MENTOR Smooth Round Moderate ProfileRecalls & reported problems across all models
Mentor Texas L.P. · 20 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 Profile model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 14,918
- Deaths reported
- 0
- Injuries reported
- 14,782
- Recalls
- 1
We found 20 models of MENTOR Smooth Round Moderate Profile by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 14,918 adverse event reports in the FDA's MAUDE database, received between Oct 24, 2017 and Sep 30, 2026 — classified as 14,782 injuries, 136 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (11,527 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 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 Moderate Profile problems
Device problems
- Material Rupture11,527
- Adverse Event Without Identified Device or Use Problem3,293
- Migration207
- Deflation Problem74
- Appropriate Device Problem Term/Code Not Available52
- No Apparent Adverse Event37
- Connection Problem35
- Off-Label Use34
Patient problems
- Deformity/ Disfigurement6,019
- No Code Available5,920
- Capsular Contracture2,149
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available562
- Pain536
- Breast Discomfort/Pain298
- Autoimmune Reaction223
- Wrinkling220
MENTOR Smooth Round Moderate Profile models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR Smooth Round Moderate Profile 3501650Prosthesis, breast, inflatable, internal, saline2,187 reports
- MENTOR Smooth Round Moderate Profile 3501660Prosthesis, breast, inflatable, internal, saline1,972 reports
- MENTOR Smooth Round Moderate Profile 3501670Prosthesis, breast, inflatable, internal, saline1,899 reports
- MENTOR Smooth Round Moderate Profile 3501645Prosthesis, breast, inflatable, internal, saline1,655 reports
- MENTOR Smooth Round Moderate Profile 3501655Prosthesis, breast, inflatable, internal, saline1,534 reports
- MENTOR Smooth Round Moderate Profile 3501640Prosthesis, breast, inflatable, internal, saline1,294 reports
- MENTOR Smooth Round Moderate Profile 3501680Prosthesis, breast, inflatable, internal, saline1,095 reports
- MENTOR Smooth Round Moderate Profile 3501635Prosthesis, breast, inflatable, internal, saline864 reports
- MENTOR Smooth Round Moderate Profile 3501685Prosthesis, breast, inflatable, internal, saline623 reports
- MENTOR Smooth Round Moderate Profile 3501630Prosthesis, breast, inflatable, internal, saline528 reports
- MENTOR Smooth Round Moderate Profile 3501690Prosthesis, breast, inflatable, internal, saline354 reports
- MENTOR Smooth Round Moderate Profile 3501625Prosthesis, breast, inflatable, internal, saline282 reports
- MENTOR Smooth Round Moderate Profile 3501695Prosthesis, breast, inflatable, internal, saline188 reports
- MENTOR Smooth Round Moderate Profile 3501697Prosthesis, breast, inflatable, internal, saline1 recall127 reports
- MENTOR Smooth Round Moderate Profile 3501620Prosthesis, breast, inflatable, internal, saline166 reports
- MENTOR Smooth Round Moderate Profile 3501615Prosthesis, breast, inflatable, internal, saline1 recall88 reports
- MENTOR Smooth Round Moderate Profile 3501610Prosthesis, breast, inflatable, internal, saline59 reports
- MENTOR Smooth Round Moderate Profile 3501655DProsthesis, breast, inflatable, internal, saline1 report
- MENTOR Smooth Round Moderate Profile 3501660DProsthesis, breast, inflatable, internal, saline1 report
- MENTOR Smooth Round Moderate Profile 3501615DProsthesis, breast, inflatable, internal, saline1 report
Recent MENTOR Smooth Round Moderate 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 patient underwent a breast augmentation revision procedure with a MENTOR Smooth Round Moderate 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 is scheduled to undergo explantation.
Patient problems: Deformity/ Disfigurement
MAUDE report 50949104 ↗InjurySep 30, 2026Material Rupture
It was reported that a female patient underwent Breast Augmentation Revisionwith MENTOR Smooth Round Moderate Profile, 300cc Saline prosthesis. Subsequently the patient experienced right side deflation post operation. The issue was diagnosed through physical examination. As a result, the patient underwent bilateral replacements with CAT: 3501650 on (b)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 50949030 ↗InjurySep 29, 2026Material Rupture
It was reported that a patient underwent a primary breast augmentation procedure with a MENTOR Smooth Round Moderate 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 is scheduled to undergo explantation.
Patient problems: Deformity/ Disfigurement
MAUDE report 50936721 ↗InjurySep 28, 2026Material Rupture
Patient problems: Deformity/ Disfigurement
MAUDE report 50926111 ↗InjurySep 28, 2026Material Rupture
Patient problems: Deformity/ Disfigurement
MAUDE report 50924818 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50924238 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50924237 ↗InjurySep 28, 2026Material Rupture
Patient problems: Deformity/ Disfigurement
MAUDE report 50923354 ↗InjurySep 28, 2026Material Rupture
Patient problems: Deformity/ Disfigurement
MAUDE report 50923194 ↗InjurySep 28, 2026Material Rupture
Patient problems: Deformity/ Disfigurement
MAUDE report 50923193 ↗InjurySep 28, 2026Material Rupture
It was reported that a patient with Saline MENTOR Smooth Round Moderate Profile breast implants experienced deflation on the right side post-operatively, which was confirmed during a physical exam. The event reportedly occurred after the patient jumped into a pool. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.The reported implantation date is prior to the device manufacture date. If additional information is received regarding the correct date of implantation or device lot number, a supplemental report will be submitted.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement
MAUDE report 50917164 ↗InjurySep 28, 2026Material Rupture
It was reported that a patient with Saline MENTOR Smooth Round Moderate 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 50915690 ↗InjurySep 24, 2026Material Rupture
It was reported that a patient with Saline MENTOR Smooth Round Moderate Profile breast implants experienced deflation on the right 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 50885569 ↗InjurySep 24, 2026Material Rupture
It was reported that a patient underwent primary breast augmentation with two 425cc MENTOR Smooth Round Moderate Profile saline breast prostheses. Post-operatively, the patient was diagnosed with left breast implant deflation. As a result, the patient underwent breast implant removal and replacement surgery on (b)(6)2026. The replacement devices were two Mentor saline breast prostheses.
Patient problems: Deformity/ Disfigurement
MAUDE report 50882771 ↗InjurySep 23, 2026Material Rupture
Patient problems: Deformity/ Disfigurement
MAUDE report 50873830 ↗
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 Plus Profile22 models · 6,091 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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