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FDA to Reconsider Silicone Implants

FDA to Reconsider Silicone Implants

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Dr. Kim Mulvihill ReportingThirteen years ago the Food and Drug Administration banned the use of silicon gel breast implants in most women because of serious health concerns. Today a panel of health experts began hearing arguments for and against the cosmetic procedure.

Two companies that make the implants are asking the FDA to once again allow them to be used for cosmetic surgery. For the next three days the FDA will hear from doctors, scientists, manufacturers and patients. The stories are emotional, the research is conflicting, and the agency -- criticized for its oversight of painkillers -- is under pressure not to make a mistake.

Patients said the old silicone breast implants ruptured and leaked. Women claim they caused depression, cancer, and lupus.

Carolyn Wolfe, Patient: “Please do not inflict this on another generation.”

Supporters say that happened with the old implants. They claim new ones are safer than ever.

Dr. Laurie Casas, American Society of Plastic Surgeons: “They’re very much like gummy bears. They hold their memory. They hold their cohesiveness. They do not leak. They stay where they are.”

This is the second time in less than two years that the agency is debating the issue. The last time advisers narrowly recommended allowing the implants to be sold again. The agency declined to follow that advice.

The testimony will go on for three days. On Wednesday the advisory panel will vote on a recommendation to pass on to the FDA for final consideration.

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