Myrl Jeffcoat myrlj@jps.net

I'm Eugene Goldberg. I direct the Biomaterials Center at the University of Florida. I have no financial interest in breast implants. I traveled here at my own expense.

My group has conducted research on the biocompatibility of silicone implants for more than ten years. In addition to my comments here, I have appended more information for you.

We published the only large cohort clinical evaluation of gel implants. This is a meta analysis of about 10,000 implants from 42 different papers. A high prevalence of rupture and additional surgeries was found. A plot of failure versus time showed 29 percent of rupture at 5 years and 70 percent of rupture at 17 and a half years. When the next slide comes up, you will see that.

One of every three women with implants required additional surgery within six years due to pain, hardness, disfigurement, or rupture. In an FDA-NIH study using MRI plus explant surgery, Brown and coworkers confirmed our results. They found 69 percent rupture at 16 and a half years. And that falls directly on our implant rupture curve that is shown up there.

A Mentor consultant states that "Rupture is a critical safety parameter," but Inamed in a letter to the FDA says that rupture is "an unintended patient outcome." Frequent additional surgeries are truly also unintended, but both pose major safety risks.

Inamed now tells us that surgical damage is the leading cause of failure. If so, why aren't gel implants properly designed for normal surgical procedures? Inamed's 4 year clinical results show still a high 10-22 percent rupture, despite a presumably thicker shell with phenyl siloxane as a barrier. Short-term rupture is actually not much lower than reported before.

Also note that crazing and cracking of phenyl siloxane coatings can occur after four to five years. And the barrier properties and strength may deteriorate as a result after five years. Four-year clinical data are not adequate.

Finally, an increased risk for cancer of the lung, cervix, and brain is reported for gel implant recipients. It is simply not reasonable for Inamed to blame this on lifestyle with no scientific evidence. This is another potentially serious problem, and it must be resolved.

Thank you.