MENTOR MemoryGel Xtra Breast ImplantRecalls & reported problems across all models
Mentor Texas L.P. · 88 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5,679
- Deaths reported
- 0
- Injuries reported
- 5,372
- Recalls
- 0
We found 88 models of MENTOR MemoryGel Xtra Breast Implant by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 5,679 adverse event reports in the FDA's MAUDE database, received between Jul 27, 2018 and Sep 30, 2026 — classified as 5,372 injuries, 307 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (1,009 reports).
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
Most reported MENTOR MemoryGel Xtra Breast Implant problems
Device problems
- Adverse Event Without Identified Device or Use Problem4,462
- Material Rupture1,009
- Migration242
- Appropriate Device Problem Term/Code Not Available104
- Material Discolored41
- Material Deformation33
- Use of Device Problem31
- Off-Label Use27
Patient problems
- Capsular Contracture3,744
- Deformity/ Disfigurement808
- No Code Available375
- No Clinical Signs, Symptoms or Conditions325
- Hematoma196
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available164
- Breast Discomfort/Pain134
- Wrinkling100
MENTOR MemoryGel Xtra Breast Implant models
88 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR MemoryGel Xtra Breast Implant SMPX350Prosthesis, breast, noninflatable, internal, silicone gel-filled339 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX325Prosthesis, breast, noninflatable, internal, silicone gel-filled314 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX295Prosthesis, breast, noninflatable, internal, silicone gel-filled299 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX405Prosthesis, breast, noninflatable, internal, silicone gel-filled261 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX370Prosthesis, breast, noninflatable, internal, silicone gel-filled213 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX450Prosthesis, breast, noninflatable, internal, silicone gel-filled200 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX270Prosthesis, breast, noninflatable, internal, silicone gel-filled196 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX415Prosthesis, breast, noninflatable, internal, silicone gel-filled176 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX350Prosthesis, breast, noninflatable, internal, silicone gel-filled164 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX380Prosthesis, breast, noninflatable, internal, silicone gel-filled155 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX355Prosthesis, breast, noninflatable, internal, silicone gel-filled148 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX490Prosthesis, breast, noninflatable, internal, silicone gel-filled148 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX650Prosthesis, breast, noninflatable, internal, silicone gel-filled147 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX240Prosthesis, breast, noninflatable, internal, silicone gel-filled145 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX440Prosthesis, breast, noninflatable, internal, silicone gel-filled143 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX595Prosthesis, breast, noninflatable, internal, silicone gel-filled138 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX400Prosthesis, breast, noninflatable, internal, silicone gel-filled129 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX700Prosthesis, breast, noninflatable, internal, silicone gel-filled126 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX375Prosthesis, breast, noninflatable, internal, silicone gel-filled126 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX535Prosthesis, breast, noninflatable, internal, silicone gel-filled125 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX465Prosthesis, breast, noninflatable, internal, silicone gel-filled115 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX790Prosthesis, breast, noninflatable, internal, silicone gel-filled114 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX465Prosthesis, breast, noninflatable, internal, silicone gel-filled112 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX560Prosthesis, breast, noninflatable, internal, silicone gel-filled112 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX310Prosthesis, breast, noninflatable, internal, silicone gel-filled107 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX330Prosthesis, breast, noninflatable, internal, silicone gel-filled99 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX285Prosthesis, breast, noninflatable, internal, silicone gel-filled92 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX335Prosthesis, breast, noninflatable, internal, silicone gel-filled90 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX430Prosthesis, breast, noninflatable, internal, silicone gel-filled79 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX490Prosthesis, breast, noninflatable, internal, silicone gel-filled75 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX280Prosthesis, breast, noninflatable, internal, silicone gel-filled64 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX525Prosthesis, breast, noninflatable, internal, silicone gel-filled63 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX755Prosthesis, breast, noninflatable, internal, silicone gel-filled63 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX470Prosthesis, breast, noninflatable, internal, silicone gel-filled63 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX215Prosthesis, breast, noninflatable, internal, silicone gel-filled57 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX545Prosthesis, breast, noninflatable, internal, silicone gel-filled49 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX500Prosthesis, breast, noninflatable, internal, silicone gel-filled49 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX260Prosthesis, breast, noninflatable, internal, silicone gel-filled39 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX545Prosthesis, breast, noninflatable, internal, silicone gel-filled39 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX605Prosthesis, breast, noninflatable, internal, silicone gel-filled35 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX560Prosthesis, breast, noninflatable, internal, silicone gel-filled34 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX255Prosthesis, breast, noninflatable, internal, silicone gel-filled33 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX645Prosthesis, breast, noninflatable, internal, silicone gel-filled29 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX630Prosthesis, breast, noninflatable, internal, silicone gel-filled24 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX580Prosthesis, breast, noninflatable, internal, silicone gel-filled22 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX190Prosthesis, breast, noninflatable, internal, silicone gel-filled21 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX685Prosthesis, breast, noninflatable, internal, silicone gel-filled21 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX235Prosthesis, breast, noninflatable, internal, silicone gel-filled21 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX630Prosthesis, breast, noninflatable, internal, silicone gel-filled21 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX755Prosthesis, breast, noninflatable, internal, silicone gel-filled18 reports
- MENTOR MemoryGel Xtra Breast Implant TMPX295Prosthesis, breast, noninflatable, internal, silicone gel-filled14 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX775Prosthesis, breast, noninflatable, internal, silicone gel-filled14 reports
- MENTOR MemoryGel Xtra Breast Implant TMPX325Prosthesis, breast, noninflatable, internal, silicone gel-filled13 reports
- MENTOR MemoryGel Xtra Breast Implant THPX285Prosthesis, breast, noninflatable, internal, silicone gel-filled11 reports
- MENTOR MemoryGel Xtra Breast Implant THPX365Prosthesis, breast, noninflatable, internal, silicone gel-filled10 reports
- MENTOR MemoryGel Xtra Breast Implant THPX455Prosthesis, breast, noninflatable, internal, silicone gel-filled10 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX200Prosthesis, breast, noninflatable, internal, silicone gel-filled9 reports
- MENTOR MemoryGel Xtra Breast Implant TMPX405Prosthesis, breast, noninflatable, internal, silicone gel-filled9 reports
- MENTOR MemoryGel Xtra Breast Implant THPX255Prosthesis, breast, noninflatable, internal, silicone gel-filled9 reports
- MENTOR MemoryGel Xtra Breast Implant THPX515Prosthesis, breast, noninflatable, internal, silicone gel-filled9 reports
- MENTOR MemoryGel Xtra Breast Implant THPX620Prosthesis, breast, noninflatable, internal, silicone gel-filled9 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX230Prosthesis, breast, noninflatable, internal, silicone gel-filled9 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX130Prosthesis, breast, noninflatable, internal, silicone gel-filled7 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX160Prosthesis, breast, noninflatable, internal, silicone gel-filled7 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX150Prosthesis, breast, noninflatable, internal, silicone gel-filled7 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX180Prosthesis, breast, noninflatable, internal, silicone gel-filled7 reports
- MENTOR MemoryGel Xtra Breast Implant THPX405Prosthesis, breast, noninflatable, internal, silicone gel-filled7 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX700Prosthesis, breast, noninflatable, internal, silicone gel-filled7 reports
- MENTOR MemoryGel Xtra Breast Implant THPX325Prosthesis, breast, noninflatable, internal, silicone gel-filled6 reports
- MENTOR MemoryGel Xtra Breast Implant THPX765Prosthesis, breast, noninflatable, internal, silicone gel-filled6 reports
- MENTOR MemoryGel Xtra Breast Implant TMPX525Prosthesis, breast, noninflatable, internal, silicone gel-filled5 reports
- MENTOR MemoryGel Xtra Breast Implant TMPX440Prosthesis, breast, noninflatable, internal, silicone gel-filled4 reports
- MENTOR MemoryGel Xtra Breast Implant TMPX545Prosthesis, breast, noninflatable, internal, silicone gel-filled4 reports
- MENTOR MemoryGel Xtra Breast Implant THPX470Prosthesis, breast, noninflatable, internal, silicone gel-filled4 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX210Prosthesis, breast, noninflatable, internal, silicone gel-filled4 reports
- MENTOR MemoryGel Xtra Breast Implant TMPX215Prosthesis, breast, noninflatable, internal, silicone gel-filled3 reports
- MENTOR MemoryGel Xtra Breast Implant TMPX240Prosthesis, breast, noninflatable, internal, silicone gel-filled3 reports
- MENTOR MemoryGel Xtra Breast Implant TMPX350Prosthesis, breast, noninflatable, internal, silicone gel-filled3 reports
- MENTOR MemoryGel Xtra Breast Implant THPX425Prosthesis, breast, noninflatable, internal, silicone gel-filled3 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX115Prosthesis, breast, noninflatable, internal, silicone gel-filled2 reports
- MENTOR MemoryGel Xtra Breast Implant TMPX270Prosthesis, breast, noninflatable, internal, silicone gel-filled2 reports
- MENTOR MemoryGel Xtra Breast Implant THPX340Prosthesis, breast, noninflatable, internal, silicone gel-filled2 reports
- MENTOR MemoryGel Xtra Breast Implant THPX570Prosthesis, breast, noninflatable, internal, silicone gel-filled2 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX150Prosthesis, breast, noninflatable, internal, silicone gel-filled2 reports
- MENTOR MemoryGel Xtra Breast Implant TMPX465Prosthesis, breast, noninflatable, internal, silicone gel-filled1 report
- MENTOR MemoryGel Xtra Breast Implant TMPX560Prosthesis, breast, noninflatable, internal, silicone gel-filled1 report
- MENTOR MemoryGel Xtra Breast Implant THPX175Prosthesis, breast, noninflatable, internal, silicone gel-filled1 report
- MENTOR MemoryGel Xtra Breast Implant THPX545Prosthesis, breast, noninflatable, internal, silicone gel-filled1 report
Recent MENTOR MemoryGel Xtra Breast Implant 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
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952545 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of a 470cc MENTOR MemoryGel Xtra Breast Implant prosthesis. Post-operatively, the patient was diagnosed with right breast Baker Grade III Capsular Contracture by a medical professional. As a result, the patient underwent right-sided exchange with a Mentor gel implant on (b)(6), 2026.
Patient problems: Capsular Contracture
MAUDE report 50950067 ↗InjurySep 30, 2026Material Rupture
Patient problems: Capsular Contracture
MAUDE report 50948540 ↗InjurySep 30, 2026Material Rupture
It was reported that a patient implanted with a 560cc MENTOR MemoryGel Xtra Breast Implant experienced a rupture, breast pain, and a burning sensation on the left side post-operatively. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.
Patient problems: Breast Discomfort/Pain; Paresthesia
MAUDE report 50947403 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50937638 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent breast augmentation revision with a 350cc MENTOR MemoryGel Xtra Breast Implant on the left breast. Post-operatively, the patient was diagnosed, via ultrasonography, with left breast capsular contracture (baker grade III). As a result, the patient underwent breast implant removal and replacement surgery on (b)(6)2026. The replacement device was a Mentor gel implant.
Patient problems: Capsular Contracture
MAUDE report 50936696 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient with MENTOR MemoryGel Xtra Breast Implants experienced capsular contracture Baker Grade III on the right side post-operatively, which was confirmed during a physical exam. As a result, the patient underwent device removal and replacement.
Patient problems: Capsular Contracture
MAUDE report 50936639 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient implanted with a 560cc MENTOR MemoryGel Xtra Breast Implant experienced capsular contracture Baker Grade 3 on the right side post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.
Patient problems: Capsular Contracture
MAUDE report 50935268 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent breast augmentation revision with two 790cc MENTOR MemoryGel Xtra Breast Implants. Post-operatively, the patient was diagnosed, via physical examination, with left breast capsular contracture (baker grade III). At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.
Patient problems: Capsular Contracture
MAUDE report 50935035 ↗InjurySep 29, 2026Material Rupture
On initial evaluation, the patient had previously undergone breast augmentation with a MENTOR Smooth Round Moderate Profile 350 cc saline prosthesis. She subsequently developed symptoms consistent with implant rupture, including a local inflammatory reaction and impaired wound healing; mammography confirmed the suspected rupture. On (b)(6) 2026, the patient underwent bilateral breast augmentation revision with implant replacement (left implant: (b)(6), catalog/lot 2181500-026). During postoperative follow-up, the inferior aspect of the left breast demonstrated erythema, swelling, and delayed wound healing. On (b)(6) 2026, MD performed revision wound repair of the left breast and identified a suspected rupture of the originally implanted device; the ruptured implant was removed and replaced at that time.
Patient problems: Impaired Healing; Local Reaction
MAUDE report 50934798 ↗InjurySep 28, 2026Migration
Patient problems: Deformity/ Disfigurement
MAUDE report 50926064 ↗InjurySep 28, 2026Migration
Patient problems: Deformity/ Disfigurement
MAUDE report 50926063 ↗InjurySep 28, 2026Migration
It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of a 490cc MENTOR MemoryGel Xtra Breast Implant prosthesis. Post-operatively, the patient was diagnosed with bilateral implant migration/displacement using Ultrasound Imaging. As a result, the patient underwent bilateral exchange with Mentor gel implants on (b)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 50920026 ↗InjurySep 28, 2026Migration
Patient problems: Deformity/ Disfigurement
MAUDE report 50920025 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient who underwent a primary breast augmentation procedure with a MENTOR MemoryGel Xtra Breast Implant gel breast prosthesis developed Baker Grade III capsular contracture in her left breast post implantation. As a result, the patient underwent explantation and replacement with a MENTOR MemoryGel Xtra Breast Implant gel breast prosthesis.
Patient problems: Capsular Contracture
MAUDE report 50876646 ↗
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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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