MENTOR MemoryShape Breast Implant 3341259Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00081317005087), received between Jun 12, 2019 and Sep 7, 2026 — classified as 57 injuries.

The most frequently reported specific device problem is “Material Rupture” (16 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.

• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50656385 ↗
• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50656382 ↗
• InjurySep 11, 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 REVISION SURGERY WITH IMPLANTATION OF A 395CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RIGHT BREAST HEMATOMA AND A LOWER POLE REVISION WAS CONDUCTED. MORE RECENTLY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM IN ADDITION TO FIRM, UNCOMFORTABLE BREASTS WITH WATERFALL DEFORMITY AND PTOSIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Hematoma

  MAUDE report 23028755 ↗
• InjurySep 11, 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 REVISION SURGERY WITH IMPLANTATION OF A 395CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A RIGHT BREAST HEMATOMA AND A LOWER POLE REVISION WAS CONDUCTED. MORE RECENTLY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM IN ADDITION TO FIRM, UNCOMFORTABLE BREASTS WITH WATERFALL DEFORMITY AND PTOSIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23028753 ↗
• InjuryJun 16, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 395CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED A DEVICE MIGRATION 1ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 22213456 ↗
• InjuryApr 24, 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 WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 395CC AND EXPERIENCED BREAST PAIN ON THE LEFT 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: Breast Discomfort/Pain

  MAUDE report 21901086 ↗
• InjuryJan 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 395CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS REPORTED TO HAVE EXPERIENCED AUTOIMMUNE-LIKE SYMPTOMS, FATIGUE, JOINT DISEASE, MUSCLE ACHES, BACK PAIN, BREAST PAIN, WEIGHT GAIN, AND POSSIBLE SYSTEMIC INFLAMMATION. THE PATIENT ALSO HAD CONCERNS OF BREAST IMPLANT ILLNESS. MANY TESTS WERE PERFORMED REGARDING HER SYMPTOMS, BUT NO DIAGNOSES WERE MADE. MAMMOGRAM AND ULTRASOUND IMAGING WERE PERFORMED AND NO SIGNIFICANT FINDINGS WERE INDICATED. SHE WAS EVALUATED BY A PLASTIC SURGEON AND DIAGNOSED WITH BILATERAL BREAST PTOSIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2024. HOWEVER, DURING THE SURGERY, BILATERALLY RUPTURED BREAST IMPLANTS WERE DISCOVERED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE DISCOVERY. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

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

  MAUDE report 21172995 ↗
• InjuryJan 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 395CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS REPORTED TO HAVE EXPERIENCED AUTOIMMUNE-LIKE SYMPTOMS, FATIGUE, JOINT DISEASE, MUSCLE ACHES, BACK PAIN, BREAST PAIN, WEIGHT GAIN, AND POSSIBLE SYSTEMIC INFLAMMATION. THE PATIENT ALSO HAD CONCERNS OF BREAST IMPLANT ILLNESS. MANY TESTS WERE PERFORMED REGARDING HER SYMPTOMS, BUT NO DIAGNOSES WERE MADE. MAMMOGRAM AND ULTRASOUND IMAGING WERE PERFORMED AND NO SIGNIFICANT FINDINGS WERE INDICATED. SHE WAS EVALUATED BY A PLASTIC SURGEON AND DIAGNOSED WITH BILATERAL BREAST PTOSIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2024. HOWEVER, DURING THE SURGERY, BILATERALLY RUPTURED BREAST IMPLANTS WERE DISCOVERED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE DISCOVERY. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

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

  MAUDE report 21172989 ↗
• InjuryOct 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 395CC GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING HAIR LOSS, ULCERATIVE COLITIS FLARE-UPS, AND ADDITIONAL UNSPECIFIED BREAST IMPLANT ILLNESS PROBLEMS. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2024. DURING EXPLANT SURGERY, IT WAS OBSERVED THAT THE REMOVED RIGHT BREAST PROSTHESIS WAS RUPTURED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

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

  MAUDE report 20526203 ↗
• InjuryOct 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 PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 395CC GEL BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING HAIR LOSS, ULCERATIVE COLITIS FLARE-UPS, AND ADDITIONAL UNSPECIFIED BREAST IMPLANT ILLNESS PROBLEMS. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2024. DURING EXPLANT SURGERY, IT WAS OBSERVED THAT THE REMOVED RIGHT BREAST PROSTHESIS WAS RUPTURED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

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

  MAUDE report 20526149 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 395CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING FATIGUE, TIRED ALL THE TIME, DRY EYES, CHANGES IN HAIR AND NAILS. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. 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-SIDED DEVICE.

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

  MAUDE report 20505861 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 395CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING FATIGUE, TIRED ALL THE TIME, DRY EYES, CHANGES IN HAIR AND NAILS. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. 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-SIDED DEVICE.

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

  MAUDE report 20505793 ↗
• InjuryOct 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 395CC AND EXPERIENCED BREAST PAIN AND RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA CT/ULTRASOUND. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6) 2024.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 20472724 ↗
• InjuryAug 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYSHAPE BREAST IMPLANTS 395CC AND 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: Deformity/ Disfigurement

  MAUDE report 20077797 ↗
• InjuryJun 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 395CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. ADDITIONALLY, THE PATIENT DEVELOPED PAIN IN HER LEFT BREAST 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; Deformity/ Disfigurement; Granuloma

  MAUDE report 19514167 ↗
• InjuryJun 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 395CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. ADDITIONALLY, THE PATIENT DEVELOPED PAIN IN HER LEFT BREAST 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: Breast Discomfort/Pain; Capsular Contracture; Granuloma

  MAUDE report 19514164 ↗
• InjuryJan 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION SURGERY WITH A 395CC MENTOR MEMORYSHAPE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT UNDERWENT A REVISION SURGERY, WHERE IT WAS DISCOVERED THAT SHE EXPERIENCED A RUPTURE OF HER LEFT PROSTHESIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT SURGERY WITH UNSPECIFIED MENTOR SILICONE BREAST IMPLANTS ON (B)(6) 2023. THERE WERE NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED DUE TO THE RUPTURE DISCOVERED DURING THE REVISION SURGERY. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18609773 ↗
• InjuryDec 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 395CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS USING ULTRASOUND AND MAMMOGRAM IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2023. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-14474 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18288112 ↗
• InjuryDec 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 395CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS USING ULTRASOUND AND MAMMOGRAM IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2023. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-14475 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18288111 ↗
• InjuryNov 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 395CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION AND MRI, WITH BILATERAL BREAST IMPLANT RUPTURES. IN ADDITION, IT IS COMPLICATED BY GRANULOMA FORMATION IN THE LEFT AXILLA REGION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. THE REPLACEMENT DEVICES WERE: (LEFT) 425CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3504254BC LOT: 9884491 SN: (B)(6) AND (RIGHT) 425CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3504254BC LOT: 9634438 SN: 9634438-070. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18126272 ↗
• InjuryNov 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 395CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION AND MRI, WITH BILATERAL BREAST IMPLANT RUPTURES. IN ADDITION, IT IS COMPLICATED BY GRANULOMA FORMATION IN THE LEFT AXILLA REGION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. THE REPLACEMENT DEVICES WERE: (LEFT) 425CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3504254BC LOT: 9884491 SN: (B)(6) AND (RIGHT) 425CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3504254BC LOT: 9634438 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; Granuloma

  MAUDE report 18126247 ↗
• InjuryNov 12, 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 48-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 395CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE, AND BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture; Skin Inflammation/ Irritation

  MAUDE report 18117351 ↗
• InjuryNov 12, 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 48-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 395CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURE, AND BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture; Skin Inflammation/ Irritation

  MAUDE report 18117350 ↗
• InjurySep 20, 2023Adverse 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 MENTOR MEMORYSHAPE BREAST IMPLANT 395CC GEL BREAST PROSTHESES UNDERWENT A BILATERAL EXPLANTATION PROCEDURE ON AN UNKNOWN DATE. THE REASON FOR THE EXPLANTATION WAS NOT PROVIDED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Insufficient Information

  MAUDE report 17783559 ↗
• InjurySep 20, 2023Adverse 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 MENTOR MEMORYSHAPE BREAST IMPLANT 395CC GEL BREAST PROSTHESES UNDERWENT A BILATERAL EXPLANTATION PROCEDURE ON AN UNKNOWN DATE. THE REASON FOR THE EXPLANTATION WAS NOT PROVIDED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Insufficient Information

  MAUDE report 17783558 ↗