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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

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MENTOR BREAST IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE Back to Search Results
Lot Number 5593781
Event Date 07/01/2017
Event Type  Injury  
Event Description

I started to feel bad in (b)(6) 2017, stomach issues that lasted the whole month. I ended up going to a gastroenterologist and was diagnosed with ibs. Then starting in (b)(6) 2017 i had what i thought was a sinus infection. Extreme fatigue, sinus pain and achy. Two prescriptions later and the symptoms never went away. Saw an ent and was told i needed to get my deviated septum fixed and that's why i was so tired and had sinus pain. He believed i had sleep apnea. Had my surgery in (b)(6). No relief after surgery. As the months continued i still suffered from extreme fatigue, joint and muscle pain, and sinus issues. Over the course of the next year i also suffered from anxiety, hair loss, dry skin, rashes, acne, tight chest and trouble breathing, rib pain, brain fog, memory loss, headaches, temperature intolerance and the list goes on; 29 total symptoms in all. In 15 months, i saw 6 different drs and had multiple blood tests done. Never getting a diagnosis because my blood work was always negative. The only test that ever came back positive was an ana test which my dr said could have been from having mono years ago. In (b)(6) 2018, i came across a website about breast implant illness. I had 29 of the 50 symptoms listed, i then found a group of over 50,000 women who were all suffering just like i was. I met with two surgeons which confirmed breast implant illness for me and i then scheduled my surgery for (b)(6) 2018. I am two weeks out from surgery and i am healing every day. Some symptoms have already gone away and some have gotten better. My mentor saline implants that i got back in (b)(6) 2008 were making me extremely sick.

 
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Brand NameBREAST IMPLANTS
Type of DevicePROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
Manufacturer (Section D)
MENTOR
MDR Report Key8023735
Report NumberMW5080954
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 10/28/2018
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received10/30/2018
Is This An Adverse Event Report? Yes
Device Operator NO INFORMATION
Device LOT Number5593781
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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