NATRELLE Silicone-Filled Breast Implants 20-375Recalls & reported problems
Allergan, Inc. · NATRELLE Style 20-375 High 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 Allergan Natrelle silicone breast implant has 91 adverse event reports, with 91 injuries and no deaths. Reports mostly describe material rupture and capsular contracture, sometimes with rejection or implant failure. The past 12 months had 27 reports versus 12 in the prior 12 months. No recalls name this device.
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
- 91
- Deaths reported
- 0
- Injuries reported
- 91
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 10888628001695), received between May 21, 2019 and Sep 30, 2026 — classified as 91 injuries.
The most frequently reported specific device problem is “Material Rupture” (57 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 Rupture57
- Device Appears to Trigger Rejection30
- Patient-Device Incompatibility13
- Migration1
- No Apparent Adverse Event1
Patient problems
- Capsular Contracture44
- Failure of Implant39
- No Clinical Signs, Symptoms or Conditions9
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported "Rupture", "fibroadenoma", "Capsular contracture" Baker Grade III, " breast tissue hangs off inferiorly", " implants sit high on the chest" and "past medical history of Depression/Anxiety". This record is for the right side. Device remains implanted. Healthcare professional also reported "Ptosis" and "past medical history of cold sores" which are not device related. Patient is taking the following medications: GLP1, Ambien, Estrogen 0.5 mg, Ezetimibe 5 mg, Progesterone micronized 200 mg capsule, Prozac, Rosuvastatin, Testosterone, Tizanidine 4 mg capsule. Patient was prescribed Hibiciens soap and scopolamine patch.
Patient problems: Capsular Contracture
MAUDE report 50943780 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture" Baker Grade III, " breast tissue hangs off inferiorly", " implants sit high on the chest" and "past medical history of Depression/Anxiety". This record is for the left side. Device remains implanted. Healthcare professional also reported "Ptosis" and "past medical history of cold sores" which are not device related. Patient is taking the following medications: GLP1, Ambien, Estrogen 0.5 mg, Ezetimibe 5 mg, Progesterone micronized 200 mg capsule, Prozac, Rosuvastatin, Testosterone, Tizanidine 4 mg capsule. Patient was prescribed Hibiciens soap and scopolamine patch.
Patient problems: Capsular Contracture
MAUDE report 50943665 ↗InjurySep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926022 ↗InjurySep 21, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847340 ↗InjurySep 16, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50796809 ↗InjurySep 14, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761086 ↗InjurySep 14, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760604 ↗InjurySep 13, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50746924 ↗InjuryJul 15, 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 25825312 ↗InjuryJul 8, 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 25745434 ↗InjuryJul 7, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". HEALTHCARE PROFESSIONAL LATER REPORTED "ANY CREASES". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25742729 ↗InjuryMay 12, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25152976 ↗InjuryMar 17, 2026Material Rupture
PATIENT REPORTED ¿RUPTURE¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24619139 ↗InjuryFeb 5, 2026Migration
Later healthcare professional reported "rupture" collateral side only. Later healthcare professional reported Capsular Contracture Baker Grade IV and ptosis. Ptosis is considered not device related. Patient underwent a capsulectomy. This record is for the left side. Device was explanted.
Patient problems: Failure of Implant
MAUDE report 24268087 ↗InjuryFeb 5, 2026Material Rupture
Later healthcare professional reported "rupture". Later healthcare professional reported Capsular Contracture Baker Grade IV, ptosis and "free silicone". Ptosis is considered not device related. Patient underwent a capsulectomy. This record is for the right side. Device was explanted.
Patient problems: Failure of Implant
MAUDE report 24267687 ↗InjuryFeb 5, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". LATER HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 24265166 ↗InjuryJan 6, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "WAS TOLD IT WAS RUPTURED" VIA ULTRASOUND. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED. THE DEVICE WILL NOT BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23974843 ↗InjuryJan 5, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23956421 ↗InjuryJan 3, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "WAS TOLD IT WAS RUPTURED" VIA ULTRASOUND. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED. THE DEVICE WILL NOT BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23953682 ↗InjuryDec 31, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED AND IT WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23933031 ↗InjuryDec 17, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23835616 ↗InjuryDec 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED AND IT WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23807645 ↗InjuryDec 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED AND IT WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23807568 ↗InjuryDec 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "INFECTION (LATE ONSET)", "METASTATIC BREAST CANCER: METS TO BONE AND LUNGS"-NDR (NOT DEVICE RELATED) AND "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture; Unspecified Infection
MAUDE report 23728847 ↗InjuryDec 1, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23687217 ↗
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-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-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-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
- 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-
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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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