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Device Problem Patient-Device Incompatibility (2682)
Patient Problems Autoimmune Disorder (1732); Fatigue (1849); Hair Loss (1877); Muscle Weakness (1967); Pain (1994); Scleroderma (2062); Swelling (2091); Tingling (2171); Joint Swelling (2356); Malaise (2359); Numbness (2415); Sleep Dysfunction (2517)
Event Date 05/30/2016
Event Type  Injury  
Event Description
My situation was as such: in (b)(6) 2015 after being diagnosed with ductal carcinoma in situ (dcis) for a third time in 12 years, i had a mastectomy with immediate reconstruction on my right side, with a mentor gel-filled implant.Within two months of my operation, i had an odd perspiration odor which remained with me permanently.In the spring of 2016, i began feeling tired after my gym workouts, quite unusual as i had always exercised regularly, and i was in perfect health.By (b)(6) 2016, i began experiencing tingling and numbness in my fingers, which was not going away.I then began to have swollen fingers, hands and wrists in (b)(6) of the same year, which led to my being diagnosed with carpel tunnel syndrome by a rheumatologist.The rheumatologist took blood tests and results showed i had an autoimmune disease known as scleroderma.I was shocked as nothing like this was ever heard of in my family.I come from a long line of healthy people who mostly live into their nineties.By this time, too, i began feeling malaise, and i then was weakened to the point of being unable to walk unaided.From the middle of (b)(6)(the date my plastic surgeon explanted the implant), i became so debilitated that i could no longer walk.I lost 20lbs of muscle during this above-noted period, as my arm, leg and rear muscles atrophied, resulting in me being totally debilitated.I was in extreme pain, and i began losing my hair.I couldn¿t think clearly, and i could not sleep.I suffered from extreme fatigue, and my joints were swollen, especially my right knee.I had upper back and neck weakness.I could not raise my arms, move my legs or use my hands.All symptoms started on the right side of my body, and were more severe than on the left side of my body.When i told the rheumatologist on (b)(6), that i had an implant and that i had made an appointment to see my plastic surgeon the very next day she said, ¿you are right to mention this to me.Autoimmune diseases are often caused by external reasons, and are not always hereditary.¿ in this way, she confirmed that it could be breast implant illness that i was suffering from.The next day, my plastic surgeon agreed to explant my mentor gel-filled implant stating that he could not guarantee that the implant was causing my debilitation and that i might not regain my health.The surgery was on a thursday morning, and i needed a wheelchair by this time.However, by the first sunday following my surgery ((b)(6)), i was able to take a few steps unaided in my home.Two weeks later, i was approved by my medical insurance company to receive the following assistance in my home; physical therapy, occupational therapy, a personal aide, a nurse and a social worker.I was able to have a visiting nun come once a week also.It is now (b)(6) 2017 and i am able to walk again.I will continue to receive services from the occupational therapist and the social worker.My physical therapist told me i must maintain an exercise program that he prescribed for me.My personal aide and the nurse have stopped coming now as i am finally showing signs of recovery.I continue to have swelling in my hands and weakness in my upper arms, neck and back.It is quite difficult to believe that the mentor gel-filled implant was leeching or bleeding toxins into my body to the extent that i was totally debilitated for over 10 months of my life.I thank the rheumatologist for validating the fact that the implant could be the cause.I have been on a detox diet since (b)(6) 2016.I was unable to leave my house unaided from (b)(6) due to this illness.I only left the house for doctor appointments.I could not take myself to these appointments.At present, i cannot sit for long, tire easily and cannot drive far.My upper body muscles ache, and i continue to have difficulty sleeping.I continue with occupational therapy sessions.
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Brand Name
Type of Device
Manufacturer (Section D)
MDR Report Key6575692
MDR Text Key75546313
Report NumberMW5069851
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 05/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Weight63