Myrl Jeffcoat myrlj@jps.net

DR. BERG: Dr. Choti, members of the panel, I am Dr. Wendie Berg, a radiologist specializing in breast imaging. And I have served on the Radiologic Devices Panel of the FDA previously.

I wanted to just review the literature on screening for breast cancer in women with implants. If I could actually go two slides forward, please? My credentials are in the paperwork.

Mammography is the only screening test to date which has been shown to reduce deaths due to breast cancer. And across numerous randomized controlled trials, there has been overall a 40 percent reduction in breast cancer mortality among women who are actually screened.

Next. Importantly, screen-detected cancers have a much better prognosis than those that are clinically found with 50 percent of screen? Detected cancers found with good prognosis, translating to 95 percent 20-year survival compared to only 19 percent of those that are clinically found having good prognosis and nearly half having a poor prognosis with 40
percent 20?year survival.

Next. Also, the lymph node status of the breast cancer correlates with survival. And in the trials where there was a benefit to screening mammography, you can closely correlate that, the reduction in mortality with the reduction in node? positive cancers.

Next. Importantly, mammography and implants, there are issues of limitations. All implants, including both saline and silicone implants, hide some of the breast tissue, requiring both routine and displaced views to be obtained, resulting in twice the radiation dose to the patient for every mammogram performed.

Implants cause mass effect on the remaining breast tissue and reduce the compression that we can achieve, which results in poorer quality mammograms as well as increased radiation. And the patients, of course, often experience pain and contracture, which limits the ability to position and compress the breast.

It's worse if the implants are in subglandular location. It's better for mammography if they're in subpectoral, behind the muscle, position. And in some women, there is so little breast tissue to start with that the mammography is just not possible after implant.

There is patient concern about rupture and discomfort, resulting in non? participation in mammographic screening. Here is an example of a patient who did have a mammogram that was successful in depicting her small focus of cancer that was manifest as calcifications. This was DCIS.

The next slide, however, shows another patient who with the implant we were unable to obtain any visualization of the breast tissue. And, in fact, you can see on the right her cancer adjacent to the implant on ultrasound only. This was a lump that she felt and was, therefore, clinically detected.

Even after removal of the implants, we can have severe limitations to mammography, as in this patient, who on the left? hand side, had extensive silicone granulomas in her breasts that mimic suspicious masses, required further evaluation, and on the right-hand side had seroma.

Over several studies, there has been a reduction in the mammographic sensitivity to the level of 45 to 57 percent. That's rather severe, 33 to 40 percent reduction overall. Cancers were more likely palpable. And in one study, there were fewer in situ cancers. There's a trend toward larger size and more node? positive cancers.

This is the last issue here. These studies have not distinguished with patients who have smaller breasts, dense breasts, contracture, or subglandular implants. So there is a need for more studies.

Thank you.

CHAIRMAN CHOTI: Dr. Berg, can I ask you a question?

DR. BERG: Yes.

CHAIRMAN CHOTI: You mentioned that women with implants may not be as compliant for screening.

DR. BERG: That's correct.

CHAIRMAN CHOTI: Do you have data on that?

DR. BERG: I don't think there's been any systematic study on that issue, to my knowledge, but on a frequent basis, at least weekly, I get phone calls from women demanding to have an MRI, instead of a mammogram. It's not the standard of care. It's a $1,000 to $3,000 test, instead of a $70 test. It's not practical for screening. Ultrasound can be done, but it does not
find DCIS. And so this is another issue.

Many of the women who do do mammography have severe pain and contracture. They're not thrilled to come back for their mammograms next year.

CHAIRMAN CHOTI: But you're not familiar in the radiology literature that the compliance, the percent of women that follow breast cancer screening is diminished in women who have implants?

DR. BERG: I don't know that it's been systematically studied. I think that's one of the problems.

CHAIRMAN CHOTI: Thank you.