NATRELLE Silicone-Filled Breast Implants 15-492Recalls & reported problems
Allergan, Inc. · NATRELLE Style 15-492 Moderate plus profile |smooth|round|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · NATRELLE Silicone-Filled Breast Implants (128)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This NATRELLE silicone-filled breast implant has 87 adverse event reports, with no deaths and 87 injuries. Reports mostly describe implants rupturing or leaking silicone, along with hardening of scar tissue around the implant that can cause pain and the implant to fail. No recalls name this device. Reports have risen sharply, from 8 in the previous 12 months to 36 in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 95
- Deaths reported
- 0
- Injuries reported
- 95
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 10888628001510), received between May 8, 2019 and Sep 28, 2026 — classified as 95 injuries.
The most frequently reported specific device problem is “Material Rupture” (66 reports).
4 other recalls cover devices cleared under the same FDA submission (P020056); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture66
- Device Appears to Trigger Rejection21
- Patient-Device Incompatibility17
- Improper or Incorrect Procedure or Method2
- Adverse Event Without Identified Device or Use Problem1
- Material Invagination1
- No Apparent Adverse Event1
Patient problems
- Failure of Implant39
- Capsular Contracture38
- No Clinical Signs, Symptoms or Conditions24
- Breast Mass1
- Pain1
- Seroma1
Recent adverse event reports
The 25 most recent of 95 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926124 ↗InjurySep 28, 2026Material Rupture
Patient reported "moderate pain". Later, healthcare professional reported "ruptured". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912229 ↗InjurySep 25, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903933 ↗InjurySep 23, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50875959 ↗InjurySep 23, 2026Material Invagination
Healthcare professional reported "herniation" and "bulging and device fold towards walls". This record is for right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863230 ↗InjurySep 22, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862330 ↗InjurySep 18, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818998 ↗InjurySep 17, 2026Device Appears to Trigger Rejection
Healthcare professional reported "contralateral Rupture". Later healthcare professional reported "capsular contracture Baker Grade III". Later healthcare professional reported "no complaint", "it was found without abnormality". This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50806555 ↗InjurySep 14, 2026Improper or Incorrect Procedure or Method
Healthcare professional reported "found nothing wrong with device resulting in reimplantation with same device". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757258 ↗InjurySep 14, 2026Device Appears to Trigger Rejection
Patient reported "soreness", "pain", "tenderness", "burning sensation" and "Capsular Contracture Baker Grade Unknown", "Lupus" and "Rheumatoid arthritis" which are not device related. Patient was prescribed with injections every three months and Etoricoxib as needed. This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50752971 ↗InjurySep 11, 2026Improper or Incorrect Procedure or Method
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744598 ↗InjurySep 11, 2026Material Rupture
Healthcare professional reported a "Rupture". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734617 ↗InjurySep 10, 2026Material Rupture
Healthcare professional reported "pain" and "rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713429 ↗InjurySep 9, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691486 ↗InjurySep 8, 2026Material Rupture
Healthcare professional reported a "Rupture". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50676121 ↗InjuryAug 31, 2026Material Rupture
Healthcare professional reported "leaking silicone implant". This record is for left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50531781 ↗InjuryAug 24, 2026Material Rupture
Healthcare professional reported "Rupture" against the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50408471 ↗InjuryAug 17, 2026Material Rupture
Patient reported "lymph node reaction in armpit, lots of burning, pain, a little marble like mass under armpit and rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50275527 ↗InjuryAug 14, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50262948 ↗InjuryAug 12, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228926 ↗InjuryAug 5, 2026Device Appears to Trigger Rejection
Healthcare professional reported Capsular Contracture Baker Grade unknown, "nipple ptosis" and "thickened and heavily calcified capsule". Healthcare professional later reported "Capsular Contracture Baker Grade IV" and "found to be intact during surgery". This record is for the left side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50147888 ↗InjuryJul 9, 2026Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED "PAIN" AND "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 25774093 ↗InjuryJul 1, 2026Material Rupture
Patient reported "exchange with no complaint against the device." Later Patient reported "rupture." Later Healthcare professional reported "rupture and exchange." Later healthcare professional reported "capsular contracture Baker grade II." This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25677117 ↗InjuryJun 29, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25651609 ↗InjuryJun 25, 2026Material Rupture
Healthcare professional reported "possible rupture". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25630244 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P020056. One submission often covers many models, so check the product and lot details in each record.
- Z-0700-2020 · Nov 6, 2019 · TerminatedNatrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod
- Z-0701-2020 · Nov 6, 2019 · TerminatedNatrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 762
- Z-2454-2019 · Jul 24, 2019 · Open, ClassifiedNatrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-
- Z-2453-2019 · Jul 24, 2019 · Open, ClassifiedNatrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TR
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- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
- MENTOR MemoryGel Breast Implant 3504501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,690 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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