Washington Times: A Split Decision on Breast Implants

Discussion in 'Health and medical' started by Ilena, Dec 16, 2003.

  1. Ilena

    Ilena Guest

    Washington Times, Sunday, Oct 26, 2003, p B5

    A Split Decision on Breast Implants By Diana Zuckerman

    Breast implants are back in the headlines, with two equally passionate sides to the story. Both
    claim the science is on their side. Who is right?

    In a split decision on October 15, advisers to the Food and Drug Administration voted to recommend
    that silicone gel breast implants are safe enough to have the FDA ‘seal of approval.'

    The 9-6 vote for approval was orchestrated by the six plastic surgeons and breast surgeons on the
    panel who voted in lock-step. In contrast, most of the other doctors and scientists voted against
    approving the implants, citing the lack of safety information. To add to the drama, a panel member
    who seemed ready to vote against approval mysteriously disappeared before the vote. And the panel
    chairman, who only votes when there is a tie, said he would have voted against and was flabbergasted
    by the lack of safety information.

    The spin machines are already working overtime. Plastic surgeons and implant manufacturers (and the
    lobbying and PR firms they generously support) remind us that women like silicone gel breast
    implants. They tell us that there is "no scientific evidence" that breast implants cause disease and
    that it is time to make them widely available again. They often back up this statement with a 4-year
    old Institute of Medicine report, which they claim proves that implants are safe.

    On the other side, patients testified about the pain and deformity of having leaked silicone scraped
    from their chest wall-- a problem that is considered a "local complication" rather than a "health
    risk." Their testimony is the heartbreaking illustration of the Institute of Medicine report's
    concerns that breast implants can break, leaking silicone inside the body. Although the Institute
    concluded that research did not prove implants cause disease, their report was only a review of the
    research available four years ago, most of it of women with implants for just a few months or years.

    Most diseases -- lung cancer for example -- take more than a few years to develop. Implants tend to
    break after eight years or more, and the health risks of leaking silicone implants aren't known.
    When scientists from the National Cancer Institute and the FDA recently conducted several studies on
    women who had implants for at least seven years, their results were frightening: Women with breast
    implants were twice as likely to die from brain cancer, 3 times as likely to die from lung diseases,
    and 4 times as likely to commit suicide, compared to other plastic surgery patients. Women with
    leaking implants were more likely to have fibromyalgia and several other autoimmune diseases.

    The FDA advisors who voted against approval included a toxicologist, epidemiologist, radiologist,
    statistician, dermatologist, and cancer surgeon. They understood diseases take time to develop,
    especially since breast implants tend to break after 10 years, not two years. Their vote against
    approval was based on their concerns about long-term safety, and their criticisms that the company
    didn't bother to study women who had implants for more than three years.

    There's even a divided opinion among our government health officials about the safety of breast
    implants. At the very moment when the FDA is considering lifting restrictions on silicone gel
    implants, the Medicare program has successfully sued implant manufacturers for tens of millions of
    dollars. Why? Because the government claims that women who became sick from their silicone implants
    have cost Medicare a lot of money in medical care.

    You might wonder why the FDA would consider making a product more available when scientists question
    their safety and when government experts believe that it has cost our already-strapped healthcare
    system millions of dollars. This is a health question where it doesn't help to ask your doctor --but
    you might try the lobbyists on Washington's K Street. The companies that were successfully sued for
    billions of dollars by breast implant patients -- such as Dow Corning, 3M, and Bristol Myers Squibb
    -- are among the most powerful companies in the country. Perhaps their lobbyists are more effective
    than the women with implants who are coping with leaking silicone in their bodies.

    The FDA's mission is to safeguard all of us when we eat, use medical products, or are vaccinated.
    The division of opinion among FDA advisers reflects a frequent split -- between those who are
    selling a product or procedure and think it is safe based on personal clinical experience, and those
    who believe research is necessary to prove such safety

    There is passion (often called hysteria when it's the "other side") and science on both sides of
    this issue. The short-term research shows most women with breast implants don't get diseases in the
    first few years. But there is little long-term research, and those studies raises serious questions
    about leaking silicone, illness, and death related to implants. In the meantime, research also shows
    extremely high complication rates -- including the need for repeated surgeries. The bottom line is:
    Will the FDA demand a company prove its product is safe before "approving" it, or decide a company
    can experiment on millions of women while we wait for research to be completed?

    We'll find out soon.

    Diana Zuckerman, Ph.D. is president of the National Center for Policy Research (CPR) for Women
    & Families.


    Dr. Zuckerman's website is:


    For more information on the breast implant debacle, you are welcome to visit:


  2. Wc

    Wc Guest

    >>Washington Times, Sunday, Oct 26, 2003, p B5

    A Split Decision on Breast Implants By Diana Zuckerman

    Breast implants are back in the headlines, with two equally passionate sides to the story. Both
    claim the science is on their side. Who is right? << snip

    For starters, one does not look for who is "right" in the Washington Times. Why, one might as well
    ask the Rev. Moon for the truth.

    Will, crna