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How Safe Are Implants?
by Margaret Chiffwiller
Silent Silicone Implant Ruptures
Is it safe to go back to silicone?
Recently, the US Food and Drug Administration (FDA) reported that as many as 80% of women with silicone gel breast implants had at least one ruptured implant within 11 to 15 years.
The rate is usually quoted at only about 1% to 2%. The women in this study did not know the implants were leaking - there were no warning signs or symptoms.
Silicone prostheses were used in millions of women for both cosmetic and reconstructive surgery.
Only For Reconstruction
They were banned from sale in 1992 due to questions of safety that arose when legions of women suffered ill effects after their silicone implants ruptured. Since that time, the silicone-filled models have been available only to women who wanted reconstruction after a mastectomy and were enrolled in a clinical trial.
Testing The Safety
The FDA recently began a study of women who wanted silicone implants for cosmetic breast augmentation only. The FDA enrolled 344 women who reported that their implants were fine.
The women had all received the implant at least six years before the study began.
They were given MRI exams to determine the condition of the implant.
The results were checked by three different radiologists.
They showed that 67% of the women had a ruptured implant and were not aware of the damage.
There were no changes in the outward appearance and no other symptoms.
Almost half had a rupture within six to ten years of getting the implants.
In 21% of the ruptures, the silicone gel filling had migrated outside the breast tissue.
Rupture rates might even be higher than reported in the FDA study. This study did not count women with silicone implants which had already been removed because of breakage, leakage or pain.
The study was ordered by Congress, responding to the pressure from advocacy groups demanding more information on how often silicone implants rupture or leak. The FDA's data was presented at the World Biomaterials Congress in Hawaii.
Shock and Outrage
Cynthia Pearson, executive director of the National Women's Health Network expressed shock and outrage in statements issued to the press. The National Center is seeking an immediate moratorium on the use of silicone implants.
There is an ongoing debate about the adverse effects of silicone.
Many women claim that they suffer from diseases such as Lupus and arthritis due to ruptured silicone implants.
The results from studies of this problem are not clear. "Migrating silicone is dangerous, if only because the silicone is sometimes impossible to remove," Dr. Zuckerman, executive director of the Washington DC-based National Center for Policy Research for Women and Families stated to a Reuters reporter.
The study shows that women have not been properly informed about the risk of implants rupturing and the consequences of silicone being released into the body.
Saline filled implants also have a high risk of rupturing, but the saline is able to be absorbed by the body. There are currently two saline implants that are approved for distribution in the US by the FDA.
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