Natrelle Inspira SoftTouch Breast Implants SSX-615Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SSX 615cc Extra Full profile |smooth|round|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · Natrelle Inspira SoftTouch Breast Implants (195)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
These Natrelle Inspira silicone breast implants appear in 51 adverse event reports, with no deaths and 51 injuries. Reports mostly describe scar tissue around the implant tightening and hardening, the implant rupturing or failing, and infection, often leading to removal or replacement of the implant. No recalls name this device.
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
- 53
- Deaths reported
- 0
- Injuries reported
- 53
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10888628033429), received between Jul 12, 2019 and Sep 23, 2026 — classified as 53 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (26 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 Rejection26
- Material Rupture13
- Patient-Device Incompatibility8
- Adverse Event Without Identified Device or Use Problem7
Patient problems
- Capsular Contracture32
- Failure of Implant11
- Unspecified Infection6
- Impaired Healing3
- Foreign Body Reaction2
- Necrosis2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Hematoma1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture, baker grade IV". Patient was prescribed massage and Vitamin E in (b)(6) 2025. This record is for the right side. The device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 50868700 ↗InjurySep 21, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50849222 ↗InjuryAug 14, 2026Device Appears to Trigger Rejection
Device has been explanted and replaced.
Patient problems: Capsular Contracture
MAUDE report 50258479 ↗InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "WOUND PROBLEMS". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED. IT'S UNKNOWN IF THE DEVICE WILL BE RETURNED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24021229 ↗InjurySep 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23164065 ↗InjuryAug 29, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED ¿MALPOSITION¿ AND ¿DEFECT¿. LATER REPORTED ¿RUPTURED WITH A HOLE IN IT¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22922515 ↗InjuryJul 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22476334 ↗InjuryDec 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18360556 ↗InjuryOct 25, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 18001247 ↗InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "INFECTION". DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 17942941 ↗InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED RIGHT SIDE "REQUESTED 400 CC'S, BUT WAS GIVEN 650 CC'S." PATIENT ADDITIONALLY REPORTED ¿LOST HALF OF MY NIPPLE, GOT NECROSIS AND IT ROTTED OFF¿ AND ¿THEY TOUCHED IN THE MIDDLE BECAUSE THEY ARE TOO BIG.¿ DEVICE REMAINS IMPLANTED.
Patient problems: Necrosis
MAUDE report 17668356 ↗InjuryAug 24, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17611775 ↗InjuryAug 14, 2023Material Rupture; Material Rupture
InjuryApr 12, 2023Material Rupture; Material Rupture
InjuryApr 11, 2023Material Rupture; Material Rupture
InjuryFeb 15, 2023Material Rupture; Material Rupture
COMPANY REPRESENTATIVE REPORTED "BUBBLES" AGAINST LEFT SIDE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED "HOLE, NON-SPECIFIC". THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16379944 ↗InjuryNov 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT-SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15883364 ↗InjuryOct 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15526421 ↗InjurySep 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15506989 ↗InjurySep 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "EXPLANT WOUND EXPOSURE¿, ¿PT HAD INFECTION AND INCISIONS WOULD NOT CLOSE¿ AND ¿IMPLANTS HAD TO BE REMOVED TO LET HER INCISION HEAL¿ DEVICE HAS BEEN EXPLANTED.
Patient problems: Foreign Body Reaction; Impaired Healing; Unspecified Infection
MAUDE report 15477915 ↗InjurySep 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "EXPLANT WOUND EXPOSURE¿, ¿PT HAD INFECTION AND INCISIONS WOULD NOT CLOSE¿ AND ¿IMPLANTS HAD TO BE REMOVED TO LET HER INCISION HEAL¿ DEVICE HAS BEEN EXPLANTED.
Patient problems: Foreign Body Reaction; Impaired Healing; Unspecified Infection
MAUDE report 15477421 ↗InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "INFECTION." DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 15460226 ↗InjurySep 16, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A "RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV." DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15439288 ↗InjurySep 1, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "NON HEALING WOUND," "BUBBLE IN SILICONE," AND "POSSIBLE RUPTURE." DEVICE HAS BEEN EXPLANTED.
Patient problems: Impaired Healing
MAUDE report 15337342 ↗InjuryAug 29, 2022Device 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 15317502 ↗
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-
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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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