NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MM-410320Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE MM 320CC 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 gel-filled breast implant is made by Allergan. The 32 reports mostly describe implants rupturing or leaking, with scarring that tightens around the implant (capsular contracture), fluid buildup, and some reports of the body mounting a rejection-like inflammatory reaction to the textured surface. These reports describe 32 injuries and no deaths. One open recall, started in July 2019, followed FDA notice of a higher rate of a rare lymphoma (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 10888628003637), received between May 14, 2019 and Mar 19, 2026 — classified as 31 injuries.
The most frequently reported specific device problem is “Material Rupture” (16 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 Rupture16
- Device Appears to Trigger Rejection7
- Patient-Device Incompatibility7
- Adverse Event Without Identified Device or Use Problem5
Patient problems
- Capsular Contracture14
- Failure of Implant12
- Seroma4
- Swollen Lymph Nodes/Glands2
- No Clinical Signs, Symptoms or Conditions1
- Pain1
- Swollen Lymph Nodes1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH". HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE" AND "EXPLODED". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24639182 ↗InjuryJan 6, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "PAIN", "RUPTURE" AND "EXCHANGE OF TEXTURED DEVICES DUE TO CONCERN WITH PRODUCT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED AND IT WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23979787 ↗InjuryDec 12, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23789424 ↗InjuryOct 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULAR CONTRACTURE BAKER GRADE IV¿ AND ¿EXCHANGE OF TEXTURED DEVICES DUE TO PRODUCT CONCERN¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23371751 ↗InjuryMay 8, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED TEXTURED IMPLANT AND RUPTURE. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 21986344 ↗InjuryJul 7, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED TEXTURED TO SMOOTH IMPLANT EXCHANGE ON RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED. HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE "HOLE, NON-SPECIFIC RUPTURE."
Patient problems: Failure of Implant
MAUDE report 17277954 ↗InjuryJun 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17175583 ↗InjuryMay 19, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV, RUPTURE, AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANT DUE TO PATIENT'S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16970381 ↗InjuryAug 17, 2022Material Rupture; Material Rupture
PATIENT CALLED TO REPORT DEVICE MIGRATION, EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15243532 ↗InjuryAug 17, 2022Material Rupture; Material Rupture
PATIENT CALLED TO REPORT DEVICE MIGRATION, EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15242991 ↗InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "TEXTURED, PAIN UNDER ARMS, IMPLANTS MOVING TO SIDE, MUSCLE ACHES, 'HEALTH ISSUES', 'MAKING ME SICK', NAUSEA, AND SWOLLEN LYMPH NODES UNDER ARM" AGAINST LEFT DEVICE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Swollen Lymph Nodes/Glands
MAUDE report 15114564 ↗InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "TEXTURED, PAIN UNDER ARMS, IMPLANTS MOVING TO SIDE, MUSCLE ACHES, 'HEALTH ISSUES', 'MAKING ME SICK', NAUSEA, AND SWOLLEN LYMPH NODES UNDER ARM" AGAINST RIGHT DEVICE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Swollen Lymph Nodes/Glands
MAUDE report 15114442 ↗InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED A "BILATERAL EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT, AND ¿THE PATIENT HAS PAIN AND SWELLING IN THE LEFT BREAST, A MRI CONFIRMED EXCESS FLUID AND THE PATIENT IS CONCERNED ABOUT ALCL.¿ THIS IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 14704565 ↗InjuryOct 14, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryOct 14, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryJun 10, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND FLUID COLLECTION. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 11978999 ↗InjuryMar 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEVICE REMOVAL DUE TO "PAIN, TEXTURE." DEVICE HAS BEEN EXPLANTED.
Patient problems: Pain
MAUDE report 11580181 ↗InjuryMar 18, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11520556 ↗InjuryNov 18, 2020Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PATIENT ADDITIONALLY REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV AND HARDENING." DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 10860991 ↗InjuryOct 19, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PATIENT'S CONCERN WITH THE PRODUCT". ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10697136 ↗InjurySep 11, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULE BAKER III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10525392 ↗InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED RIGHT SIDE "ANXIETY" AND "ENLARGED LYMPH NODES." PATIENT ADDITIONALLY REPORTED "FATIGUE, ARTHRITIS, AND BREAST PLANT ILLNESS;" THESE EVENTS ARE NOT RELATED TO THE DEVICE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Swollen Lymph Nodes
MAUDE report 10263916 ↗InjuryMay 4, 2020Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE, ANXIETY RELATED TO TEXTURED IMPLANTS AS WELL AS "TWINGES OF PAIN." DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10021823 ↗InjuryMay 4, 2020Material Rupture; Material Rupture
PATIENT REPORTED A RIGHT SIDE RUPTURE, ANXIETY RELATED TO TEXTURED IMPLANTS AS WELL AS "TWINGES OF PAIN." DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10021760 ↗InjuryJan 22, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED RIGHT SIDE ITCHING, "MISSHAPEN BREASTS," CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, AND "DISCOMFORT." THE FOLLOWING PATIENT REPORTED EVENTS HAVE BEEN DEEMED NOT RELATED TO THE DEVICE: NEUROPATHY IN HANDS AND FEET AND OVARIAN CANCER. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9617132 ↗
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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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