MENTOR Smooth Round Moderate Plus ProfileRecalls & reported problems across all models
Mentor Texas L.P. · 22 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 Moderate Plus Profile model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6,091
- Deaths reported
- 0
- Injuries reported
- 5,972
- Recalls
- 1
We found 22 models of MENTOR Smooth Round Moderate Plus Profile by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 6,091 adverse event reports in the FDA's MAUDE database, received between Oct 24, 2017 and Sep 30, 2026 — classified as 5,972 injuries, 119 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (4,062 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 Moderate Plus 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 · Recall details · FDA record ↗
Most reported MENTOR Smooth Round Moderate Plus Profile problems
Device problems
- Material Rupture4,062
- Adverse Event Without Identified Device or Use Problem1,901
- Migration198
- Connection Problem32
- Appropriate Device Problem Term/Code Not Available27
- Off-Label Use18
- Deflation Problem16
- No Apparent Adverse Event16
Patient problems
- Deformity/ Disfigurement2,276
- No Code Available2,088
- Capsular Contracture1,162
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available291
- Pain271
- Breast Discomfort/Pain183
- Wrinkling125
- No Clinical Signs, Symptoms or Conditions101
MENTOR Smooth Round Moderate Plus Profile models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR Smooth Round Moderate Plus Profile 3502350Prosthesis, breast, inflatable, internal, saline672 reports
- MENTOR Smooth Round Moderate Plus Profile 3502325Prosthesis, breast, inflatable, internal, saline578 reports
- MENTOR Smooth Round Moderate Plus Profile 3502375Prosthesis, breast, inflatable, internal, saline573 reports
- MENTOR Smooth Round Moderate Plus Profile 3502300Prosthesis, breast, inflatable, internal, saline566 reports
- MENTOR Smooth Round Moderate Plus Profile 3502400Prosthesis, breast, inflatable, internal, saline471 reports
- MENTOR Smooth Round Moderate Plus Profile 3502425Prosthesis, breast, inflatable, internal, saline396 reports
- MENTOR Smooth Round Moderate Plus Profile 3502450Prosthesis, breast, inflatable, internal, saline386 reports
- MENTOR Smooth Round Moderate Plus Profile 3502275Prosthesis, breast, inflatable, internal, saline372 reports
- MENTOR Smooth Round Moderate Plus Profile 3502500Prosthesis, breast, inflatable, internal, saline352 reports
- MENTOR Smooth Round Moderate Plus Profile 3502550Prosthesis, breast, inflatable, internal, saline286 reports
- MENTOR Smooth Round Moderate Plus Profile 3502800Prosthesis, breast, inflatable, internal, saline260 reports
- MENTOR Smooth Round Moderate Plus Profile 3502475Prosthesis, breast, inflatable, internal, saline258 reports
- MENTOR Smooth Round Moderate Plus Profile 3502250Prosthesis, breast, inflatable, internal, saline253 reports
- MENTOR Smooth Round Moderate Plus Profile 3502600Prosthesis, breast, inflatable, internal, saline158 reports
- MENTOR Smooth Round Moderate Plus Profile 3502650Prosthesis, breast, inflatable, internal, saline120 reports
- MENTOR Smooth Round Moderate Plus Profile 3502700Prosthesis, breast, inflatable, internal, saline105 reports
- MENTOR Smooth Round Moderate Plus Profile 3502225Prosthesis, breast, inflatable, internal, saline96 reports
- MENTOR Smooth Round Moderate Plus Profile 3502175Prosthesis, breast, inflatable, internal, saline1 recall39 reports
- MENTOR Smooth Round Moderate Plus Profile 3502750Prosthesis, breast, inflatable, internal, saline79 reports
- MENTOR Smooth Round Moderate Plus Profile 3502200Prosthesis, breast, inflatable, internal, saline69 reports
- MENTOR Smooth Round Moderate Plus Profile 3502375DProsthesis, breast, inflatable, internal, saline1 report
- MENTOR Smooth Round Moderate Plus Profile 3502550DProsthesis, breast, inflatable, internal, saline1 report
Recent MENTOR Smooth Round Moderate Plus 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; Migration
Patient problems: Deformity/ Disfigurement
MAUDE report 50951870 ↗InjurySep 30, 2026Material Rupture; Migration
Patient problems: Deformity/ Disfigurement
MAUDE report 50951827 ↗InjurySep 30, 2026Material Rupture
It was reported that a 63-year-old Caucasian female patient underwent a breast augmentation revision with a 375cc MENTOR Smooth Round Moderate Plus Profile saline breast prosthesis and experienced a deflation on the left side post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 50942148 ↗InjurySep 29, 2026Material Rupture
Patient problems: Deformity/ Disfigurement
MAUDE report 50938091 ↗InjurySep 29, 2026Material Rupture
It was reported that a patient underwent a primary breast augmentation 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 diagnosed via a physical exam. As a result, the patient underwent explantation.
Patient problems: Deformity/ Disfigurement
MAUDE report 50936607 ↗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 24, 2026Migration
Patient problems: Deformity/ Disfigurement
MAUDE report 50888975 ↗InjurySep 24, 2026Migration
It was reported that a female patient underwent a breast augmentation with two 300cc MENTOR Smooth Round Moderate Plus Profile saline breast prostheses and experienced bilateral device migration (superior positioning) post-operatively. 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: Deformity/ Disfigurement
MAUDE report 50888974 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a female patient underwent Breast Augmentation Primary with MENTOR Smooth Round Moderate Plus Profile, 200cc Saline prosthesis. subsequently the patient experienced right sided Capsular contracture grade III postoperatively. The issue was diagnosed through physical examinations. At the time of this report, Mentor received no information regarding explantation or an expected explantation date.
Patient problems: Capsular Contracture
MAUDE report 50872114 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a 55-year-old Caucasian female patient underwent a breast augmentation revision with a 400cc MENTOR Smooth Round Moderate Plus Profile saline breast prosthesis and experienced a breast mass 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: Breast Mass
MAUDE report 50871427 ↗InjurySep 22, 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. The patient noticed ripples on her right breast. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.
Patient problems: Deformity/ Disfigurement
MAUDE report 50857343 ↗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 ↗InjurySep 17, 2026Material Rupture
It was reported that a patient underwent a Primary Breast Augmentation Surgery with implantation of a 275cc MENTOR Smooth Round Moderate Plus Profile saline breast implant prosthesis. Post-operatively, the patient was diagnosed with a deflated left implant during a physical exam. As a result, the patient underwent bilateral exchange with Mentor saline implants on (b)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 50803388 ↗InjurySep 16, 2026Material Rupture
It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of a 475cc MENTOR Smooth Round Moderate Plus Profile saline breast implant prosthesis. Post-operatively, the patient was diagnosed with a deflated left implant during a physical exam. At the time of this report, Mentor has received no information regarding explantation or an expected explantation 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.
Patient problems: Deformity/ Disfigurement
MAUDE report 50792452 ↗
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 MemoryGel Xtra Breast Implant88 models · 5,679 reports
- MENTOR Smooth Round High Profile17 models · 4,098 reports · 1 recall
- 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.
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