MENTOR SILTEX CONTOUR PROFILE High 3542711Recalls & reported problems
Mentor Texas L.P. · Saline Breast Implant with Diaphragm Valve, 275cc · Class 3 · Implant
All models of MENTOR SILTEX CONTOUR PROFILE High (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Mentor Siltex Contour Profile High saline breast implant is used for breast augmentation or revision. The 57 reports mostly describe implants losing their saline fill and flattening after surgery, sometimes alongside hardening of the surrounding tissue or changes in breast shape, with several patients needing the implants removed and replaced. There were no deaths, and all 57 reports describe injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 57
- Deaths reported
- 0
- Injuries reported
- 57
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00081317001904), received between Mar 20, 2018 and Dec 12, 2025 — classified as 57 injuries.
The most frequently reported specific device problem is “Material Rupture” (48 reports).
2 other recalls cover devices cleared under the same FDA submission (P990075); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Material Rupture48
- Adverse Event Without Identified Device or Use Problem9
- No Apparent Adverse Event1
Patient problems
- No Code Available24
- Deformity/ Disfigurement23
- Capsular Contracture11
- Crushing Injury2
- No Clinical Signs, Symptoms or Conditions2
- Thrombosis2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 275CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) , 2025, AND REPLACED WITH A 350CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 23796622 ↗InjuryFeb 6, 2025Material Rupture; Material Rupture
A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH, 275CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST IMPLANTATION. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21323999 ↗InjuryOct 15, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SILTEX CONTOUR PROFILE HIGH BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR GEL BREAST IMPLANTS ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20455684 ↗InjuryJun 27, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR SILTEX ROUND MODERATE PROFILE 325CC SALINE BREAST PROSTHESES THAT BOTH DEFLATED POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED BAKER GRADE II CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL BREAST PROSTHESES ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 19625784 ↗InjuryJun 27, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR SILTEX ROUND MODERATE PROFILE 325CC SALINE BREAST PROSTHESES THAT BOTH DEFLATED POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED BAKER GRADE II CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL BREAST PROSTHESES ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 19625752 ↗InjuryDec 20, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH, 275CC, SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18369490 ↗InjuryDec 20, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION 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 18368412 ↗InjuryOct 26, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR SILTEX CONTOUR PROFILE HIGH 275CC BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MAMMOGRAM/ULTRASOUND. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement
MAUDE report 18015642 ↗InjurySep 11, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH A SALINE MENTOR SILTEX CONTOUR PROFILE HIGH 275CC BREAST IMPLANT AND EXPERIENCED DEFLATION (SIDE UNKNOWN) POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2007.
Patient problems: Deformity/ Disfigurement
MAUDE report 17720253 ↗InjurySep 7, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH, 275CC SALINE PROSTHESIS EXPERIENCED BILATERAL DEFLATION POST PROCEDURE. THE ISSUE WAS DISCOVERED VISUALLY. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT ON (B)(6), 2023. THIS REPORT RELATES TO THE RIGHT SIDE.
Patient problems: Deformity/ Disfigurement
MAUDE report 17700210 ↗InjurySep 7, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH, 275CC SALINE PROSTHESIS EXPERIENCED BILATERAL DEFLATION POST PROCEDURE. THE ISSUE WAS DISCOVERED VISUALLY. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT ON MARCH 31, 2023. THIS REPORT RELATES TO THE LEFT SIDE.
Patient problems: Deformity/ Disfigurement
MAUDE report 17700118 ↗InjuryAug 1, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 59-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR SILTEX CONTOUR PROFILE HIGH 275CC BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MAMMOGRAM/ULTRASOUND. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 17433342 ↗InjuryJul 17, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A 53-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH A 275CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST IMPLANT EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A LIKE DEVICE ON (B)(6) 2005.
Patient problems: Deformity/ Disfigurement
MAUDE report 15036671 ↗InjuryJul 14, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A 70-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 2755C MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.
Patient problems: Deformity/ Disfigurement
MAUDE report 15017853 ↗InjuryJun 3, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) 275CC MENTOR SILTEX CONTOUR PROFILE HIGH AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED AFTER 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 14593793 ↗InjuryApr 14, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 275CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA A PHYSICAL EXAM. ADDITIONALLY, IT WAS REPORTED THAT THE DEFLATION MAY HAVE BEEN CAUSED BY A MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2022.
Patient problems: Crushing Injury
MAUDE report 14116223 ↗InjuryJan 7, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) ASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A SALINE 275CC SALINE MENTOR SILTEX CONTOUR PROFILE HIGH IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATION OF THE LEFT BREAST PROSTHESIS OVER A PHONE CALL WITH THEIR HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 13191895 ↗InjuryDec 28, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 275CC MENTOR SILTEX CONTOUR PROFILE HIGH PROSTHESIS AND EXPERIENCED LEFT-SIDED DEFLATION POSTOPERATIVELY. THE DIAGNOSIS WAS CONFIRMED BASED ON PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 13102337 ↗InjuryDec 20, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH A 275CC MENTOR SILTEX CONTOUR PROFILE HIGH PROSTHESIS AND EXPERIENCED RIGHT-SIDED DEFLATION POSTOPERATIVELY. THE DIAGNOSIS WAS CONFIRMED BASED ON THE PATIENT¿S SYMPTOMS AND UNSPECIFIED IMAGING. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH TWO MENTOR BREAST IMPLANTS (CATALOG #: 334-1206, LEFT SERIAL #: (B)(4), RIGHT SERIAL #: (B)(4)) ON (B)(6) 2021. AFTER THE REVISION SURGERY, THE PATIENT WAS FULLY RECOVERED.
Patient problems: Deformity/ Disfigurement
MAUDE report 13047501 ↗InjuryNov 2, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SILTEX CONTOUR PROFILE HIGH 275CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON 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
MAUDE report 12738298 ↗InjuryOct 14, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH A 275CC MENTOR SILTEX CONTOUR PROFILE HIGH EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAS A PLANNED EXPLANTATION ON (B)(6) 2021.
Patient problems: Deformity/ Disfigurement
MAUDE report 12637369 ↗InjuryOct 12, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH, 275CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. THE PATIENT STATED THAT RUPTURE ON THE LEFT IMPLANT, AND PATIENT NOTICED DIFFERENCE AFTER SHE HAD A MAMMOGRAM EXAMINATION ABOUT 2-3 DAYS LATER, IT WAS GETTING SOFTER. PATIENT VISITED DOCTOR AND SHE WAS INFORMED THAT THE LEFT IMPLANT HAS BEEN DEFLATED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Crushing Injury
MAUDE report 12616197 ↗InjurySep 17, 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 PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR SILTEX CONTOUR PROFILE HIGH IMPLANTS, EXPERIENCED NO COMPLICATIONS BUT WANTED TO HAVE THE IMPLANTS REMOVED, POST-PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2021. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12493019 ↗InjurySep 17, 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 PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR SILTEX CONTOUR PROFILE HIGH IMPLANTS, EXPERIENCED NO COMPLICATIONS BUT WANTED TO HAVE THE IMPLANTS REMOVED, POST-PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2021. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12493018 ↗InjurySep 2, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH SALINE MENTOR SILTEX CONTOUR PROFILE HIGH 275CC BREAST IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV ON THE RIGHT SIDE AND SUSPECTED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL AND REPLACEMENT WITH MENTOR SALINE BREAST IMPLANTS (CATALOG NUMBER 3503330) ON (B)(6) 2021. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 12416616 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P990075. One submission often covers many models, so check the product and lot details in each record.
- Z-0367-2022 · Sep 30, 2021 · Open, ClassifiedMENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shel
- Z-2070-2017 · Mar 27, 2017 · TerminatedMentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
Other Prosthesis, breast, inflatable, internal, saline devices
- MENTOR Smooth Round Moderate Profile 3501650Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline2,187 reports
- MENTOR Smooth Round Moderate Profile 3501660Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,972 reports
- MENTOR Smooth Round Moderate Profile 3501670Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,899 reports
- MENTOR Smooth Round Moderate Profile 3501645Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,655 reports
- MENTOR Smooth Round Moderate Profile 3501655Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,534 reports
- MENTOR Smooth Round Moderate Profile 3501640Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,294 reports
- MENTOR Smooth Round Moderate Profile 3501680Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,095 reports
- MENTOR Smooth Round Moderate Profile 3501635Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline864 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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