NATRELLE Silicone-Filled Breast Implants 15-575Recalls & reported problems
Allergan, Inc. · NATRELLE Style 15-575 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 (Moderate plus profile, smooth, round) is made by Allergan. The 31 reports mostly describe implants rupturing or breaking, and scar tissue tightening around them (capsular contracture) that sometimes required removal or replacement surgery. All 31 reports involved injuries, and no deaths were reported. Reports doubled from 6 in the prior 12 months to 12 in the last 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
- 38
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10888628001534), received between Jun 17, 2019 and Sep 23, 2026 — classified as 38 injuries.
The most frequently reported specific device problem is “Material Rupture” (27 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 Rupture27
- Device Appears to Trigger Rejection9
- Patient-Device Incompatibility4
- Migration2
- No Apparent Adverse Event1
Patient problems
- Failure of Implant17
- Capsular Contracture13
- No Clinical Signs, Symptoms or Conditions6
- Nodule2
- Facial Paralysis1
- Seroma1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Material Rupture
Patient reported no complaint against the device. Later patient reported "Rupture". This record is for the left side. The device remains implanted. Patient received antibiotics as treatment.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873981 ↗InjurySep 11, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741382 ↗InjurySep 8, 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 50670612 ↗InjuryAug 7, 2026Device Appears to Trigger Rejection
Healthcare professional reported " Capsular Contracture Baker Grade III". This record is for the right side. Device remains implanted. Patient underwent a capsulectomy as treatment.
Patient problems: Capsular Contracture
MAUDE report 50175005 ↗InjuryAug 7, 2026Device Appears to Trigger Rejection
Healthcare professional reported " Capsular Contracture Baker Grade III". This record is for an unknown side. Device remains implanted. Patient had a Capsulectomy.
Patient problems: Capsular Contracture
MAUDE report 50174741 ↗InjuryJul 20, 2026Material Rupture
PATIENT REPORTED MODERATE BREAST PAIN. PATIENT ADDITIONALLY REPORTED ¿A LUMP OR THICKENING IN OR NEAR THE BREAST OR IN THE UNDERARM AREA". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE EXPLANTED.
Patient problems: Nodule
MAUDE report 25877008 ↗InjuryJul 20, 2026Material Rupture
Patient reported moderate breast pain. Patient additionally reported ¿A lump or thickening in or near the breast or in the underarm area". Later healthcare professional reported "rupture". This record is for the left side. Device was explanted.
Patient problems: Nodule
MAUDE report 25872535 ↗InjuryJun 23, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "SUBCENTIMETER T2 HYPERINTENSE NONENHANCING STRUCTURES MOST CONSISTENT WITH CYSTS". LATER HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE I. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25603026 ↗InjuryJun 18, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25548264 ↗InjuryMay 14, 2026Device Appears to Trigger Rejection; Material Rupture
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 25175823 ↗InjuryApr 21, 2026Material Rupture
InjuryMar 23, 2026Material Rupture; Migration
PATIENT REPORTS "RUPTURES", "AUTO IMMUNE DISEASES", "IMPLANTS ARE ODDLY SHAPED AND HAVE MOVED UNDER THE ARMPITS", "FEVER", AND "ITCHING" AND LATER REPORTED "BROKE IN HALF". THIS IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24662264 ↗InjuryMar 20, 2026Material Rupture; Migration
PATIENT REPORTS "RUPTURES", "AUTO IMMUNE DISEASES", "IMPLANTS ARE ODDLY SHAPED AND HAVE MOVED UNDER THE ARMPITS", "FEVER", AND "PAIN" AND LATER REPORTED "BROKE IN HALF". THIS IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24656066 ↗InjuryFeb 27, 2026Material Rupture; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION FOR A SILICONE DEVICE". LATER HCP "SURFACE IRREGULARITY ON THE SKIN". THIS RECORD IS FOR THE LEFT SIDE. DEVICE EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24474585 ↗InjuryJan 2, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED. DEVICE WILL NOT BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23943289 ↗InjuryDec 10, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE AND EXCHANGE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED. THE DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23771759 ↗InjuryDec 4, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE AND EXCHANGE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23716852 ↗InjuryNov 30, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE AND EXCHANGE" CONFIRMED BY MAMMOGRAM. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23677008 ↗InjuryNov 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "FIRM AND LOOKS ABNORMAL DUE TO CAPSULAR CONTRACTURE", BAKER GRADE III, AND BEING DIAGNOSED WITH A NEUROLOGICAL DISEASE SPECIFIED AS "BELL'S PALSY". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture; Facial Paralysis
MAUDE report 23458420 ↗InjuryOct 9, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RELATES TO THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED AND WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23251780 ↗InjuryJul 7, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND DISCARDED.
Patient problems: Failure of Implant
MAUDE report 22413636 ↗InjuryJun 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III/IV". THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22216088 ↗InjuryMay 26, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "SLIGHT DIFFERENCE" DIAGNOSED VIA MAMMOGRAM. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22084764 ↗InjuryApr 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21887107 ↗InjuryApr 8, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL LATER REPORTED "MALIGNANT NEOPLASM OF FEMALE BREAST, UNSPECIFIED ESTROGEN RECEPTOR STATUS, UNSPECIFIED LATERALITY, UNSPECIFIED SITE OF BREAST" (NOT DEVICE RELATED).
Patient problems: Failure of Implant
MAUDE report 21802529 ↗
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-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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