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Adverse Event Report

BAXTER HEALTHCARE CORP. BAXTER/3M SILICONE GEL IMPLANTS   back to search results
Patient Outcome  Other; Disability
Event Description

A 42 yr old white female gravida 0 status post bilateral transaxillary, subglandular gels (possibly, mcghan, no records, size, type) placed for augmentation on 06/81. Left got firmer and different size. (she thinks larger). Magnetic resonance imaging showed intracapsular rupture. Arthralgias, (morning stiffness)/myalgias, paresthesias/dyesthesias, spasms, fatigue, sleep disturbances, low grade fevers, hot flashes, headaches, gum/tooth pain, visual changes, memory loss, sicca, hair loss, rashes/dermatographia, sensitivity to chemicals, shortness of breath/cough (non-productive). Decreased "bh"/increased cholesterol, gastrointestinal/irregularities. Left ruptured breast implant with granuloma in continuity with capsule.

 
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Type of DeviceSILICONE GEL IMPLANTS
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
BAXTER HEALTHCARE CORP. BAXTER/3M
rt. 120 & wilson rd.
round lake IL 60073
Device Event Key161172
MDR Report Key165606
Event Key155619
Report NumberMW1013673
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Report Date 04/14/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/21/1998
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Was Device Available For Evaluation? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on January 30, 2009

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