Photo Courtesy of Kathy Nye

Myrl Jeffcoat myrlj@jps.net

MS. JOHNSTON: Thank you.

OPEN PUBLIC COMMENT

MS. JOHNSTON: Good morning. My name is Kathy Keithley Johnston. I'm the Executive Director and founder of Toxic Discovery, a national not-for-profit consumer advocacy organization. I am also a registered nurse. And I myself used to have silicone gel breast implants. I have no conflicts of interest.

I am here today carrying the voices of thousands who have been directly affected by the failure of the FDA to require long-term safety studies concerning breast implants.

We believe the FDA made the right decision in 2004 when they decided not to approve Inamed's silicone breast implants. The new guidance that the FDA issued at the same time was an important step forward, demonstrating the FDA's commitment to assure that breast implants are safe for long-term health studies before they allow them to be widely sold.

I am here today counting on you to help the FDA to adhere to the guidance document. Silicone breast implants should not be approved until a company can prove the safety of devices for long-term use. Since safety cannot be proven, we ask you to deny the manufacturer's application.

Implant lobbyists claim that there are over 100 studies of women with implants that show no evidence of harm. That is clearly and absolutely false. These groups conveniently ignore the following studies: a study by the FDA of women with silicone breast implants that at least found for six years that women had at least one failed breast implant, even though they
did not know it. This is referred to as a "silent rupture."

That same study found that 21 percent had silicone leakage outside the scar capsule surrounding their implant. From there, silicone could harm breast tissue, could migrate into lymph nodes and, thereby, travel to lungs, liver, or other vital organs.

The FDA also found that women with leaking silicone breast implants were more likely to report fibromyalgia and other connective tissue diseases. Scientists at the National Cancer Institute found that women having breast implants for at least seven years were twice as likely to die of brain cancer, three times as likely to die of lung cancer, and four times as
likely to commit suicide compared to other plastic surgery patients.

A Canadian study found that women with breast implants for augmentation were more likely to be hospitalized and had more physician visits than women of the same age living in the same communities.

These are just a few of the studies that were a serious concern about risk of silicone leakage. Research has not yet been done to determine exactly what chemicals leak into a woman's body and what long-term health consequences then results from that leakage and migration of silicone. How can informed consent be obtained when information is not even known by the very physician implanting these risky devices?

Neither Inamed nor Mentor has conducted studies of the health impact of leaking silicone in a woman's body. Dow-Corning has funded one such study. In a Danish study, Holmich claimed that leakage was not significantly related to connective tissue disease. However, there were only 23 women in this study with extracapsular leakage, a sample that is much too small to provide meaningful safety data. In fact, the study showed that women were four times as likely in that study to report a connective tissue disease compared to women whose implants were not ruptured. But these impressive differences were not statistically significant because the sample was too small.

You would certainly think after 40 years that implant manufacturers should find more than 23 women with extracapsular rupture. Without a doubt, there are more than 40 in this very room today. There are hundreds of thousands of women in this nation whose body would show you that leakage is present if testing was provided.

Our organization has serious concerns about the integrity of the studies conducted by Inamed and Mentor. Patients in these studies have informed us of their fears that they believed that their problems with implants were never reported by their physician or the manufacturer.

In closing, let me remind you of the duties of the FDA. First and foremost, the FDA is a public health agency charged with protecting American consumers. The FDA should be the consumer watchdog and not the advocate of the breast implant manufacturer.

It is your job to make sure that the FDA protects patient safety concerning breast implants. This can only be done by requiring long-term health studies before approval and not after approval.

It is certainly not your job to protect the livelihood of plastic surgeons or implant makers. Both have failed in their promises to protect women, which will not make the situation better. It will only allow it to continue. And we ask you, please protect the women of this nation.

CHAIRMAN CHOTI: Thank you.