MAUDE Adverse Event Report: ALLERGAN SALES, LLC/ABBVIE, INC. NATRELLE INSPIRA BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	SRL-200
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Gastritis (1874); Hair Loss (1877); Pain (1994); Tinnitus (2103); Sleep Dysfunction (2517); Tics/Tremor (4425)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
After having a bilateral breast implant exchange from 375ml saline (implanted in 1997) to 200 ml silicone implants, i began having a multitude of symptoms that i had never experienced before.Severe insomnia, fatigue, muscle and joint pain, palpitations, tinnitus, gastritis, shortness of breath, hair loss and hand tremors.I had a complete cardiac workup including blood work, ekg(electrocardiogram), echocardiogram and a holter monitor.I also had a gi workup that included abdominal and pelvic ct scans, blood work and an egd (esophagogastroduodenoscopy).I saw multiple primary care physicians and had more bloodwork and exams.All of my testing came back normal.I reached out to my plastic surgeon in (b)(6) 2025 and subsequently had the implants removed on (b)(6) 2025.Since that time my symptoms have either disappeared or improved greatly.Reference report#: mw5168869.

• Brand Name: NATRELLE INSPIRA BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN SALES, LLC/ABBVIE, INC.
• MDR Report Key: 21825178
• Report Number: MW5168870
• Device Sequence Number: 19905656
• Product Code: FTR
• UDI-Device Identifier: 10888628006683
• UDI-Public: 10888628006683
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 04/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: SRL-200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DITROPAN XL.; LISINOPRIL. ; LUNESTA. ; MULTIVITAMIN.; PROBIOTIC.; PROTONIX.
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White