Dr. Wendie Berg_Dawn _

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Note: forwarded message attached.

Kathynye@... wrote:

From: Kathynye@...Date: Sun, 1 May 2005 12:31:39 EDTSubject: POST:Dr. Wendie Berg_Dawn _Kathynye@...Subj: Wendie Berg Testimony - FDA Panel Hearings - April 2005 From: myrlj@... DR. BERG: Dr. Choti, members of the panel, I am Dr. Wendie Berg, aradiologist specializing in breast imaging. And I have served on theRadiologic Devices Panel of the FDA previously.I wanted to just review the literature on screening for breast cancer inwomen with implants. If I could actually go two slides forward, please? Mycredentials are in the paperwork.Mammography is the only screening test to date which has been shown toreduce deaths due to breast cancer.

And across numerous randomizedcontrolled trials, there has been overall a 40 percent reduction in breastcancer mortality among women who are actually screened.Next. Importantly, screen-detected cancers have a much better prognosisthan those that are clinically found with 50 percent of screen?detectedcancers found with good prognosis, translating to 95 percent 20-yearsurvival compared to only 19 percent of those that are clinically foundhaving good prognosis and nearly half having a poor prognosis with 40percent 20?year survival.Next. Also, the lymph node status of the breast cancer correlates withsurvival. And in the trials where there was a benefit to screeningmammography, you can closely correlate that, the reduction in mortality withthe reduction in node?positive cancers.Next. Importantly, mammography and implants, there are issues oflimitations. All implants, including both saline

and silicone implants,hide some of the breast tissue, requiring both routine and displaced viewsto be obtained, resulting in twice the radiation dose to the patient forevery mammogram performed.Implants cause mass effect on the remaining breast tissue and reduce thecompression that we can achieve, which results in poorer quality mammogramsas well as increased radiation. And the patients, of course, oftenexperience pain and contracture, which limits the ability to position andcompress the breast.It's worse if the implants are in subglandular location. It's better formammography if they're in subpectoral, behind the muscle, position. And insome women, there is so little breast tissue to start with that themammography is just not possible after implant.There is patient concern about rupture and discomfort, resulting innon?participation in mammographic screening. Here is an example of

apatient who did have a mammogram that was successful in depicting her smallfocus of cancer that was manifest as calcifications. This was DCIS.The next slide, however, shows another patient who with the implant we wereunable to obtain any visualization of the breast tissue. And, in fact, youcan 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 tomammography, as in this patient, who on the left?hand side, had extensivesilicone granulomas in her breasts that mimic suspicious masses, requiredfurther evaluation, and on the right-hand side had seroma.Over several studies, there has been a reduction in the mammographicsensitivity to the level of 45 to 57 percent. That's rather severe, 33 to40 percent reduction overall. Cancers were more likely

palpable. And inone study, there were fewer in situ cancers. There's a trend toward largersize and more node?positive cancers.This is the last issue here. These studies have not distinguished withpatients who have smaller breasts, dense breasts, contracture, orsubglandular 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 ascompliant 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, tomy knowledge, but on a frequent basis, at least weekly, I get phone callsfrom women demanding to have an MRI, instead of a mammogram. It's not thestandard 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 notfind 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 thatthe compliance, the percent of women that follow breast cancer screening isdiminished in women who have implants?DR. BERG: I don't know that it's been systematically studied. I thinkthat's one of the problems.CHAIRMAN CHOTI: Thank you.==========================================================Subj: Dawn Testimony - FDA Panel Hearings - April 2005 From: myrlj@... MS. MILLER: I am Dawn . I am from Massachusetts. I have noconflicts of interest.I had silicone

breast implants in 1990 at the age of 20 as a part of acorrection for congenital deformity of my rib cage. It was recommended bymy surgeons that I have implants at age 16. I waited until age 20 because Ifelt I really needed to explore the safety of the devices prior to surgery.When I finally decided on reconstruction, an 80 cc silicone implant wasimplanted on my left side and a 200 cc silicone implant was implanted on myright side, filling in the cavity of my chest wall and creating anormal-appearing breast.I consulted with four plastic surgeons prior to my surgery. And theyinformed me that silicone was essentially synthetic sand, a building blockof life and completely inert in the human body. I was told that it wouldtake a severe physical trauma to rupture an implant.In August of 2002, I experienced permanent hearing loss in my left ear andproblems with my equilibrium. In January of 2004,

I began to have heartarrhythmias. I never associated either of these conditions with my siliconeimplants.Two years later, in August 2004, my sister heard a news report thatscientists found high levels of platinum in some women who had siliconeimplants. Women with these platinum levels were experiencing neurologicalproblems that included hearing loss.At this time I contacted the manufacturer of my implants, InamedCorporation, and inquired about my implants. I was told, and I quote, that"The same materials, silicone elastomers for the shell and silicone gel, areused in the fabrication of the Style 40 devices today."Very concerned, I sent a sample of my urine to the scientists who performedthe platinum testing on breast-implanted women. My urine tested positivefor high levels of platinum.My implants were removed last November. My surgeon told me that my leftimplant was ruptured and

leaking and my right implant appeared to be intact.Free silicone was found in the skeletal muscle and connective tissue takenfrom both my right and left sides. Platinum is a well?known neurotoxin, asreported in the literature. The hearing loss, equilibrium problems, andheart arrhythmias I experience very closely resemble that experienced bythose exposed to platinum through chemotherapy.I had silicone implants for 14 years. At no time did I suspect a rupture.This is consistent with the FDA's study that showed that most women withimplants will have at least one ruptured implant within ten years. And,just like me, the women in that study never knew they had a rupturedimplant.The fear, the outrage, and the sadness are with me still. These samefeelings are shared by my family and friends, who support me through this.It has been devastating to learn that the same implants that have caused meharm

are being considered for reintroduction to the open market.The industry's four-year studies are completely inadequate because they donot provide any information about the long-term safety of these products. Iurge you to recommend that the FDA not approve these PMAs.Thank you.==========================================================