FDA Advisers Recommend Lifting Ban On Breast Implants

Company Must Follow Some Conditions To Resume Sales

WASHINGTON -- Government health advisers recommended Wednesday lifting a ban on most silicone-gel breast implants. It comes 11 years after most procedures involving the implants were prohibited.

The recommendation by the Food and Drug Administration's advisory panel comes after two days of testimony from supporters and opponents of the ban.

In 1992, the FDA took silicone breast implants off the market because of safety concerns. But the company that makes the implants has always claimed that silicone implants are no more dangerous than saline, or saltwater, implants that are still being used for breast augmentation.

But Wednesday's recommendation, which would allow Inamed Corp. to resume sales, comes with conditions.

The advisers call for detailed brochures explaining the known risks, such as frequent procedures to relieve pain or correct breakage. And women will still need annual exams to ensure an implant hasn't sprung a leak.

SURVEY Do you think the ban on silicone-gel breast implants should be lifted? Yes, people who want them should be able to get them. No, there's too much uncertainty about their safety. I don't know enough about them. Results | Disclaimer

Panel advisers also said they were concerned about the implants' long-term effects. The company's own statistics show that up to 46 percent of silicone implant recipients needed additional surgeries because of painful scar tissue. And one-fourth of the women who had the silicone implants had to have the devices removed or replaced.

Thus, the conditions also require that implant recipients be enrolled in a registry to track their health, and that Inamed increase the time spent on tracking women having the procedure from three years to 10 years.

The implants were first taken off the market because of complaints that the implants could leak and the silicone could cause scaring, serious illness or even cancer.

Inamed manufactures and sells gel-filled implants internationally in more than 60 countries. For more than a decade, the implants in the United States have been restricted to patients undergoing reconstruction or revision surgery and who are also participating in clinical studies.

After the favorable recommendation, Inamed's stock was up some 22 percent Thursday to a 52-week high in heavy Nasdaq volume.

Inamed says the devices have improved and many of the complications women have had are not caused by the product.

"Complications such as asymmetry, bruising, scarring, hematoma, swelling, etc., are not implant-related, but surgery-related complications. These same complications occur at similar or higher rates with saline implants and occur in other breast operations," Inamed spokesman Dr. Scott Spear told the panel.

However, many women who suffered from ruptured silicone implants warned the panel of the implants' long-term effects.

"I continue to suffer with extreme fatigue and depression," one of the implant patients told the panel.

During the hearing, Inamed stressed that most of the data to date showed little evidence that the implants caused major diseases like cancer or lupus.

The FDA usually follows the recommendations of its advisory panels. A decision could come at any time.

Additional Resources

• Inamed
• Food and Drug Administration

Previous Stories:

• October 15, 2003: Hearing Continues On Silicone Breast Implants
• October 14, 2003: FDA Panel Hears Pros, Cons Of Breast Implants
• October 13, 2003: Dow Corning Could Gain If Breast Implants OK'd
• October 8, 2003: Demonstrators: Keep Silicone Implants Banned

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