NATRELLE Silicone-Filled Breast Implants 10-420Recalls & reported problems
Allergan, Inc. · NATRELLE Style 10-420 Moderate 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 (Style 10-420, moderate profile) is a smooth, round breast prosthesis made by Allergan. The 30 reports mostly describe implants rupturing or leaking, and the surrounding scar tissue tightening around the implant so the breast becomes hard, swollen, or painful; some implants were removed and replaced. There were 30 injuries and no deaths, with no recalls naming this device. Reports rose sharply, from 3 in the prior 12 months to 16 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
- 26
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10888628001282), received between Jun 12, 2020 and Sep 24, 2026 — classified as 26 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 Rejection11
- Adverse Event Without Identified Device or Use Problem3
- Patient-Device Incompatibility1
Patient problems
- Capsular Contracture12
- Failure of Implant7
- No Clinical Signs, Symptoms or Conditions4
- Seroma2
- Arthritis1
- Nervous System Injury1
- Pallor1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Device Appears to Trigger Rejection
Patient reported "Capsular Contracture Baker grade unknown" and "Really high". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50880473 ↗InjuryAug 18, 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 50305810 ↗InjuryJul 30, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported "capsular contracture Baker grade IV", "rupture" and "calcification". Patient received capsulectomy treatment. This record is for left side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50091674 ↗InjuryJun 3, 2026Material Rupture
PATIENT REPORTED "RUPTURE, BREAST ENGORGING/GETTING BIGGER, DISCOMFORT, AND EXTREMELY SHARP". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25386295 ↗InjuryJun 1, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED OF THE RIGHT SIDE DEVICE: "RUPTURE". THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 25356428 ↗InjuryMar 26, 2026Material Rupture
PATIENT REPORTED "RUPTURE", "AUTOIMMUNE PROBLEMS", "INFLAMMATION", "HAIR LOSS", "FATIGUE" AND "HEART PALPITATIONS". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699421 ↗InjuryMar 26, 2026Material Rupture
PATIENT REPORTED "RUPTURE", "AUTOIMMUNE PROBLEMS", "INFLAMMATION", "HAIR LOSS", "FATIGUE" AND "HEART PALPITATIONS". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699262 ↗InjuryMar 11, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24575805 ↗InjuryMar 4, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 24513596 ↗InjuryMar 4, 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 WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 24508366 ↗InjuryJan 7, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "POSSIBLE RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23989443 ↗InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "RAYNAUD'S PHENOMENON" THAT HAVE BEEN DEEMED NOT DEVICE RELATED. PATIENT LATER REPORTED "ULNAR NERVE DAMAGE, CORPAL AND CARPEL TUNNEL DAMAGE ELBOW AND WRIST", "LITTLE SIDE MOTION STRENGTH IN MY ARM WITHOUT SEVERE PAIN" AND "RED SPOTS ON MY FOREARMS AND VULVAR SWELLING APPEAR THEN DISAPPEAR, BUT THE VULVAR ITCHING". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.
Patient problems: Arthritis; Nervous System Injury; Pallor; Skin Inflammation/ Irritation
MAUDE report 23969917 ↗InjuryMar 5, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURE". DEVICE HAS BEEN EXPLANTED AND DISCARDED.
Patient problems: Failure of Implant
MAUDE report 21532113 ↗InjuryDec 11, 2024Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CHANGE IN SHAPE/PROJECTION OF IMPLANT", "SUSPECTED LEFT IMPLANT RUPTURE ON SURGEON ULTRASOUND", AND CAPSULAR CONTRACTURE, BAKER GRADE III. RECORD IS FOR LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 20904057 ↗InjuryDec 9, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "PAIN", "CHANGE IN SHAPE/PROJECTION OF IMPLANT", AND "BAKER GRADE III CAPSULAR CONTRACTURE." RECORD IS FOR RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 20880895 ↗InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED A LEFT SIDE "RASH ON BOTH BREASTS." PATIENT LATER REPORTED "REJECTING, BIGGER, AND WATER AROUND." DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 18968621 ↗InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED A RIGHT SIDE "RASH ON BREAST." PATIENT LATER REPORTED "REJECTING, BIGGER, AND WATER AROUND." DEVICE REMAIN IMPLANTED.
Patient problems: Seroma
MAUDE report 18968557 ↗InjuryJan 12, 2024Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18503602 ↗InjuryOct 31, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "RUPTURE". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15703619 ↗InjuryNov 22, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED A BUCKLE/RIPPLE/FOLD THAT THEY CAN SEE AND FEEL. HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV, VISUAL DISTORTION, AND PAIN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12855570 ↗InjuryNov 18, 2021Material Rupture; Material Rupture
InjuryJul 14, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 12166765 ↗InjuryJul 9, 2021Material Rupture; Material Rupture
THE DEVICE HAS BEEN EXPLANTED, REPLACED, AND DISCARDED.
Patient problems: Failure of Implant
MAUDE report 12144592 ↗InjuryMar 11, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11463845 ↗InjuryDec 10, 2020Material Rupture; Material Rupture
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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