NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MF-410335Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE MF 335CC 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 breast implant from Allergan is a soft-shell breast implant used in surgery. The 29 reports mostly describe implants rupturing and the surrounding scar tissue tightening around them so the breast feels hard, turns or becomes deformed, along with fluid collections and swelling; 29 reports describe injuries and no deaths. One open recall, started in July 2019, follows FDA notice of a higher rate of a rare breast implant-related lymphoma in patients with textured 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
- 29
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10888628003460), received between Mar 19, 2019 and May 7, 2025 — classified as 29 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
- Patient-Device Incompatibility10
- Device Appears to Trigger Rejection7
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Capsular Contracture17
- Failure of Implant9
- Seroma5
- Unspecified Infection2
- Lymphoma1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED TEXTURED IMPLANT AND RUPTURE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 21975803 ↗InjuryJun 14, 2024Material Rupture; Material Rupture
PATIENT CALLED TO REPORT RIGHT SIDE RUPTURE. DEVICE WAS EXPLANTED. LATER, HCP REPORTED CALLED TO REPORT RIGHT SIDE REPLACEMENT FROM TEXTURED TO SMOOTH DUE TO THE PATIENTS CONCERN OF THE PRODUCT. LATER, HCP REPORTED DOUBLE CAPSULE AND PATIENT DEFORMITY.
Patient problems: Failure of Implant
MAUDE report 19535747 ↗InjuryAug 25, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE HARD, FLIPPED, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERN WITH THE PRODUCTS. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17627065 ↗InjuryAug 25, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE HARD, FLIPPED, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERN WITH THE PRODUCTS. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17625084 ↗InjuryJun 2, 2023Material Rupture; Material Rupture
InjuryApr 19, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE RUPTURED SUBPECTORAL IMPLANTS, ANATOMIC TEXTURED GEL, WITH CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND ANIMATION DEFORMITY. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16770785 ↗InjuryMar 22, 2023Material Rupture; Material Rupture
InjuryMar 20, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL LATER REPORTED INFECTION OR INFLAMMATION (3MONTHS) ON LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 16576475 ↗InjuryDec 4, 2022Material Rupture; Material Rupture
HEALTHCARE PROVIDER CALLED TO REPORT A RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH DUE TO PRODUCT CONCERN. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED RIGHT SIDE RUPTURE, "MALROTATED", AND "ANY CREASES". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15912654 ↗InjuryNov 20, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE SEROMA-LATE AND CAPSULAR CONTRACTURE, BAKER GRADE III. HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE WAS IDENTIFIED DURING SURGERY. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 15831500 ↗InjuryNov 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15831477 ↗InjurySep 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE REPORTED LEFT SIDE DEVICE CAPSULAR CONTRACTURE BAKER GRADE III AND ANXIETY. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15502713 ↗InjurySep 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE REPORTED RIGHT SIDE DEVICE CAPSULAR CONTRACTURE BAKER GRADE IV AND ANXIETY. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15502484 ↗InjuryJun 9, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED PATIENT'S CONCERN WITH THE PRODUCT AND RUPTURE. AFFECTED SIDE IS LEFT. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 14647494 ↗InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "FLUID BUILD UP IN CHEST CAVITY," "CONSTANT PAIN," "ITCHING" AND "EXCHANGE OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT." PATIENT ADDITIONALLY REPORTED BEING "REALLY SICK FOR 3 YEARS." DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.
Patient problems: Seroma
MAUDE report 11651294 ↗InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 5, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED A LEFT SIDE "SWOLLEN BREAST" AND "FLUID AROUND THE IMPLANT."
Patient problems: Failure of Implant; Seroma
MAUDE report 11286311 ↗InjuryOct 29, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED A RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10759095 ↗InjuryJul 22, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "EXCHANGE DUE TO CONCERNS WITH THE PRODUCT". HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10308416 ↗InjuryJul 13, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED PATIENT CONCERN WITH THE PRODUCT AND ADDITIONALLY REPORTED CAPSULAR CONTRACTURE, BAKER GRADE "III/IV." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10268169 ↗InjuryMar 26, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9882884 ↗InjuryMar 24, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9871660 ↗InjuryFeb 19, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED AND CONFIRMED CAPSULAR CONTRACTURE, BAKER GRADE III, AND PAIN. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9726955 ↗InjuryFeb 13, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9708712 ↗InjuryDec 13, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. HEALTHCARE PROFESSIONAL CONFIRMED EVENT. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9470144 ↗
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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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