NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FF-410475Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE FF 475CC 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 is an Allergan Natrelle 410 textured silicone-gel breast implant. The 31 reports mostly describe implants rupturing and the surrounding scar tissue tightening around them (capsular contracture), along with fluid collections and two cases of lymphoma;30 reports describe injuries and 1 death. One recall remains open, started in July 2019 over FDA notice of a higher rate of anaplastic large cell lymphoma in patients with textured breast implants. Reports rose from 1 in the prior 12 months to 5 in the most recent.
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
- 31
- Deaths reported
- 1
- Injuries reported
- 30
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10888628002692), received between Feb 12, 2019 and Aug 3, 2026 — classified as 1 death, 30 injuries.
The most frequently reported specific device problem is “Material Rupture” (11 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 Rupture11
- Device Appears to Trigger Rejection9
- Patient-Device Incompatibility9
- Adverse Event Without Identified Device or Use Problem5
Patient problems
- Capsular Contracture18
- Failure of Implant8
- Seroma6
- Lymphoma2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Inflammation1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
InjuryAug 3, 2026Material Rupture
Healthcare professional reported "possible rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50123599 ↗InjuryJan 7, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE DUE TO RECALL". LATER PHYSICIAN REPORTED "RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE II". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23989217 ↗InjuryDec 5, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE", "PAIN" AND "CONCERNS WITH THE PRODUCT". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23729722 ↗InjuryNov 3, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED RUPTURE, TEXTURED IMPLANTS HAVE BEEN RECALLED, CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23459515 ↗InjuryNov 3, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED RUPTURE, TEXTURED IMPLANTS HAVE BEEN RECALLED, CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23459264 ↗InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPRESENTATIVE REPORTED "SEVERE AND PERMANENT HARM, WITH ENDURE PAIN, SUFFERING, DISABILITY, IMPAIRMENT, DISFIGUREMENT, INFLAMMATION, EMOTIONAL DISTRESS, LOSS OF ENJOYMENT OF LIFE, SCARRING AND ADDITIONAL SCAR TISSUE, INCURRED COSTS FOR MEDICAL CARE AND TREATMENT, AND OTHER ECONOMIC AND NON-ECONOMIC DAMAGES". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Pain
MAUDE report 23358809 ↗InjuryMar 18, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROVIDER REPORTED A RIGHT SIDE EXCHANGE DUE TO "TEXTURED IMPLANTS". HEALTHCARE PROVIDER ADDITIONALLY NOTED "PRE-OP AND POST OP DIAGNOSIS IMPLANT EXCHANGE-DISSATISFACTION WITH IMPLANT SIZE, LATERAL DISPLACEMENT AND CAPSULAR CONTRACTURE". HEALTHCARE PROVIDER REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18925617 ↗InjuryFeb 28, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE EXCHANGE DUE TO "TEXTURED IMPLANTS." HEALTHCARE PROFESSIONAL ADDITIONALLY NOTED "PRE-OP AND POST OP DIAGNOSIS IMPLANT EXCHANGE-DISSATISFACTION WITH IMPLANT SIZE, LATERAL DISPLACEMENT AND CAPSULAR CONTRACTURE". HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 18802456 ↗InjuryMar 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16582644 ↗InjuryDec 19, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16008219 ↗InjuryNov 8, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15752785 ↗InjuryNov 7, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15749572 ↗InjurySep 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15400777 ↗InjuryApr 19, 2022Device 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 ADDITIONALLY REPORTED UPON REMOVAL, CAPSULAR CONTRACTURE BAKER GRADE UNSPECIFIED. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 14142984 ↗InjuryFeb 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV AS WELL AS PATIENT'S CONCERNS WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13424442 ↗InjuryNov 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LEFT SIDE "FLUID FOUND AROUND LEFT BREAST WITH NO RUPTURE FOUND." DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 12755949 ↗InjuryNov 1, 2021Material Rupture; Material Rupture
PATIENT REPORTED AND HEALTHCARE PROFESSIONAL CONFIRMED LEFT SIDE RUPTURE AND "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO CONCERN WITH THE PRODUCT." DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 12728918 ↗InjuryApr 16, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT'S CONCERNS WITH THE PRODUCT. PATIENT REPORTED "RUPTURE". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11679216 ↗InjuryApr 13, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE II. HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11655340 ↗InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE REMOVAL WAS NOTED AS "THICKENED CAPSULE" AND "SEROMA" . DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 10871346 ↗InjuryMar 11, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9819971 ↗InjuryFeb 25, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKERS GRADE UNKNOWN, AND "CONCERN WITH THE PRODUCT." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9750792 ↗InjuryJan 9, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED BREAST HARDNESS, POSSIBLE CAPSULAR CONTRACTION, BAKER GRADE UNKNOWN AND BUBBLES AROUND INCISION THROUGH THE SCAR TISSUE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9573209 ↗InjuryDec 23, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER'S GRADE UNKNOWN. PATIENT ADDITIONALLY REPORTED " I HAVE HAD A RASH AROUND THE NIPPLE ON BOTH BREASTS AS WELL AS FLUID COLLECTION". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 9513078 ↗InjuryDec 17, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED A LEFT SIDE "IMPLANT HAS FALLEN FROM ITS ORIGINAL LOCATION ". HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III/IV AND EXPLANT DUE TO "VOLUNTARY RECALL". DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9481739 ↗
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