MENTOR MemoryGel Breast ImplantsRecalls & reported problems across all models
Mentor Texas L.P. · 368 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 56,155
- Deaths reported
- 0
- Injuries reported
- 55,010
- Recalls
- 0
We found 368 models of MENTOR MemoryGel Breast Implants by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 56,155 adverse event reports in the FDA's MAUDE database, received between Jan 5, 2018 and Sep 30, 2026 — classified as 55,010 injuries, 1,144 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (25,728 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 Breast Implants problems
Device problems
- Adverse Event Without Identified Device or Use Problem30,115
- Material Rupture25,728
- Migration1,920
- Appropriate Device Problem Term/Code Not Available979
- Gel Leak312
- Off-Label Use232
- Use of Device Problem226
- Material Discolored197
Patient problems
- Capsular Contracture27,845
- Deformity/ Disfigurement15,584
- No Code Available10,148
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2,447
- Breast Discomfort/Pain2,026
- Pain1,736
- No Clinical Signs, Symptoms or Conditions1,582
- Wrinkling968
MENTOR MemoryGel Breast Implants models
368 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR MemoryGel Breast Implant 3503501BCProsthesis, breast, noninflatable, internal, silicone gel-filled2,167 reports
- MENTOR MemoryGel Breast Implant 3504001BCProsthesis, breast, noninflatable, internal, silicone gel-filled2,130 reports
- MENTOR MemoryGel Breast Implant 3504004BCProsthesis, breast, noninflatable, internal, silicone gel-filled2,012 reports
- MENTOR MemoryGel Breast Implant 3504504BCProsthesis, breast, noninflatable, internal, silicone gel-filled1,754 reports
- MENTOR MemoryGel Breast Implant 3503001BCProsthesis, breast, noninflatable, internal, silicone gel-filled1,752 reports
- MENTOR MemoryGel Breast Implant 3503504BCProsthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
- MENTOR MemoryGel Breast Implant 3504501BCProsthesis, breast, noninflatable, internal, silicone gel-filled1,690 reports
- MENTOR MemoryGel Breast Implant 3503251BCProsthesis, breast, noninflatable, internal, silicone gel-filled1,684 reports
- MENTOR MemoryGel Breast Implant 3503751BCProsthesis, breast, noninflatable, internal, silicone gel-filled1,671 reports
- MENTOR MemoryGel Breast Implant 3505004BCProsthesis, breast, noninflatable, internal, silicone gel-filled1,540 reports
- MENTOR MemoryGel Breast Implant 3503754BCProsthesis, breast, noninflatable, internal, silicone gel-filled1,363 reports
- MENTOR MemoryGel Breast Implant 3504254BCProsthesis, breast, noninflatable, internal, silicone gel-filled1,300 reports
- MENTOR MemoryGel Breast Implant 3505504BCProsthesis, breast, noninflatable, internal, silicone gel-filled1,250 reports
- MENTOR MemoryGel Breast Implant 3502751BCProsthesis, breast, noninflatable, internal, silicone gel-filled1,129 reports
- MENTOR MemoryGel Breast Implant 3503254BCProsthesis, breast, noninflatable, internal, silicone gel-filled1,061 reports
- MENTOR MemoryGel Breast Implant 3502501BCProsthesis, breast, noninflatable, internal, silicone gel-filled1,044 reports
- MENTOR MemoryGel Breast Implant 3503004BCProsthesis, breast, noninflatable, internal, silicone gel-filled1,018 reports
- MENTOR MemoryGel Breast Implant 3505001BCProsthesis, breast, noninflatable, internal, silicone gel-filled980 reports
- MENTOR MemoryGel Breast Implant 3506004BCProsthesis, breast, noninflatable, internal, silicone gel-filled923 reports
- MENTOR MemoryGel Breast Implant 3504251BCProsthesis, breast, noninflatable, internal, silicone gel-filled805 reports
- MENTOR MemoryGel Breast Implant 3505501BCProsthesis, breast, noninflatable, internal, silicone gel-filled683 reports
- MENTOR MemoryGel Breast Implant 3504754BCProsthesis, breast, noninflatable, internal, silicone gel-filled655 reports
- MENTOR MemoryGel Breast Implant 3506504BCProsthesis, breast, noninflatable, internal, silicone gel-filled619 reports
- MENTOR MemoryGel Breast Implant 3507350BCProsthesis, breast, noninflatable, internal, silicone gel-filled563 reports
- MENTOR MemoryGel Breast Implant 3507004BCProsthesis, breast, noninflatable, internal, silicone gel-filled520 reports
- MENTOR MemoryGel Breast Implant 3504751BCProsthesis, breast, noninflatable, internal, silicone gel-filled495 reports
- MENTOR MemoryGel Breast Implant 3502754BCProsthesis, breast, noninflatable, internal, silicone gel-filled481 reports
- MENTOR MemoryGel Breast Implant 3508004BCProsthesis, breast, noninflatable, internal, silicone gel-filled481 reports
- MENTOR MemoryGel Breast Implant 3507325BCProsthesis, breast, noninflatable, internal, silicone gel-filled464 reports
- MENTOR MemoryGel Breast Implant 3507400BCProsthesis, breast, noninflatable, internal, silicone gel-filled460 reports
- MENTOR MemoryGel Breast Implant 3507300BCProsthesis, breast, noninflatable, internal, silicone gel-filled455 reports
- MENTOR MemoryGel Breast Implant 3506001BCProsthesis, breast, noninflatable, internal, silicone gel-filled400 reports
- MENTOR MemoryGel Breast Implant 3507275BCProsthesis, breast, noninflatable, internal, silicone gel-filled377 reports
- MENTOR MemoryGel Breast Implant 3507375BCProsthesis, breast, noninflatable, internal, silicone gel-filled359 reports
- MENTOR MemoryGel Breast Implant 3502251BCProsthesis, breast, noninflatable, internal, silicone gel-filled358 reports
- MENTOR MemoryGel Breast Implant 3507450BCProsthesis, breast, noninflatable, internal, silicone gel-filled342 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX350Prosthesis, breast, noninflatable, internal, silicone gel-filled339 reports
- MENTOR MemoryGel Breast Implant 3502504BCProsthesis, breast, noninflatable, internal, silicone gel-filled338 reports
- MENTOR MemoryGel Breast Implant 3505535BCProsthesis, breast, noninflatable, internal, silicone gel-filled325 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 Breast Implant 3502001BCProsthesis, breast, noninflatable, internal, silicone gel-filled295 reports
- MENTOR MemoryGel Breast Implant 3505590BCProsthesis, breast, noninflatable, internal, silicone gel-filled274 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX405Prosthesis, breast, noninflatable, internal, silicone gel-filled261 reports
- MENTOR MemoryGel Breast Implant 3507275MCProsthesis, breast, noninflatable, internal, silicone gel-filled250 reports
- MENTOR MemoryGel Breast Implant 3507001BCProsthesis, breast, noninflatable, internal, silicone gel-filled242 reports
- MENTOR MemoryGel Breast Implant 3507300MCProsthesis, breast, noninflatable, internal, silicone gel-filled231 reports
- MENTOR MemoryGel Breast Implant 3505480BCProsthesis, breast, noninflatable, internal, silicone gel-filled226 reports
- MENTOR MemoryGel Breast Implant 3507255MCProsthesis, breast, noninflatable, internal, silicone gel-filled225 reports
- MENTOR MemoryGel Breast Implant 3505251BCProsthesis, breast, noninflatable, internal, silicone gel-filled220 reports
- MENTOR MemoryGel Breast Implant 3507360MCProsthesis, breast, noninflatable, internal, silicone gel-filled216 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX370Prosthesis, breast, noninflatable, internal, silicone gel-filled213 reports
- MENTOR MemoryGel Breast Implant 3507250BCProsthesis, breast, noninflatable, internal, silicone gel-filled212 reports
- MENTOR MemoryGel Breast Implant 3505650BCProsthesis, breast, noninflatable, internal, silicone gel-filled203 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX450Prosthesis, breast, noninflatable, internal, silicone gel-filled200 reports
- MENTOR MemoryGel Breast Implant 3507320MCProsthesis, breast, noninflatable, internal, silicone gel-filled199 reports
- MENTOR MemoryGel Breast Implant 3505455BCProsthesis, breast, noninflatable, internal, silicone gel-filled199 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX270Prosthesis, breast, noninflatable, internal, silicone gel-filled196 reports
- MENTOR MemoryGel Breast Implant 3507504BCProsthesis, breast, noninflatable, internal, silicone gel-filled194 reports
- MENTOR MemoryGel Breast Implant 3507500BCProsthesis, breast, noninflatable, internal, silicone gel-filled191 reports
- MENTOR MemoryGel Breast Implant 3543007Prosthesis, breast, noninflatable, internal, silicone gel-filled184 reports
- MENTOR MemoryGel Breast Implant 3543507Prosthesis, breast, noninflatable, internal, silicone gel-filled182 reports
- MENTOR MemoryGel Breast Implant 3505400BCProsthesis, breast, noninflatable, internal, silicone gel-filled181 reports
- MENTOR MemoryGel Breast Implant 3505430BCProsthesis, breast, noninflatable, internal, silicone gel-filled179 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX415Prosthesis, breast, noninflatable, internal, silicone gel-filled176 reports
- MENTOR MemoryGel Breast Implant 3506501BCProsthesis, breast, noninflatable, internal, silicone gel-filled175 reports
- MENTOR MemoryGel Breast Implant 3508001BCProsthesis, breast, noninflatable, internal, silicone gel-filled167 reports
- MENTOR MemoryGel Breast Implant 3544007Prosthesis, breast, noninflatable, internal, silicone gel-filled166 reports
- MENTOR MemoryGel Breast Implant 3507225BCProsthesis, breast, noninflatable, internal, silicone gel-filled165 reports
- MENTOR MemoryGel Breast Implant 3507340MCProsthesis, breast, noninflatable, internal, silicone gel-filled165 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX350Prosthesis, breast, noninflatable, internal, silicone gel-filled164 reports
- MENTOR MemoryGel Breast Implant 3543257Prosthesis, breast, noninflatable, internal, silicone gel-filled160 reports
- MENTOR MemoryGel Breast Implant 3507385MCProsthesis, breast, noninflatable, internal, silicone gel-filled157 reports
- MENTOR MemoryGel Breast Implant 3505800BCProsthesis, breast, noninflatable, internal, silicone gel-filled157 reports
- MENTOR MemoryGel Breast Implant 3507405MCProsthesis, breast, noninflatable, internal, silicone gel-filled155 reports
- MENTOR MemoryGel Breast Implant 3505350BCProsthesis, breast, noninflatable, internal, silicone gel-filled155 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 Breast Implant 3507215MCProsthesis, breast, noninflatable, internal, silicone gel-filled146 reports
- MENTOR MemoryGel Breast Implant 3505375BCProsthesis, breast, noninflatable, internal, silicone gel-filled145 reports
- MENTOR MemoryGel Xtra Breast Implant SMPX240Prosthesis, breast, noninflatable, internal, silicone gel-filled145 reports
- MENTOR MemoryGel Breast Implant 3507235MCProsthesis, breast, noninflatable, internal, silicone gel-filled143 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 Breast Implant 3544507Prosthesis, breast, noninflatable, internal, silicone gel-filled130 reports
- MENTOR MemoryGel Breast Implant 3542757Prosthesis, breast, noninflatable, internal, silicone gel-filled129 reports
- MENTOR MemoryGel Xtra Breast Implant SMHX400Prosthesis, breast, noninflatable, internal, silicone gel-filled129 reports
- MENTOR MemoryGel Breast Implant 3544001Prosthesis, breast, noninflatable, internal, silicone gel-filled126 reports
- MENTOR MemoryGel Breast Implant 3505751BCProsthesis, breast, noninflatable, internal, silicone gel-filled126 reports
- MENTOR MemoryGel Breast Implant 3505700BCProsthesis, breast, noninflatable, internal, silicone gel-filled126 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 Breast Implant 3507550BCProsthesis, breast, noninflatable, internal, silicone gel-filled125 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX535Prosthesis, breast, noninflatable, internal, silicone gel-filled125 reports
- MENTOR MemoryGel Breast Implant 3507200BCProsthesis, breast, noninflatable, internal, silicone gel-filled123 reports
- MENTOR MemoryGel Breast Implant 3502254BCProsthesis, breast, noninflatable, internal, silicone gel-filled119 reports
- MENTOR MemoryGel Breast Implant 3543501Prosthesis, breast, noninflatable, internal, silicone gel-filled115 reports
- MENTOR MemoryGel Xtra Breast Implant SHPX465Prosthesis, breast, noninflatable, internal, silicone gel-filled115 reports
Recent MENTOR MemoryGel Breast Implants 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
Patient problems: Capsular Contracture
MAUDE report 50952391 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50952369 ↗InjurySep 30, 2026Migration
Patient problems: Deformity/ Disfigurement
MAUDE report 50952138 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent breast augmentation revision with two 350cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient was diagnosed with bilateral breast asymmetry and wrinkling. 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: Deformity/ Disfigurement; Wrinkling
MAUDE report 50950086 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent breast augmentation revision with two 350cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient was diagnosed with bilateral breast asymmetry and wrinkling. 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: Deformity/ Disfigurement; Wrinkling
MAUDE report 50950078 ↗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, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50949884 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50949879 ↗InjurySep 30, 2026Migration
It was reported that a patient underwent breast augmentation revision with two 400cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient was diagnosed with bilateral breast implant malposition and displacement. As a result, the patient underwent breast implant removal and replacement surgery on (b)(6)2020. The replacement devices were two Mentor gel implants.This Medwatch form is for the right breast prosthesis.
Patient problems: Deformity/ Disfigurement
MAUDE report 50949863 ↗InjurySep 30, 2026Material Rupture
It was reported that a female patient underwent Breast Augmentation Revisionwith MENTOR MemoryGel, 250cc Silicone prosthesis. Subsequently the patient experienced left sided silent rupture post operation. The issue was confirmed through MRI examination. As a result, the patient scheduled for removal surgery on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948671 ↗InjurySep 30, 2026Material Rupture
Patient problems: Capsular Contracture
MAUDE report 50948540 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a female patient underwent Breast Augmentation Primarywith MENTOR MemoryGel, 650cc Silicone prosthesis. Subsequently the patient experienced right sided capsular contracture grade IV post operation. The issue was diagnosed through physical examination. As a result, the patient scheduled for removal surgery on (b)(6) 2026.
Patient problems: Capsular Contracture
MAUDE report 50948361 ↗InjurySep 30, 2026Material Rupture
It was reported that a female patient underwent unspecified breast augmentation with MENTOR MemoryGel, 325cc silicone implants. The patient subsequently presented with right-sided capsular contracture grade III, symptomatic rupture and left sided silent rupture. Rupture were discovered during surgery. As a result, the patient underwent bilateral replacements with unspecified Mentor Gel on (b)(6)2026. This report relates to the left side.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948113 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient implanted with a 425cc MENTOR MemoryGel Breast Implant experienced ptosis 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: Deformity/ Disfigurement
MAUDE report 50947605 ↗
Other Mentor Texas L.P. products
- 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 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, combining the brand names used for this product line.
- 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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