Judy McCaul


In September 2007, I had a double mastectomy. I had been scheduled to have my thyroid removed at the time I found my lump, but that was obviously postponed. About six months later, my plastic surgeon recommended silicone breast implants. I was interested in having a flap surgery using my own tissue but since there wasn’t any surgeon versed in doing a free-flap in my area (in my state at that time), I wasn’t opposed to having implants since I was assured they were safe. My plastic surgeon advised me that if there were any problems it would be easier to remove the implants and have flap surgery than it would be to correct a problem with flap surgery.

Three months after I got my silicone implants, I started to feel horrible. I was terribly tired and achy, making it difficult for me to move. My husband commented that I seemed like an old woman, though I was only 48. Something was obviously very wrong, but I had no idea what. I had no reason to expect that the implants were the cause of my symptoms. I looked into a number of possible causes including bone cancer, the tamoxifin I was taking, my thyroid replacement, depression, or rheumatic disease. When nothing I or my physicians tried worked, I began to suspect the implants.

I decided to have my implants removed and my breasts reconstructed using the DIEP flap surgery. Initially, my health insurance provider agreed to cover the DIEP surgery, but I was surprised when despite my surgeon’s and my doctor’s approval of my choice, my provider changed its mind and decided not to cover DIEP reconstruction after all. The provider argued that it had already paid for breast reconstruction once and that there was no proof that it was my implants making me feel so terrible. I told them that the way I felt with silicone breast implants was worse than when I was on chemotherapy, and finally after going back and forth with them for almost a year while I was in poor health, they agreed to pay for DIEP reconstruction if I could prove that the implants were causing my pain. If I had the implants removed and my symptoms stopped, they would consider this proof and cover the DIEP surgery.

I had my silicone breast implants removed in August 2010. Exactly one week after they were removed, I woke up and felt like my old self again. This past January, I had a successful DIEP reconstruction. This is definitely a difficult surgery, but I feel better than I have in about 3 years.

I was never told that women with thyroid problems could have an autoimmune disease that makes them more vulnerable to health problems if they get breast implants. It was only when I was preparing my statement that I learned that the patient booklet required by the FDA says that the safety of breast implants has not been established for women with autoimmune diseases. I might have been given the booklet at the time I was fighting my breast cancer, but this was an extremely difficult time and I was researching and reading a lot of material. One small statement in all that material would not have had a significant impact.

I wish I was there to ask you to make sure that research is done to determine if breast implants are more risky for women with thyroid conditions or other autoimmune symptoms or conditions. It seems that FDA requirements are getting ignored by the implant companies and I don’t believe plastic surgeons want to believe that implants may be causing women health issues.

Meanwhile, the FDA needs a better warning than the one sentence on page 12 of a patient booklet that most patients never see. Additionally, I wish you were also the insurance commission, because no one should have had to fight their insurance for their health!

Judy’s story was read at the FDA Advisory Committee Meeting on breast implants in August 2011.