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Adverse Event Report

DOW CORNING CORP. SILASTIC II BREAST IMPLANT   back to search results
Catalog Number P014-245
Event Description

On 7/15/83, when rptr was 34-yr-old the dr inserted breast implants into the subpectoral spaces in her chest. This was done due to bilateral mammary hypoplasia after breastfeeding 3 children. She had requested mastopexy only but the dr advised implants because he felt it would be less scarring. Over at least the last 7 yrs she has been experiencing: shoulder, arm, wrist and hand pain, numbness and weakness, muscle and nerve twitching, amnesia, aphasia, headaches, depression, fagigue and itching nipples. Her fourth child, born 3/13/88, has poor weight gain, multiple allergies and learning difficulties. She continues to have a very poor appetite.

 
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Brand NameSILASTIC II BREAST IMPLANT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
DOW CORNING CORP.
midland MI 48686
Device Event Key13117
MDR Report Key13119
Event Key9446
Report NumberMW1001875
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Report Date 05/02/1994
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/06/1994
Is This An Adverse Event Report? No
Device Operator Invalid Data
Device Catalogue NumberP014-245
Device LOT NumberHX10375
Was Device Available For Evaluation? No
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on February 28, 2009

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