Date: Sun, 26 Mar 2000 00:01:15 -0700

~~~ This is an interesting thread. dr. Zuckerman's summary from the fda meeting, O'leary's critique, and Eileen Swanson's response to him.

Dr Patrick J O'leary, who hid under the name of "mplnt" for around 4 years on the newsgroup, denied he worked for one of the top 2 silicone manufacturers in the world. in fact, for much of that time he was president of mcghan, Ireland.

as has been his way since november, 95, he has been hypercritical of all of the science that backs the ills of the women, while claiming NO manufacturer ties. here is a quote from him below referring to a paragraph of Dr. Zuckerman's work:

"I think that this last statement was what made me respond to the crap that was being posted. If one presents data to support a stance that is one thing. But to just throw darts at things and not state ones own bias is another. "

At the the FDA hearings, he was one of the team of the failed, PIP implant, and he was listed in the IRG as "International Association of Prosthesis Manufacturers: McGhan" yet, he wants us to believe "I do not think women should get implants."

Immediately below is Eileen Swanson, who was a speaker at that conference. Ilena ~~~

Dear Pat,

1. Diana's article is not slanted. Women are STILL NOT being informed of the risks. They STILL think implants are FDA approved (IF they think about that at all). Since food manufacturers are required to list all ingredients, and drugs are regulated, why on EARTH would most women think that a device that is being permanently implanted in her body is anything but approved? As a support group leader, women write to me all the time, and they are angry because they are sick, they are having to have multiple surgeries, and they did not know it could happen. Also, your comment re most women following the news about implants is not valid since a) it is mostly just the women in the class action who follow the news about that, b) only a fraction of implanted women are on the internet and seeking information about implants, and c) when they DO look for information about implants, they are looking for information which validates their choice, which they easily find at a plastic-surgeon sponsored site.

2. Yes, the studies were done mostly on gel implants, which is the POINT! There is STILL no valid research proving salines safe. Of course, there is no research proving gel-filled implants safe, either. And no one is saying that gel is worse than saline, least of all me. Based on the women who find my saline implant group, the saline-implanted women are getting sick in exactly the same way as the gel-implanted women. For years I have been telling women that the shell is silicone, and they have been shocked. And people who have solid silicone implants (same silicone, according to the ASPS) are turning up with the same symptoms.

3. Poll of the audience? Were you there at the Mentor presentation? Or were you readying for your presentation on Thursday? I can't speak for the entire audience, but everyone I spoke with was stunned that Mentor was approved. Based on the panel's criticisms and the FDA presentation of Mentor's data, it did not look good for Mentor.

4. It is not speculation that mammography is hindered by implants. It is a known fact and is well-acknowledged by medical professionals, especially radiologists. Your cavalier attitude toward women's health is arrogant and dangerous.

5. The panel was told that lack of approval would mean removal of the implants from the market. You say, "Now it is left up to the women receiving implants to obtain the correct information.." Same old same old. Caveat emptor, buyer beware. That is not good enough, sorry.

6. As far as MedWatch reporting goes, it is more likely that adverse events are UNDERreported, not duplicated. My original plastic surgeon did not even report my first adverse event (deflation in the recovery room) in my operative report, much less file a MedWatch form. There can be no doubt that I am the only one who reported the rest of my local and systemic complications which occurred later. Plastic surgeons' egos aside, they have a financial interest in implant surgeries being successful.

7. Yes, the quality of the data presented was poor, so poor that Mentor is now under a criminal investigation. And recall that PIP did not even get approved. One panel member stated that he was surprised the company got as far as they did in the process of getting to the hearing, considering the state of their research.

Oh, and the data said that 43% of augmentation patients, and 73% of reconstruction patients, had complications during the 3 year clinical trial. (Mentor data)

8. "Complete crap"? Considering your level of education, is this the best you can do? Loss to follow up is a serious issue, and as you stated yourself, most of those women are considered to have had a bad experience. So what are you arguing about?

9. Now this one makes me really angry. Women who have had cancer are not EXPECTED to have a better quality of life because "they have CANCER" ?????? Excuse me? I think you owe the thousands of us who received breast implants in hopes of improving the quality of our lives after losing our breasts to cancer, a HUGE apology. Oh, and for the record, I celebrate 12 years cancer-free (Stage II) in May, but my quality of life was DESTROYED by my SALINE implants.

10. Yes, all of the data was presented by the manufacturers, which makes it quite biased. Now, if there was data presented by an independent organization, one which studied the women who were already sickened by these devices, it would have been a fair fight. Those of us who are sick and disabled are a poor match for wealthy manufacturers.

11. "Mechanical testing is pure crap" ?? Ok, we agree on something.

12. Diana is accurate in her assessment about a patient being polite to her plastic surgeon. Believe me, the last thing you want to do is make your plastic surgeon angry or feel inadequate, especially if you are having problems. As for myself, after months of pleading with my plastic surgeons to remove my implants, one of them pressured me with "Don't you think they look pretty nice?" He kept it up, and finally I found myself saying, "I guess they don't look too bad." I knew I was lying, but I wanted him to shut up. So what do you think he wrote in my record? You guessed it...

13. You don't think women should get implants? So why not find another job? We were told quite some time ago that you were out of the industry. Imagine my surprise when you stood up during PIP's presentation and said, "Hi, I'm Dr. Pat O'Leary, and I can answer that question." What hypocrisy. See, even though I don't have a PhD, I can find another word to use besides "crap."

Eileen Swanson

Survivors of Salines

**From: mplnt@aol.com (Mplnt)

**Newsgroups: alt.support.breast-implant

**Subject: Re: Summary

By Diana Zuckerman, Ph.D. and Patricia B. Lieberman, Ph.D.

This came as a surprise to many of the hundreds of thousands of women with implants >who believed that saline implants were already FDA-approved.

This is a nice play on words, as those who have kept up with the global settlement, this newsgroup and many other avenues of information, know that they are not. But that is a nice way to slant the story from the beginning.

The FDA did not require long-term studies, and did not require the manufacturers to determine whether saline breast implants cause systemic disease. Instead, the FDA instructed the panel to assume that saline implants do not cause systemic disease, based on 17 epidemiological studies that found few statistically significant increases in connective tissue disease among women with silicone-gel breast implants. This assumption was criticized in the testimony by CPR for Women and Families, based on our analysis showing that only one of the 17 studies had specifically analyzed women with saline breast implants.

We'll just forget that the other studies were on Gel which this board had repeated said is far worse than saline. So if one does not find the adverse condition in gel do you really think it will show up miraculously in saline implants?

The advisory committee recommendation to conditionally approve the Mentor and McGhan implants came as a surprise to many in the audience, after listening to the panel members' criticisms of the studies and their findings.

I certainly did not see a poll of the people in the audience, but if the FDA was working with the companies to get the appropriate data, delayed the calling until the data was in, and then called for the data and panel meeting, why would anyone be surprized? This sounds like a cross between head in the sand and story telling to me.

Based on the research studies, Berg estimated that the cancer diagnoses of 20,000-40,000 of the women who currently have breast implants will be delayed because their implants interfere with mammography.

Unfortunatley, the research that is peer reviewed and published, does not support this speculation. Women with implants no not have a mean time to detection, or a size of tumor at detection any larger then women without implants. Go figure.

Panel members demanded that additional studies be conducted to determine whether the implants were truly safe, but when advised by FDA officials that the devices would need to be approved in order to continue to be available, they agreed to recommend approval as "reasonably safe and effective" as long as women were warned of the risks and the FDA ensured that the additional research be conducted.

Dianne is a PhD. so she knows the drill. What to do about any problem, well lets demand more study, (we'll stay away from who gets the grant money for these studies). But to imply that the panel was coerced into approving the implants is an opinion with out facts provided to support this view. Obviously, there are NO implants that are 100% safe. So that is OBVIOUSLY not the gold standard. The level of threshold is, are they safe and effective. We know that they are effective in increasing breast size so they are effective for their stated use. Safety is relative. It goes to the risk/benefit ratio. Does the risk outweigh the benefit? This is where the women failed to make their arguement! Now it is left up to the women receiving the implants to obtain the correct information about the risks and dangers of breast implants prior to implantation.

The advisory committee was presented with conflicting information and given inappropriate instructions about how to weigh that information. For example, the FDA presented statistical analyses by the FDA scientists, indicating that the manufacturers had misrepresented the complication rates of saline breast implants. The panel also heard from women who reported problems with their saline implants, some of whom stated that their doctors did not report their health problems to the FDA. Unfortunately, the panel was instructed to ignore their testimony because it was not scientific. Meanwhile, several plastic >surgeons, including two panel members, reassured the advisory panel that women were satisfied with the implants despite the high complication rates.

It is nice that overstament here is not included. If a surgeon sees a problem he should present to the FDA, if a patient sees the probleml she can present to the FDA. If the company hears of the problem via the surgeon, patient, submited forms, or a reported article then they must tell the FDA. So with one incident, the FDA could have many many reports of the same situation. That is why the numbers there do not mean too much. but lets not dwel on the facts. And please this is not to say that there are no problems. There are many, but the reporting mechanism is not adequate.

The quality of the studies submitted by the manufacturers was poor.

Nice opinon.

Panelist Brent Blumenstein, a biostatistician with the American College of Surgeons Oncology Group, claimed that the studies were not good enough for a peer-reviewed scientific journal. He stated that "accuracy is not manifest in the presentation of the data," with regard to the McGhan data, and that Mentor's data was "kind of smelly."

So what did the data itself say? Not the presentation of the data.

After reviewing the data presented by the first sponsor, several panel members expressed concerns about the implants and urged that additional research should be conducted to prove whether they are safe. Despite their reservations, the panel was openly encouraged by FDA officials to vote for approval to keep the implants on the market.

I am sorry, I did not see the FDA OPENLY encourage anyone to do anything. But again it was late that night and there could have been some hand signals.

None of the manufacturers had any information about the large number of women who dropped out of studies. The manufacturers assumed that these women did not return to their plastic surgeons because they had no problems, but FDA scientists pointed out that they may have had health problems that resulted in them going to another doctor. The high "loss to follow-up" is a serious shortcoming of these studies, and could have biased the data in favor of the manufacturers.

this is complete crap. The followup rate for both manufacturers was actually pretty good. I think in excess of 85%. It is well know that the women who did not come back are considered to have had a bad fate not a good fate. So this arguement does not hold water.

The manufacturers did not provide persuasive evidence that implants improved women's self-esteem or well-being. For example, Mentor presented data showing that cancer patients who received implants were less depressed several years after getting their implants than before their implants. However, since most women got implants soon after they were diagnosed with cancer, the study should have compared the reconstruction patients with breast cancer patients who were not given breast implants, to determine whether that decrease in depression was due to implants, or perhaps more likely, due to surviving cancer. In the public comment period, Dr. Anne Kasper, a researcher from the University of Illinois, reported that most breast cancer patients in her study were disappointed in their implants: reconstruction did not meet their hopes and expectations or the assurances of well-being promoted by their doctors, it did not erase the reality of cancer, nor did it assure the woman's return to normalcy.

This is really a cute example. The women with breast cancer are not expected to have a Quality of Life that is better. They have CANCER. They are expected to have a Qof L that brings them back to the range that they were before the cancer. It is interesting that Ms. Zuckerman chose this for an example. The augmentation patients should have a higher QofL. Witch I think is what the data indicated. But lets not quote the data.

Overall, the panel meeting exposed several systemic weaknesses:

1. The information and processing of information was not balanced. Most of the information was provided by the manufacturers and other experts with conflicts of interest, the plastic surgeons on the panel were not balanced with other experts with concerns about implants, and the panel was urged to disregard the testimony of women with implants.

Big me a break. Almost all of the data was presented by the manufacturers! It is data which the FDA and any one else is well versed in analyzing. You can put any bias that you want on it, but it is still the data. Come up with some other data instead of just complaining.

2. The manufacturers' data were confusing. For the McGhan studies, the panel was unable to determine the complication rate because the manufacturer included some surgical procedures that should not have been considered complications of implants. For both McGhan and Mentor, the manufacturers' mechanical testing was not consistent with the high rupture rate, suggesting that the tests were not appropriate, or that the implants deteriorated in the human body.

Confusing is a relative term. I did not find it confusing, but I am used to see data. the mechanical testing is pure crap. Everyone knows it. The tests do not accurately reflect what is happening in the body. When someone comes up with that test I believe it will not be hard to implement. But that test does not exist at this moment. What exists are test which are the best approximation of a stress believed to be relevant.

3. The standards of what is "safe and effective" were not clear. Since these are implanted devices, long-term safety is important. However, FDA only asked for two-year studies, so does that mean that two years is long enough to prove the implants are safe? Another complication was that the manufacturers' studies reported that almost all the women were satisfied. That seems to imply that they are not having problems, and that therefore implants must be safe enough. This again gets to the issue of bias in the surveys, since the plastic surgeon is the one asking his patient to rate how satisfied she is with her implants. Her desire to "be polite" or not embarrass him (by complaining in a survey that he and others would see) could bias the results. In summary, the panel was asked to vote on whether the implants were safe, but were not given adequate information to make that judgment.

I think that this last statement was what made me respond to the crap that was being posted. If one presents data to support a stance that is one thing. But to just throw darts at things and not state ones own bias is another. I can't believe that the patient was being polite if she had problems with her implants. The form is closed and the MD doesn't even understand what it means even if he were to read the results. So I just don't buy the slanted remarks.

Before you all jump on me, I do not think women should get implants. But if a women with informed conscent wants them , who am I or anyone else to deny this women what she wants to do with her own life?

Diana Zuckerman, Ph.D.

Executive Director

National Center for Policy Research for Women and Families

1444 Eye Street, NW

Suite 900

Washington, DC 20005