NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MX-410370Recalls & reported problems
Allergan, Inc. · STYLE 410, MX, 370G 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
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10888628003736), received between Nov 13, 2019 and Aug 5, 2026 — classified as 23 injuries.
The most frequently reported specific device problem is “Material Rupture” (8 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 Rupture8
- Device Appears to Trigger Rejection6
- Patient-Device Incompatibility6
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Capsular Contracture12
- Failure of Implant7
- Seroma3
- Fluid Discharge2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryAug 5, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Baker Grade IV capsular contracture". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50141031 ↗InjuryAug 3, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Baker Grade IV capsular contracture". This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50123868 ↗InjuryJun 2, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE FOUND DURING EXPLANT SURGERY". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25359050 ↗InjuryFeb 19, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24387878 ↗InjuryJul 14, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17330133 ↗InjuryFeb 28, 2023Material Rupture; Material Rupture
InjuryAug 24, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PATIENT WHO HAS TEXTURED IMPLANTS AND IS HAVING THEM REPLACED", AND LATER ADDED "RUPTURED-NON-RETURNABLE." THE DEVICE HAS BEEN REPLACED AND DISCARDED.
Patient problems: Failure of Implant
MAUDE report 15286770 ↗InjuryJul 19, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15061389 ↗InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPRESENTATIVE REPORTED RIGHT SIDE "CHRONIC INFLAMMATION AND FEAR OF ALCL, REDNESS, RASH, SWELLING, PAIN, FLUID, SUBCELLULAR CHANGES, FEVER AND DISCHARGE. PATIENT REPRESENTATIVE ALSO REPORTED " GI UPSET, INSOMNIA, MENTAL ANGUISH AND DEPRESSION," WHICH ARE NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.
Patient problems: Fluid Discharge; Seroma
MAUDE report 14774587 ↗InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPRESENTATIVE REPORTED LEFT SIDE "CHRONIC INFLAMMATION, MENTAL ANGUISH AND FEAR OF ALCL, REDNESS, RASH, SWELLING, PAIN, FLUID, AND DISCHARGE. PATIENT REPRESENTATIVE ALSO REPORTED " SUBCELLULAR CHANGES, FEVER, GI UPSET, INSOMNIA, AND DEPRESSION," WHICH ARE NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.
Patient problems: Fluid Discharge; Seroma
MAUDE report 14755277 ↗InjuryApr 11, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14079610 ↗InjuryJul 23, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND AN EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12217769 ↗InjuryJul 20, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED, REPLACED, AND DISCARDED.
Patient problems: Failure of Implant
MAUDE report 12198144 ↗InjuryFeb 12, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT AND CAPSULAR CONTRACTURE, BAKER GRADE III/IV". DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11320523 ↗InjuryFeb 11, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryDec 15, 2020Material Rupture; Material Rupture
InjuryOct 22, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE PAIN AND "PATIENT'S CONCERN WITH THE PRODUCT." ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III, AND "SUB AREOLAR BREAST LESIONS." DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10717211 ↗InjuryOct 22, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE PAIN AND "PATIENT'S CONCERN WITH THE PRODUCT." ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10717181 ↗InjuryAug 18, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED LEFT SIDE "HAS GAIN IN CUP SIZE", "HARDENING" AND "CONCERN WITH THE PRODUCT". ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10420689 ↗InjuryApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "DEVELOPED FLUID AROUND THE RIGHT BREAST IMPLANT". PATIENT ADDITIONALLY REPORTED "A MONTH AND A HALF LATER THEY TOOK THEM OUT, THE INCISION WOULD NOT CLOSE, AND HAD AN INFECTION FOR A YEAR"; THESE EVENTS ARE NOT DEVICE RELATED. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 9950250 ↗InjuryDec 23, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III-IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9512019 ↗InjuryDec 12, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III WITH "BREAST PAIN," AND REMOVAL DUE TO VOLUNTARY MARKET WITHDRAWAL. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9462064 ↗InjuryNov 13, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE," BAKER GRADE III AND "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9316127 ↗
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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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