MENTOR MemoryShape Breast Implant 3341155Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00081317005315), received between May 22, 2019 and May 11, 2026 — classified as 46 injuries.

The most frequently reported specific device problem is “Material Rupture” (14 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 46 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 295CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED A BREAST MASS ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT REQUIRED SURGICAL INTERVENTION TO TREAT VIA BIOPSY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Breast Mass

  MAUDE report 25137703 ↗
• InjuryFeb 17, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS INITIALLY REPORTED. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT SUFFERED FROM RECURRENT LEFT BREAST SEROMAS. THE PATIENT WAS SUFFERING FROM PAIN, REDNESS, AND SWELLING IN THE LEFT BREAST. BOTH ULTRASOUND AND MRI RESULTS INDICATED A LARGE PERIIMPLANT FLUID COLLECTION IN THE LEFT BREAST. THE PATIENT UNDERWENT ULTRASOUND GUIDED ASPIRATION OF THE FLUID, AND A SAMPLE WAS COLLECTED AND SENT TO CYTOLOGY. NO MALIGNANT CELLS WERE IDENTIFIED. MRI RESULTS INDICATED AN ENLARGED LEFT AXILLARY LYMPH NODE. ULTRASOUND RESULTS SUGGESTED SILICONE UPTAKE BY THE LYMPH NODE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MOTIVA GEL BREAST PROSTHESES. DURING EXPLANT SURGERY, RUPTURE OF THE RIGHT BREAST PROSTHESIS WAS DISCOVERED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2025-13873 FOR THE REPORT FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24373568 ↗
• InjuryDec 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 295CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement; Fluid Discharge; Granuloma; Local Reaction; Seroma

  MAUDE report 23794542 ↗
• InjurySep 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED RUPTURE 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.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Granuloma; Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22946485 ↗
• InjuryAug 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MAMMOGRAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions; Wrinkling

  MAUDE report 22897470 ↗
• InjuryAug 15, 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 PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 295CC GEL BREAST PROSTHESES WAS VERY DISSATISFIED WITH THE PROCEDURAL OUTCOME. THE PATIENT IS DISSATISFIED WITH THE POSITION OF HER IMPLANTS ON HER CHEST AND HOW NATURALLY HER BREASTS SIT/HANG. 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: Deformity/ Disfigurement

  MAUDE report 22822392 ↗
• InjuryAug 15, 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 PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 295CC GEL BREAST PROSTHESES WAS VERY DISSATISFIED WITH THE PROCEDURAL OUTCOME. THE PATIENT IS DISSATISFIED WITH THE POSITION OF HER IMPLANTS ON HER CHEST AND HOW NATURALLY HER BREASTS SIT/HANG. 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: Deformity/ Disfigurement

  MAUDE report 22822391 ↗
• InjuryJul 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 295CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED A RUPTURE AND A GRANULOMA REQUIRING FLUID COLLECTION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Granuloma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669018 ↗
• InjuryApr 1, 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 PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 295CC GEL BREAST PROSTHESES WAS DISSATISFIED WITH THE AMOUNT OF RIPPLING (WRINKLING) THAT SHE COULD SEE AND FEEL ON 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 EFT BREAST PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 21748550 ↗
• InjuryApr 1, 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 PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 295CC GEL BREAST PROSTHESES WAS DISSATISFIED WITH THE AMOUNT OF RIPPLING (WRINKLING) THAT SHE COULD SEE AND FEEL ON 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: Wrinkling

  MAUDE report 21748548 ↗
• InjuryNov 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 42-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 295CC GEL BREAST PROSTHESES THAT BOTH RUPTURED AFTER IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED BY BOTH MAMMOGRAM AND ULTRASOUND. IN ADDITION, THE ULTRASOUND RESULTS SHOWED SILICONE-LADEN LYMPH NODES IN THE RIGHT AXILLA. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS LATER DIAGNOSED. ADDITIONALLY, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE IN BOTH BREASTS (BAKER GRADE IV IN LEFT BREAST, BAKER GRADE UNKNOWN IN RIGHT BREAST). LASTLY, THE PATIENT DEVELOPED A LATE ONSET SEROMA IN HER LEFT BREAST. A SAMPLE OF THE PATIENT¿S LEFT BREAST SEROMA WAS TAKEN AND SENT TO PATHOLOGY. THE RESULTS OF A CYTOLOGY REPORT HAVE NOT BEEN PROVIDED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2021-03982 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 20782082 ↗
• InjuryAug 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 295CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA MRI. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20072117 ↗
• InjuryJun 7, 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)). IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH TWO MENTOR MEMORYSHAPE BREAST IMPLANTS AND, ON (B)(6) 2024, WAS DIAGNOSED WITH SJOGREN'S SYNDROME. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, NOT SERIOUS, AND NOT RELATED TO THE STUDY DEVICE. HOWEVER, THE RELATIONSHIP OF THE EVENT TO THE DEVICE CANNOT BE EXCLUDED. THIS EVENT HAS NOT BEEN TREATED AND IS STILL ONGOING. 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: Autoimmune Disorder

  MAUDE report 19490620 ↗
• InjuryJun 6, 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)). IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH TWO MENTOR MEMORYSHAPE BREAST IMPLANTS AND, ON (B)(6) 2024, WAS DIAGNOSED WITH SJOGREN'S SYNDROME. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, NOT SERIOUS, AND NOT RELATED TO THE STUDY DEVICE. HOWEVER, THE RELATIONSHIP OF THE EVENT TO THE DEVICE CANNOT BE EXCLUDED. THIS EVENT HAS NOT BEEN TREATED AND IS STILL ONGOING. 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: Autoimmune Disorder

  MAUDE report 19480978 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FILE WAS CREATED TO DOCUMENT 1Y FOLLOW UP BREAST FEEDING DETAILS REPORTING "PATIENT DISSATISFACTION" IN IMEDIDATA. FOR MORE DETAILS, PLEASE REFER TO "BREAST-Q AUGMENTATION (POST-OPERATIVE) - 1 YEAR FOLLOW-UP_430-054". THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL, SUBJECT ID: (B)(6). ON (B)(6) 2018 THE PATIENT¿S FIRST-YEAR FOLLOW-UP WAS COMPLETED WHERE THE PATIENT REPORTED ISSUES WITH RIPPLING/WRINKLING VIA THE ¿BREAST-Q AUGMENTATION (POST-OPERATIVE)¿. THE RELATIONSHIP TO THE DEVICE WAS NOT PROVIDED AT THE TIME OF THIS REVIEW. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS NOTE WILL BE UPDATED AND THE CASE WILL BE REASSESSED.

  Patient problems: Wrinkling

  MAUDE report 19448623 ↗
• InjuryMay 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 295CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL 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

  MAUDE report 19355590 ↗
• InjuryMay 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 295CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL 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

  MAUDE report 19355580 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A BREAST AUGMENTATION SURGERY WITH 295CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT PRESENTED WITH A BREAST MASS/CYST WHICH REQUIRED BIOPSY. AT THE TIME OF THIS REPORT, MENTOR HAS NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Mass

  MAUDE report 18899102 ↗
• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 295CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING BILATERAL BREAST PAIN AND UNSPECIFIED PELVIC PAIN (POSSIBLY DUE TO HER MENSTRUAL CYCLE). A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS YET TO BE CONDUCTED. NO FURTHER INFORMATION WAS PROVIDED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-01250 FOR THE CONTRALATERAL EVENT.

  Patient problems: Breast Discomfort/Pain; Pain

  MAUDE report 18647353 ↗
• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 295CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING BILATERAL BREAST PAIN AND UNSPECIFIED PELVIC PAIN (POSSIBLY DUE TO HER MENSTRUAL CYCLE). A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS YET TO BE CONDUCTED. NO FURTHER INFORMATION WAS PROVIDED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-01249 FOR THE CONTRALATERAL EVENT.

  Patient problems: Breast Discomfort/Pain; Pain

  MAUDE report 18647352 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL. IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AUGMENTATION SURGERY WITH MENTOR GLOW STUDY GEL DEVICES ON (B)(6) 2017. ADVERSE EVENT # 2. NUMBNESS IN THE LEFT BREAST, (LEFT SIDE, IMPLANT SERIAL NUMBER: (B)(6). DOI: ((B)(6) 2017). ON (B)(6) 2023, SHE PRESENTED WITH NUMBNESS IN THE LEFT BREAST, WHICH REQUIRED. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, NON-SERIOUS, UNKNOWN RELATED TO THE DEVICE. [SAFETY_NOTE] SUBJECT ID:(B)(6). THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL. IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AUGMENTATION SURGERY WITH MENTOR GLOW STUDY GEL DEVICES ON (B)(6) 2017. ADVERSE EVENT # 2. NUMBNESS IN THE LEFT BREAST, (LEFT SIDE, IMPLANT SERIAL NUMBER: (B)(6). DOI: (B)(6) 2017). ON (B)(6) 2023, SHE PRESENTED WITH NUMBNESS IN THE LEFT BREAST. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, NON-SERIOUS, UNKNOWN RELATED TO THE DEVICE. ADVERSE EVENT # 2. NUMBNESS IN THE LEFT BREAST, (LEFT SIDE, IMPLANT SERIAL NUMBER: (B)(6) . DOI: (B)(6) 2017). ON (B)(6) 2023, SHE PRESENTED WITH NUMBNESS IN THE LEFT BREAST, WHICH REQUIRED. THE PRINCIPAL INVESTIGATOR AS

  Patient problems: Autoimmune Disorder; Deformity/ Disfigurement; Paresthesia

  MAUDE report 17887661 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL. IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AUGMENTATION SURGERY WITH MENTOR GLOW STUDY GEL DEVICES ON (B)(6) 2017. ADVERSE EVENT # 1. NUMBNESS IN THE RIGHT BREAST, (RIGHT SIDE, IMPLANT SERIAL NUMBER: (B)(6). DOI: (B)(6) 2017). ON (B)(6) 2023, SHE PRESENTED WITH NUMBNESS IN THE RIGHT BREAST. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, NON-SERIOUS, UNKNOWN RELATED TO THE DEVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED.

  Patient problems: Autoimmune Disorder; Deformity/ Disfigurement; Paresthesia

  MAUDE report 17887491 ↗
• InjuryJun 1, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY AUGMENTATION SURGERY WITH MENTOR GLOW STUDY GEL DEVICES ON (B)(6) 2020. ADVERSE EVENT # 1. BREAST CYST, (LEFT SIDE, IMPLANT SERIAL NUMBER: (B)(6). DOI: (B)(6) 2020). ON (B)(6) 2020, SHE PRESENTED WITH BREAST CYST, WHICH REQUIRED CYST ASPIRATION ON (B)(6) 2020. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, NON-SERIOUS, NOT RELATED TO THE DEVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED.

  Patient problems: Cyst(s)

  MAUDE report 17038737 ↗
• InjuryMay 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 295CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE, BAKER GRADE 3 AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 16934313 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 29-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 295CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV 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.

  Patient problems: Capsular Contracture

  MAUDE report 16491834 ↗