FDA Approves Silicone Breast Implants Despite Safety Concerns

Diana Zuckerman, PhD, National Center for Health Research: November 17, 2006

The FDA’s decision to approve silicone gel breast implants is a triumph of corporate lobbying and hype over sound science and women’s health.

The FDA’s standards for implants have reached a new low with this decision. It’s important for women to know that the FDA has not determined that silicone gel breast implants are safe – only that they are “reasonably safe.” What does that mean? In this case, it means that if a woman lives for 25 years after getting these implants, she will need to remove them at least once, probably twice, and possibly more than that. If she doesn’t, the implants are likely to break inside her body, and possibly leak silicone into her breasts, lungs, and other organs.

What do we know about the risks? Most women with silicone gel breast implants experienced at least one complication within the first three years of getting implants, including breasts that were hard or painful, oddly shaped, or had lost sensation, or the need for additional surgery to fix implant problems. The additional surgery is often very expensive, and almost never covered by health insurance. FDA scientists found that women with silicone breast implants for two years had a significant increase in several auto-immune symptoms, such as joint pain and chronic fatigue. Contrary to the hype, breast augmentation patients did not report a significant improvement in self-esteem and tended to report a lower quality of life after implants. Perhaps that is why scientists at the National Cancer Institute found that women with breast implants were twice as likely to kill themselves, compared to other plastic surgery patients.

The impact of silicone implants on breast milk is unknown. The long-term health risks (after three years) are unknown. Given the known risks and the unknown risks, silicone breast implants should be considered less “reasonably safe” than sky diving or other high-risk adventures. Most sky divers are not harmed, but some are harmed a little, and some die as a result. According to the information provided by implant manufacturers to the FDA, most women with silicone breast implants will be harmed. The harm after can be to her health, her mental health, her appearance, or to her pocketbook, or all four.

We support the FDA’s decision to require 10-year studies of 40,000 women. This clearly indicates that the FDA acknowledges the need for information about long-term risks. We will do all we can to make sure that the FDA enforces that research requirement, but we wonder what FDA will do if the companies do not complete those studies.

We support FDA’s recommendation that women have breast MRIs to check for leakage every two years, but we know that most women can’t afford the $2,000+ that breast MRIs cost.

We support the FDA’s age restriction, limiting augmentation with silicone gel breast implants to women ages 22 and over. We strongly encourage plastic surgeons to abide by those restrictions, since younger women are still developing physically and emotionally.

FDA’s announcement was made at 5:30 on the Friday before Thanksgiving, in an effort to reduce media coverage. Since FDA offices are normally closed at 5 pm, apparently even they are ashamed of their own decision.

The National Center for Health Research is a nonprofit research and education organization focused on health and safety issues. The Center is not opposed to silicone implants but is opposed to FDA approval of any implanted medical devices that are not proven safe for long-term use. For more information about breast implants and the personal stories of women with implants, see www.breastimplantinfo.org. For information about numerous other women’s health issues, see the Center’s website at www.center4research.org.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.