NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MX-410685Recalls & reported problems
Allergan, Inc. · STYLE 410, MX, 685G 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 Allergan Natrelle 410 is a textured, shaped silicone-gel breast implant. The 32 adverse event reports mostly describe the scar tissue tightening around the implant (capsular contracture), implants breaking or failing, and swelling or infection in the breast and underarm lymph nodes. All 32 involve injuries, with no deaths. One open recall, started in July 2019, followed FDA safety information about a rare lymphoma (BIA-ALCL) seen with textured breast 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
- 32
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10888628003798), received between Jun 5, 2019 and Mar 20, 2026 — classified as 32 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (9 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 Problem10
- Device Appears to Trigger Rejection9
- Material Rupture8
- Patient-Device Incompatibility5
Patient problems
- Capsular Contracture14
- Failure of Implant7
- Unspecified Infection5
- Wound Dehiscence4
- Cellulitis2
- Swollen Lymph Nodes/Glands2
- Lymphoma1
- Seroma1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". LATER, HEALTHCARE PROFESSIONAL REPORTED "HISTORY OF DCIS BREAST CANCER AND EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". PATIENT LATER REPORTED "SLIMY AND EVERYTHING ELSE, WAS TOLD EXPLANT COULD HAVE CAUSED A REAL ISSUE, AND WAS TOLD SOMETHING REALLY BAD GOING ON WITH EXPLANT". LATER REPORTED, "LEFT BREAST SHOWED ABNORMAL ENLARGED LEVEL 1 LEFT AXILLARY LYMPH NODE" AND "SILICONE LYMPHADENOPATHY". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Swollen Lymph Nodes/Glands
MAUDE report 24649821 ↗InjuryJan 24, 2024Material Rupture; Material Rupture
PHYSICIAN REPORTED RIGHT SIDE EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT. LATER PHYSICIAN REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 18572861 ↗InjuryApr 4, 2023Device 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 16677512 ↗InjuryApr 3, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16667541 ↗InjuryAug 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15302473 ↗InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPRESENTATIVE REPORTED RIGHT 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 15153862 ↗InjuryJul 6, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPRESENTATIVE REPORTED LEFT SIDE "CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN), BREAST PAIN, OPEN BREAST WOUND, AND INCREASED RISK OF ALCL." DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Wound Dehiscence
MAUDE report 14937737 ↗InjuryJun 30, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPRESENTATIVE REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN), BREAST PAIN, OPEN BREAST WOUND, AND INCREASED RISK OF ALCL." DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Wound Dehiscence
MAUDE report 14882007 ↗InjuryApr 5, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING FORM LEFT SIDE REMOVAL DUE TO "CELLULITIS." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED CAPSULAR CONTRACTURE BAKER GRADE IVDEVICE HAS BEEN EXPLANTED AND REMOVED.
Patient problems: Capsular Contracture; Cellulitis
MAUDE report 14013979 ↗InjuryFeb 24, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13596187 ↗InjurySep 22, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED CELLULITIS AND INFLAMMATION.
Patient problems: Cellulitis; Failure of Implant
MAUDE report 12515404 ↗InjurySep 22, 2021Material Rupture; Material Rupture
PATIENT REPORTED, A RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 12514379 ↗InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT AND RIGHT SIDE FLUID COLLECTION. DEVICE WAS EXPLANTED.
Patient problems: Seroma
MAUDE report 12467527 ↗InjuryMar 31, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO PATIENT¿S CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL ALSO REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11598959 ↗InjuryMar 17, 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. HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11507973 ↗InjuryMar 16, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND IMPLANT EXCHANGE DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11495481 ↗InjuryOct 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED RIGHT SIDE "OPENED BACK UP AND DOCTOR HAD TO PUT THEM BACK IN," "CONCERN WITH THE PRODUCT", AND " WENT THROUGH A LOT OF PAIN". DEVICE HAS BEEN EXPLANTED.
Patient problems: Wound Dehiscence
MAUDE report 10647868 ↗InjuryOct 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LEFT SIDE "OPENED BACK UP AND DOCTOR HAD TO PUT THEM BACK IN," "CONCERN WITH THE PRODUCT", AND " WENT THROUGH A LOT OF PAIN". DEVICE HAS BEEN EXPLANTED.
Patient problems: Wound Dehiscence
MAUDE report 10647853 ↗InjuryJun 6, 2020Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE AND EXCHANGE DUE TO CONCERN WITH TEXTURED PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 10126399 ↗InjuryApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED THEY HAD THEIR IMPLANTS TAKEN OUT BECAUSE THEY CAUSED AN INFECTION. DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.
Patient problems: Unspecified Infection
MAUDE report 9948404 ↗InjuryApr 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LEFT SIDE INFECTION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 9933494 ↗InjuryMar 24, 2020Material Rupture; Material Rupture
InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED THE RIGHT SIDE IMPLANT WAS POSITIVE FOR ALCL. DEVICE WAS EXPLANTED. PATHOLOGICAL MARKERS HAVE NOT BEEN PROVIDED.
Patient problems: Lymphoma
MAUDE report 9792625 ↗InjuryMar 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE PAIN, CAPSULAR CONTRACTURE BAKER GRADE III, TIGHTNESS, DEFORMITY AND PATIENT'S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9788798 ↗InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED A LEFT SIDE "BREAST INFECTION." DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 9622237 ↗
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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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