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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: J&J / MENTOR SALINE BREAST IMPLANT
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J&J / MENTOR SALINE BREAST IMPLANT Back to Search Results
Device Problems Fluid/Blood Leak (1250); Material Rupture (1546); Patient-Device Incompatibility (2682)
Patient Problems Autoimmune Disorder (1732); Autoimmune Disorder (1732); Autoimmune Reaction (1733); Autoimmune Reaction (1733); Fungus (1872); Fungus (1872); Pain (1994); Pain (1994); Tissue Damage (2104); Tissue Damage (2104); Toxicity (2333); Toxicity (2333); Disability (2371); Disability (2371); Sweating (2444); Sweating (2444); Alteration In Body Temperature (2682); Alteration In Body Temperature (2682); No Code Available (3191)
Event Date 09/30/2013
Event Type  Injury  
Event Description
I have pages of dr appointments that had doctors misdiagnosed me and caused body parts to be removed and killed all in the past two and a half (2.5) years.Pictures of my mammos catch mold growing for years making me sick and i was never told.I have two doctors and mammo techs willing to speak on my behalf.As a matter of fact they have already written letters for my disability attorney.The mammos speak for themselves, but the photographs of my surgery and explanted implants speak even louder.In midsummer 2013, the pain in my right breast was flaring up again as my left breast grew along with the strange rashes and ill feelings again.This has been going on for approx 4-5 years as documented on my mammo reports.As my newest gp was still trying to get hormones and thyroid regulated from the thyroid ablation 2011 and last ovary removal 2010.My symptoms were not making sense and i was getting worse again even though my blood said the thyroid should be ok; thank goodness doctor (b)(6) goes off how the pt feels and not the blood.As my left breast reached the next cup size and the pain in the right was so bad i had tremors, again, i called to get a mammo, since it had been 2 years due to my almost being in a coma the year before according to dr (b)(6), endocrinologist 2012.The mammo was scheduled for a week to 10 days later on (b)(6) 2013.Friday (b)(6) 2013, as i woke up to do my routine self exam since my mother had breast and ovarian cancers."ohhhh no! i think i sprung a leak in my right implant." my mammo is monday the 30th and all the crazy symptoms come back with a vengeance, lethargic, strangulation feeling times 10, can't speak and when i do it is super painful with a strange froggy toad sound, the thought of speech puts me in excruciating pain, the strain my body feels, makes a permanent crease in the brow furrow, fingers/toes split open and bleed, the sore on my foot comes back and breaks open, i bruise easily, i look swollen, the lesions on my face return, i am so depressed at how i look and feel, yet i am a positive outgoing person so i put make-up on and pretend i am happy but i feel like dying.I feel and look like a freak, i am ugly.I document my low body temp even though i am sweating as if i have a fever.I take pictures and videos of me taking my temps, the red face, neck, and lesions, i have it all documented.I am diagnosed with biotoxin illness, silicone sensitivity from the silicone shell of the saline implant, the leakage of mold coming from the implant, fibromyalgia, mastodynia in addition to the hashimoto's thyroiditis and raynaud's.Dr (b)(6) explains false diagnosis due to the biotoxin disease from the mold.I have pictures and videos of the last 2 years.
 
Event Description
I was very ill, on deaths door, my saline implant ruptured.I have so many issues since having implants.I will be 1 med watch per new diagnosis.Mycoplasma blood infection.
 
Event Description
I have pages of dr appointments that had doctors misdiagnosed me and caused body parts to be removed and killed all in the past two and a half (2.5) years.Pictures of my mammos catch mold growing for years making me sick and i was never told.I have two doctors and mammo techs willing to speak on my behalf.As a matter of fact they have already written letters for my disability attorney.The mammos speak for themselves, but the photographs of my surgery and explanted implants speak even louder.In midsummer 2013, the pain in my right breast was flaring up again as my left breast grew along with the strange rashes and ill feelings again.This has been going on for approx 4-5 years as documented on my mammo reports.As my newest gp was still trying to get hormones and thyroid regulated from the thyroid ablation 2011 and last ovary removal 2010.My symptoms were not making sense and i was getting worse again even though my blood said the thyroid should be ok; thank goodness doctor (b)(6) goes off how the pt feels and not the blood.As my left breast reached the next cup size and the pain in the right was so bad i had tremors, again, i called to get a mammo, since it had been 2 years due to my almost being in a coma the year before according to dr (b)(6), endocrinologist 2012.The mammo was scheduled for a week to 10 days later on (b)(6) 2013.Friday (b)(6) 2013, as i woke up to do my routine self exam since my mother had breast and ovarian cancers."ohhhh no! i think i sprung a leak in my right implant." my mammo is monday the 30th and all the crazy symptoms come back with a vengeance, lethargic, strangulation feeling times 10, can't speak and when i do it is super painful with a strange froggy toad sound, the thought of speech puts me in excruciating pain, the strain my body feels, makes a permanent crease in the brow furrow, fingers/toes split open and bleed, the sore on my foot comes back and breaks open, i bruise easily, i look swollen, the lesions on my face return, i am so depressed at how i look and feel, yet i am a positive outgoing person so i put make-up on and pretend i am happy but i feel like dying.I feel and look like a freak, i am ugly.I document my low body temp even though i am sweating as if i have a fever.I take pictures and videos of me taking my temps, the red face, neck, and lesions, i have it all documented.I am diagnosed with biotoxin illness, silicone sensitivity from the silicone shell of the saline implant, the leakage of mold coming from the implant, fibromyalgia, mastodynia in addition to the hashimoto's thyroiditis and raynaud's.Dr (b)(6) explains false diagnosis due to the biotoxin disease from the mold.I have pictures and videos of the last 2 years.
 
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Brand Name
SALINE BREAST IMPLANT
Type of Device
SALINE BREAST IMPLANT
Manufacturer (Section D)
J&J / MENTOR
MDR Report Key3651118
MDR Text Key4202340
Report NumberMW5034717
Device Sequence Number1
Product Code FWM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 05/31/2017
3 Devices were Involved in the Event: 1   2   3  
2 Patient was Involved in the Event
Date FDA Received02/24/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number0
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Age42 YR
Patient Weight88
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