NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MF-410470Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE MF 470CC 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 Allergan Natrelle 410 silicone-gel breast implant is a soft, shaped implant used in breast reconstruction or augmentation. The 29 reports mostly describe implants that rupture or leak, and scar tissue that tightens around the implant (capsular contracture), along with fluid collections (seroma) and pain;29 injuries and no deaths were reported. One open recall, started in July 2019, followed FDA notice of a higher rate of a rare immune-cell cancer (BIA-ALCL) in patients 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
- 31
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10888628003491), received between Jun 19, 2019 and Sep 15, 2026 — classified as 31 injuries.
The most frequently reported specific device problem is “Material Rupture” (11 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 Rupture11
- Adverse Event Without Identified Device or Use Problem7
- Device Appears to Trigger Rejection7
- Patient-Device Incompatibility7
Patient problems
- Capsular Contracture15
- Failure of Implant9
- Seroma5
- Pain2
- Swollen Lymph Nodes/Glands2
- Lymphoma1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 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 50778582 ↗InjuryMay 28, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 25319485 ↗InjuryApr 23, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED OF THE LEFT SIDE DEVICE: "SEROMA", "GRADE IV CAPSULAR CONTRACTURE" AND "DOUBLE CAPSULE". THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 24967471 ↗InjuryApr 16, 2026Material Rupture
PATIENT REPORTED A "RUPTURE" CONFIRMED VIA MRI. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24905861 ↗InjuryMar 18, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24631955 ↗InjuryDec 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23917191 ↗InjuryDec 29, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23906639 ↗InjuryAug 7, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE CONFIRMED VIA MAMMOGRAM. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22740169 ↗InjuryNov 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 18058645 ↗InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "SEROMA, DUE TO BICYCLE ACCIDENT"; THIS IS NOT DEVICE RELATED. PHYSICIAN FURTHER REPORTED "RADIAL FOLDS" AND "AXILLARY LYMPHADENOPATHY" CONFIRMED VIA MRI. THE DEVICE REMAINS IMPLANTED.
Patient problems: Swollen Lymph Nodes/Glands
MAUDE report 16274695 ↗InjuryJun 16, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 14714586 ↗InjurySep 15, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT AND SEROMA". PHYSICIAN LATER ADDED "DURING EXPLANT SURGERY THE DOCTOR NOTICED A RIGHT SIDE RUPTURE." DEVICE HAS BEEN REPLACED AND DISCARDED.
Patient problems: Seroma
MAUDE report 12474461 ↗InjuryApr 30, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE BURNING AND SHOOTING PAINS IN ARMS & SHOULDERS, PLUS RIPPLES. HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11757870 ↗InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "LEFT-SIDE EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT" AND "SEROMA". DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 11323182 ↗InjuryNov 16, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL CONFIRMED LEFT SIDE RUPTURE.
Patient problems: Failure of Implant; Swollen Lymph Nodes/Glands
MAUDE report 10846851 ↗InjuryAug 28, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE DUE TO CONCERNS WITH THE PRODUCT AND CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10468977 ↗InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 29, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "FLUID" AND CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Lymphoma; Seroma
MAUDE report 10102807 ↗InjuryApr 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED IMPLANTS "GOT INFECTED." DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.
Patient problems: Unspecified Infection
MAUDE report 9963632 ↗InjuryMar 23, 2020Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL CONFIRMED THE EVENT OF RUPTURE AND EXCHANGE DUE TO TEXTURED IMPLANTS. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "WRINKLING, BRUISED LOOKING BREASTS, REDNESS, SWELLING, BIG AND FIRM, CONTRACTURE". DEVICE WAS DISCARDED AFTER SURGERY.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 9865315 ↗InjuryMar 18, 2020Material Rupture; Material Rupture
COMPANY REPRESENTATIVE REPORTED LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL CONFIRMED AND REPORTED "ASYMMETRY AND DEFORMITY" DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9848233 ↗InjuryJan 21, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE AND "BILATERAL DEFORMITIES, PAIN AND IMPLANTS HAD FLIPPED." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9611673 ↗InjuryDec 30, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9532656 ↗InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LEFT SIDE, "FLUID AROUND IMPLANT AND HARDNESS" AND "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANT DUE TO CONCERN WITH THE PRODUCT." DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 9511862 ↗InjuryNov 13, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "IMPLANT RECALL; CAPSULAR CONTRACTURE," BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9315564 ↗
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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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