Panelist Transcript Quotes

Panel Vote

Dr. S. Lori Brown, page 464: "When breast implants rupture, silicone gel may migrate out of the scar capsule and through tissues. Across a series of studies, gel migration was observed for 11 to 23 percent of ruptured implants. There have also been cases of gel migration from intact implants. These may be cases of silicone oil migration from intact implants or possibly gel migration from minimally ruptured implants. The frequency and severity of distant gel migration are unknown."

Ms. Nancy Dubler, Bioethicist, page 495: "The final issue is I have been rather startled today by what I see as the lack of obligation that the sponsor felt to pursue a better product over the decade that I have been engaged in these discussions. I find it strange that this obligation of wise stewardship of the product that they are producing didn’t leave any room for at least attempts to improve it in the last decade."

Dr. Amy Newburger, Dermatologist, page 496: "I am troubled by the device failure rate in terms of morbidity of second operations…I don’t put in breast implants, but I certainly see the repercussions of some of these ruptured implants in my patients, specifically breast cancer patients who have had reconstruction where they will be in for a body exam and we will find hard nodules in the region of the skin around the breast that has been reconstructed and we have had to sample these to see whether it is metastatic disease. With a patient who has had reconstruction, those hard papules or nodules have been silicone granulomas, these having developed early after their implantation. Of course I don’t know when the rupture was. I do see that sometimes the impact of the silicone, which has traveled a distance, may not become manifest for a decade or more. I also feel a little uncomfortable right now about the short duration of the study in terms of long-term safety."

Dr. Mary McGrath, Plastic Surgeon, page 501: "First of all, the reoperation rates. Now, we know that they are running about 20 percent over three years on the core augment group, they are running about 45 percent over three years on the reconstruction group. Somehow I had been going along thinking this was – or I had heard or the word was that this was because patients wanted to change their implants to get bigger ones or smaller ones or they didn’t like the way they look. That is not what the data is saying now. What it is saying is that it was because of complications. If the augmentation group, 70 percent of them went back for an implant, a second operation because of complications, and 92 percent of the reconstruction patients who went back, went because of complications, not because of some wish to change size or the type of implant. I think those numbers are high."

Dr. McGrath, Plastic Surgeon, page 503: costs to patients for MRIs) "Also, the question of how to detect these ruptures, to put that financial burden on patients of going for an MRI at frequent intervals, it is a very high price for them, and then if it’s ruptured, whether to remove it…..This puts a financial burden on them, particularly the ones that aren’t operating under health insurance. It’s a health risk…."

Dr. Phyllis Chang, Plastic Surgeon, page 509: "Remaining unanswered questions, as Dr. McGrath said, the important question is why do ruptures occur. It is a fairly high rate for reconstructive patients, 6 percent, why are they caused, how can we improve and try to diminish these numbers."

Dr. Michael Choti, Cancer Surgeon, page 512: "I think that a lot of the concerns we have are related to the delayed effects, and that is really not addressed by two- and three-year follow-up."

Dr. Brent Blumenstein, Statistician, page 513: "From a statistical viewpoint, the presentation of the PMA data is deficient and unimaginative. The FDA guidance document was inadequately implemented, and there was no effort to go beyond the underlying principles of the guidance document."

"The length of follow-up is inadequate. The amount of follow-up does not meet the minimal requirements in the FDA guidance document."

"In addition, it is my judgment that the minimal follow-up specified in the FDA guidance document is inadequate."

Dr. Emily Conant, Radiologist, page 517: "I am concerned that not only are we underestimating the ruptures because of lack of long-term follow-up and small numbers screened even at one-year and three-year, that we are not fully evaluating the extracapsular extent of silicone."

Dr. Ruth Lawrence, OB/GYN, page 519: "For the woman who is still in her childbearing years, it is a very important decision because we are talking about putting a foreign body in and some interesting chemistry into the breast. I think the data is not very robust as to the effect on the child who is born to a mother who has an implant, because there have been no controls and the follow-up has not been very extensive."

Dr. Ellice Lieberman, Epidemiologist, page 521: "Looking at the data, I am concerned at the high rate of local complications, and I think that they are serious."

"I think there is clearly a need for much more data and for much longer term follow-up to get more data on some of these outcomes, such as connective tissue diseases, cancer."

Dr. Barbara Manno, Toxicologist, pages 523-524: "I am concerned about the rupture problem, the etiology of the problem, what is happening to that silicone. There was a comment that it [silicone] is not moving out of the capsule, but yet it looks like, according to the physicians who work with these things, they can’t see it.

Ms. Alisa Gilbert, Breast Cancer Survivor and Consumer Representative, page 533: "I think the consumers simply need to have more answers, more honest answers to some of the concerns raised. The sobering testimony provided today was a contrast to the findings of the sponsor. I strongly recommend long-term studies to address failure and rupture, follow-up, delayed effects of gel migration, again, the follow-up concerns and the need for recommendations."

Dr. Michael Miller, Plastic Surgeon, page 535: "I am satisfied with the safety that I have seen in terms of the long-term effects of these implants. I think there are questions that exist but I think that the experience of 40 years, I think that the nice analysis of the data, and the published studies that were done by both the FDA and the sponsor summarized the literature very well."

"To me, it is fairly convincing that there is no evidence that these things harm people in the long term with systemic problems."

Dr. Benjamin Anderson, Breast Surgeon, page 539: "I must say that it was the presentation of the company that actually made me back off from my confidence in the device, because I didn’t hear the answers to the questions that we were looking for in terms of the local complications of these, and also addressing these possible systemic effects…."

Dr. Stephen Li, Biomaterials scientist, pages 545: "My problem with the mechanical tests is they don’t seem to reflect our clinical experience. In your fatigue tests, you can’t seem to break them, but patients seem to do it kind of regularly. Your fatigue tests would say it is impossible to break these things during mammography, yet, at least we have a series of patients who appear to have done it at that time"

Dr. Thomas Whalen, Panel Chair, page 550: "As chair of this panel today and in the past, I don’t often articulate my analysis or opinions on matters that are being considered….I remain astounded at the questions that FDA asked them [Inamed], and with all due respect to this being the normal process and we never ask for more than two years, et cetera, that has been articulated and is the situation as it stands, we have been getting ulcers today over a matter of a product that was taken off the market a decade ago for concerns about long-term issues in these patients, a decade has passed, and we sat here today talking about two and three year data, and I am just flabbergasted by that, that we are going to be asked to give a cogent answer to safety and effectiveness when the data wasn’t asked for, nor was it given."

FDA Question #1: Please discuss the adequacy of the information to determine the safety of this product with respect to asymptomic rupture.

Dr. Newburger, Dermatologist, page 552: "I don’t feel that there is information available to us to determine the safety of the product with respect to asymptomatic rupture."

Dr. Dennis Boulware, Rheumatologist, page 552: "I am comfortable, I guess, with the short-term data, but not the long-term."

Dr. McGrath, Plastic Surgeon, page 553: "If it were short term, and they were responding to a request for three-year data, it sounds like not much of it was three-year data, most of it is one-year data in point of fact, as we understood it today, therefore, that is another issue that comes up that it really isn’t even three-year data at this point."

Dr. Ann Marilyn Leitch, Breast Surgeon, page 555: "The question is not so much what is the safety of an asymptomatic rupture, as what is the long-term outcome of rupture that is identified in the asymptomatic state, what is the long-term outcome of that. Data wasn’t presented to that…."

Dr. Chang, Plastic Surgeon, page 556: "If they [patient] had a rupture, it was asymptomatic, and the patient kept it in for a year and had this amorphous gel in a subpectoral plane for one year, we haven’t had the opportunity to examine any data of what happens to those patients, so I think we are asked to make a conjecture without data."

Dr. Choti, Cancer Surgeon, page 557: "I think we don’t have adequate information regarding the safety with regards to asymptomatic rupture. I think, if anything, the information is of concern."

Dr. Blumenstein, Statistician, page 557: "The number of events too small and follow-up is too short." [Dr. Conant agreed, page 558]

Dr. Lieberman, Epidemiologist, page 558, 559: "We also have to keep in mind that only about a third of the patients were screened with MRI, so the rate of asymptomatic rupture in the whole population is really much higher than what we know." "We also don’t know the consequences of detecting an asymptomatic rupture sooner rather than later, is it more likely to result in extracapsular silicone, and what is the importance of that, so we don’t know that either. So, I think that we have a lot more that we need to know."

Dr. Manno, Toxicologist, page 559: "There is insufficient information on the short term, there is only one year’s worth of data completely analyzed and part of the third year group, and nothing on the long term. So, I think there is insufficient data here."

Dr. Miller, Plastic Surgeon, page 564: "I think that we don’t know the rate of rupture beyond one year, but we also don’t know the implications of rupture should it happen."

Dr. Li, Biomaterials scientist, page 565: "I will just answer from a device standpoint. It really just echoes what everybody else said, that it appears that the rupture rate is really kind of unknown beyond one year. It’s unlikely it will get better with time, so I am a little taken aback that I don’t know how we can answer the safety question when we are not quite sure how to answer the simplest question of how much they rupture.

Ms. Dubler, Bioethicist, page 565,566: "I have been a lawyer hanging out in medicine for 27 years, and it is rare that something shocks me, but I sat on the panel in ’92, and that was 11 years ago. How we could have come from 11 years ago, where we were going to collect data, to a point where we have a year’s data simply boggles the mind."

"I am also shocked by a second point, and that is that clearly, the rupture of these implants is a very serious issue, and yet the company over the 11 years, the sponsor over the 11 years between the first hearings and now, has made no attempt to make this a better implant, so that it might have a lower rupture rate."

"Given that and given that I don’t think we have anything more than a year’s data on asymptomatic rupture, I would say that we can’t make a determination on safety."

FDA Question: Given these data, is there reasonable assurance that the device is safe for augmentation and reconstruction patients?

Dr. McGrath, Plastic Surgeon, page 578: "Is there reasonable assurance that it is safe with regard to the local complications as have been reported in the studies today, I am going to say no to that."

"With regard to the asymptomatic/silent rupture information, do we have reasonable assurance that the device is safe based on the fact that approximately 30 percent of the patients have data…..I think the answer from many of us was that we don’t know. We don’t have enough information…."

Dr. Choti, Cancer Surgeon, page 582: "I am concerned about asymptomatic and silent rupture in this group, as well as reconstruction, as well as historical and preclinical data."

Dr. Conant, Radiologist, page 582: "I am concerned again about the long-term follow-up for local complications, for silent ruptures, and that we just don’t have that data particularly when maybe we will be looking at these. I am also concerned about the ability to truly provide informed consent without longer term follow-up, particularly to educate a young woman choosing implants when she may not have a clue about her lactational interests 10 years later, or the importance of breast cancer screening."

Ms. Dubler, Bioethicist, page 589: "When we sat on this panel, some of us, and we considered the saline implants, we were challenged by a member of the public to say how could you possibly approve them given the rupture rate, on the one hand, and the local complications and resurgical intervention rate. I was comfortable then, and I am not comfortable now. It seems to me that the one year data that we have don’t provide us sufficient information on [the questions of safety]."

Dr. Newburger, Dermatologist, page 590: "I agree with Dr. Dubler and without a prospective long-term study, I am uncomfortable about the impact of what will ultimately turn into probably extracapsular silicone, and without that information, and this isn’t something that I saw in the literature search, without the information, I don’t see how a patient can really give an informed consent."

Dr. Leitch, Breast Surgeon, page 617: "This one- and three- year business, that is where the risk of rupture is lowest. But the more years out you get, the higher risk there is so the greater yield you would have from doing those studies."

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