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'Gummy Bear' Breast Implants Inch Closer To U.S.

Makers Hope Silicone Implants Will Be Approved In U.S.

UPDATED: 3:56 pm EST November 22, 2005

A new type of breast implant already available in other countries may soon be making its way to the United States.

The implants are made up of a silicone gel different from the silicone implants that have been banned in this country, reported WRC-TV in Washington, D.C.

Silicone gel implants were banned 13 years ago amid concerns they could rupture, leak and cause major health problems. Recently, two makers of the implants have been making strides to get their products back on the market.

But experts say a new type of implants are made differently, so they are safer.

The new implants, made by Silimed, are known as the "gummy bear" breast implants because of the consistency of the gel inside the implant.

Doctors say the gummy bear implants have been on the market in countries including France, Germany, Spain, and Japan for the last 10 years.

Stephene Kelley, of New Market, Md., did a lot of research before she got breast implants two years ago. She had heard that silicone implants felt more natural than saline, but she didn't think she'd have a choice, since silicone implants weren't available.

Then Kelley learned about a clinical trial testing a new implant made of a high-strength cohesive silicone gel, and she decided to try them out for herself.

"My natural breast tissue is almost nonexistent, so I went from nothing to exactly what I wanted," Kelley said.

Dr. Donald Kress, the founder of Plastic Surgery One in Frederick, Md., is a plastic surgeon taking part in the trial of the new silicone implant. He says the implants are much safer than the banned ones because of the molecular structure of the silicone.

"The cohesive gel implant can be sliced in half, punctured or damaged, and nothing leaks out," Kress said.

However, some experts are still concerned, saying long-term studies need to be conducted before they are allowed on the market.

Kelley said she would recommend high-strength gel implants to anyone considering implants.

It is still unclear when the gummy bear implants will be submitted to the Food and Drug Administration for approval. Approval for another type of silicone gel breast implant is pending.

The companies Inamed and Mentor also are conducting studies of their versions of the cohesive gel implants.

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