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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SILIMED/ SIENTRA, INC. COHESIVE GEL SILICONE BREAST IMPLANTS

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SILIMED/ SIENTRA, INC. COHESIVE GEL SILICONE BREAST IMPLANTS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Chest Pain (1776); Diarrhea (1811); Dry Eye(s) (1814); Fatigue (1849); Muscle Weakness (1967); Necrosis (1971); Pain (1994); Raynauds Phenomenon (2034); Swelling (2091); Anxiety (2328); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)
Event Date 03/01/2007
Event Type  Injury  
Event Description
I had silimed smooth cohesive gel silicone implants put in (b)(6) 2006. I was put on a 10 yr study by the company, but was told they didn't need to follow me after about 4 yrs. By the 1st year of being followed, i had developed joint pain. Although mild at first my symptoms over the past 9 yrs have progressed significantly. The past 3 or 4 years, i have suffered with debilitating joint pain and stiffness, muscle pain, joint swelling, horrible insomnia, extreme fatigue, dry eyes, constant diarrhea, anxiety, brain fog, muscle weakness, raynauds disease. Right sided chest pain and right sided abdominal pain just under the right implant. I have been to multiple specialists including 3 rheumatologists and had hundreds of labs, xrays and other testing. Always to be told everything is normal. I feel like my body is attacking itself with no explanation. I did test positive for a gene called hla b27, but everything else is "normal. " a few weeks ago, i had a natural healing woman tell me she was pretty sure it's my implants and i have since been researching it a lot! i was amazed to read of thousands of other women with the exact same unexplained symptoms. I am currently working on getting all my records from the past 10 years and seeing a plastic surgeon for explantation. I have had to take narcotic pain medications daily for the past 2 years just to be able to work, and have been on so much prednisone for the joint pain that i now have bilateral avascular necrosis in both hips that may require surgery to fix. I have spent (b)(6) of dollars with no answers, have suffered greatly and now need to figure out how i am going to come up with thousands more to get them out. More research has got to be done. Thousands of women are suffering and going broke and destroying relationships.
 
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Brand NameCOHESIVE GEL SILICONE BREAST IMPLANTS
Type of DeviceCOHESIVE GEL SILICONE BREAST IMPLANTS
Manufacturer (Section D)
SILIMED/ SIENTRA, INC.
MDR Report Key5842969
MDR Text Key51226262
Report NumberMW5063797
Device Sequence Number1
Product Code FTR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/29/2016
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received07/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/29/2016 Patient Sequence Number: 1
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