMPIT. THE PATIENT ALSO STATED SUFFERING WITH LUNG CANCER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE IMPLANTATION DATE IS THE BEST ESTIMATE BASED ON AVAILABLE INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS APPLICABLE. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 11750590 ↗
• InjuryApr 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD NON-HISPANIC FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL IMPLANT RUPTURE, LEFT-SIDED CAPSULAR CONTRACTURE (UNKNOWN GRADE) AND LEFT-SIDED LOCAL REACTION POSTOPERATIVELY. THE PATIENT REPORTED COMPLICATIONS OF PAIN, BILATERAL LUMPS, AND THAT THE LEFT SIDE IS SWOLLEN NEAR THE ARMPIT. THE PATIENT ALSO STATED SUFFERING WITH LUNG CANCER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE IMPLANTATION DATE IS THE BEST ESTIMATE BASED ON AVAILABLE INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS APPLICABLE. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: Capsular Contracture; Local Reaction

  MAUDE report 11750589 ↗
• InjuryApr 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 700CC AND SUFFERED FROM A RIGHT SIDE RUPTURE. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 400CC ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11712284 ↗
• InjuryNov 28, 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 BREAST RECONSTRUCTION REVISION SURGERY WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED LEFT SIDED FOLD AND RIGHT SIDED TENDERNESS POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 10916113 ↗
• InjuryNov 28, 2020Adverse 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 WHO UNDERWENT BREAST RECONSTRUCTION REVISION SURGERY WITH TWO 700 CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED LEFT SIDED FOLD AND RIGHT SIDED TENDERNESS POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Pain

  MAUDE report 10916109 ↗
• InjuryOct 19, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 700CC GEL BREAST PROSTHESIS THAT RUPTURED AFTER IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DISCOVERED DURING AN IMPLANT EXCHANGE SURGERY ON (B)(6) 2020. THE PATIENT HAD BOTH OF HER BREAST PROSTHESES REMOVED AND THEY WERE REPLACED WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 800CC SALINE BREAST PROSTHESES.

  Patient problems: No Code Available

  MAUDE report 10702391 ↗
• InjuryOct 7, 2020Adverse 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 BREAST AUGMENTATION REVISION SURGERY WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CHANGE IN SHAPE, CHANGE IN SIZE, RIPPLING UNDER MUSCLE, BREAST PAIN, RHEUMATOID ARTHRITIS AND THYROID ISSUES POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Autoimmune Reaction; Wrinkling

  MAUDE report 10643852 ↗
• InjuryOct 7, 2020Adverse 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 BREAST AUGMENTATION REVISION SURGERY WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CHANGE IN SHAPE, CHANGE IN SIZE, RIPPLING UNDER MUSCLE, BREAST PAIN, RHEUMATOID ARTHRITIS AND THYROID ISSUES POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Autoimmune Reaction; Wrinkling

  MAUDE report 10643803 ↗
• InjuryOct 1, 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 PRIMARY BREAST RECONSTRUCTION SURGERY WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST MASS POSTOPERATIVELY. PATIENT FELT LUMPS IN HER BREASTS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Breast Mass

  MAUDE report 10615417 ↗
• InjuryOct 1, 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 PRIMARY BREAST RECONSTRUCTION SURGERY WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST MASS POSTOPERATIVELY. PATIENT FELT LUMPS IN HER BREASTS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Breast Mass

  MAUDE report 10615404 ↗