Diana Zuckerman, PhD, National Center for Health Research, Fox News: April 25, 2005
Women have the right to buy products that will make them look better or feel better about themselves. Are silicone breast implants part of that inalienable right to choose?
The companies that make silicone breast implants, the plastic surgeons who use them, and the women who want them are all focused on that right, and angry that it has been restricted for the last 13 years. They question the motives of government officials, women’s organizations, and health advocates that question that right.
On the other side of the debate, consumer groups, public health advocates and others remind us that the Food and Drug Administration has the responsibility of approving medical products only if they are proven safe and effective. Implants are especially worrisome because it costs thousands of dollars to have them removed. If these products are risky or can break inside the body, that risk should outweigh the benefits.
Breast implants have become such a hot topic that pundits who otherwise wouldn’t talk about the FDA or women’s issues have gravitated toward the topic. Many pundits have become instant experts on the subject, even if they have never spoken to any woman about her implant experiences and never read any of the safety studies they quote.
But like most hot topics, this one is complicated. If you talk to women, read the research, and try to figure out why there are such strong opinions on both sides of the issue, you’ll find out why the controversy has continued for 15 years and is not yet resolved.
This is what we already know about breast implants:
Dozens of studies of women who had implants for a short time find no significant increase in diseases. Most of these studies are funded by companies with a financial interest in breast implants. Studies conducted by implant makers and analyzed by the FDA found that more than one in three patients report complications such as breast pain and hardness and the need for additional surgery within the first three years.
Only two studies have been conducted on the health of women with leaking silicone implants. One, conducted by FDA scientists, found a significant increase in fibromyalgia and other autoimmune diseases. A study funded by a silicone manufacturer found an increase in autoimmune symptoms such as fatigue and mental confusion but not in diagnosed diseases.
Studies conducted by the National Cancer Institute are the best-designed because they compare women who had implants for at least seven years to other plastic surgery patients and to women in the general population. They found that all plastic surgery patients, including breast augmentation patients, tend to be healthier and wealthier than women of the same age in the general population. Plastic surgery patients also have similar health habits.
However, compared to other plastic surgery patients, breast augmentation patients are twice as likely to die of brain cancer, three times as likely to die of lung cancer, and four times as likely to commit suicide. They are more likely to report autoimmune diseases, but their medical records indicate that patients are not always accurate in their reporting (for example, many women who report having rheumatoid arthritis actually have osteo-arthritis instead). These government scientists concluded that the results were inconclusive and more research was needed.
The testimony of women with breast implants was surprisingly consistent with these research studies. Many of the women praising their implants had them for just a year or two. The women who were testifying against implants usually had them for 10 years or more. Many spoke of being happy with their implants for years, and then slowly becoming disabled from chronic fatigue, mental confusion, and aches and pains at the ripe old age of 32. After years of being told that their illness was unrelated to their implants, they eventually had their implants removed, and only then learned that the implants had ruptured and were leaking.
Ed Brent, a widower from Atlanta, described his wife, P.J., as very happy with her implants for years. When she became ill, she sought medical treatment but none of the doctors were able to help her. Frustrated by the lack of effective medical care and feeling guilty because her children became seriously ill after she breastfed them with implants, P.J. Brent committed suicide.
Ed testified that after her death, doctors found exceptionally high levels of platinum in her blood, and in the blood of the children she breastfed after implants (but not those breastfed before). Platinum is a potentially toxic substance that is used to make breast implants. Research published last year found high levels in the breast milk, blood and urine of women with implants, compared to other women.
This is what we don’t know about breast implants:
We don’t know how long they last, although many studies suggest that 10-15 years is likely.
We don’t know how often they leak silicone outside the implant area, but the FDA estimates one in four women with leaking implants have such leakage. Will that eventually become 100 percent if a woman doesn’t have her implants removed? Nobody knows.
We don’t know what percentage of women will get sick from breast implants that are intact and what percentage will get sick from breast implants that are leaking. No studies have been done to examine that over time.
We don’t know if breast implants make most women feel better about themselves. According to the companies’ own studies, women who got breast implants two years earlier tend to feel worse about their lives and themselves, not better, than they felt before getting their implants.
Can women make an informed choice about breast implants? Most women who make a decision about breast implants get their information from their plastic surgeon, the implant maker’s patient booklet, or the Internet. The plastic surgeons tend to be very positive, the company brochures tend to be confusing, and the Internet has information ranging from extremely positive to extremely negative and everything in-between.
The bottom line: men and women have a right to choose safe medical products, and it is the FDA’s job to determine if a medical product is safe. Whether the product is a painkiller, an anti-depressant, or a breast implant, FDA approval should be made on science, not wishful thinking or philosophical musings about choice.
Read the original article here.