NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MF-410295Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE MF 295CC 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
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10888628003453), received between Sep 6, 2019 and Jun 20, 2026 — classified as 14 injuries.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture4
- Patient-Device Incompatibility4
- Device Appears to Trigger Rejection2
- No Apparent Adverse Event1
Patient problems
- Capsular Contracture6
- Failure of Implant4
- Seroma3
- Unspecified Infection2
- Abscess1
- No Clinical Signs, Symptoms or Conditions1
- Swollen Lymph Nodes1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryJun 20, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED ¿PATIENT DEVELOPED A LATE SEROMA¿. CAPSULECTOMY WAS PERFORMED. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Seroma
MAUDE report 25570279 ↗InjuryNov 11, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 23528846 ↗InjuryJun 29, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A LEFT-SIDE RUPTURE AND EXCHANGE DUE TO CONCERNS WITH THE PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17226217 ↗InjuryApr 4, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16674706 ↗InjuryJan 30, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16269119 ↗InjuryJul 14, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant; Seroma
MAUDE report 15018619 ↗InjuryJan 21, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPRESENTATIVE REPORTED PATIENT EXPERIENCED ¿SEROMA,¿ ¿SWELLING,¿ ¿CAPSULAR CONTRACTURE,¿ BAKER GRADE UNKNOWN, ¿CHRONIC PAIN,¿ ¿PAIN PRIOR TO EXPLANT PROCEDURE,¿ ¿RASHES,¿ ¿ITCHING¿ AND ¿HEAT SENSATION.¿ PATIENT REPRESENTATIVE ALSO REPORTED PATIENT ¿SUFFERED PERSONAL INJURIES AND RELATED DAMAGES,¿ ¿DEPRESSION,¿ ¿CHRONIC INSOMNIA,¿ ¿DISFIGUREMENT¿ AND ¿ANXIETY, PTSD;¿ THESE EVENTS ARE NOT RELATED TO THE DEVICE. DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.
Patient problems: Capsular Contracture; Seroma
MAUDE report 11208386 ↗InjuryDec 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE IMPLANT EXCHANGE DUE TO PATIENT CONCERN WITH THE PRODUCT. PATIENT REPRESENTATIVE REPORTED PATIENT EXPERIENCED ¿MENTAL PAIN,¿ ¿ENLARGED LYMPH NODES¿ AND ¿CHRONIC AND SEVERE INFLAMMATION, AUTO INFLAMMATORY RESPONSE.¿ PATIENT REPRESENTATIVE ALSO REPORTED PATIENT ¿SUFFERED PERSONAL INJURIES AND RELATED DAMAGES,¿ ¿URTICARIAL RASHES ON LEGS, BACK AND ABDOMEN,¿ ¿SEVERE JOINT AND BODY ACHES,¿ ¿FEVERS,¿ ¿ACUTE LIVER AND KIDNEY INJURY,¿ ¿CHILLS, NIGHT SWEATS, SORE THROATS,¿ ¿SUFFERING¿ AND ¿DISFIGUREMENT;¿ THESE EVENTS ARE NOT RELATED TO THE DEVICE. DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.
Patient problems: Swollen Lymph Nodes
MAUDE report 10992597 ↗InjuryApr 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED A PATIENT EXPERIENCED THE EVENTS OF ¿LEFT BREAST ABSCESS AND INFECTED BREAST IMPLANT¿, ¿FRANK PUS SURROUNDING BREAST IMPLANT¿, AND ¿DEVELOPED SOME DRAINAGE¿. THE DEVICE WAS EXPLANTED.
Patient problems: Abscess; Unspecified Infection
MAUDE report 9999553 ↗InjuryApr 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED FOR THE LEFT SIDE "REMOVAL DUE TO THEIR BODY REJECTING THE IMPLANT AND AN INFECTION." DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 9968546 ↗InjuryFeb 12, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND EXCHANGE OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9702614 ↗InjuryJan 2, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III, AND "CONCERN WITH THE PRODUCT." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9539373 ↗InjurySep 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8970879 ↗InjurySep 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8969856 ↗
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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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