MENTOR MemoryShape Breast Implant 3341305Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00081317005346), received between Jul 10, 2019 and May 18, 2026 — classified as 57 injuries.

The most frequently reported specific device problem is “Material Rupture” (15 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 57 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 420CC MENTOR MEMORYSHAPE BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST THAT WAS NOT PRODUCING ENOUGH MILK. 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: Unspecified Reproductive System or Breast Problem

  MAUDE report 25207355 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 420CC MENTOR MEMORYSHAPE BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST THAT WAS NOT PRODUCING ENOUGH MILK. 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: Unspecified Reproductive System or Breast Problem

  MAUDE report 25207337 ↗
• InjuryJan 26, 2026Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 395CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED A RUPTURE ON RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

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

  MAUDE report 24182951 ↗
• InjuryNov 10, 2025Adverse 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 IP-(B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 420CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA AN EXAMINATION. IT WAS LATER REPORTED BY THE PATIENT THAT HER LEFT BREAST WAS MUCH BIGGER THAN HER RIGHT AND IT WAS PRODUCING MORE MILK. A FINE NEEDLE ASPIRATION WAS PERFORMED AND THE FLUID WAS DISCOVERED TO BE A SEROMA. THE SEROMA WAS BENIGN. THE PATIENT LATER UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESIS AND A MENTOR MEMORYGEL BREAST IMPLANT 350CC GEL BREAST PROSTHESIS ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23513999 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 420CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA AN EXAMINATION. IT WAS LATER REPORTED BY THE PATIENT THAT HER LEFT BREAST WAS MUCH BIGGER THAN HER RIGHT AND IT WAS PRODUCING MORE MILK. A FINE NEEDLE ASPIRATION WAS PERFORMED AND THE FLUID WAS DISCOVERED TO BE A SEROMA. THE SEROMA WAS BENIGN. THE PATIENT LATER UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESIS AND A MENTOR MEMORYGEL BREAST IMPLANT 350CC GEL BREAST PROSTHESIS ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Seroma

  MAUDE report 23513997 ↗
• InjurySep 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 420CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A RUPTURED LEFT IMPLANT. ULTRASOUND IMAGING WAS CONDUCTED; HOWEVER, A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS NOT. 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: Deformity/ Disfigurement

  MAUDE report 23025504 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 420CC GEL BREAST PROSTHESES DEVELOPED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. ADDITIONALLY, THE LEFT BREAST PROSTHESIS ROTATED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 545CC GEL BREAST PROSTHESES ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2025-07325 FOR THE REPORT FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22615634 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 420CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 545CC GEL BREAST PROSTHESES ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22391557 ↗
• InjuryDec 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 420CC GEL BREAST PROSTHESIS THAT POSSIBLY RUPTURED POST IMPLANTATION. PROBABLE INTRACAPSULAR RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA IMAGING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21031391 ↗
• InjuryOct 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 420CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20413298 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 420CC GEL BREAST PROSTHESIS DEVELOPED VARIOUS ISSUES IN HER LEFT BREAST POST IMPLANTATION. THE PATIENT FIRST NOTICED RIPPLES ON THE LEFT BREAST. AN ULTRASOUND WAS PERFORMED YEARS LATER AND IT DETECTED A FLUID THAT WAS SAID TO BE NORMAL. NOW THE LEFT BREAST FEELS TENDER, APPEARS PUFFY, AND HAS AN OCCASIONAL PAIN THAT COMES AND GOES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Fluid Discharge

  MAUDE report 20158922 ↗
• InjuryMay 29, 2024Adverse 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 420CC MENTOR MEMORY SHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANTS THAT WERE ALMOST POKING THROUGH THEIR SKIN. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6), 2024. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Pocket Erosion

  MAUDE report 19420429 ↗
• InjuryMay 29, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 420CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANTS THAT WERE ALMOST POKING THROUGH THEIR SKIN. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Breast Mass; Pocket Erosion

  MAUDE report 19420426 ↗
• 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 SURGERY WITH A 420CC MENTOR MEMORYSHAPE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT REPORTED THAT SHE BEGAN TO SUCCESSFULLY FEED HER BABY. IT WAS REPORTED THAT THE PATIENT THEN STOPPED BREASTFEEDING DUE TO MASTITIS. THE DEVICE IDENTITIES WERE PROVIDED FOR TWO IMPLANTED DEVICES, BUT THE SIDE OF THE COMPLICATION WAS NOT DISCLOSED. THE LOT AND CATALOG NUMBERS FOR BOTH DEVICES ARE THE SAME. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement; Post Operative Wound Infection

  MAUDE report 19392416 ↗
• InjuryNov 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 475CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 2) AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 18049658 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 420CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED LEFT SIDED CAPSULAR CONTRACTURE AND A RIGHT SIDED BREAST LUMP POST PROCEDURE. THE CAPSULAR CONTRACTURE WAS ACCOMPANIED BY RIPPLING, DISCOMFORT, HARDNESS, INCREASED ROUNDNESS, AND THE IMPLANT SITTING HIGH. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2023-11706 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Breast Mass; Capsular Contracture

  MAUDE report 17865941 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 420CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED LEFT SIDED CAPSULAR CONTRACTURE AND A RIGHT SIDED BREAST LUMP POST PROCEDURE. THE CAPSULAR CONTRACTURE WAS ACCOMPANIED BY RIPPLING, DISCOMFORT, HARDNESS, INCREASED ROUNDNESS, AND THE IMPLANT SITTING HIGH. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2023-11707 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 17865939 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 33-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION WITH A 495CC MENTOR MEMORYSHAPE BREAST IMPLANT (LEFT) AND A 420CC MENTOR MEMORYSHAPE BREAST IMPLANT (RIGHT) EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2023. SEE 1645337-2023-07010 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 17121311 ↗
• InjuryApr 20, 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 420CC (RIGHT) AND A 375CC (LEFT) MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED BILATERAL BREAST PAIN AND IMPLANT SITE FLUID COLLECTION POST-OPERATIVELY. THE PATIENT REPORTED THAT AN MRI AND MAMMOGRAM SHOWED FLUID AROUND THE IMPLANTS. 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16782101 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 33-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 420CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE AND LEFT SIDED SEROMA POST PROCEDURE. THE LEFT SIDED DEVICE WAS SWOLLEN, AND ASPIRATION OF FLUID WAS PERFORMED. CYTOPATHOLOGY WAS PERFORMED AND THE FLUID WAS NEGATIVE FOR MALIGNANT CELLS. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2023. SEE 1645337-2023-03105 FOR CONTRALATERAL PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 16559769 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 33-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 420CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE AND LEFT SIDED SEROMA POST PROCEDURE. THE LEFT SIDED DEVICE WAS SWOLLEN, AND ASPIRATION OF FLUID WAS PERFORMED. CYTOPATHOLOGY WAS PERFORMED AND THE FLUID WAS NEGATIVE FOR MALIGNANT CELLS. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2023. SEE 1645337-2023-03103 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 16559604 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 420CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE 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 LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 16343812 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 420CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE 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: Capsular Contracture

  MAUDE report 16343811 ↗
• InjuryFeb 3, 2023Adverse 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 A BREAST AUGMENTATION REVISION WITH A 420CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED PTOSIS ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16295382 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 52-YEAR-OLD FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 420CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES ON (B)(6) 2017 AND EXPERIENCED BREAST IMPLANT RUPTURE ON THE RIGHT SIDE CONFIRMED BY MAMMOGRAM. ADDITIONAL INFORMATION RELATED TO THE EVENT WAS RECEIVED ON DECEMBER 2, 2022. ACCORDING TO THE INFORMATION PROVIDED THE PATIENT DEVELOPED LATE ONSET SEROMA IN BOTH BREASTS, SEROMA FLUID WAS COLLECTED DURING BILATERAL EXPLANT SURGERY, PERFORMED ON (B)(6) 2022, AND SENT FOR CYTOLOGY. AT THIS TIME, THE RESULTS OF PATHOLOGY REPORT HAVE NOT BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED, NOTES WILL BE UPDATED, AND SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Seroma

  MAUDE report 15960898 ↗