The government has ended a 14-year virtual ban on silicone-gel breast implants despite lingering safety questions and a history of lawsuits. The FDA approved the implants for women 22 and older, or those undergoing breast reconstruction surgery, but warned that patients probably would need at least one additional operation because the implants don't last a lifetime. Despite FDA assurances, a longtime opponent of the product called the implants "the most defective medical device FDA has ever approved."
November 20, 2006 at 12:00 AM
1 minute read
The original version of this story was published on Law.Com
The government has ended a 14-year virtual ban on silicone-gel breast implants despite lingering safety questions, making the devices available to tens of thousands of women who have clamored for them.
The Food and Drug Administration approved the implants for women 22 and older, or those undergoing breast reconstruction surgery, but warned that patients probably would need at least one additional operation because the implants don’t last a lifetime.
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