MENTOR Smooth Round High ProfileRecalls & reported problems across all models
Mentor Texas L.P. · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one MENTOR Smooth Round High Profile model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4,098
- Deaths reported
- 0
- Injuries reported
- 4,039
- Recalls
- 1
We found 17 models of MENTOR Smooth Round High Profile by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 4,098 adverse event reports in the FDA's MAUDE database, received between Jan 23, 2018 and Sep 30, 2026 — classified as 4,039 injuries, 59 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2,448 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
MENTOR Smooth Round High Profile recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 30, 2021Open, Classified
Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.
Z-0367-2022 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported MENTOR Smooth Round High Profile problems
Device problems
- Material Rupture2,448
- Adverse Event Without Identified Device or Use Problem1,594
- Migration91
- Off-Label Use23
- Connection Problem21
- Deflation Problem19
- Microbial Contamination of Device12
- Migration or Expulsion of Device12
Patient problems
- No Code Available1,358
- Deformity/ Disfigurement1,262
- Capsular Contracture929
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available247
- Pain242
- Breast Discomfort/Pain176
- Wrinkling95
- Autoimmune Reaction79
MENTOR Smooth Round High Profile models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR Smooth Round High Profile 3503330Prosthesis, breast, inflatable, internal, saline679 reports
- MENTOR Smooth Round High Profile 3503380Prosthesis, breast, inflatable, internal, saline672 reports
- MENTOR Smooth Round High Profile 3503420Prosthesis, breast, inflatable, internal, saline596 reports
- MENTOR Smooth Round High Profile 3503460Prosthesis, breast, inflatable, internal, saline413 reports
- MENTOR Smooth Round High Profile 3503500Prosthesis, breast, inflatable, internal, saline330 reports
- MENTOR Smooth Round High Profile 3503310Prosthesis, breast, inflatable, internal, saline290 reports
- MENTOR Smooth Round High Profile 3503560Prosthesis, breast, inflatable, internal, saline258 reports
- MENTOR Smooth Round High Profile 3503290Prosthesis, breast, inflatable, internal, saline254 reports
- MENTOR Smooth Round High Profile 3503630Prosthesis, breast, inflatable, internal, saline218 reports
- MENTOR Smooth Round High Profile 3503270Prosthesis, breast, inflatable, internal, saline187 reports
- MENTOR Smooth Round High Profile 3503250Prosthesis, breast, inflatable, internal, saline92 reports
- MENTOR Smooth Round High Profile 3503190Prosthesis, breast, inflatable, internal, saline1 recall10 reports
- MENTOR Smooth Round High Profile 3503170Prosthesis, breast, inflatable, internal, saline1 recall5 reports
- MENTOR Smooth Round High Profile 3503230Prosthesis, breast, inflatable, internal, saline49 reports
- MENTOR Smooth Round High Profile 3503210Prosthesis, breast, inflatable, internal, saline43 reports
- MENTOR Smooth Round High Profile 3503380DProsthesis, breast, inflatable, internal, saline1 report
- MENTOR Smooth Round High Profile 3503500DProsthesis, breast, inflatable, internal, saline1 report
Recent MENTOR Smooth Round High Profile adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Material Rupture
It was reported that a 55-year-old female patient underwent revision breast augmentation with 420cc MENTOR Smooth Round High Profile and experienced breast implant deflation on her right side postoperatively; diagnosed after physical exam. The patient has consulted with the healthcare professional. As a result, the patient underwent replacement surgery with non-Mentor device on (b)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 50946083 ↗InjurySep 29, 2026Material Rupture
Patient problems: Deformity/ Disfigurement
MAUDE report 50935446 ↗InjurySep 28, 2026Migration
Patient problems: Deformity/ Disfigurement
MAUDE report 50923590 ↗InjurySep 28, 2026Migration
Patient problems: Deformity/ Disfigurement
MAUDE report 50923589 ↗InjurySep 28, 2026Material Rupture
It was reported that a 29-year-old Hispanic female patient underwent revision breast augmentation with 500cc MENTOR Smooth Round High Profile and experienced breast implant deflation on her left side postoperatively; diagnosed after physical exam. The patient has consulted with the healthcare professional. As a result, the patient underwent replacement surgery on (b)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 50916619 ↗InjurySep 22, 2026Material Rupture
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture; Seroma
MAUDE report 50862921 ↗InjurySep 22, 2026Material Rupture
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture; Seroma
MAUDE report 50862920 ↗InjurySep 22, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859295 ↗InjurySep 21, 2026Material Rupture
Patient problems: Deformity/ Disfigurement
MAUDE report 50846239 ↗InjurySep 18, 2026Material Rupture
It was reported that a female patient underwent unspecified Breast Augmentation with MENTOR Smooth Round High Profile, 630cc Saline implants, subsequently the patient experienced left sided deflation. As a result, the patient scheduled for removal surgery on (b)(6), 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 50818990 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50809786 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50809784 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent a Primary Breast Reconstruction Surgery with implantation of a 420cc MENTOR Smooth Round High Profile saline breast implant prosthesis. Post-operatively, the patient reported experiencing left breast Capsular Contracture and a deflated right implant. A consultation with a medical professional has yet to be conducted. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.The date of event and implantation were provided to Mentor as a best estimate.A discrepancy was noted; the provided implant date precedes the manufacturing date of the device. However, the patient was unsure of the implant date.Follow-ups have been conducted, and no additional information has been received. If more information becomes available, Mentor will submit a supplemental report accordingly.This report is for the left breast prosthesis.
Patient problems: Capsular Contracture
MAUDE report 50778206 ↗InjurySep 15, 2026Material Rupture
It was reported that a patient underwent a Primary Breast Reconstruction Surgery with implantation of a 420cc MENTOR Smooth Round High Profile saline breast implant prosthesis. Post-operatively, the patient reported experiencing left breast Capsular Contracture and a deflated right implant. A consultation with a medical professional has yet to be conducted. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.The date of event and implantation were provided to Mentor as a best estimate.A discrepancy was noted; the provided implant date precedes the manufacturing date of the device. However, the patient was unsure of the implant date.Follow-ups have been conducted, and no additional information has been received. If more information becomes available, Mentor will submit a supplemental report accordingly.This report is for the right breast prosthesis.
Patient problems: Deformity/ Disfigurement
MAUDE report 50778205 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient who underwent a breast augmentation revision procedure with MENTOR Smooth Round High Profile saline breast prostheses developed pain with itching and burning in both breasts post implantation. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.This MedWatch report is for the patient¿s left breast prosthesis.
Patient problems: Breast Discomfort/Pain; Skin Inflammation/ Irritation
MAUDE report 50766131 ↗
Other Mentor Texas L.P. products
- MENTOR MemoryGel Breast Implants368 models · 56,155 reports
- MENTOR MemoryGel Breast Implant211 models · 49,379 reports
- MENTOR Smooth Round Moderate Profile20 models · 14,918 reports · 1 recall
- MENTOR Smooth Round Moderate Plus Profile22 models · 6,091 reports · 1 recall
- MENTOR MemoryGel Xtra Breast Implant88 models · 5,679 reports
- MENTOR SILTEX Round Moderate Profile13 models · 2,160 reports
- MENTOR MemoryShape Breast Implant65 models · 1,595 reports
- MENTOR MemoryGel BOOST Breast Implant53 models · 1,078 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page