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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIENTRA SILIMED BREAST IMPLANT

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SIENTRA SILIMED BREAST IMPLANT Back to Search Results
Model Number SILIMED
Device Problems Leak/Splash (1354); Material Rupture (1546)
Patient Problems Fatigue (1849); Hematoma (1884); Pain (1994); Swelling (2091); Sleep Dysfunction (2517)
Event Date 10/25/2013
Event Type  Injury  
Event Description
In 2010 i experienced a hematoma in the lower inside of my left breast accompanied by great pain. Gradually the breast developed a painful capsular contracture and a mass in my left armpit lymph nodes which was treated by the (b)(6) with an asthma medication that did not work. I then received a letter about alcl which alarmed me even further and saw several doctors of which none knew how to test for alcl. I began experiencing a sensation in my chest that felt like an abscess that was spreading through my ribcage into my lung which makes it incredibly hard to sleep at night. I am in constant pain. Recently, my office at (b)(4)was closed, so i was forced to go into a field technician or lineman position. As i have progressed in my training for the last 6 months, i have experienced an unbelievable amount of pain, lack of sleep and uber fatigue. I went to the (b)(6) did not automatically provide insurance this last year and asked for an mri. I finally got the mri and the radiologist stated the implant was possibly ruptured and there was evidence of 2 leaks (exact wording subject to interpretation). Since i received that information 2 weeks ago, i have researched the internet and found that (b)(4) is providing explant money under certain conditions. Unfortunately, the conditions or stipulations are extremely subjective, for example, the explant money is only allotted if the implant was not subject to or exposed to some sort of stress or accident. Also, the lifetime warranty in some cases will not be applicable. This brings up the question of when that determination will be made. In my own case, if the implants are not under warranty, i would choose not to have them replaced. So what are the dynamics of an explant surgery? will (b)(4) provide breast implants in the case that my explant fits into their perfect little box they have created and will my surgeon be compelled to go through this checklist in the middle of surgery to det.
 
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Brand NameSILIMED BREAST IMPLANT
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
SIENTRA
MDR Report Key3474013
MDR Text Key15266478
Report NumberMW5032896
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 11/13/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/25/2014
Device Model NumberSILIMED

Patient Treatment Data
Date Received: 11/13/2013 Patient Sequence Number: 1
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