NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FX-410690Recalls & reported problems
Allergan, Inc. · STYLE, 410, FX, 690G 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 from Allergan is a shaped breast prosthesis. The 39 reports mostly describe implants rupturing or leaking, sometimes with the implant shifting position, plus hardening of the tissue around the implant (capsular contracture), fluid collection, pain, and infection. No deaths were reported and 39 injuries were. One recall began in July 2019 and remains open; it followed FDA notice of a higher rate of anaplastic large cell 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
- 39
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10888628003033), received between May 7, 2019 and Jun 9, 2025 — classified as 39 injuries.
The most frequently reported specific device problem is “Material Rupture” (15 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
- Adverse Event Without Identified Device or Use Problem15
- Material Rupture15
- Patient-Device Incompatibility10
- Device Appears to Trigger Rejection2
- Fluid/Blood Leak2
- Migration1
Patient problems
- Failure of Implant13
- Capsular Contracture12
- Seroma6
- Pain5
- Unspecified Infection3
- Cellulitis1
- Edema1
- Granuloma1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" CONFIRMED VIA MRI. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22172090 ↗InjuryJun 6, 2025Material Rupture; Material Rupture
InjuryDec 20, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE EXCHANGE DUE TO CONCERNS WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED MIGRATION. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH NON-ALLERGAN DEVICE.
Patient problems: Failure of Implant
MAUDE report 18370002 ↗InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Unspecified Infection
MAUDE report 18133925 ↗InjuryAug 10, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17505194 ↗InjuryAug 10, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED, A LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17505058 ↗InjuryFeb 15, 2023Material Rupture; Material Rupture
PATIENT REPORTED RUPTURE. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Failure of Implant
MAUDE report 16380138 ↗InjuryFeb 15, 2023Material Rupture; Migration; Material Rupture; Migration
PATIENT REPORTED RUPTURE. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE LEFT SIDE.
Patient problems: Failure of Implant; Granuloma; Swollen Lymph Nodes/Glands
MAUDE report 16380091 ↗InjurySep 28, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE "CONTRACTURE," BAKER GRADE UNKNOWN AND AN "IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12541937 ↗InjuryJul 27, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT AND LATER ADDED "RUPTURE". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 12232265 ↗InjuryJun 4, 2021Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE IS "MISSHAPEN," "RECALLED," "DISFIGURED WITH CREASES AND KIND OF DEFLATED AND HARD." PATIENT ADDITIONALLY REPORTED HEADACHES, FATIGUE, JOINT PAIN, "DIZZINESS, UNBALANCE, WEAKNESS, [AND] BREAST GET SO SORE IT FEELS LIKE STABBING" WHICH ARE NOT DEVICE RELATED. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 11941097 ↗InjuryApr 16, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11677557 ↗InjuryNov 20, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "HEALING AND CONTRACTURE CHANGES" AND EXCHANGE DUE TO CONCERN WITH PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 10879372 ↗InjuryNov 20, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "HEALING CHANGES" AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED "PATIENT'S CONCERN WITH THE PRODUCT." DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Impaired Healing
MAUDE report 10876216 ↗InjuryOct 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED RIGHT SIDE "IS HAVING ISSUES." HEALTHCARE PROFESSIONAL REPORTED "PAIN, FLUID AROUND IMPLANT, HARDENING OF IMPLANT." DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 10710127 ↗InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LEFT SIDE "PAIN, VERY HARD, TEXTURED, VERY SWOLLEN, AND HAS A SIGNIFICANT AMOUNT OF FLUID BUILD UP". DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 10437987 ↗InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED A LOT OF SWELLING AND PAIN AROUND THE LEFT SIDE BREAST IMPLANT AND HAS "LYMPHEDEMA". SWELLING GOES AROUND THE IMPLANT UP TO THE BACK AND UPON TOUCHING IT HURTS. DEVICE REMAINS IMPLANTED.
Patient problems: Edema
MAUDE report 10013949 ↗InjuryApr 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE REASON FOR REMOVAL AS 'PAIN'. DEVICE HAS BEEN EXPLANTED.
Patient problems: Pain
MAUDE report 10001443 ↗InjuryApr 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE REASON FOR REMOVAL AS 'PAIN'. DEVICE HAS BEEN EXPLANTED.
Patient problems: Pain
MAUDE report 10001427 ↗InjuryApr 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LEFT SIDE INFECTION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 9999537 ↗InjuryApr 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED RIGHT SIDE INFECTION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 9985370 ↗InjuryApr 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LEFT SIDE "REACTION INFECTION/CELLULITIS". DEVICE HAS BEEN EXPLANTED.
Patient problems: Cellulitis
MAUDE report 9967668 ↗InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "SWELLING AND FLUID COLLECTIONS AROUND THE IMPLANTS". PATIENT ADDITIONALLY REPORTED "OVERNIGHT SWELLING," "VERY PAINFUL", AND "FORMING VISIBLE SIGNS THAT SOMETHING WAS NOT RIGHT". DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.
Patient problems: Seroma
MAUDE report 9943550 ↗InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "SWELLING AND FLUID COLLECTIONS AROUND THE IMPLANTS". PATIENT ADDITIONALLY REPORTED "OVERNIGHT SWELLING," "VERY PAINFUL", AND "FORMING VISIBLE SIGNS THAT SOMETHING WAS NOT RIGHT". DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.
Patient problems: Seroma
MAUDE report 9943498 ↗InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LEFT SIDE "A LITTLE BIT OF FLUID" AROUND THEM. PATIENT ALSO HAS SOME SYMPTOMS OF PAIN; AND THAT "SOMETIMES IT'S SHARP AND IT WILL WAKE ME UP IN THE MIDDLE OF THE NIGHT.". DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 9818106 ↗
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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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