NATRELLE Silicone-Filled Breast Implants 15-339Recalls & reported problems
Allergan, Inc. · NATRELLE Style 15-339 Moderate plus profile |smooth|round|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · NATRELLE Silicone-Filled Breast Implants (128)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Allergan Natrelle silicone breast implant is a silicone gel-filled implant. All 171 reports are filed as injuries, and most describe the implant rupturing, while others describe capsular contracture, a tightening of scar tissue around the implant. The reports mention no deaths, and no recalls name this device. Reports rose sharply over the past 12 months, with 68 compared with 20 in the year before.
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
- 188
- Deaths reported
- 0
- Injuries reported
- 188
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 188 adverse event reports that list this exact device (DI 10888628001466), received between Aug 9, 2019 and Sep 30, 2026 — classified as 188 injuries.
The most frequently reported specific device problem is “Material Rupture” (132 reports).
4 other recalls cover devices cleared under the same FDA submission (P020056); they may or may not involve this specific model.
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
Most reported problems
Device problems
- Material Rupture132
- Device Appears to Trigger Rejection49
- Patient-Device Incompatibility21
- Adverse Event Without Identified Device or Use Problem3
- Gel Leak3
- No Apparent Adverse Event2
- Improper or Incorrect Procedure or Method1
- Material Protrusion/Extrusion1
Patient problems
- Failure of Implant89
- Capsular Contracture70
- No Clinical Signs, Symptoms or Conditions29
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Autoimmune Disorder1
- Pain1
- Swollen Lymph Nodes/Glands1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 188 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949652 ↗InjurySep 29, 2026Material Rupture
Healthcare professional reported "Rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937924 ↗InjurySep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925406 ↗InjurySep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922948 ↗InjurySep 18, 2026Material Rupture
Patient problems: Pain
MAUDE report 50812776 ↗InjurySep 14, 2026Material Rupture
Healthcare professional reported "possible rupture". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755462 ↗InjurySep 14, 2026Material Rupture
Healthcare professional reported "possible rupture". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753957 ↗InjurySep 10, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported "hardness, pain, capsular contracture Baker grade III" and "rupture". This record is for the right side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50717787 ↗InjurySep 10, 2026Material Rupture
Healthcare professional reported: "rupture". This record is for the left-side device. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717481 ↗InjurySep 9, 2026Device Appears to Trigger Rejection; Material Rupture
Patient problems: Capsular Contracture
MAUDE report 50702747 ↗InjurySep 9, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported "hardness, pain, capsular contracture Baker grade III" and "rupture". This record is for the left side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50694620 ↗InjurySep 8, 2026Material Rupture
Patient reported ¿exchange with no complaint against the device¿. Later healthcare professional reported ¿exchange with no complaint against the device¿. Later healthcare professional reported ¿ruptured¿ and ¿leaking evident¿. This record is for the right side. Device Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50676216 ↗InjurySep 7, 2026Device Appears to Trigger Rejection; Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50649401 ↗InjuryAug 16, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50268293 ↗InjuryAug 4, 2026Material Rupture
Patient reported "possible leak or rupture", "pain when push on nipple/implant" and "looks smaller". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50132716 ↗InjuryAug 3, 2026Material Rupture
Patient reported ¿Rupture¿. Later healthcare professional reported ¿Rupture¿. This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50110033 ↗InjuryJul 28, 2026Material Rupture
The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50058798 ↗InjuryJul 28, 2026Material Rupture
Healthcare Professional reported "rupture". This record is for the right side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50051845 ↗InjuryJul 21, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25891628 ↗InjuryJul 9, 2026Material Rupture
SALES REPRESENTATIVE REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25765647 ↗InjuryJul 3, 2026Material Rupture
Healthcare professional reported "rupture". Healthcare Professional later reported "hole in radius (edge) and large rupture". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25709227 ↗InjuryJun 30, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25674059 ↗InjuryJun 30, 2026Material Rupture
PATIENT REPORTED "RUPTURE". HEALTHCARE PROFESSIONAL LATER CONFIRMED RUPTURED IMPLANT. THIS RECORD IS FOR AN RIGHT SIDE. DEVICE EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662846 ↗InjuryJun 22, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED PATIENT REQUEST AS REASON FOR REMOVAL. HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE", BAKER GRADE III. CAPSULECTOMY WAS PERFORMED. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25578999 ↗InjuryJun 22, 2026Gel Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED PATIENT REQUEST AS REASON FOR REMOVAL. HEALTHCARE PROFESSIONAL LATER REPORTED "IMPLANT 'BLEEDING'" AND "CAPSULAR CONTRACTURE", BAKER GRADE IV. HEALTHCARE PROFESSIONAL CONFIRMED IMPLANT SHELL WAS INTACT. CAPSULECTOMY WAS PERFORMED. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25578924 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P020056. One submission often covers many models, so check the product and lot details in each record.
- Z-0700-2020 · Nov 6, 2019 · TerminatedNatrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod
- Z-0701-2020 · Nov 6, 2019 · TerminatedNatrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 762
- Z-2453-2019 · Jul 24, 2019 · Open, ClassifiedNatrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TR
- Z-2454-2019 · Jul 24, 2019 · Open, ClassifiedNatrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-
Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices
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- 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
- 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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