Statement by Ruby Rahn

General and Plastic Surgery Devices Panel Center for Devices and Radiological Health Food and Drug Administration, DHHS

October 15, 2003

My name is Ruby Rahn. I received breast implants after being diagnosed with fibrocystic disease and micromastia disease (small breast disease). I have a similar story to many women who've made statements here. I got breast implants, I got very sick after ten years, and then once my implants were removed my health improved. When I got sick I wanted to find out how this could happen to me. I wanted to take responsibility for my health and so it seemed reasonable to start looking for answers. I have spent the last decade trying to find those answers.

In my search, I came across an advertisement for silicone in an issue of Plastic and Reconstructive Surgery where they talked about the wonders of silicone products. It showed pictures of breast implants and other medical devices made of silicone. I wondered if other products made of silicone were having problems, and I discovered that they do.

Wear debris is a well-known and documented complication of a long list of medical devices including breast implants. Wear debris occurs when implants age and degrade inside the body. As implants degrade they start to break down into small particles where they can travel, through the lymphatic and vascular systems, into regional and distant parts of the body. This includes the brain, lung, liver, spleen and lymph nodes.

To illustrate wear debris, I have included some photographs of breast implants that were removed from a friend of mine. One implant is still intact, while the other shell has broken down and disintegrated. These breast implants were removed "en bloc" - where the implant and capsules were removed in one piece. While the scar capsules held much of the silicone gel inside the capsules, the elastomer shell has broken down and is no longer visible. What happened to it? Where did it go and what are the short- and long-term effects of having this elastomer shell break down and migrate inside the body?

For millions of years, the main function of the human immune system has been to determine "self" from "non-self." To distinguish and determine what is "our" biological system from "other" biological systems, such as bacteria and viruses. Our survival and evolution has relied on this primal form of protection.

When our immune system detects these particles, it responds by creating a chronic, inflammatory, foreign body reaction. A similar foreign body reaction can occur when a splinter gets into your hand or foot, only in this case the inflammation is visible on the outside of your skin, the process happens internally.

Compound this reaction by having multiple implants over a period of twenty or thirty years and there is no question that you will develop a "chronic inflammatory syndrome" from countless, splinter-like, shed particles or wear debris. This is not a local complication but a chronic, systemic and progressive condition. The result is a very serious long-term health problem that has no cure.

It is important to note that once the phagocytic cells of the immune system becomes chronically activated it leads to an ever-increasing attempt to destroy a foreign object that cannot be destroyed by the weapons our immunity has in its arsenal. Our immune system is designed for destroying biological entities, not indigestible made-man chemical composites like silicone elastomer.

In the attempt and failure to destroy these particles, our immune system activates macrophages that produce destructive cytokines. Cytokines and the chemical cascade they produce are destructive to human tissue are implicated in a long list of serious health concerns including depression. The over production of inflammatory cytokines may be the leading reason why so many women who've had breast implants have committed suicide.

I strongly urge this committee to recommend to the Food and Drug Administration to require further long-term studies to investigate whether a cellular response to particulate debris be causing the health problems that hundreds of thousands of women, who've already had breast implants, are currently experiencing.

Specifically,

1. How does silicone elastomer and gel age and degrade inside the body at 98.6 degrees?
2. Does the chemical composition of the shell or gel change during any stage of degradation?
3. What size and how many particles can be generated inside the body in five and ten years?
4. How does the absorption of silicone fluid and body fats (lipids) by the elastomer shell weaken and accelerate degradation and breakdown of the elastomer shell?
5. Can these particles further degrade into smaller and more reactive particles inside the body?

I think these are important questions to ask and understand before making silicone gel implants available again.

Thank you for the opportunity to make this statement.