Fw: Tuesday's FDA hearing on breast implants

[Guest guest]

----- Original Message ----- From: Zuckerman

Sent: Wednesday, July 10, 2002 9:34 AM

Subject: Tuesday's FDA hearing on breast implants

Dear Friends,

The FDA Advisory Committee hearing on saline implants took place on Tuesday. The purpose of the meeting was to update the advisory committee on new research since saline implants were approved in May 2000. Although the Advisory Committee had recommended approval of saline implants, they expressed a lot of concerns.

Some progress was made. The panel was extremely critical of Mentor's study, which lost 95% of its patients by year 5! That means that 5 years after getting implants, only 60 of the 1200 augmentation patients in the study were available for follow-up information. The rate was approximately 50% for reconstruction patients, which is better but still not adequate.

The panel was virtually unanimous that women can't make an informed choice when no good studies are available. I was pleased that these comments were very similar to what I had said in my public comment.

McDonough, Kim Hoffman, and Helman also provided great testimony, as did Pearson from the National Women's Health Network. Dr Jae Lee from our staff made an excellent critique of the statistics involved.

However, the panel was so pleased by the 80% response rate for the 5-year study by Inamed (McGhan) that most didn't even mention the terribly high complication rate. For example, during the first five years of having implants, 45 percent of breast cancer reconstruction patients required additional unplanned surgery, 28 percent had their implants removed, 39 percent had breasts that did not match in appearance, 36 percent had capsular contracture (hardness), 27 percent had implants that were visible or could be felt, and 25 percent had implants that created a wrinkling appearance, 18 percent had implants that had moved to the wrong location, 18 percent had breast pain, and 8 percent had implants that leaked or deflated. The rates of 10 other complications such as infections, skin necrosis (death) and implants extruding through the skin ranged from 3% to 7% each.

My testimony is below and will soon be on our websites. As soon as the FDA transcript of the event is available, we will link to it.

Best wishes,

Zuckerman, Ph.D.PresidentNational Center for Policy Research (CPR) for Women & Families1901 Pennsylvania Avenue, NWSuite 901Washington, DC 20006www.center4policy.org

www.breastimplantinfo.org

Statement of Zuckerman, Ph.D., President

National Center for Policy Research for Women & Families

At the July 9, 2002 Meeting of The FDA Advisory Committee on Saline Breast Implants

My name is Dr. Zuckerman and I am President of the National Center for Policy Research (CPR) for Women and Families, a nonprofit research-based organization that explains medical and scientific information so that it can be used to improve the health and well-being of women, children, and families.

Our research center works on a wide range of health issues, with particular attention to the safety of medical products. Unfortunately, as the new research on hormone replacement therapy has reminded us, manufacturers’ claims about medical products are not always supported by research. Our goal is to balance the hype by scrutinizing the research and determining the facts -- whatever they may be.

In the case of breast implants, the more than 150,000 adverse reactions reported to the FDA is inconsistent with the manufacturers’ claims that implants are very safe and that implant patients are so satisfied that even when their implants break or cause hardness or pain their only desire is to replace a problematic implant with an even larger one. So, we have used our expertise in epidemiology, biostatistics, and public health to carefully scrutinize the research.

I was at the FDA Advisory Committee meeting when saline implants were approved in 2000. For those of you who weren’t here, I want you to know that the Advisory Committee expressed a great deal of concern about the extremely poor quality of the data and the exceedingly high complication rates. I heard the shocked gasps in the audience when the Advisory Committee voted to recommend approval despite their very strongly expressed concerns.

The Advisory Committee recommended approval with the caveat that long-term safety data, and better studies, be required of the manufacturers, Mentor and McGhan. I am sorry that many of those members are not here today. I think they would be very disappointed that the manufacturers made many of the same "mistakes" or misrepresentations now that they were criticized for two years ago.

For example, Dr. Brent Blumenstein, the statistician on the Advisory Committee, clearly stated that the McGhan presentations did not meet the standards of "good, peer-reviewed articles" and specifically stated that "accuracy is not manifest in the presentation of the data." The FDA statistician, Telba Irony, specifically criticized using Kaplan-Meier analysis when many women are lost to follow-up

and the researchers don’t know if those who dropped out are like those who are in the study. Both statisticians criticized the large number of patients who were lost to follow-up. Of course, in the new data presented today, even more women are lost to follow-up.

In the Mentor study, Dr. Blumenthal criticized the company for taking patients out of the analysis if they had their implants removed. He said "This is an extreme limitation and misrepresents the data." He concluded by saying "I cannot accept the accuracy of any of the data here because of the limitations I’m pointing out…. I cannot feel good about any of the data presented with respect to accuracy and giving that information to an individual patient and having that patient understand what the real risks are."

Phyllis Silverman, the FDA statistician stated "because of the approximately 50% loss to follow-up with the large, simple trial, the ability to draw meaningful conclusions from this trial is limited." I agree -- and obviously it’s even worse for the new Mentor data, which has a 95% loss to follow-up at 5 years or a 76% loss at six years.

A response rate under 50 percent can not provide useful safety data, because we know nothing about the women who are no longer in the study. If we don’t know if they are alive or dead, or healthy or sick, we don’t really know if these implants are safe.

Are these manufacturers unable to afford good researchers to do this research? They have spent millions of dollars to advertise in every major women’s magazine, including those read by millions of teenage girls.

Perhaps lack of research skills is not the problem here. Two members of Congress wrote to the FDA last month and again yesterday to ask about a criminal investigation of Mentor and to ask to see inspection reports for both Mentor and McGhan. A have a copy of their letters, which specifically asked that this Advisory Committee be informed of the criminal investigation, since it might have implications for the integrity of the research data. The Congressmen also asked that you be provided information about studies published by the National Cancer Institute last year. One showed an increased risk of cancer for women with saline or silicone implants compared to other women. The other showed an increase risk of deaths from brain cancer, lung cancer, and several other diseases among women with saline or silicone breast implants, compared to other plastic surgery patients.

I agree with these Congressmen that in order for you to make wise recommendations to the FDA, you need all relevant information. That would include any information that raises questions about the long-term safety of breast implants, as well as inspections and investigations that apparently raise questions about the research conducted by these companies and the manufacturing quality control practices of the companies.

On behalf of our research center, I am respectfully asking each of you to carefully scrutinize these studies and express your views about their quality -- or lack thereof -- in the strongest and clearest possible terms. I also ask you to request information about the NCI studies -- which were co-authored by an FDA scientist, who also analyzed the adverse reaction reports for breast implants several years ago. If you don’t insist on better long-term research and on accurate reporting of that research and of adverse reactions, teenage girls and women will continue to assume that breast implants are proven safe, despite the lack of long-term safety research.