Natrelle INSPIRA Breast Implants SRLP-590Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRLP-590 Low Plus 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
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888628006980), received between Jul 16, 2020 and Jul 16, 2026 — classified as 8 injuries.
The most frequently reported specific device problem is “Material Rupture” (4 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 Rupture4
- Patient-Device Incompatibility3
- Device Appears to Trigger Rejection1
Patient problems
- Capsular Contracture4
- No Clinical Signs, Symptoms or Conditions2
- Failure of Implant1
- Unspecified Infection1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJul 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 25849706 ↗InjuryJul 10, 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 25787336 ↗InjuryMar 14, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR OF LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE II AND SUSPECTED / ACTUAL RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16539537 ↗InjuryMay 4, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING "AS "CAPSULAR CONTRACTURE", BAKER GRADE NOT SPECIFIED; BAKER GRADE UNKNOWN AGAINST RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 14280852 ↗InjuryNov 2, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
InjuryOct 19, 2020Material Rupture; Material Rupture
COMPANY REPRESENTATIVE REPORTED LEFT SIDE "COLLECTION OF FLUID THAT GOT INFECTED AROUND THE IMPLANT". "PATIENT COULD NOT REMEMBER THE EXACT DIAGNOSIS BUT SAID THAT IT MAY HAVE BEEN "A SEPTIC POCKET OF FLUID." "IMPLANT CAUSING PAIN, ESPECIALLY IN THE BACK AND CHEST AREA AND HER UNDERARMS ARE SORE." DEVICE REMAINS IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 10696922 ↗InjuryJul 16, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
InjuryJul 16, 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-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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- 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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