Ed Kensik11.17.06
The FDA has lifted a 14-year virtual ban on silicone-gel breast implants on Friday despite despite lingering safety concerns, making the devices available to tens of thousands of women who have clamored for them.
The FDA approved the implants made by Irvine, CA-based Inamed Corp. — now part of Allergan Inc. — and Santa Barbara, CA-based Mentor Corp., the two companies said.
The action opens the implants to much wider use by women seeking to reconstruct or augment their breasts. Since 1992, the silicone implants had been available only as part of research studies.
They first went on the market in 1962, before the FDA required proof that all medical devices be safe and effective. Thirty years later, they were banned amid concerns about their safety.
At the time, there were worries about a possible connection to a variety of diseases, including cancer and lupus. Alarming cases of ruptures added to the concern.
Since then, most studies have failed to find a link between silicone breast implants and disease.
The FDA approved the implants made by Irvine, CA-based Inamed Corp. — now part of Allergan Inc. — and Santa Barbara, CA-based Mentor Corp., the two companies said.
The action opens the implants to much wider use by women seeking to reconstruct or augment their breasts. Since 1992, the silicone implants had been available only as part of research studies.
They first went on the market in 1962, before the FDA required proof that all medical devices be safe and effective. Thirty years later, they were banned amid concerns about their safety.
At the time, there were worries about a possible connection to a variety of diseases, including cancer and lupus. Alarming cases of ruptures added to the concern.
Since then, most studies have failed to find a link between silicone breast implants and disease.