At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
It is unknown at this time if the device will be made available for return.
As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.
As such, the investigation will be closed.
If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.
Since no lot number was provided, no device history record (dhr) review could be performed.
(b)(4).
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It was reported (via fda medwatch) that a female patient of unknown age who underwent breast prostheses implantation with mentor saline implants on (b)(6) 2000 experienced the following: "in 2000 i got mentor spectrum adjustable implants; 5 years ago i started getting sick.
I'm getting worse.
I was healthy prior to 5 years ago, currently show autoimmune symptoms with neg blood work.
Hair falling out, weight gain, lymph nodes swollen, breast pain left side.
Bruising on body, brain fog, joint muscle chronic pain, body swollen, use walker or cane.
Headaches, fevers, fatigue, urinate on myself avg 5 times a day.
Ibs, osteoporosis, told i have lupus and ra, but negative blood work.
Low white blood count.
Depression, asthma, hard time breathing at times.
I want to get the implants taken out, but can't afford to do so.
" no product issue, such as rupture, was reported.
No date of revision or explantation was reported.
This report is for the right implant.
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