MENTOR MemoryGel Breast Implant 3544700Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00081317001157), received between Jun 6, 2019 and May 12, 2025 — classified as 30 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 700 CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED PARESTHESIA, RIGHT SIDED CUTANEOUS CONTOUR DEFORMITY, AND RIGHT SIDED DEVICE MIGRATION POST PROCEDURE. THE DEVICE IS STATED TO FEEL WEIRD, BE RIPPLED NEAR THE ARMPIT, AND DOES NOT STAY IN PLACE WHEN THE PATIENT IS LAYING DOWN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Paresthesia; Wrinkling

  MAUDE report 22002841 ↗
• InjurySep 11, 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 RECONSTRUCTION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 700CC (L) AND AN UNSPECIFIED MENTOR GEL BREAST IMPLANT (R) AND EXPERIENCED BILATERAL BREAST PAIN ALONG WITH A RASH ON THE RIGHT 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. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 20191403 ↗
• InjuryApr 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 700CC SILICONE BREAST IMPLANT EXPERIENCED RIGHT SIDED SILENT RUPTURE POSTOPERATIVE. THE RUPTURE WAS DISCOVERED DURING THE SURGERY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH NON -MENTOR PROSTHESIS ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19176090 ↗
• InjuryJan 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18539621 ↗
• InjuryNov 8, 2023Adverse 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 PATIENT IMPLANTED WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL BREAST PAIN AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 18097350 ↗
• InjuryNov 8, 2023Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL BREAST PAIN AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 18097348 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 700CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENT SURGERY WITH ALLERGAN DEVICES ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 15914414 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 700CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENT SURGERY WITH ALLERGAN DEVICES ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 15914413 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE WITH A BREAST LUMP POST PROCEDURE. THE LUMP WAS A GOLF BALL SIZED NODULE THAT WAS GROWING AND PAINFUL. THE PAIN SOMETIMES RADIATES TO THE ARMPIT. THE BREAST WAS DISTORTED AND HARDENED. THE IMPLANT HAD BUBBLED OUT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Mass; Capsular Contracture

  MAUDE report 15160561 ↗
• InjuryJan 27, 2022Material 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) CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND RUPTURE POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2022. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13375180 ↗
• InjuryJan 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND RUPTURE POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2022. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13375168 ↗
• InjuryNov 16, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED SPONTANEOUS LEFT SIDED RUPTURE ACCOMPANIED BY PAIN POST PROCEDURE. THE PAIN WAS NEAR THE ARMPIT. 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 12824432 ↗
• InjuryJul 20, 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 A REVISION BREAST AUGMENTATION WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE LEFT-SIDED GRADE III CAPSULAR CONTRACTURE. THE DIAGNOSIS WAS CONFIRMED BASED ON PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT CATALOG #: 3544700, LEFT SERIAL #: (B)(4)) ON (B)(6) 2021.

  Patient problems: Capsular Contracture

  MAUDE report 12200582 ↗
• InjuryJun 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 700CC BREAST IMPLANT EXPERIENCED RIGHT-SIDED RUPTURE POST PROCEDURE. THE MRI EXAMINATION WAS INCONCLUSIVE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11962974 ↗
• InjuryDec 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 PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A MENTOR MEMORYGEL 700CC SILICONE PROSTHESIS EXPERIENCED LATE ONSET OF SEROMA ON THE LEFT SIDE POST PROCEDURE. THE ULTRASOUND EXAMINATION TAKEN ON (B)(6) 2020 REPORTED FLUID IN THE LEFT PROSTHESIS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Seroma

  MAUDE report 10929311 ↗
• InjuryFeb 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 UNDERWENT A BREAST AUGMENTATION REVISION WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED RIPPLING. THE PATIENT REPORTED THAT THE IMPLANT IS PINCHED AND THAT SHE CAN HEAR THE IMPLANT RUB. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Wrinkling

  MAUDE report 9728437 ↗
• InjuryFeb 5, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 700CC GEL BREAST PROSTHESIS DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 700CC GEL BREAST PROSTHESIS ON (B)(6) 2020. DURING EXPLANTATION SURGERY, IT WAS OBSERVED THAT THE RIGHT BREAST PROSTHESIS HAD RUPTURED.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9673574 ↗
• InjuryJan 15, 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 AN UNSPECIFIED BREAST SURGERY WITH 700CC TEXTURED MENTOR MEMORYGEL BREAST IMPLANT HAS EXPERIENCED POSTOPERATIVE UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING DIFFICULTY BREATHING, EXHAUSTION, HIGH BLOOD PRESSURE, AND SUDDEN ONSET OF ITCHING WITHIN THE BODY THAT STARTS AT THE TOP OF BREAST AND UP TO THE NECK. THE PATIENT ALSO REPORTED THAT THE IMPLANTS WERE TOO HEAVY, AND THAT THE RIGHT IMPLANT HAD FOLDED OVER. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: No Code Available

  MAUDE report 9594467 ↗
• InjuryJan 15, 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 AN UNSPECIFIED BREAST SURGERY WITH 700CC TEXTURED MENTOR MEMORYGEL BREAST IMPLANT HAS EXPERIENCED POSTOPERATIVE UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING DIFFICULTY BREATHING, EXHAUSTION, HIGH BLOOD PRESSURE, AND SUDDEN ONSET OF ITCHING WITHIN THE BODY THAT STARTS AT THE TOP OF BREAST AND UP TO THE NECK. THE PATIENT ALSO REPORTED THAT THE IMPLANTS WERE TOO HEAVY, AND THAT THE RIGHT IMPLANT HAD FOLDED OVER. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

  Patient problems: No Code Available

  MAUDE report 9594465 ↗
• InjuryDec 12, 2019Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV, CHRONIC PAIN, SCAR TISSUE, INABILITY TO PERFORM ADLS, BURNING SENSATION UNDERNEATH AND AROUND AREOLA, BACK PAIN AND DEFORMITY IN IMPLANTS POST PROCEDURE. AS A RESULT, PATIENT HAS A PLANNED EXPLANTATION ON (B)(6) 2020. IN 2017, PATIENT UNDERWENT A SURGICAL PROCEDURE TO RE-POSITION THE RIGHT AND LEFT BREAST IMPLANTS. THE RIGHT AND LEFT BREAST IMPLANTS WERE RE-USED. PER MENTOR IFU, THESE DEVICES ARE FOR SINGLE USE ONLY AND SHOULD NOT BE RE-IMPLANTED. THEREFORE, THESE DEVICES WERE USED OFF LABEL. THIS REPORT IS FOR THE RIGHT SIDED DEVICE. SEE 1645337-2019-25601 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9459030 ↗
• InjuryDec 12, 2019Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV, CHRONIC PAIN, SCAR TISSUE, INABILITY TO PERFORM ADLS, BURNING SENSATION UNDERNEATH AND AROUND AREOLA, BACK PAIN AND DEFORMITY IN IMPLANTS POST PROCEDURE. AS A RESULT, PATIENT HAS A PLANNED EXPLANTATION ON (B)(6) 2020. IN 2017, PATIENT UNDERWENT A SURGICAL PROCEDURE TO RE-POSITION THE RIGHT AND LEFT BREAST IMPLANTS. THE RIGHT AND LEFT BREAST IMPLANTS WERE RE-USED. PER MENTOR IFU, THESE DEVICES ARE FOR SINGLE USE ONLY AND SHOULD NOT BE RE-IMPLANTED. THEREFORE, THESE DEVICES WERE USED OFF LABEL. THIS REPORT IS FOR THE LEFT SIDED DEVICE. SEE 1645337-2019-25602 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9459024 ↗
• InjuryDec 9, 2019Adverse 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 UNDERWENT PRIMARY RECONSTRUCTION BREAST SURGERY WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS ON BOTH SIDES AND WAS PRESENTED WITH BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN, AND BURNING SENSATION. IT WAS REPORTED THAT ISSUE IS WORSE IN LEFT THAN RIGHT SIDE. 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: Capsular Contracture; Neurological Deficit/Dysfunction

  MAUDE report 9436803 ↗
• InjuryDec 9, 2019Adverse 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 UNDERWENT PRIMARY RECONSTRUCTION BREAST SURGERY WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS ON BOTH SIDES AND WAS PRESENTED WITH BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN, AND BURNING SENSATION. IT WAS REPORTED THAT ISSUE IS WORSE IN LEFT THAN RIGHT SIDE. 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: Capsular Contracture; Neurological Deficit/Dysfunction

  MAUDE report 9436801 ↗
• InjuryNov 28, 2019Adverse 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 UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANT AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING BURNING, PAIN, HEAVINESS, CHEST PRESSURE ACROSS ENTIRE BREAST AND BACK BUT PRIMARILY ON THE LEFT-SIDE, FATIGUE AND JOINT PAIN. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. THIS WAS THE PATIENT¿S PRIMARY RECONSTRUCTION PROCEDURE AFTER A BREAST CANCER DIAGNOSIS IN (B)(6) 2016. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 9388398 ↗
• InjuryNov 28, 2019Adverse 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 UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH TWO 700CC MENTOR MEMORYGEL BREAST IMPLANT AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING BURNING, PAIN, HEAVINESS, CHEST PRESSURE ACROSS ENTIRE BREAST AND BACK BUT PRIMARILY ON THE LEFT-SIDE, FATIGUE AND JOINT PAIN. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. THIS WAS THE PATIENT¿S PRIMARY RECONSTRUCTION PROCEDURE AFTER A BREAST CANCER DIAGNOSIS IN (B)(6) 2016. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 9388396 ↗