Natrelle Inspira Cohesive Breast Implants SCX-615Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCX 615cc Extra Full profile |smooth|round|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · Natrelle Inspira Cohesive Breast Implants (192)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Natrelle Inspira silicone gel-filled breast implant from Allergan. The 53 reports mostly describe the scar tissue around the implant tightening and shrinking the breast (capsular contracture), sometimes along with rupture, the implant shifting position, or infection and fluid buildup. No deaths were reported, and all 53 reports involved an injury or illness. No recalls name this device. Reports fell sharply in the past year, from 13 to 2.
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
- 56
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10888628030381), received between Jun 20, 2019 and Sep 3, 2026 — classified as 55 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (35 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
- Device Appears to Trigger Rejection35
- Patient-Device Incompatibility7
- Adverse Event Without Identified Device or Use Problem5
- Material Rupture5
- Device Dislodged or Dislocated2
- Malposition of Device2
- Migration2
- Difficult to Open or Remove Packaging Material1
Patient problems
- Capsular Contracture40
- Failure of Implant5
- Unspecified Infection3
- Deformity/ Disfigurement2
- Foreign Body Sensation in Eye2
- No Clinical Signs, Symptoms or Conditions2
- Seroma2
- Wound Dehiscence2
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported an "infection". This record is for the left side. The device was explanted.
Patient problems: Unspecified Infection
MAUDE report 50591260 ↗InjuryAug 19, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular Contracture Baker Grade III/IV" against the right side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50323886 ↗InjuryJul 20, 2026Material Rupture
Healthcare professional reported "rupture". Later healthcare professional reported "ruptured". Patient underwent superior, medical and posterior capsulectomy. This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25884389 ↗InjuryJul 9, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "BREAST IS FIRM AND IMPLANT SITS HIGHER AND THERE IS PAIN ASSOCIATED AND CAPSULAR CONTRACTURE BAKER GRADE III". PATIENT WAS PRESCRIBED SINGULAIR. THIS RECORD IS THE LEFT. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25769861 ↗MalfunctionMay 29, 2026Difficult to Open or Remove Packaging Material
SALES REPRESENTATIVE REPORTED "THE PACKAGING WAS STICK TO THE PLASTIC WHEN THEY PEELED THE TOP OFF". DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25338382 ↗InjuryOct 27, 2025Malposition of Device; Migration; Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23398607 ↗InjuryOct 23, 2025Malposition of Device; Migration; Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23366083 ↗InjuryOct 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III, CORRECTION OF ASYMMETRY, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23337290 ↗InjuryAug 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULAR CONTRACTURE BAKER GRADE IV¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22868372 ↗InjuryAug 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22840759 ↗InjuryAug 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22834406 ↗InjuryAug 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22798543 ↗InjuryAug 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE". LATER CONFIRMED BAKER GRADE 3. THIS RELATES TO THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22768079 ↗InjuryJul 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
HEALTHCARE PROFESSIONAL REPORTED "SYMMASTIA". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Deformity/ Disfigurement
MAUDE report 22538857 ↗InjuryJul 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
HEALTHCARE PROFESSIONAL REPORTED "SYMMASTIA". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Deformity/ Disfigurement
MAUDE report 22535090 ↗InjuryMay 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
COMPANY REPRESENTATIVE REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21971958 ↗InjuryApr 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryApr 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 21911067 ↗InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED, A LEFT SIDE INFECTION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Unspecified Infection
MAUDE report 19690846 ↗InjuryMar 1, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18817355 ↗InjuryNov 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18157641 ↗InjuryAug 28, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
COMPANY REPRESENTATIVE REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17633886 ↗InjuryAug 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17549945 ↗InjuryAug 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17549881 ↗InjuryJul 21, 2023Material Rupture; Material Rupture
DEVICE ANALYSIS LAB RECEIVED A "RUPTURED" DEVICE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Erosion; Failure of Implant
MAUDE report 17374935 ↗
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-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-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-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-
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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
- 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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