MENTOR MemoryGel Breast Implant 3544650Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00081317001140), received between May 3, 2019 and May 22, 2026 — classified as 41 injuries.

The most frequently reported specific device problem is “Material Rupture” (24 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 41 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING WEIGHT LOSS, HAIR LOSS, THYROID ISSUES, SICKNESS, AND GRANULOMA ON THE RIGHT SIDE. PER THE INFORMATION PROVIDED, "THE GEL IS ON THE RIGHT AND HAS CREATED 2 NODULES GOING UP TO THE RIGHT SIDE OF HER HEAD". 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 REPORT IS FOR THE LEFT BREAST PROSTHESIS.

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

  MAUDE report 25256872 ↗
• InjuryMay 7, 2025Adverse 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 A 325CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE, RIGHT SIDED CAPSULAR CONTRACTURE, AND BILATERAL PTOSIS POST PROCEDURE. THE RIGHT CAPSULE WAS THICKENED. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2025. REPLACEMENT WITH MENTOR GEL WAS PERFORMED WITH EXPLANT. THE RIGHT SIDED ISSUE WAS REPORTED INITIALLY UNDER 1645337-2025-00655. ON (B)(6) 2025 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21979722 ↗
• InjuryJun 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST IMPLANT SURGERY WITH MENTOR MEDICAL DEVICES (SILTEX HPG, 650CC, DATE OF IMPLANT (B)(6) 2013) HAS EXPERIENCED BREAST IMPLANT RUPTURE ON THE RIGHT SIDE CONFIRMED BY MRI. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED SEROMA IN THE RIGHT BREAST. AT THIS TIME, THE RESULTS OF CYTOLOGY REPORT HAVE NOT BEEN PROVIDED. AS A RESULT, THE PATIENT UNDERWENT THE RIGHT IMPLANT EXPLANTATION ON (B)(6) 2024. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED.

  Patient problems: Seroma

  MAUDE report 19543293 ↗
• InjuryMay 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 650CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH LEFT BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19361337 ↗
• InjuryMar 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 650CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE BREAST PROSTHESIS WAS DISCOVERED DURING A BILATERAL IMPLANT REMOVAL SURGERY ON (B)(6) 2024. THE REMOVED BREAST PROSTHESES WERE NOT REPLACED. INFORMATION ABOUT TWO BREAST PROSTHESES WAS REPORTED: LEFT: LOT #6958410, SERIAL #(B)(6); RIGHT: LOT #7338073, SERIAL #(B)(6). IT WAS NOT SPECIFIED WHICH SIDE RUPTURED (LEFT, RIGHT, OR BILATERAL). IF CLARIFICATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18897179 ↗
• InjuryDec 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 650CC SILICONE IMPLANT, EXPERIENCED RIGHT-SIDED SYMPTOMATIC RUPTURE POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH PATIENT SYMPTOMS. AS A RESULT, PATIENT UNDERWENT REPLACEMENT WITH NON-MENTOR PROSTHESIS ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18401443 ↗
• InjuryOct 16, 2023Adverse 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 PROCEDURE WITH A MENTOR MEMORY GEL BREAST IMPLANT 800CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORY GEL BREAST IMPLANT 650CC GEL BREAST PROSTHESIS (RIGHT DEVICE) WHEN THE RIGHT BREAST PROSTHESIS RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA MRI. ADDITIONALLY, THE MRI RESULTS INDICATED AN ENLARGED LEFT INTERNAL MAMMARY CHAIN LYMPH NODE. LASTLY, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER LEFT BREAST POST IMPLANTATION AS WELL AS PTOSIS IN THE RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESIS AND A MENTOR MEMORYGEL BREAST IMPLANT 650CC ON (B)(6) 2023. DURING EXPLANTATION SURGERY, IT WAS OBSERVED THAT BOTH REMOVED DEVICES WERE INTACT. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2023-10165 FOR THE REPORT FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17940436 ↗
• InjuryMar 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 650CC AND EXPERIENCED BREAST PAIN AND 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: Breast Discomfort/Pain

  MAUDE report 13689463 ↗
• InjuryNov 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH TWO 650CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES AND EXPERIENCED BILATERAL RUPTURE POSTOPERATIVELY. THE DIAGNOSIS OF THE RIGHT-SIDED RUPTURE WAS CONFIRMED BASED ON MAMMOGRAM. A HEALTHCARE PROFESSIONAL REPORTED THAT THE LEFT-SIDED DEVICE IS GOING TO BE REMOVED DUE TO SUSPECTED RUPTURE (DUE TO THE AGE OF THE IMPLANT). AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO REMOVAL AND REPLACEMENT WITH UNSPECIFIED GEL BREAST IMPLANT ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT-SIDED PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12755654 ↗
• InjuryNov 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH TWO 650CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES AND EXPERIENCED BILATERAL RUPTURE POSTOPERATIVELY. THE DIAGNOSIS OF THE RIGHT-SIDED RUPTURE WAS CONFIRMED BASED ON MAMMOGRAM. A HEALTHCARE PROFESSIONAL REPORTED THAT THE LEFT-SIDED DEVICE IS GOING TO BE REMOVED DUE TO SUSPECTED RUPTURE (DUE TO THE AGE OF THE IMPLANT). AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO REMOVAL AND REPLACEMENT WITH UNSPECIFIED GEL BREAST IMPLANT ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12755649 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 650CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT SIDE AND BREAST PAIN ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2021. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Pain

  MAUDE report 11385981 ↗
• InjuryFeb 26, 2021Adverse 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 BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 650CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE LEFT SIDE AND BREAST PAIN ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2021. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 11385911 ↗
• InjuryNov 17, 2020Adverse 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 AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 650CC AND SUFFERED FROM A CAPSULAR CONTRACTURE BAKER GRADE III AND PAIN ON THE RIGHT SIDE. AS A RESULT, THE PATIENT WILL UNDERGO REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2021.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10854303 ↗
• InjuryNov 12, 2020Material Rupture; Material Rupture

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 650CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2017. ON (B)(6) 2020, MENTOR BECAME AWARE THAT PATIENT REPLACEMENT SURGERY ON (B)(6) 2020. UPON FURTHER CLARIFICATION REQUEST, ON (B)(6) 2020, MENTOR BECAME AWARE THAT THE EXPLANT WAS ON (B)(6) 2017.

  Patient problems: No Code Available

  MAUDE report 10829245 ↗
• InjuryOct 8, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 650CC GEL BREAST PROSTHESIS THAT RUPTURED AFTER IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED BY ULTRASOUND. IN ADDITION, THE PATIENT SUFFERED FROM SWELLING AND PAIN IN HER LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 650CC GEL BREAST PROSTHESES ON (B)(6) 2020.

  Patient problems: Local Reaction; No Code Available

  MAUDE report 10653451 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS REPORTED TO THE FDA UNDER MW5095229. IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST SURGERY WITH TWO 650CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED AUTOIMMUNE ISSUES, JOINT PAIN, RASHES, HEADACHES AND SWELLING POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2020. THIS MEDWATCH FORM IS FOR PRODUCT B.

  Patient problems: No Code Available

  MAUDE report 10519098 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS REPORTED TO THE FDA UNDER MW5095229 IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST SURGERY WITH TWO 650CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED AUTOIMMUNE ISSUES, JOINT PAIN, RASHES, HEADACHES AND SWELLING POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2020. THIS MEDWATCH FORM IS FOR PRODUCT A.

  Patient problems: No Code Available

  MAUDE report 10519096 ↗
• InjuryAug 12, 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 WHO UNDERWENT A BREAST SURGERY WITH A 600CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT) AND A 650CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) EXPERIENCED BILATERAL INFECTION AND SEROMA POSTOPERATIVELY. THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2017. THE DEVICES WERE DISCARDED AND ARE NOT AVAILABLE FOR DEVICE EVALUATION. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

  Patient problems: No Code Available; Seroma; Unspecified Infection

  MAUDE report 10396724 ↗
• InjuryJul 15, 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 REVISION BREAST AUGMENTATION WITH A 650CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE II ON THE RIGHT AND BAKER GRADE UNKNOWN ON THE LEFT SIDE, AND LEFT SIDE SEROMA. IT WAS REPORTED THAT PATIENT¿S SEROMA WAS RADIOGRAPHICALLY DRAINED TWICE AND ONCE IN THE OFFICE. ALSO AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture; No Code Available; Unspecified Infection

  MAUDE report 10280193 ↗
• InjuryJul 15, 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 REVISION BREAST AUGMENTATION WITH A 650CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE II ON THE RIGHT AND BAKER GRADE UNKNOWN ON THE LEFT SIDE, AND LEFT SIDE SEROMA. IT WAS REPORTED THAT PATIENT¿S SEROMA WAS RADIOGRAPHICALLY DRAINED TWICE AND ONCE IN THE OFFICE. ALSO AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture; No Code Available; Seroma; Unspecified Infection

  MAUDE report 10280117 ↗
• InjuryJun 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH MENTOR MEMORYGEL BREAST IMPLANT 650CC AND EXPERIENCED BILATERAL PAIN, RUPTURES, SEROMAS, AND CAPSULAR CONTRACTURE, BAKER GRADE 2 POST-OPERATIVELY, WHICH WERE CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION OF THE DEVICES ON (B)(6) 2020. THE SEROMA FLUID WAS ASPIRATED DURING THE EXPLANT SURGERY. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture; No Code Available; Seroma; Unspecified Infection

  MAUDE report 10111071 ↗
• InjuryJun 2, 2020Material 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) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH MENTOR MEMORYGEL BREAST IMPLANT 650CC AND EXPERIENCED BILATERAL PAIN, RUPTURES, SEROMAS, AND CAPSULAR CONTRACTURE, BAKER GRADE 2 POST-OPERATIVELY, WHICH WERE CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION OF THE DEVICES ON (B)(6) 2020. THE SEROMA FLUID WAS ASPIRATED DURING THE EXPLANT SURGERY. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture; No Code Available; Seroma

  MAUDE report 10110937 ↗
• InjuryMay 13, 2020Material Rupture; Material Rupture

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 650CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST, SUFFERED BREAST IMPLANT RUPTURE, BREAST CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN), BREAST PAIN, IRRITATION, AND GRANULOMA, POST-OPERATIVELY. MAMMOGRAM AND ULTRASOUND DIAGNOSED THE RUPTURE AND GRANULOMA. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH THE FOLLOWING DEVICES ON (B)(6) 2018: (RIGHT) 700CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3547001 LOT: 7282494 SN: (B)(4) AND (LEFT) 750CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3547501 LOT: 6868100 SN: (B)(4).

  Patient problems: Capsular Contracture; Granuloma; No Code Available; Skin Irritation

  MAUDE report 10054434 ↗
• InjuryMar 23, 2020Adverse 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 MENTOR MEMORYGEL BREAST IMPLANT 650CC AND HAD UNDERGONE REMOVAL OF THE IMPLANT FOR AN UNKNOWN REASON. ONCE MORE INFORMATION IS AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICES WERE REMOVED ON (B)(6) 2019. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 9868152 ↗
• InjuryMar 23, 2020Adverse 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 MENTOR MEMORYGEL BREAST IMPLANT 650CC AND HAD UNDERGONE REMOVAL OF THE IMPLANT FOR AN UNKNOWN REASON. ONCE MORE INFORMATION IS AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICES WERE REMOVED ON (B)(6) 2019. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 9868141 ↗