Susan Helman

Tennessee

I am Susan Helman from Gatlinburg, Tennessee.

I am here to address the question of post-market long-term safety studies and issues resulting from silicone gel breast implants.

I wrote a book, now in second edition, which included interviews with more than 50 women and was based on information from more than 250 women –all different, yet all suffering with similar illnesses, just different levels of disease directly related to the silicone gel in breast implants.

The eventual rupture of the implant allows this gel to travel throughout the entire body, including crossing the blood/brain barrier. Once the silicone gel has spread throughout the body there is NO way to remove it!

The long-term exposure to the chemicals and microscopic platinum and heavy metals in silicone gel implants causes debilitating, acute and chronic symptoms, similar but not identical to some of the symptoms of diseases such as: multiple sclerosis, lupus, chronic fatigue syndrome, fibromyalgia, rare lymphomas, multiple neuropathies, and multiple chemical sensitivities. In fact, research has clearly shown an increase of giant macrophages after breast implants are in the body,

Long-term research is important here because I was not diagnosed with Reynaud’s disease or Sjogren’s until over 11 years after implantation. My diagnoses stand as silicone gel induced disease processes and silicosis.

We, the women who have been “guinea pigs” for plastic surgeons and manufacturers, have never had the opportunity for informed consent because of the lack of objective, long-term scientific data.

When women with implants tell their doctors about their health problems they are treated as hypochondriacs! We have been told by most doctors our health problems could not possibly be caused by our implants. Yet, many of us do get better when the implants are removed.

Silicone gel breast implants provide a very comfortable income for plastic surgeons and manufacturers F D A requires the implant manufacturers to conduct long-term research, but there are 2 major problems with the research:

1. F D A did not do a good job of making sure the studies were well designed, so that even those that are completed lack some of the most important information about health effects. The F D A did not seem to care that the manufacturers did NOT want to measure the increase of autoimmune symptoms. Instead of evaluating the symptoms that are most strongly associated with silicone gel implants, F D A allowed the companies to focus on the diagnoses of connective tissue diseases, most of which are rare. These kinds of diseases are diagnosed after years of symptoms, so that 10 year studies are not long enough.

2. In most of the studies, the companies lost track of the patients early on. What happened to women whose implants were removed? It seems that in most cases the women were removed from the studies, so that the very women whose problems were most severe are NOT included in the studies! The manufacturers and the plastic surgeons helping with the studies were happy to focus on the women who had no problems with their implants.

This has biased the results!

My implants ruptured and have been removed. However, I still have platinum and silicone that has crystallized in my saliva, my mucous, urine, and blood. My eyes, ears and nose also ooze crystallized platinum and silicone. As a direct result from the chemicals and heavy metals used to manufacture silicone gel breast implants, I suffer daily with the symptoms of M.S, lupus, visual problems, fibromyalgia, multiple chemical sensitivities, severe migraines, peripheral neuropathies, and demyelinating lesions on my brain!

The remaining capsules, tissue, lymph nodes, 3 bone marrow samples and foreign materials found upon subsequent surgeries over eleven years after implantation, were sent to the pathology lab of Dr Hardt at the University of Florida Department of Pathology, as well as a Forensic Toxicology Lab in Houston. These samples were found to have extremely high levels of the identical silicone, polymers, platinum and foams found in the silicone gel in my implants. These levels of residual silicone gel in my body are most definitely causing my illnesses. I have been told that I cannot donate my organs as they all contain silicone and polymers.

I hope the panel will make sure future studies of breast implants include the most important questions regarding health risks, and are conducted appropriately. The implant makers should pay for the studies, but they should NOT design the questionnaires or analyze them. The companies now have a track record of poor study design and implementation. It is time to have independent researchers take over those studies – designing them, running them, and analyzing and interpreting the data.

Thank you.