NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MX-410325Recalls & reported problems
Allergan, Inc. · STYLE 410, MX, 325G 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 shaped silicone breast implant is a textured implant. The 24 reports mostly describe scar tissue tightening around the implant, fluid buildup, hard or misshapen breasts, and implant rupture or silicone leakage; there were no deaths and 24 injuries. One open recall began in July 2019 because textured implants were linked to a higher incidence of BIA-ALCL, a rare lymphoma.
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
- 25
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10888628003729), received between Aug 23, 2019 and Sep 8, 2026 — classified as 25 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (10 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
- Patient-Device Incompatibility10
- Material Rupture8
- Adverse Event Without Identified Device or Use Problem7
- Device Appears to Trigger Rejection4
- Migration1
Patient problems
- Capsular Contracture15
- Failure of Implant5
- Seroma5
- Inflammation2
- Fluid Discharge1
- Hematoma1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2026Material Rupture
Healthcare professional, through the National Breast Implant Registry, reported: "Suspected/Actual Rupture/Deflation". The patient received a capsulectomy. This record is for the right-side device. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671960 ↗InjuryJul 30, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "LATE SEROMA" DIAGNOSED VIA ULTRASOUND. LATER HEALTHCARE PROFESSIONAL REPORTED "UNSPECIFIED LUMP", "SWELLING", "ABUNDANT VACUOLATED HISTIOCYTES SUGGESTIVE OF SILICONE LEAKAGE". LATER HEALTHCARE PROFESSIONAL REPORTED "HOLE, NON SPECIFIC". THIS IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Seroma
MAUDE report 22671466 ↗InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "ITCHING AROUND THE BREAST AND CHEST INTO SIDE" (NOT DEVICE RELATED), "CONSISTENT COUGH" (NOT DEVICE RELATED), "TENDERNESS THAT IS SIMILAR TO PREMENSTRUAL SYMPTOMS." PATIENT LATER REPORTED "SEROMA FLUID" VIA MRI, "MISSHAPED", AND "HARD." THIS RECORD WILL BE FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 20723944 ↗InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(6) REPORTED, AN UNKNOWN SIDE "ITCHING AROUND THE BREAST AND CHEST INTO SIDE". "CONSISTENT COUGH", "TENDERNESS THAT IS SIMILAR TO PREMENSTRUAL SYMPTOMS". (B)(6) LATER REPORTED, "SEROMA FLUID", "MISSHAPED" AND "HARD". THIS RECORD WILL BE FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 20694779 ↗InjuryApr 3, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 19034617 ↗InjuryApr 3, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 19034609 ↗InjuryNov 10, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT-SIDE RUPTURE AGAINST TEXTURED SILICONE DEVICE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 18109438 ↗InjuryJun 22, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED, RUPTURE. THE DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Failure of Implant
MAUDE report 17182714 ↗InjuryApr 24, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. DEVICE EXPLANTED. LATER, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN.
Patient problems: Capsular Contracture
MAUDE report 16797237 ↗InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT¿S RELATIVE REPORTED LEFT SIDE REPLACEMENT SURGERY DUE TO IMPLANT RECALL. HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE MILD WATERFALL DEFORMITY AND MILD BUMP MILD DRAINAGE AND SUTURE GRANULOMA WHICH IS NOT DEVICE RELATED AND AN IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Fluid Discharge
MAUDE report 15501807 ↗InjuryApr 4, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED DEVICE WAS FOUND TO BE RUPTURED DURING EXPLANT SURGERY. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14001158 ↗InjuryMar 28, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT., AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE DISCOVERED DURING EXPLANT SURGERY. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13928303 ↗InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE IMPLANT EXCHANGE OF TEXTURED DEVICE DUE TO "INCREASED RISK FOR ALCL." PATIENT ALSO REPORTED "PAIN AND BURNING IN UPPER BODY" AND "CHRONIC INFLAMMATION." PATIENT ADDITIONALLY REPORTED "DISCOMFORT AND MUSCLE AND JOINT PAINT AS WELL" AND "AUTOIMMUNE SYSTEM HAS BEEN COMPROMISED" WHICH ARE NOT DEVICE RELATED. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED CAPSULAR CONTRACTURE, BAKER GRADE I. DEVICE HAS BEEN EXPLANTED.
Patient problems: Inflammation
MAUDE report 11615082 ↗InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE IMPLANT EXCHANGE OF TEXTURED DEVICE DUE TO "INCREASED RISK FOR ALCL." PATIENT ALSO REPORTED "PAIN AND BURNING IN UPPER BODY, PAIN MORE CONSISTENTLY IN MY RIGHT BREAST" AND "CHRONIC INFLAMMATION." PATIENT ADDITIONALLY REPORTED "DISCOMFORT AND MUSCLE AND JOINT PAINT AS WELL" AND "AUTOIMMUNE SYSTEM HAS BEEN COMPROMISED" WHICH ARE NOT DEVICE RELATED. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED CAPSULAR CONTRACTURE, BAKER GRADE II. DEVICE HAS BEEN EXPLANTED.
Patient problems: Inflammation
MAUDE report 11614980 ↗InjuryOct 29, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. ADDITIONALLY, HEALTHCARE PROVIDER REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10759712 ↗InjuryOct 12, 2020Material Rupture; Patient-Device Incompatibility; Migration; Material Rupture; Patient-Device Incompatibility; Migration
HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND SILICONE MIGRATION.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 10665304 ↗InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "LEFT SIDE HEMATOMA". DEVICE HAS BEEN EXPLANTED.
Patient problems: Hematoma
MAUDE report 10413479 ↗InjuryFeb 12, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9700802 ↗InjuryFeb 12, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9699480 ↗InjuryJan 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III-IV AND RIGHT SIDE "FLUID." DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 9601967 ↗InjuryJan 15, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III-IV. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9591997 ↗InjurySep 26, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "SEROMA" AND "CAPSULAR CONTRACTURE," BAKER GRADE IV. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 9125511 ↗InjurySep 10, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A RIGHT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8982667 ↗InjurySep 10, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A LEFT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8982585 ↗InjuryAug 23, 2019Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility
PATIENT REPORTED RIGHT SIDE "ROTATED" DEVICE, "SWOLLEN AND TENDER" AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. PATIENT INDICATED THE ROTATION HAD BEEN PREVIOUSLY TREATED WITH "CORRECTIVE MANIPULATION". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 8927647 ↗
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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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