NATRELLE Silicone-Filled Breast Implants 20-800Recalls & reported problems
Allergan, Inc. · NATRELLE Style 20-800 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 Natrelle silicone-filled breast implant is a smooth, round, high-profile implant made by Allergan. The 34 reports mostly describe implants rupturing or leaking gel, and the scar tissue around the implant tightening so the breast becomes hard, firm and smaller (capsular contracture); some implants were removed and replaced. There were34 injuries and no deaths, and no recalls name this device. Nine reports came in the last 12 months, while none did in the prior 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
- 35
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10888628001800), received between May 20, 2019 and Sep 9, 2026 — classified as 35 injuries.
The most frequently reported specific device problem is “Material Rupture” (18 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 Rupture18
- Device Appears to Trigger Rejection15
- Patient-Device Incompatibility3
- Adverse Event Without Identified Device or Use Problem2
- Fluid/Blood Leak1
Patient problems
- Capsular Contracture18
- Failure of Implant14
- No Clinical Signs, Symptoms or Conditions2
- Swollen Lymph Nodes/Glands2
- Lymphoma1
- Swollen Lymph Nodes1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Material Rupture
Healthcare professional reported "explant ruptured". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50681823 ↗InjuryJun 12, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular Contracture Baker Grade IV". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 25488182 ↗InjuryJun 12, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported "Capsular Contracture Baker Grade IV" and "rupture". This record is for the right side. Device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 25487329 ↗InjuryApr 15, 2026Material Rupture
PATIENT REPORTED "RUPTURE, IMPLANT IS SMALLER THEN THE CONTRALATERAL SIDE AND BOTTOM OF THE IMPLANT FEELS LIKE A NATURAL BREAST COMPARED TO THE CONTRALATERAL SIDE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24887394 ↗InjuryMar 17, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED THROUGH SALES REPRESENTATIVE "RUPTURED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24623906 ↗InjuryMar 4, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24514249 ↗InjuryJan 22, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE AND CAPSULAR CONTRACTURE, BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24144677 ↗InjuryJan 9, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 24019988 ↗InjuryJan 9, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24017920 ↗InjuryDec 23, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23885092 ↗InjuryFeb 21, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18749782 ↗InjuryOct 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 18015270 ↗InjurySep 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED AND REPLACED. THIS RELATES TO THE LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 17804154 ↗InjuryJun 12, 2023Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE "POSSIBLE RUPTURE, GOLF BALL KNOT, CAN'T LIFT ARM - WHICH IS NOT DEVICE RELATED, SCAR TISSUE, PAIN AND IMPLANT NOT IN THE RIGHT SPOT". THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17113471 ↗InjuryApr 21, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED, A LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16791942 ↗InjuryFeb 21, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE VIA COMPANY REPRESENTATIVE LATER CONFIRMED TO BE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH NON-ALLERGAN DEVICE.
Patient problems: Failure of Implant
MAUDE report 16410428 ↗InjuryJan 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16138118 ↗InjuryDec 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT "CAPSULAR CONTRACTURE, BAKER GRADE IV." THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16071759 ↗InjuryDec 29, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT "CAPSULAR CONTRACTURE, BAKER GRADE IV". HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16068037 ↗InjuryDec 6, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. LATER, HEALTHCARE PROFESSIONAL REPORTED, CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED. TREATMENT - CAPSULOTOMY.
Patient problems: Capsular Contracture
MAUDE report 15924185 ↗InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPRESENTATIVE REPORTED RIGHT SIDE ¿SEVERE INFLAMMATION OF LYMPH NODES,¿ ¿RASHES,¿ ¿TINGLING SKIN,¿ ¿FEAR OF CANCER RECURRENCE, EMOTIONAL DISTRESS,¿ ¿PAIN AND SUFFERING.¿ PATIENT REPRESENTATIVE ADDITIONALLY REPORTED ¿HAIR LOSS¿ NOT RELATED TO THE DEVICE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Swollen Lymph Nodes/Glands
MAUDE report 14197640 ↗InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPRESENTATIVE REPORTED LEFT SIDE ¿DIAGNOSIS OF BIA-ALCL,¿ ¿SEVERE INFLAMMATION OF LYMPH NODES,¿ ¿RASHES,¿ ¿TINGLING SKIN,¿ ¿FEAR OF CANCER RECURRENCE, EMOTIONAL DISTRESS,¿ ¿PAIN AND SUFFERING.¿ PATIENT REPRESENTATIVE ADDITIONALLY REPORTED ¿HAIR LOSS¿ NOT RELATED TO THE DEVICE. HISTOPATHOLOGICAL MARKERS CONFIRMING ALCL HAVE NOT BEEN RECEIVED. THE DEVICE HAS BEEN EXPLANTED. TREATMENT: DEVICE EXPLANT, TOTAL MASTECTOMY, CHEMOTHERAPY, RADIATION.
Patient problems: Lymphoma; Swollen Lymph Nodes/Glands
MAUDE report 14196480 ↗InjuryNov 16, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 12823933 ↗InjuryOct 28, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12712871 ↗InjuryFeb 24, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED THE REASON FOR RIGHT SIDE DEVICE REMOVAL IS NOTED AS "CAPSULE CONTRACTURE," BAKER GRADE NOT SPECIFIED. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11373665 ↗
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-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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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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