NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MM-410400Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE MM 400CC 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.
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10888628003651), received between Jun 6, 2019 and Feb 12, 2025 — classified as 11 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 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 Problem4
- Patient-Device Incompatibility4
- Material Rupture2
- Device Appears to Trigger Rejection1
Patient problems
- Capsular Contracture5
- Failure of Implant2
- Impaired Healing2
- Wound Dehiscence2
- Seroma1
- Swollen Lymph Nodes/Glands1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2025Material Rupture; Material Rupture
THE PREVIOUSLY REPORTED "PREVIOUS BREAST CANCER WITH TEXTURED IMPLANTS" IS HISTORICAL DATA AND NOT DEVICE RELATED.
Patient problems: Failure of Implant
MAUDE report 21364857 ↗InjuryDec 20, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE EXCHANGE DUE TO CONCERNS WITH THE PRODUCT. LATER, PATIENT REPORTED RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 18369041 ↗InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPRESENTATIVE REPORTED LEFT SIDE BREAST PAIN (THROBBING AND ACHING), EMOTIONAL DISTRESS, ASYMMETRY, AND SWELLING OF LYMPH NODES UNDER THE ARM. THE DEVICE REMAINS IMPLANTED.
Patient problems: Swollen Lymph Nodes/Glands
MAUDE report 15160973 ↗InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "LATE SEROMA AND BILATERAL REMOVAL OF TEXTURED BREAST IMPLANTS." DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 13472483 ↗InjuryJan 13, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE ¿FDA RECALL, CAPSULAR CONTRACTURE," BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11166864 ↗InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LEFT SIDE "SWELLING NEAR BOTH INCISIONS AND IN THE GLANDS", "INCISION HAD OPEN WOUNDS AND WOULDN'T HEAL" AND "HEAVY WEIGHT ON THE CHEST." PATIENT ALSO REPORTED "NAUSEA, VOMITING AND FELT LIKE PASSING OUT"; THESE EVENTS ARE NOT DEVICE RELATED. DEVICE WAS EXPLANTED.
Patient problems: Impaired Healing; Wound Dehiscence
MAUDE report 10312019 ↗InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED RIGHT SIDE "COMPLICATIONS WITH TEXTURED IMPLANTS", "SWELLING NEAR BOTH INCISIONS AND IN THE GLANDS", "THE INCISION HAD OPEN WOUNDS AND WOULDN'T HEAL", "NAUSEA AND VOMITING AND FELT LIKE PASSING OUT" AND "HEAVY WEIGHT ON THE CHEST". DEVICE HAS BEEN EXPLANTED.
Patient problems: Impaired Healing; Wound Dehiscence
MAUDE report 10311078 ↗InjuryAug 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "SLIGHT ROTATION," "SEVERE DEFORMITY" AND "IT HAS TWISTED, LIKE A CAPSULAR CONTRACTURE." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8867348 ↗InjuryAug 5, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "90 DEGREE ROTATION," "SEVERE DEFORMITY" AND "IT HAS TWISTED, LIKE A CAPSULAR CONTRACTURE," BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8861144 ↗InjuryJun 11, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8688256 ↗InjuryJun 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTH PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8675782 ↗
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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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