MENTOR MemoryShape Breast Implant 3341202Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00081317005209), received between May 30, 2019 and Mar 18, 2026 — classified as 59 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (17 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT GEL BREAST PROSTHESIS NOTICED THAT HER RIGHT BREAST APPEARED LARGER. FLUID COLLECTION IN THE RIGHT BREAST WAS DIAGNOSED VIA ULTRASOUND BIOPSY. THE PATIENT UNDERWENT FINE NEEDLE ASPIRATION OF THE FLUID. DURING THE INTERVENTION, RUPTURE OF THE RIGHT BREAST PROSTHESIS WAS OBSERVED. AS A RESULT, THE PATIENT LATER UNDERWENT EXPLANTATION.

  Patient problems: Deformity/ Disfigurement; Fluid Discharge

  MAUDE report 24630978 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 390CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED GENERALIZED ILLNESS SYMPTOMS POST-OPERATIVELY. 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

  MAUDE report 23074626 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 390CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED GENERALIZED ILLNESS SYMPTOMS POST-OPERATIVELY. 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

  MAUDE report 23074621 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 390CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED A GRANULOMA AND A RUPTURE ON THE LEFT SIDE AND PTOSIS ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22851546 ↗
• InjuryAug 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 390CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED A GRANULOMA AND A RUPTURE ON THE LEFT SIDE AND PTOSIS ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Granuloma

  MAUDE report 22851540 ↗
• InjuryMar 7, 2025Adverse 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 TWO 390CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT WAS BOTHERED BY THE APPEARANCE OF HER BREASTS AND HAD PREVIOUS SURGICAL INTERVENTIONS AND A CAPSULOTOMY/PARTIAL CAPSULECTOMY INFERIORLY WAS PERFORMED TO GET THESE IMPLANTS TO SETTLE. ADDITIONALLY, SOME GLANDULAR EXCESS HAD BEEN REMOVED ACROSS THE LOWER POLE TO IMPROVE THE OVERALL CONTOUR. 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: Capsular Contracture

  MAUDE report 21554320 ↗
• InjuryMar 7, 2025Adverse 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 TWO 390CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT WAS BOTHERED BY THE APPEARANCE OF HER BREASTS AND HAD PREVIOUS SURGICAL INTERVENTIONS AND A CAPSULOTOMY/PARTIAL CAPSULECTOMY INFERIORLY WAS PERFORMED TO GET THESE IMPLANTS TO SETTLE. ADDITIONALLY, SOME GLANDULAR EXCESS HAD BEEN REMOVED ACROSS THE LOWER POLE TO IMPROVE THE OVERALL CONTOUR. 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: Capsular Contracture

  MAUDE report 21554319 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 390CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED HARD MASS/SWELLING ON THE LEFT BREAST. PER MAMMOGRAM, THE PATIENT WAS DIAGNOSED WITH SKIN THICKENING AND SILICONE IN THE LEFT AXILLARY. IN ADDITION, THE PATIENT WAS ALSO DIAGNOSED WITH LEFT BREAST IMPLANT RUPTURE, BILATERAL BREAST PAIN, DEFORMITY AND BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV ON THE LEFT AND UNKNOWN BAKER GRADE ON THE RIGHT). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21270786 ↗
• InjuryJan 28, 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 RECONSTRUCTION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 390CC GEL BREAST PROSTHESES DEVELOPED BREAST WRINKLING AND ASYMMETRY IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON AN UNKNOWN DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2024-06740 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; Post Operative Wound Infection; Wrinkling

  MAUDE report 21256615 ↗
• InjuryDec 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 390CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Local Reaction

  MAUDE report 20840589 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH 390CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL ANISOMASTIA POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS PATIENT WAS PART OF A POST APPROVAL STUDY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20441098 ↗
• InjuryJun 5, 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 WHO UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH MENTOR MEMORYSHAPE BREAST IMPLANT 390CC GEL BREAST PROSTHESES DEVELOPED BREAST WRINKLING AND ASYMMETRY POST IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. LOT NUMBERS AND SERIAL NUMBERS FOR TWO DEVICES WERE REPORTED: LEFT DEVICE: LOT #7475364-042, SERIAL # (B)(6) RIGHT DEVICE: LOT #7538580-051, SERIAL # (B)(6) IT WAS NOT SPECIFIED WHICH BREAST DEVELOPED WRINKLING AND ASYMMETRY (LEFT BREAST, RIGHT BREAST, OR BILATERAL). IF CLARIFICATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; Post Operative Wound Infection; Seroma; Wrinkling

  MAUDE report 19469026 ↗
• InjuryMar 25, 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 AUGMENTATION PROCEDURE WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 390CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL¿S EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 18970335 ↗
• InjuryFeb 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 390CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT BY A MEDICAL PROFESSIONAL USING THE PATIENT'S SYMPTOMS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 325CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS ON (B)(6) 2024. 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.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18660240 ↗
• InjuryDec 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 39-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 390CC MENTOR MEMORYSHAPE BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE IV ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. PER INFORMATION RECEIVED ON DECEMBER 7, AND 8, 2023, MENTOR BECAME AWARE THE PATIENT ALSO DEVELOPED A WATERFALL EFFECT IN ADDITION TO RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE IV. HENCE, UNDERWENT BILATERAL MASTOPEXY REVISION WITH CATALOG NUMBER SMHB400; SERIAL NUMBER (B)(6), AND WITH CATALOG NUMBER SMHB400; SERIAL NUMBER (B)(6) ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18389954 ↗
• InjuryNov 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 39-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 390CC MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE IV ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 18117354 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A 390CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE POST PROCEDURE. THIS IS ACCOMPANIED BY PAIN AND BURNING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 18094403 ↗
• InjuryOct 5, 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 390CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST PROCEDURE. THE LEFT SIDED CAPSULAR CONTRACTURE IS BAKER GRADE III. THE RIGHT SIDED CAPSULAR CONTRACTURE IS BAKER GRADE IV. THE IS ACCOMPANIED BY HARDNESS, NIPPLES SENSITIVITY, TENDERNESS TO THE TOUCH, AND THE IMPLANTS NOT SETTLING. AS A RESULT, REPLACEMENT IS PLANNED FOR (B)(6) 2023. SEE 1645337-2023-11863 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 17882565 ↗
• InjuryOct 5, 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 390CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST PROCEDURE. THE LEFT SIDED CAPSULAR CONTRACTURE IS BAKER GRADE III. THE RIGHT SIDED CAPSULAR CONTRACTURE IS BAKER GRADE IV. THE IS ACCOMPANIED BY HARDNESS, NIPPLES SENSITIVITY, TENDERNESS TO THE TOUCH, AND THE IMPLANTS NOT SETTLING. AS A RESULT, REPLACEMENT IS PLANNED FOR (B)(6) 2023. SEE 1645337-2023-11862 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 17882561 ↗
• InjuryOct 5, 2023Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV ALONG WITH RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT A CAPSULECTOMY ON THE RIGHT SIDE ON (B)(6) 2017. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE FOR THE RIGHT SIDE. THE LEFT BREAST PROSTHESIS WAS REMOVED ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2021-06948 FOR CONTRALATERAL SIDE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions; Post Operative Wound Infection

  MAUDE report 17879203 ↗
• InjuryMay 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 390CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING A PHYSICAL EXAM. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A RUPTURE ON THE LEFT SIDE. 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: Capsular Contracture

  MAUDE report 16947390 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 390CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING A PHYSICAL EXAM. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A RUPTURE ON THE LEFT SIDE. 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: Capsular Contracture

  MAUDE report 16947385 ↗
• InjuryJan 23, 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 37-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH 390CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE AND RIGHT SIDED RUPTURE POST PROCEDURE. THE LEFT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE III. THE RIGHT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE IV. THE RIGHT SIDED RUPTURE WAS DISCOVERED DURING EXPLANT. BILATERAL PROSTHESIS REPLACEMENT WITH 430CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS WAS PERFORMED ON (B)(6)2023. SEE 1645337-2023-00718 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 16230197 ↗
• InjuryJan 23, 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 37-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH 390CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE AND RIGHT SIDED RUPTURE POST PROCEDURE. THE LEFT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE III. THE RIGHT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE IV. THE RIGHT SIDED RUPTURE WAS DISCOVERED DURING EXPLANT. BILATERAL PROSTHESIS REPLACEMENT WITH 430CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2023-00717 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 16230157 ↗
• InjuryDec 27, 2022Adverse 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: 326-083). IT WAS REPORTED THAT A ASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH TWO 390CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED BILATERAL CUTANEOUS CONTOUR DEFORMITY POST-OPERATIVELY. THE PATIENT PRESENTED WITH BREAST WRINKLING, WHICH REQUIRED FAT DRAFTING ON (B)(6) 2017. 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: Wrinkling

  MAUDE report 16057184 ↗