MENTOR MemoryGel Breast Implant 3545501Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00081317000938), received between Dec 18, 2018 and Jan 30, 2026 — classified as 32 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 550CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24226949 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 550 CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A LEFT BREAST HEMATOMA WHICH CAUSED A FIRM AND BLACK/BLUE COLORED BREAST. NO INTERVENTION WAS REPORTED BUT THE EVENT WAS MONITORED. AT A LATER TIME, THE PATIENT EXPERIENCED RIGHT BREAST PAIN AND RESULTANTLY, MAGNETIC RESONANCE IMAGING WAS PERFORMED. IMAGING RESULTS INDICATED A RUPTURED LEFT IMPLANT, INTACT RIGHT IMPLANT, AND MINIMAL BILATERAL PERI-IMPLANT FLUID. DURING A PHYSICAL EXAM THE PATIENT WAS OBSERVED TO HAVE A FIRM AND HIGH LEFT BREAST AND A LITTLE RIGHT BREAST PTOSIS. SHE WAS ALSO DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE IN ADDITION TO THE RUPTURE. 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: Breast Discomfort/Pain; Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036110 ↗
• InjuryDec 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 550CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT IMPLANT DURING A PHYSICAL EXAM AND CONFIRMED USING MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Hematoma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785188 ↗
• InjuryDec 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH RIGHT BREAST IMPLANT RUPTURE AND BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADES IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23753752 ↗
• InjuryJul 22, 2025Adverse 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 MEMORYGEL BREAST IMPLANT 550CC GEL BREAST PROSTHESES WHEN THE RIGHT BREAST PROSTHESIS RUPTURED POST IMPLANTATION. AN ULTRASOUND PERFORMED DIAGNOSED RIGHT BREAST PROSTHESIS RUPTURE ALONG WITH SILICONE-LADEN LYMPH NODES IN THE RIGHT AXILLA. ADDITIONALLY, THE PATIENT SUFFERED FROM LATERAL DISPLACEMENT OF THE RIGHT BREAST PROSTHESIS AND FLATTENING OF BILATERAL INFERIOR POLES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 525CC GEL BREAST PROSTHESES ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2025-05783 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 22572791 ↗
• InjuryMay 27, 2025Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 550CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS OBSERVED DURING AN IMPLANT EXCHANGE SURGERY. THE PATIENT¿S EXPLANTED BREAST PROSTHESES WERE REPLACED WITH MENTOR MEMORYGEL BREAST IMPLANT 525CC GEL BREAST PROSTHESES.

  Patient problems: Deformity/ Disfigurement; Granuloma

  MAUDE report 22090897 ↗
• InjuryNov 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 550CC AND EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20686452 ↗
• InjuryFeb 13, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL, 550CC SILICONE, BREAST IMPLANT EXPERIENCED LEFT SIDED "DEFECTIVE DEVICE" POSTOPERATIVE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION.

  Patient problems: Insufficient Information

  MAUDE report 18697506 ↗
• InjuryFeb 6, 2024Adverse 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 550CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED A RECTION ON THE LEFT SIDE AND PTOSIS ON THE RIGHT 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: Deformity/ Disfigurement

  MAUDE report 18652800 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED A RECTION ON THE LEFT SIDE AND PTOSIS ON THE RIGHT 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: Local Reaction

  MAUDE report 18652799 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 75-YEAR-OLD CAUCASIAN FEMALE PATIENT WITH HISTORY OF BILATERAL MASTECTOMY WHO UNDERWENT BREAST IMPLANT RECONSTRUCTION WITH A 550CC MENTOR MEMORYGEL BREAST IMPLANT HAS DEVELOPED LATE ONSET SEROMA IN THE RIGHT BREAST. AS A RESULT, THE SEROMA FLUID WAS ASPIRATED UNDER ULTRASOUND CONTROL AND SENT FOR PATHOLOGY (FLOW CYTOMETRY) ON (B)(6) 2023. THE PATHOLOGY REPORT SPECIMENS NEGATIVE FOR MALIGNANT CELLS.

  Patient problems: Seroma

  MAUDE report 16436387 ↗
• InjuryOct 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 71-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BREAST IMPLANT RUPTURE ON THE RIGHT SIDE COMPLICATED BY INFLAMMATION, FLUID COLLECTION AROUND THE RIGHT IMPLANT, AND GRANULOMA FORMATION IN THE RIGHT AXILLA REGION AND CONFIRMED BY MAMMOGRAM AND ULTRASOUND. THE FLUID WAS ASPIRATED AND SENT FOR CYTOLOGY, THE FINDINGS WERE CORELATED TO INFLAMMATION REACTION AND NEGATIVE FOR CD 30. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED A RED RASH ON THE UPPER POLE OF THE RIGHT BREAST AND CAPSULAR CONTRACTURE IN BOTH BREASTS (BAKER GRADE III IN THE LEFT BREAST, AND IV IN THE RIGHT BREAST). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT ON (B)(6) 2022. THE REPLACEMENT DEVICES WERE: (RIGHT) 590CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMPB590 LOT: 9698840 SN: (B)(4) AND (LEFT) 590CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMPB590 LOT: 9772743 SN: (B)(4). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Granuloma; Local Reaction

  MAUDE report 15654032 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 71-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BREAST IMPLANT RUPTURE ON THE RIGHT SIDE COMPLICATED BY INFLAMMATION, FLUID COLLECTION AROUND THE RIGHT IMPLANT, AND GRANULOMA FORMATION IN THE RIGHT AXILLA REGION AND CONFIRMED BY MAMMOGRAM AND ULTRASOUND. THE FLUID WAS ASPIRATED AND SENT FOR CYTOLOGY, THE FINDINGS WERE CORELATED TO INFLAMMATION REACTION AND NEGATIVE FOR CD 30. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED A RED RASH ON THE UPPER POLE OF THE RIGHT BREAST AND CAPSULAR CONTRACTURE IN BOTH BREASTS (BAKER GRADE III IN THE LEFT BREAST, AND IV IN THE RIGHT BREAST). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT ON (B)(6) 2022. THE REPLACEMENT DEVICES WERE: (RIGHT) 590CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMPB590 LOT: 9698840 SN: (B)(4) AND (LEFT) 590CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMPB590 LOT: 9772743 SN: (B)(4). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15653412 ↗
• InjuryAug 11, 2022Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 550CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED HER RIGHT BREAST WAS IN SEVERE PAIN AND COMPLETELY ENCAPSULATED. HER LEFT BREAST DOESN'T FEEL NORMAL, AND SHE SUSPECTS THE LEFT BREAST IMPLANT IS RUPTURED. SHE HAS CONSULTED WITH A MEDICAL PROFESSIONAL; HOWEVER, NO DIAGNOSES HAVE BEEN PROVIDED. 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 IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-09385 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15214411 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 550CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED HER RIGHT BREAST WAS IN SEVERE PAIN AND COMPLETELY ENCAPSULATED. HER LEFT BREAST DOESN'T FEEL NORMAL, AND SHE SUSPECTS THE LEFT BREAST IMPLANT IS RUPTURED. SHE HAS CONSULTED WITH A MEDICAL PROFESSIONAL; HOWEVER, NO DIAGNOSES HAVE BEEN PROVIDED. 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 IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-09386 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 15214371 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 500CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION. BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED MENTOR GEL BREAST PROSTHESES ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 14567790 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 500CC GEL BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION. BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED MENTOR GEL BREAST PROSTHESES ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 14567786 ↗
• InjuryJan 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 550CC GEL BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA A PHYSICAL. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13321793 ↗
• InjuryDec 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 550CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED SPONTANEOUS RIGHT SIDED RUPTURE, IRRITATION, AND GRANULOMA POST PROCEDURE. THE RUPTURE WAS DIAGNOSED THROUGH MAMMOGRAPHY AND ULTRASOUND. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Granuloma

  MAUDE report 12943768 ↗
• InjuryMar 3, 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 UNDERWENT BREAST AUGMENTATION REVISION WITH 550CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE ON THE LEFT SIDE POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 11406377 ↗
• InjuryJan 7, 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 FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 550CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED FIBROMYALGIA POST PROCEDURE. THE DOCTOR DIAGNOSED THE PATIENT HAVING FIBROMYALGIA SYMPTOMS WITH POSSIBLE LINK TO TEXTURED BREAST IMPLANTS. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2020. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Autoimmune Disorder

  MAUDE report 11133966 ↗
• InjuryJan 7, 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 FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 550CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED FIBROMYALGIA POST PROCEDURE. THE DOCTOR DIAGNOSED THE PATIENT HAVING FIBROMYALGIA SYMPTOMS WITH POSSIBLE LINK TO TEXTURED BREAST IMPLANTS. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2020. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Autoimmune Disorder

  MAUDE report 11133824 ↗
• InjuryDec 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD AFRICAN AMERICAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 500CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE, BREAST PAIN, A CUTANEOUS CONTOUR DEFORMITY, AND SWOLLEN LYMPH NODES ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: Pain; Swollen Lymph Nodes/Glands; Wrinkling

  MAUDE report 11015432 ↗
• InjuryAug 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV AND BILATERAL RUPTURE POST PROCEDURE. GRANULOMA WAS ALSO CONFIRMED BY ULTRASOUND IN (B)(6) 2020. THE PATIENT ALSO REPORTED ABNORMAL SENSATIONS ON THE LEFT ARM. 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: Capsular Contracture; Granuloma

  MAUDE report 10405019 ↗
• InjuryAug 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH TWO 550CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV AND BILATERAL RUPTURE POST PROCEDURE. GRANULOMA WAS ALSO CONFIRMED BY ULTRASOUND IN (B)(6) 2020. THE PATIENT ALSO REPORTED ABNORMAL SENSATIONS ON THE LEFT ARM. 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: Capsular Contracture; Granuloma; Neurological Deficit/Dysfunction

  MAUDE report 10405012 ↗