Natrelle INSPIRA Breast Implants SRM-195Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRM-195 Moderate profile |smooth|round|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · Natrelle INSPIRA Breast Implants (197)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Natrelle INSPIRA silicone gel breast implant made by Allergan. The 33 reports mostly describe the scar tissue around the implant tightening and hardening (capsular contracture), often painful enough that the implant was removed or replaced, along with a couple of cases of the implant shell breaking. All 33 reports describe injuries, with no deaths. 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
- 35
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10888628007024), received between Jun 7, 2019 and Sep 30, 2026 — classified as 35 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (17 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 Rejection17
- Patient-Device Incompatibility16
- Adverse Event Without Identified Device or Use Problem1
- Material Rupture1
Patient problems
- Capsular Contracture33
- Failure of Implant1
- Seroma1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular Contracture Baker grade III" and "Impressioned the area of palpable concern related to the implants. Folds are seen suggesting capsular contracture". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50947649 ↗InjurySep 28, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular Contracture Baker grade III" and "Impressioned the area of palpable concern related to the implants. Folds are seen suggesting capsular contracture". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50914318 ↗InjuryJul 22, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III AND PAIN". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25904639 ↗InjuryOct 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17968090 ↗InjuryOct 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17967925 ↗InjurySep 6, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17691257 ↗InjuryApr 24, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16800216 ↗InjuryMar 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "IMPLANT IS HARD AND STATED "I HAVE BEEN RESEARCHING AND I THINK IT IS CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN". DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 16565188 ↗InjuryFeb 8, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED A RIGHT SIDE CAPSULAR CONTRACTION BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16325104 ↗InjuryJan 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III, AND PAIN. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 16216857 ↗InjuryDec 6, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15927724 ↗InjuryJan 24, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "A LEFT SIDE PAIN, BUMPS, AND CAPSULAR CONTRACTION BAKER GRADE III/IV." DEVICE REMAINS IMPLANTED. LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 13338034 ↗InjuryNov 10, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12791513 ↗InjuryOct 29, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryOct 6, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjurySep 30, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PHYSICIAN REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12556513 ↗InjuryAug 19, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN UNILATERALLY REPLACED.
Patient problems: Capsular Contracture
MAUDE report 12344425 ↗InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE INFECTION, SEROMA. DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma; Unspecified Infection
MAUDE report 11596564 ↗InjuryFeb 12, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 11324763 ↗InjuryDec 9, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10979087 ↗InjuryDec 7, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10962124 ↗InjuryDec 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10948903 ↗InjuryOct 21, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
PHYSICIAN'S ASSISTANT REPORTED A SHELL AFTER RECENT CLINICAL EXAMINATION. SIDE UNKNOWN. SURGERY SCHEDULED TO REMOVE SHELL, DEVICE STATUS UNKNOWN.
Patient problems: Capsular Contracture
MAUDE report 10710176 ↗InjuryAug 21, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
InjuryAug 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
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-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-
- 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
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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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