NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FF-410655Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE FF 655CC BIOCELL |textured|contour|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Natrelle 410 textured silicone-filled breast implant appears in 45 adverse event reports, all describing injuries and no deaths. Most reports concern the implant shell breaking or leaking, fluid collecting around the implant, and the scar tissue tightening around it (capsular contracture), often leading to removal or exchange to a smooth implant; a few mention a type of lymphoma linked to textured implants. One recall remains open, started in July 2019 over an FDA update on higher rates of anaplastic large cell lymphoma with textured breast implants.
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
- 46
- Deaths reported
- 0
- Injuries reported
- 46
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10888628002722), received between Jul 31, 2019 and Sep 8, 2026 — classified as 46 injuries.
The most frequently reported specific device problem is “Material Rupture” (23 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jul 24, 2019Class IOpen, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Z-2452-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Rupture23
- Device Appears to Trigger Rejection10
- Adverse Event Without Identified Device or Use Problem8
- Patient-Device Incompatibility8
- Migration1
- No Apparent Adverse Event1
Patient problems
- Failure of Implant20
- Capsular Contracture18
- Seroma6
- No Clinical Signs, Symptoms or Conditions3
- Pain3
- Lymphoma2
- Swollen Lymph Nodes/Glands1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2026Migration
Patient reported "falling under my arm". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667561 ↗InjuryJun 10, 2026Material Rupture
PATIENT REPORTED ¿RUPTURE¿, ¿DISCOMFORT¿, ¿PAIN¿, ¿ITCHING UNDER ARMPIT¿ AND ¿EXCHANGE FROM TEXTURED TO SMOOTH¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25465921 ↗InjuryMar 10, 2026Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "EXCHANGE FROM TEXTURED TO SMOOTH". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24558022 ↗InjuryMar 10, 2026Material Rupture
PATIENT REPORTED "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24557873 ↗InjuryFeb 5, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "DEFORMITY", "PAIN", "ASYMMETRY", "CAPSULAR CONTRACTURES, BAKER GRADE UNKNOWN" AND "IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24267359 ↗InjuryDec 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE". THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WILL NOT BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23919102 ↗InjuryDec 22, 2025Material Rupture; Material Rupture
PATIENT REPORTED "LEAKING", "FLUID AROUND THE IMPLANT", "A FEW MONTHS AGO STARTED TO FEEL OFF" AND "EXCHANGE OF A TEXTURED DEVICE DUE TO PRODUCT CONCERN". LATER HEALTHCARE PROFESSIONAL REPORTED "FLUID AROUND THE IMPLANT". LATER, HEALTHCARE PROFESSIONAL REPORTED "ANATOMY TEXTURED RECALLED IMPLANT". LATER, HEALTHCARE PROFESSIONAL REPORTED "ANY CREASES" ON RGA FORM. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23873789 ↗InjuryApr 16, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
UN-REPORTING. HEALTHCARE PROFESSIONAL LATER CONFIRMED FOR A NON-ABBVIE DEVICE.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 21849009 ↗InjuryNov 19, 2024Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE OF THE RIGHT BREAST IMPLANT." DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 20720342 ↗InjuryFeb 28, 2024Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE "BREAST PAIN AND NIPPLE DISCHARGE." PATIENT ALSO REPORTED A LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THEIR CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED A LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 18797677 ↗InjuryApr 28, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RIGHT BREAST IMPLANT RUPTURE". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16830851 ↗InjuryDec 9, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTH PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV". DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15949198 ↗InjuryDec 7, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTH PROFESSIONAL REPORT "A BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV". DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15936460 ↗InjurySep 19, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED AN UNKNOWN SIDE OF HAVING DEVELOPED THE BIA-ALCL COMPLICATION. PATIENT LATER REPORTED "TEST WAS PERFORMED FOR BIA-ALCL AND IT CAME BACK NEGATIVE." THIS RECORD WILL BE FOR THE LEFT SIDE. HEALTHCARE PROFESSIONAL ADDITIONALLY CALLED TO REPORT "LEFT-SIDE CAPSULAR CONTRACTURE, UNKNOWN BAKER GRADE AND EXCHANGE OF TEXTURED DEVICE DUE TO PATIENT'S CONCERN WITH PRODUCT." DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15451920 ↗InjuryAug 16, 2022Material Rupture; Material Rupture
A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED AN UNKNOWN SIDE "DEFECTIVE IMPLANT AND A PALPABLE LUMP", AND RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15233541 ↗InjuryJul 18, 2022Material Rupture; Material Rupture
PATIENT REPRESENTATIVE REPORTED RIGHT SIDE RUPTURE AND CONCERN WITH PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15047855 ↗InjuryJul 18, 2022Material Rupture; Material Rupture
PATIENT REPRESENTATIVE REPORTED LEFT SIDE RUPTURE AND CONCERN WITH PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15047847 ↗InjuryJul 14, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) AND IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15019706 ↗InjuryJul 14, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) AND IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15015275 ↗InjuryJun 30, 2022Material Rupture; Material Rupture
PATIENT REPORTED A LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT¿S CONCERN OF THE PRODUCT AND RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 14876135 ↗InjuryJun 27, 2022Material Rupture; Material Rupture
PATIENT REPORTED A BILATERAL EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT¿S CONCERN OF THE PRODUCT AND RUPTURE. THIS IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14835618 ↗InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPRESENTATIVE REPORTED "PATIENT'S CONCERN WITH PRODUCT, TISSUE DAMAGE, SCARRING, DISFIGUREMENT, ASYMMETRY, ACCUMULATION OF FLUID, CAPSULECTOMY, PAIN, ANXIETY, PANIC DISORDER, AND CHRONIC HEADACHE. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 14255874 ↗InjuryJan 7, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13195319 ↗InjuryNov 17, 2021Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED RIGHT CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, "SMALL AMOUNT OF FLUID IN THE RIGHT POCKET", "TEXTURED" AND "MASS OF RIGHT AXILLA" (NON DEVICE RELATED).
Patient problems: Capsular Contracture; Failure of Implant; Seroma
MAUDE report 12829605 ↗InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED A PATIENT EXPERIENCING "LATE SEROMA" AND "BIA-ALCL;" PATHOLOGY HAS NOT BEEN RECEIVED AND THE MARKERS OF CD30+ AND ALK- HAVE NOT BEEN REPORTED/CONFIRMED. AFFECTED SIDE IS LEFT. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Lymphoma; Seroma
MAUDE report 11527094 ↗
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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 · each recall links to the FDA recall notice
- 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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