Ruptured Silicone Breast Implants Linked to Debilitating Diseases

Rachael Flynn, MPH and Diana Zuckerman, PhD, National Center for Health Research

The first study to systematically evaluate the health of women with ruptured breast implants has raised serious concerns about silicone implants. A team of scientists led by Dr. Lori Brown of the Food and Drug Administration (FDA) reported that women whose ruptured breast implants leaked silicone outside the scar tissue surrounding the implant were significantly more likely to have been diagnosed with fibromyalgia (a painful soft-tissue disease), pulmonary fibrosis, and connective-tissue diseases such as dermatomyositis.

Magnetic resonance imaging (MRI) was used to examine the status of the breast implants of the women participating in the study. Based on the implant’s condition, researchers assigned cases to three groups: intact, ruptured, or indeterminable. (Those implants that appeared ruptured but were not able to be confirmed, were classified as indeterminable.) Radiologists also determined which ruptured cases had silicone that migrated outside of the scar capsule that surrounds the breast implant. A majority of the women had at least one ruptured implant, even though they were often unaware of that condition. Also, 21% had silicone that migrated outside of the breast area from at least one broken and leaking implant.

Women with ruptured implants where the silicone had traveled outside of the scar tissue were compared to women in the intact and indeterminable groups; investigators found an increase in fibromyalgia, dermatomyositis, polymyositis, Hashimoto’s thyroiditis, pulmonary fibrosis, eosinophilic fascitis, and polymyalgia. The significant association with fibromyalgia remained even after controlling for patient’s age, implant age, location, and manufacturer. Therefore, once the silicone from a broken implant migrates outside of the breast area, the woman’s risk for these serious diseases increases considerably.

This study raises serious concerns for women with ruptured implants, because it indicates that women who are unaware that an implant is ruptured and leaking could be at increased risk for health problems due to their exposure to silicone.

The study evaluated 344 women with silicone gel implants who had not sought to have their implants removed, and who were contacted from a list of patients from two medical practices. They were selected from a sample of 907 augmentation patients for a study designed to determine the percent of implants that are ruptured in the population of women who had not sought treatment for problems with their implants; 70 women who had their implants removed were excluded from the original sample of women, as were women with saline implants. Eighty-one percent of the women who were invited to participate in the study accepted.

This study is the third to be published in May 2001 with findings that indicate potentially serious health risks for women with breast implants. The other studies, conducted by scientists at the National Cancer Institute, found a 21% overall increased risk of cancer for women with implants and a 100% or more increase in mortality from brain tumors, lung cancer, other respiratory diseases, and suicide.

FDA Study:
Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS. Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women. The Journal of Rheumatology 2001;28:996-1003.

NCI Studies:
Brinton, LA, Lubin, JH, Burich, MC, Colton, T, and Hoover, RN. Mortality Among Augmentation Mammoplasty Patients, Epidemiology 2001; 12: 321-326.

Brinton, LA, Lubin, JH, Burich, MC, Colton, T, Brown, SL, and Hoover, RN. Cancer Risk at Sites Other Than the Breast Following Augmentation Mammoplasty. Annals of Epidemiology 2001;11: 248-256.

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