MENTOR Smooth Round Moderate Plus Profile 3502350Recalls & reported problems

Summary

The FDA's MAUDE database contains 672 adverse event reports that list this exact device (DI 00081317001416), received between Jan 26, 2018 and Sep 28, 2026 — classified as 666 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (452 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 672 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Material Rupture

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50926609 ↗
• InjurySep 25, 2026Material Rupture

  It was reported that a patient with Saline MENTOR Smooth Round Moderate Plus Profile breast implants experienced deflation 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: Deformity/ Disfigurement

  MAUDE report 50898038 ↗
• InjurySep 17, 2026Material Rupture

  It was reported that a female patient underwent Breast Augmentation Revision with MENTOR Smooth Round Moderate Plus Profile, 350cc saline implants, The patient subsequently presented with right sided deflation post operation. The issue was diagnosed through physical examination. As a result, the patient scheduled for removal surgery on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805768 ↗
• InjuryAug 25, 2026Migration

  It was reported that a 42-year-old female patient underwent a primary breast augmentation with a 350cc MENTOR Smooth Round Moderate Plus Profile saline breast prosthesis and experienced breast pain and device migration on the left side post-operatively. The patient mentioned that the breast prosthesis would flip over and flatten. The patient also mentioned not being sure if they had capsular contracture. 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 50436630 ↗
• InjuryAug 6, 2026Material Rupture

  It was reported that a patient with Saline MENTOR Smooth Round Moderate Plus Profile breast implants experienced deflation on the left side post-operatively, which was confirmed during a physical exam. As a result, the patient is scheduled for removal on (b)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50164269 ↗
• InjuryAug 4, 2026Material Rupture

  It was reported that a patient underwent breast augmentation revision with two 350cc MENTOR Smooth Round Moderate Plus Profile saline breast prostheses. Post-operatively, the patient suffered right breast implant deflation. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50136481 ↗
• InjuryAug 3, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50117366 ↗
• InjuryAug 3, 2026Material Rupture

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50116653 ↗
• InjuryJun 9, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25447764 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 350CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED OVER THE PHONE. THE PATIENT WAS HAVING PAIN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 25382955 ↗
• InjuryMay 22, 2026Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 28-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) AND GENERALIZED ILLNESS SYMPTOMS INCLUDING BREAST IMPLANT ILLNESS, PAIN, FEELING FAINT, BEDRIDDEN, AND NEUROLOGICAL ISSUES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. IT WAS REPORTED THAT ONLY BREAST PROSTHESES WERE REMOVED AND NOT THE BREAST CAPSULES. THE SURGEON HAD MENTIONED THAT THE BODY WOULD ABSORB THE BREAST CAPSULES. THEREAFTER, THE PATIENT BEGAN TO HAVE ¿NEUROLOGICAL PROBLEMS¿ AND WENT TO SEE ANOTHER HEALTHCARE PROVIDER WHO SPECIALIZED IN BREAST IMPLANT ILLNESS. THE PATIENT THEN UNDERWENT AN EXPLANTATION OF THE BREAST CAPSULES ON (B)(6) 2026. THE OPERATIVE DIAGNOSIS FOR THIS EXPLANTATION REPORTED SIGNIFICANT ASYMMETRY BILATERALLY AND THE LEFT SIDE WITH HYPERTROPHIC SCARRING. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

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

  MAUDE report 25262323 ↗
• InjuryMay 22, 2026Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 28-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) AND GENERALIZED ILLNESS SYMPTOMS INCLUDING BREAST IMPLANT ILLNESS, PAIN, FEELING FAINT, BEDRIDDEN, AND NEUROLOGICAL ISSUES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. IT WAS REPORTED THAT THAT ONLY BREAST PROSTHESES WERE REMOVED AND NOT THE BREAST CAPSULES. THE SURGEON HAD MENTIONED THAT THE BODY WOULD ABSORB THE BREAST CAPSULES. THEREAFTER, THE PATIENT BEGAN TO HAVE ¿NEUROLOGICAL PROBLEMS¿ AND WENT TO SEE ANOTHER HEALTHCARE PROVIDER WHO SPECIALIZED IN BREAST IMPLANT ILLNESS. THE PATIENT THEN UNDERWENT AN EXPLANTATION OF THE BREAST CAPSULES ON (B)(6) 2026. THE OPERATIVE DIAGNOSIS FOR THIS EXPLANTATION REPORTED SIGNIFICANT ASYMMETRY BILATERALLY AND THE LEFT SIDE WITH HYPERTROPHIC SCARRING. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

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

  MAUDE report 25262229 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 25117583 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES EXPERIENCED BILATERAL CAPSULAR CONTRACTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2026.

  Patient problems: Capsular Contracture

  MAUDE report 25117425 ↗
• InjuryApr 17, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT SLOW LEAK. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24906337 ↗
• InjuryMar 4, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS REPORTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24510224 ↗
• InjuryFeb 11, 2026Material Rupture

  IT WAS REPORTED THAT A 36-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 350CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH A 400CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24314774 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24082698 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT A BREAST SURGERY WITH MENTOR SMOOTH ROUND MODERATE PROFILE 350CC SALINE PROSTHESIS EXPERIENCED BILATERAL¿ INSUFFICIENT INFORMATION¿ POST OPERATION. THE PATIENT INDICATED POTENTIAL IMPACT ON HER HEALTH AND SAFETY. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 23924114 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT A BREAST SURGERY WITH MENTOR SMOOTH ROUND MODERATE PROFILE 350CC SALINE PROSTHESIS EXPERIENCED BILATERAL¿ INSUFFICIENT INFORMATION¿ POST OPERATION. THE PATIENT INDICATED POTENTIAL IMPACT ON HER HEALTH AND SAFETY. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 23924009 ↗
• InjuryDec 29, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 350CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23918719 ↗
• InjuryDec 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 350CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL¿S EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23898563 ↗
• InjuryDec 22, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT EXPERIENCED THE FOLLOWING SYMPTOMS, FATIGUE, MAJOR PAIN, DROPPED IN SIZE, RIPPLING AND AN UNSPECIFIED AUTOIMMUNE DISEASE. IN ADDITION, THE PATIENT ALSO HEARD UNSPECIFIED SOUNDS WHEN TOUCHING THE IMPLANTS. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23873387 ↗
• InjuryDec 22, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT EXPERIENCED THE FOLLOWING SYMPTOMS, FATIGUE, MAJOR PAIN, DROPPED IN SIZE, RIPPLING AND AN UNSPECIFIED AUTOIMMUNE DISEASE. IN ADDITION, THE PATIENT ALSO HEARD UNSPECIFIED SOUNDS WHEN TOUCHING THE IMPLANTS. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23873386 ↗
• InjuryDec 9, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE, 350CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION, AND CHEST INJURY POST OPERATION. THE PATIENT HAD A FALL. THE CT-SCAN CONFIRMED THE DEFLATION. AS A RESULT, THE PATIENT SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2026.

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

  MAUDE report 23761336 ↗

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, Classified
  MENTOR 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 · Terminated
  Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048