Should The Implant Ban Be Lifted?

Should the Food and Drug Administration ban on silicone implants be lifted?

Dr. Robert Rey, a plastic surgeon featured on the reality show, "Dr. 90201," believes it should be. Dr. Edward Melmed, who is also a plastic surgeon with a private practice in Dallas, Texas, believes the ban should remain.

"In my personal practice," Dr. Melmed tells The Early Show co-anchor Hannah Storm, "I have found at a pretty constant rate that by ten years after implantation, approximately 50 percent of implants are ruptured. It rises to 70 percent by 15 years, and over 90 percent by 20 years."

He began doing breast implants more than 35 years ago and performed the procedure thousands of times. In 1992, he stopped putting breast implants in and began taking them out.

Thirteen years after most use of silicone-gel breast implants was banned, the government reopened the emotional debate Monday on whether to lift the restrictions - despite lingering questions about how often the devices can break inside women's bodies and how bad those breaks really are.

The issue here is not lack of caring for patients who want to have a breast implant, but of freedom of choice, says Dr. Ray, who thinks the ban on silicone implants should be lifted.

"American women are very, very smart, and I think they should be given the option to choose what kind of implant they want," Dr. Ray says. "If you look in Europe, Australia South America, both implants are available - that is silicone and saline inplants."

Dr. Ray notes, today's silicone implants no longer leak even if the shell gets ruptured. And he adds, "In 1999, the Institute Of Medicine, which is a branch of government, showed silicone implants does not cause cancer or auto-immune diseases or other problems, nor does it affect pregnant mothers, or does it pass through the milk to the infants. So the implants have been shown to be safe. It's a new implant. The implant no longer leaks. It's cohesive. It's almost semi-solid."

Dr. Melmed, however, says the risks outweigh the benefits of having breast implants.

He says, "The risk is that you're going to put an implant into possibly 16- or 18-year-old girls. In their lifetime, they're going to be faced with the probability, if all goes well, of four to five operations. The statistics are that roughly 20 to 25 percent of women who receive implants are reoperated on within one year for complications.

"Now it's one thing if you've got a medical device that fails. Say, for example, hip prosthesis in a 70-year-old. But when we put a medical device into a 16-year-old, the so-called 'boob job for graduation,' we have to be sure that safety is paramount. Now implants deteriorate over time. The evidence that has been presented is only of four years' observation. In my personal experience, at four years, my rupture rate in patients is 4 percent. But by ten years, it's 50 percent."

About operating on young women, Dr. Ray says he does not operate on women under 18 years of age. He says, "That's at the FDA suggestion."

And using both silicon and saline inplants, he says, "The problem with saline implants is that it can make noises because bubbles can be left in it. It leaks about 5 percent a year. And it ripples. In a thin patient or patient who had lost her breast and needs reconstruction, these ripples are horrible. And you can see them from far away. Silicone just offers another option. The whole issue here is to give American women a choice. Like the rest of the world has a choice."