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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SILICONE IMPLANTS GUMMY BEAR BREAST IMPLANTS SILICONE GUMMY BEAR

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SILICONE IMPLANTS GUMMY BEAR BREAST IMPLANTS SILICONE GUMMY BEAR Back to Search Results
Event Date 04/29/2009
Event Type  Injury  
Event Description

My very healthy step daughter and a mother of 3 young boys had silicone gummy bear breast implants put in 2009. Two weeks later, she was deathly ill with severe gastro intestinal problems, back pain, vision worsening, limbs in pain, feet feeling like they were being cut with daggers, jaw in pain, severe nausea, vomiting and diarrhea. She was in a teaching hosp for approximately 2 1/2 weeks and one in her home town for 5 days. Nobody could find the cause of her problems. She weight is down in 3 months. We are coming to the conclusion much to her dismay that it is the implants. This was something she really wanted to do as her breasts become disfigured after her first child. She has been ill now for 3 months and is constantly vomiting and can hardly eat anything. She is so weak she can't pick up her one year old. Even her plastic surgeon said, he would take them out for free and do the reconstructive surgery for her. She is having them removed approx four months later. Dates of use: 2009. Diagnosis: breast reconstruction.

 
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Brand NameSILICONE IMPLANTS GUMMY BEAR
Type of DeviceBREAST IMPLANTS SILICONE GUMMY BEAR
MDR Report Key1418494
Report NumberMW5012013
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 07/17/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 07/17/2009 Patient Sequence Number: 1
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