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The Politics of Women's Health

Breast Implants

Testimony of the American College of Womenís Health Physicians at the FDA Hearing Considering Silicone Breast Implants

April 2005

The American College of Women's Health Physicians is committed to advancing women-centered healthcare. We strive to ensure that research includes women, and that it is applied appropriately to women. My name is Judy Norsigian, and I am reading this testimony on their behalf.  They have no conflicts of interest.

As we consider the case of silicone breast implants, let us remember how many physicians routinely prescribed hormone replacement therapy thinking that we were providing care that was beneficial. After well-designed studies were completed, we learned that we had been wrong.  We need to make sure that we donít repeat this kind of error with breast implants, and this meeting is your chance to do just that. Silicone breast implants may or may not cause all the diseases and symptoms they are accused of tonight. We don't know, because adequate research has not been done. We should not approve these devices, when reasonable and safe alternatives exist, until rigorous safety standards have been met.

Last year, more than 300,000 women and teenagers underwent breast implant surgery for augmentation.  The number has more than tripled since 1997.  However, many of these women are replacing old implants that have broken or caused problems.  Some women report as many as ten or more surgeries, as their implants are replaced over the years.

All breast implants will eventually break. When silicone gel breast implants break, there are often no symptoms, so accurate estimates of rupture rates depend on MRIs. In a study conducted by FDA researchers, most women had at least one broken implant within 10 years, and the likelihood of rupture increased over time.  The women in the FDA study had not had their implants removed, did not know that their implants were broken, and were not seeking help because of illness or implant concerns.  Despite the fact that these women were "satisfied customers," not seeking medical care, MRIs found that silicone had migrated outside of the breast capsule for 21% of the women.  Most were unaware that this had happened.

Numerous studies have shown silicone leakage into the scar capsules surrounding breast implants, even for implants that are not ruptured (Beekman, WH, Feitz R, van Diest PJ and Hage JJ, Migration of Silicone Through the Fibrous Capsules of Mammary Prostheses, Annals Plastic Surgery 1997: 38: 441-445).  More worrisome, researchers have found silicone in the lymph nodes of women with breast implants, which can then migrate to other organs. Silicone in the lymph nodes can only be removed by removing the lymph nodes; silicone in organs such as the lungs, liver, and brain cannot be removed.  The health risks associated with migrated silicone are unknown; however, case reports have indicated fatalities and serious health risks when liquid silicone injected in the breasts migrated to the lungs or other organs. 

A study published by the Royal Academy of Medicine in Scotland found that a woman with a broken silicone gel implant in her calf was coughing up silicone identical to the kind in her implant. This has potentially serious implications for women with leaking breast implants.

Free silicone in the body has been suggested to increase the risk of autoimmune disease and connective tissue disease.  Studies from the 1990's tend to show no increase in risk, but more recent studies suggest an increased risk of autoimmune symptoms and possibly in diseases.

Scientists at the National Cancer Institute (NCI) found a statistically significant increase in reported connective tissue diseases among breast augmentation patients, but also found that many of the women made errors in their self-reported diagnoses. Their study included women who had breast implants for at least seven years. The findings suggest that there are increased symptoms among women with breast implants, but it is not clear if there is an increase in specific diagnoses. As a result, the researchers concluded that larger studies would be necessary to draw conclusions. 

Prior to the NCI study, most published research that has focused on autoimmune or connective-tissue diseases studied women who have had implants for a relatively short time, ranging from a few months to a few years. These studies are the basis for a report on implants by the IOM, a report by Judge Pointer's scientific panel, and a meta-analysis published in the New England Journal of Medicine regarding the lack of evidence that implants cause systemic disease. All three of these reports are based on the same 17-20 epidemiological studies that were published prior to 1999.  Since many connective tissue and autoimmune diseases are relatively rare among young women and most take many years to develop and be diagnosed, these studies are not designed to answer questions about long-term safety.  They are underpowered, and include substantial numbers of women who had implants for just a few months or years, with too few women who had implants for ten years or more. Worse yet, some depended on hospital records for diagnoses. Obviously, most women with autoimmune symptoms or diseases are not treated in hospitals. Careful scrutiny of the research indicates an increase in symptoms in many studies, but it is primarily in the studies where all the augmentation patients had implants for at least six years.

Please note that the independently funded studies tend to focus on women with implants for longer periods of time, and often show increased risks that are not found in the industry-funded studies. Particularly when we have increasing numbers of healthy women and teens electing breast augmentation for purely cosmetic reasons, we have a duty to ensure that they do so safely. We need adequate long-term studies - with reasonable drop out rates and ten to fifteen years of follow-up - before we will have the answers we need.

For now, as there are not sufficient data to demonstrate safety, the American College of Women's Health Physicians recommends that you vote against the approval of silicone implants.

 

Katherine Patterson Neely, MD
President, American College of Womenís Health Physicians
Medical Director, Forbes Family Practice Residency
2566 Haymaker Road
Pittsburgh, PA 15146
412-858-3227

Janice Werbinski, MD
Past President, American College of Womenís Health Physicians

JoDean Nicolette, MD
President Select, American College of Womenís Health Physicians

Justina Trott, MD
Secretary, American College of Womenís Health Physicians

Barbara Haeckler, MD
Treasurer, American College of Womenís Health Physicians

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