Silicone Implants Make a Comeback

The FDA recently overturned a 14-year ban on silicone breast implants and gave the green light for their use in cosmetic breast augmentations in women 22 years or older.

The age limitation is related to the age at which breast development completely stops in women. Many women and their doctors prefer silicone implants over saline implants because the former are considered softer and feel more natural.

This decision marked the end of a 20-year debate that fostered thousands of lawsuits and bankrupted at least one manufacturer of the implants. The recent re-approval came after both the FDA and the Institute of Medicine concluded that the devices do not cause any major illnesses.

Many surgeons applauded the FDA decision, regarding it as a victory of science over rumor-driven hysteria. Evidence from many studies on long-term use of the implants in other countries finally convinced regulators that they were safe.

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Some experts pointed out, however, that women should not think of these implants as "permanent" or "lifetime " devices. The odds are still there that most women with silicone implants will experience a rupture at some point and will need additional surgery to replace them. Regular MRI procedures should be used to monitor the implants for silent ruptures.

Critics of the decision raise safety concerns similar to those that caused the devices to be banned in the first place. Defenders of the decision point to 10 years of additional research that failed to uncover any scientific evidence that the implants are not safe. The FDA will monitor studies conducted by the manufacturers on the 80,000 women who currently have silicone implants.