Silicone implants return, in a big way

Silicone-gel breast implants are back.

Yes, those implants, the kind that led to billions of dollars in product-liability settlements to compensate hundreds of thousands of women worldwide who contended the devices left them sick or disfigured.

The Food and Drug Administration has deemed the latest versions of gel implants to be "reasonably safe" - and that's good news for the growing number of women who want them.

"I know there's a big risk of reoperation," said Carolyn Brusilow, 44, who switched from saline-filled implants to gels. "And that they can rupture. And there can be problems with mammograms. But I was willing to take that chance."

"I'm very happy with the results," added the Ardmore wife, mother of four, and administrative assistant.

Although only 11 weeks have passed since the FDA lifted its 14-year-old ban on gel implants for "augmentation" patients, the devices are expected once again to corner that market. After all, the gummy goo has always been considered cosmetically superior to salt water.

Crystal Cienfuegos, spokeswoman for the implant-maker Allergan Inc., said a silicone resurgence would be in line with what the company sees outside the United States. "Approximately 90 percent of women prefer silicone over saline in countries where both options are available," she said.

The shift is already clear, said Bryn Mawr plastic surgeon R. Barrett Noone.

"I had two women in today," Noone said. "One wanted saline, the other wanted silicone. This doesn't surprise me at all."

What may be surprising is that, even though the considerable risks of implants have never been clearer, breast enlargement has never been more popular.

In 2005, about 360,000 American women - nine times more than when the FDA restricted implants in 1992 - paid an average $5,000 (more like $6,000 to $10,000 in the Philadelphia area) to get better bosoms. That's all out of pocket, because health insurance doesn't cover it.

Year after year, the demand increases, data from the American Society of Plastic Surgeons show.

All told, an estimated 3.7 million U.S. women have gotten bigger breasts - more than the population of Connecticut. Most of them went under the knife after 1992, even though the majority had to get cosmetically inferior saline implants, which were also the subject of safety questions. (The confusion arose because the FDA had no authority to regulate implants until 1976, more than a decade after the devices were introduced.)

Now, belatedly, there are lots of data to answer the safety questions.

On the reassuring side, expert scientific committees have concluded gel implants do not cause autoimmune or connective-tissue diseases. But they do have inherent problems that turn out to be very common, judging from studies that the FDA required Allergan and competitor Mentor Corp. to conduct.

Allergan, for example, found that 41 percent of first-time implant patients had at least one significant complication within four years, including 23 percent who needed another operation to fix breast hardening, pain, swelling, scarring, asymmetry, rupture or other problems. For patients replacing an implant, the complication rates were even higher - 57 percent.

Mentor had lower reoperation rates - but only three years of data.

Patients are also supposed to get MRIs every few years - again, at their own expense - because gel implants can rupture "silently," unlike saline devices, which deflate like a water balloon.

Women tend to accept this sobering reality as the price of what they perceive as beauty.

Rebecca Cat Kidder, 37, of Murray, S.C., was flat-chested when she caught herself admiring a woman with nice breasts.

"I thought, 'Those are pretty, I want some,' " recalled Kidder, who runs implantforum.com, a "megawebsite," complete with before-and-after photos, chats, vetted listings of surgeons, and a candid chronicle of her own breast quest. "Women want to feel more feminine, to look better in clothes.

Sherry Shelton, 34, of Forks Township, Pa., a mother of five who opted for gels because friends with saline implants had unattractive ripples, said: "For a while, my husband wanted to make sure it wasn't something I wanted because I thought he wanted it. But I've wanted it for a very long time. If I should need another surgery in 15 or 20 years, or 10 years for that matter, it'll be OK."

What if, like one in four women in Allergan's study, she needs another surgery within four years?

"I would be kind of disappointed," she said. "Four years would definitely be too soon, considering the pain and the cost and the time it takes you" to recover.

Mark Solomon, the Bala Cynwyd plastic surgeon who operated on her, said most of his patients knew the risks even before sitting down for his one-hour consultation.

"Either they're infinitely optimistic and think, 'It won't happen to me,' or they're realistic and say, 'I'll deal with it when it happens.' Either way, this is not a cavalier bunch of people."

He and other surgeons see no signs of a backlash against the Western fixation with big breasts. Quite the opposite.

"In the past three months, I've seen three Asian patients - Vietnamese, Korean and Chinese - who had implants. Now they want them bigger. Are we going to see Iraqi women getting implants? I don't see what's going to diminish" the trend.

Another apparent trend is toward bigger implants. Even the most common patient - a fortysomething soccer mom - wants to be closer to a Baywatch Babe than, say, a Desperate Housewife.

"They just keep getting larger now that it's not so taboo," said Kidder, who said the average size had gone from a C cup to a D cup over the last decade.

She is Exhibit A: "I went larger," she said of replacing her ruptured saline implants with gels.

Shelton, who is 5-foot-9, went from a small B cup to a small D cup. Still, she said: "I wish I would have gone a little larger because of my height."

Albany, Ga., plastic surgeon Walter Erhardt, chair of the American Society of Plastic Surgeons' public education committee, counsels women that size matters - and that's why being conservative is prudent.

"Long-term, the heavier the implant, the more wear and tear on the breast and the back," he said. "You may be able to put a size-eight foot in a size-seven shoe, but eventually, you're going to have a problem."