Silicone Breast Implants Approved With Caveats

Nearly 15 years after a near-total ban on silicone breast implants, the U.S. Food and Drug Administration (FDA) has approved an implant for cosmetic breast augmentation in women aged 22 and older and for reconstructive use in women of all ages.

The FDA banned silicone implants for use in cosmetic augmentation surgery in 1992 amid complaints of rupturing and worries that they could lead to problems ranging from connective-tissue disorders to cancer. While those links were never confirmed, manufacturers set aside billions of dollars to pay out to women who sued over alleged injuries. The litigation drove many companies out of the business and helped push one company, Dow Corning (Midland, MI, USA), into bankruptcy.

Since 1992, women seeking breast implants for cosmetic reasons have had to use saline implants, which are filled with salt water. They are generally viewed as less natural-looking because they can be too hard or become wrinkly if under-filled. With the reapproval of silicone implants, the FDA is also recommending that patients get regular screening, including magnetic-resonance-imaging (MRI) examinations every few years, to detect possible ruptures and/or leaking silicone. The FDA also warns that women who get the implants likely will need further surgery at some point because of issues including ruptures and hardening of breast tissue. Given the longstanding health concerns, the FDA will require extensive studies, including a stipulation that each company approved must conduct a 10-year study that will include 40,000 women.

The FDA's approval is expected to accelerate a push into this field by two companies that are heirs to the U.S. breast-implant business: Allergan (Irvine, CA, USA) and Mentor (Santa Barbara, CA, USA).



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