NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FM-410550Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE FM 550CC 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888628002890), received between Feb 25, 2020 and Dec 10, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).
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
- Device Appears to Trigger Rejection1
- Material Rupture1
- Patient-Device Incompatibility1
Patient problems
- Capsular Contracture2
- Failure of Implant1
- Seroma1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE II AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23772042 ↗InjurySep 16, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED AGAINST RIGHT SIDE "CAPSULAR CONTRACTURE", "FLUID, DOUBLE IN SIZE", AND "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO PRODUCT CONCERN". HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND "LATE SEROMA". THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 15440728 ↗InjuryFeb 25, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND EXCHANGE DUE TO CONCERN WITH DEVICE. PATIENT ADDITIONALLY REPORTED "EPILEPSY"; THIS EVENT IS NOT DEVICE RELATED. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9750826 ↗
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- 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
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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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