Myrl Jeffcoat myrlj@jps.net

MS. McDONOUGH: Good afternoon. My name is Mary McDonough. I am an actress, a mom, and a founder of In the Know, a supportive and caring community created by women in the entertainment industry to share information about health, body image, and plastic surgery. I have no conflicts.

Several of the plastic surgeons here today testifying have attempted to differentiate between the older generation and the new third generation of breast implants. It's important to point out to you that the new, "new," generation implants start in 1981. In October of 2003, Inamed stated that there had been no changes in this product since 1991. Mentor stated in their PMA that they have not changed their product since 1987. So we're talking about a product that has virtually gone unchanged for 25 years.

I was only 23 when I got my silicone gel breast implants. Because after my years of playing Erin on "The Waltons," I really wanted to continue my acting career, it was suggested to me that if I had larger breasts, that might do the trick.

Within 24 hours of my implant surgery, I broke out in a rash. Then for the first couple of years, my implants seemed like they were okay. Then by year seven, I got more and more symptoms that have led to a diagnosis of lupus.

Over the course of those ten years, I became more ill. And I felt like I was dying. When I asked my doctor about removing the implants, he told me that I would probably become too depressed. He also said that there was no link between the implants and everything that I had.

Another plastic surgeon told me, "Well, your breasts look and feel great. You know, I wouldn't touch them, at least not with a knife."

I had a mammogram at 31 to see if my implants were ruptured, but the mammogram came out clear. And then I had a breast MRI because it was supposed to be more conclusive. And, according to the MRI, the implants had not ruptured.

Inamed has said that if its PMA is approved, they will recommend an MRI every one or two years to monitor the rupture, but no one tells you what the physical experience of that MRI is like. It's long, and it's uncomfortable. Basically you lie face down in a dark enclosed tube with your breasts in these holes. And if you're in pain, like I was, it's even worse.

The other thing that Inamed doesn't mention is that MRIs are very expensive; on an average, $1,890 according to Blue Cross. That's $1,890 of your own money because they are not covered by insurance. Most women can't afford one MRI, let alone one every year or two.

Now, while Inamed has recommended the MRI, I don't see a plan that is set up or fund to pay for these MRIs. Also, not all MRIs or facilities are equipped to conduct the necessary procedures.

In clinical trials, the industry has been using very specific centers with experienced radiologists. And even those centers don't always detect rupture. And many women don't even find out they have a rupture until their implants are removed.

The industry's own data shows a high false positive rate for rupture detection through MRI. In the past, we have heard a 95 percent accuracy rate with MRI. Yet, according to Inamed's core study, more than a third of MRIs, 36 percent, falsely detect rupture. And such high rupture rates and false positives of those high rates create unnecessary anxiety for women and potentially unnecessary surgery.

In my experience, despite the fact that my MRI did not detect that my implants had ruptured, I still decided to have them out. But when they were removed, both of my implants were ruptured. And the outer shell had completely disintegrated. And now, while I still suffer from lupus, the farther I get away from my implant surgery, the better I feel.

I am not the only one with this experience. Other members of In the Know have had similar MRI experiences where a rupture was present but not detected.

MRIs are unreliable, expensive, and unpleasant. Inamed's recommendation for yearly MRIs is both unrealistic and disingenuous for the women who actually have to go through them.

Thank you very much for listening and for your time tonight.

Thank you.