NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MF-410225Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE MF 225CC 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888628003439), received between Aug 20, 2019 and Dec 10, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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
- Patient-Device Incompatibility3
- Adverse Event Without Identified Device or Use Problem1
- Material Rupture1
Patient problems
- Capsular Contracture3
- Failure of Implant1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "IMPLANT RUPTURE" AND "EXCHANGE FROM TEXTURED TO TEXTURED TO SMOOTH DUE TO THE PATIENT CONCERN OF THE IMPLANT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23769299 ↗InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED IMPLANT EXCHANGE" DUE TO AN INFECTION". THE DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.
Patient problems: Unspecified Infection
MAUDE report 9119218 ↗InjuryAug 30, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
InjuryAug 30, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
InjuryAug 20, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT ADDITIONALLY REPORTED "HAVING MUSCLE SPASM WHICH IS BLOCKING HER AIR WAY", "BREAST MUSCLE WAS NOT ATTACHED AND SHE IS GOING TO HAVE ANOTHER SURGERY TO REMOVE THE EXCESS SKIN". THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8910372 ↗
Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices
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- 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.
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