NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FF-410425Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE FF 425CC 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 breast implant is a textured silicone gel implant. The 42 reports mostly describe implant rupture and tightening of scar tissue around the implant, with some reports mentioning swollen lymph nodes and fluid buildup; there were 42 injuries and no deaths. There is 1 open recall, started in July 2019, concerning the higher incidence of a rare lymphoma in patients 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
- 43
- Deaths reported
- 0
- Injuries reported
- 43
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10888628002685), received between May 21, 2019 and Sep 29, 2026 — classified as 43 injuries.
The most frequently reported specific device problem is “Material Rupture” (21 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 Rupture21
- Adverse Event Without Identified Device or Use Problem10
- Patient-Device Incompatibility9
- Device Appears to Trigger Rejection5
- Migration2
- Malposition of Device1
- No Apparent Adverse Event1
Patient problems
- Failure of Implant18
- Capsular Contracture15
- Swollen Lymph Nodes3
- Swollen Lymph Nodes/Glands3
- Granuloma2
- No Clinical Signs, Symptoms or Conditions2
- Seroma2
- Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941029 ↗InjuryFeb 10, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24309765 ↗InjuryDec 3, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE", "PAIN" AND "CONCERNS WITH THE PRODUCT". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23709126 ↗InjuryOct 30, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURES, GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23429992 ↗InjuryOct 23, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURES, GRADE II" AND "RUPTURE". HEALTHCARE PROFESSIONAL LATER REPORTED "GRADE 2 PTOSIS". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WAS RETURNED.
Patient problems: Failure of Implant
MAUDE report 23373191 ↗InjuryJan 5, 2024Material Rupture; Material Rupture
HEALTHCARE PROVIDER REPORTED "PATIENT LOOKING TO EXCHANGE TEXTURED BREAST IMPLANTS WITH SMOOTH SILICONE BREAST IMPLANTS. PATIENT ALSO HAS A NOTED INTRACAPSULAR RUPTURE OF LEFT BREAST IMPLANT DIAGNOSED BY MRI." THIS IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 18459122 ↗InjuryJul 13, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL LATER CONFIRMED A RIGHT SIDE RUPTURE, "BIOCELL IMPLANTS, MEMBRANOUS SCAR LIKE FIBROSIS CONSISTENT WITH IMPLANT CAPSULE, FOREIGN MATERIAL PRESENT CONSISTENT WITH SILICONE, AND MINIMAL PATCHY CHRONIC INFLAMMATION". DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant; Granuloma
MAUDE report 17320100 ↗InjuryJul 13, 2023Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
THE EVENT OF RUPTURE WAS CONFIRMED TO NOT HAVE OCCURRED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 17313681 ↗InjuryMay 30, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
DEVICE HAS BEEN EXPLANTED AND DISCARDED.
Patient problems: Capsular Contracture
MAUDE report 17026748 ↗InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LYMPHADENOPATHY. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Swollen Lymph Nodes/Glands
MAUDE report 16460815 ↗InjuryFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LYMPHADENOPATHY. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE LEFT SIDE.
Patient problems: Swollen Lymph Nodes/Glands
MAUDE report 16444170 ↗InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED ¿TIGHTNESS, VERY TIGHT PAIN.¿ PATIENT REPRESENTATIVE REPORTED LEFT SIDE "BREAST PAIN (THROBBING AND ACHING)", BILATERAL SWOLLEN LYMPH NODES", AND "EMOTIONAL DISTRESS". PATIENT REPRESENTATIVE ADDITIONALLY REPORTED "NIGHT SWEATS, ASYMMETRY", "MASSES IN BREAST", AND "FATIGUE"; THESE EVENTS ARE NOT DEVICE RELATED. AFFECTED SIDE IS LEFT. THE DEVICE REMAINS IMPLANTED.
Patient problems: Swollen Lymph Nodes/Glands
MAUDE report 15393509 ↗InjuryAug 25, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND A LEFT SIDE IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15294834 ↗InjuryAug 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV, AND EXCHANGE OF TEXTURED DEVICE DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15146076 ↗InjuryAug 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV, AND EXCHANGE OF TEXTURED DEVICE DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15145985 ↗InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "PERI-IMPLANT EFFUSION." THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Seroma
MAUDE report 14349607 ↗InjuryMar 24, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13878058 ↗InjuryDec 6, 2021Device Appears to Trigger Rejection; Migration; Device Appears to Trigger Rejection; Migration
PATIENT REPORTED RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT. DEVICE REMAINS IMPLANTED. HEALTHCARE PROFESSIONAL LATER REPORT CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN.
Patient problems: Capsular Contracture; Granuloma
MAUDE report 12934922 ↗InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL INITIALLY REPORTED "PATIENT NOTED INCREASED SWELLING OF THEIR RIGHT BREAST" AND A RIGHT SIDE "LATER SEROMA FLUID AS WELL AS BILATERAL EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT". HEALTHCARE PROFESSIONAL LATER REPORTED VIA REGULATORY AGENCY "ANAPLASTIC LARGE CELL LYMPHOMA AFTER BREAST AUGMENTATION WITH NATRELLE TEXTURED SILICONE IMPLANTS. RIGHT BREAST POSITIVE FOR ALCL RELATED TO BREAST IMPLANT." IT WAS FURTHER NOTED THAT THE PATIENT ¿HAD A PET SCAN AND ULTRASOUND DONE.¿ PER ULTRASOUND GUIDED ASPIRATION, CYTOLOGICAL EVALUATION DEMONSTRATED AN ATYPICAL CD30-POSTIVE T-CELL POPULATION. LARGE ATYPICAL CELLS ARE CD3 POSITIVE, CD30 POSITIVE, AND ALK NEGATIVE. INDICATION FOR THE PROCEDURE WAS AS FOLLOWS: "LARGE RIGHT BREAST PERI-IMPLANT FLUID COLLECTION. LARGE VOLUME ASPIRATION PERFORMED FOR PATIENT CONFORM AND TO EVALUATE FOR BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA. 560 ML OF LIGHT YELLOW THIN FLUID WAS ASPIRATED." AFFECTED SIDE IS RIGHT. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL); Seroma
MAUDE report 12682506 ↗InjuryMar 15, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED PATIENT'S CONCERN WITH THE PRODUCT. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "IMPLANTS WERE CLEARLY MALPOSITIONED", "HAD RIDGES, RIPPLING AND THEY WERE QUITE PALPABLE" AND "ANTERIOR ASPECT RUPTURE". DEVICE WAS EXPLANTED AND DISCARDED.
Patient problems: Failure of Implant
MAUDE report 11485036 ↗InjuryFeb 1, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "HOLE ON THE PATCH SIDE" AND EXCHANGE DUE TO CONCERN WITH THE PRODUCT. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11261156 ↗InjuryDec 3, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE IMPLANT REMOVAL "OUT OF CONCERN WITH THE DEVICE" AND CAPSULAR CONTRACTURE, BAKER GRADE III-IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10942926 ↗InjuryOct 29, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 10759791 ↗InjurySep 16, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED ¿LEFT SIDE RECALL AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN¿. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10539809 ↗InjuryJul 30, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND EXCHANGE DUE TO CONCERN WITH TEXTURED PRODUCT. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10345244 ↗
Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices
- MENTOR MemoryGel Breast Implant 3503501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,167 reports
- MENTOR MemoryGel Breast Implant 3504001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,130 reports
- MENTOR MemoryGel Breast Implant 3504004BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,012 reports
- MENTOR MemoryGel Breast Implant 3504504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,754 reports
- MENTOR MemoryGel Breast Implant 3503001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,752 reports
- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
- MENTOR MemoryGel Breast Implant 3504501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,690 reports
- MENTOR MemoryGel Breast Implant 3503251BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,684 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page