Karen D


I am a 36-year-old mother and wife. Five years ago I decided to have saline implants put in.
My surgeon had very positive things to say about them and said they would last a lifetime unless I happened to get in a very bad car accident. And even if that did happen, and they ended up rupturing, it would be perfectly safe because they were filled with saline, not silicone. At the time, I didn’t even know they weren’t FDA approved.

As soon as I had the implants put in, my breasts became very sensitive, but my doctors kept telling me not to worry, that it was just my hormones. About two years after this, I started having memory problems to the point that I couldn’t remember things that had happened the night before. I also began having problems in my job as a medical assistant because I couldn’t remember medications and general things I knew very well. It was also a problem that I was so tired all the time. My husband and I started to get very concerned so I went to a specialist and has some different tests done. Everything came back “normal.”

I had sharp, jabbing pains constantly running through my breasts. I also had aches and pains that left me virtually unable to move my joints, and there was overwhelming heat of my own skin. Soon my right arm began hurting so badly that I went in to have it checked out. The test results confirmed that I was having a lot of spasms in my neck and problems in my back. Finally I went in to the doctor again and my ANA test revealed that I had lupus.

It’s been a little over a month since I’ve been explanted. My right breast has swelled up twice since then, and each time they had to put a large tube in it for a week to drain. I’ve been on antibiotics all month. Today the new surgeon I’m seeing got the results of my culture, and it turns out that I have two infections in there still. So I’m now on penicillin, and another strong antibiotic. The hole is still there and I have to put an antibacterial ointment on gauze and push it in with a Q-tip. I go back at the end of February to see how my infection is doing.

My left breast is healing fine. The hot skin I was having for months went completely away after explantation. I no longer get sharp, jabbing pains through my breasts, and my ANA is back to normal. I am still on celebrex and I’m not sure how long I will need to take that for my joints. I am still tired but I guess that’s normal with the infections. I am just glad that my implants are out, I have noticed improvements even with this infection. However, my memory problem is still there, but I hope in time that also changes around. Now only time will tell on the rest of my symptoms.

Karen’s testimony before the FDA Advisory Panel in March 2000 was read by Gwen Lewis.