NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MM-410450Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE MM 450CC 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 10888628003668), received between May 20, 2019 and Nov 13, 2025 — classified as 11 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (5 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 Incompatibility5
- Adverse Event Without Identified Device or Use Problem3
- Device Appears to Trigger Rejection2
- Material Rupture1
Patient problems
- Capsular Contracture7
- Seroma2
- Unspecified Infection2
- Failure of Implant1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "INFECTION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED AND IT IS UNKNOWN IF WILL BE RETURNED. PATIENT WAS INITIALLY PRESCRIBED WITH "PENICILLIN DERIVATIVE, HAD AN ALLERGIC REACTION TO, SO CHANGED TO VANCOMYCIN AND ZIPRO."
Patient problems: Unspecified Infection
MAUDE report 23543257 ↗InjuryJun 10, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14658294 ↗InjuryJun 24, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12061345 ↗InjuryFeb 8, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PERIPROSTHETIC CAPSULAR CONTRACTURE". HEALTHCARE PROFESSIONAL ALSO REPORTED "CARCINOMA" AND "CONTOUR IRREGULARITIES", THESE EVENTS ARE NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11298703 ↗InjuryJul 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
InjuryJul 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "DISCOLORATION OF THE SKIN IN THE BREAST AREA, PAIN, SWELLING," AND "FLUID WAS FOUND AROUND THE BREAST." DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 9711408 ↗InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "PATIENT WAS RECENTLY HOSPITALIZED DUE TO A SEVERE INFECTION IN THE RIGHT BREAST, BILATERAL DISCOLORATION OF THE SKIN IN THE BREAST AREA, PAIN, SWELLING, AND FLUID FOUND AROUND THE BREAST." DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.
Patient problems: Seroma; Unspecified Infection
MAUDE report 9705995 ↗InjuryJun 8, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8681266 ↗InjuryJun 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE "III PLUS." DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8675558 ↗InjuryMay 20, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV, SWELLING, AND FLUID. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8623657 ↗
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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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