Silicone breast implants, such as this one from plastic surgeon Richard Rosenblum’s office, are
back on the market after the FDA banned them
in 1992 over fears that ruptures caused diseases.
BILL TIERNAN/THE VIRGINIAN-PILOT
© April 9, 2007
Kimberly Moore couldn’t find the body she wanted at the gym.
“You can’t build breast tissue,” the 23-year-old Chesapeake resident said. So to go from a B-cup to a C-cup, Moore thought she had only one option: breast augmentation surgery.
The next decision: saline implants versus silicone.
That’s not a choice women had a year ago, when a ban on silicone implants for cosmetic procedures was still in effect in the United States. In 1992 , with fears swirling that ruptured implants were causing diseases such as cancer and lupus, the Food and Drug Administration banned silicone for cosmetic procedures. After that, the implants could be used only for breast cancer patients and others seeking reconstructive surgeries.
However, that changed in November, when the FDA allowed them again for cosmetic use after several studies failed to link silicone implants to disease.
“There was a mass hysteria” about the alleged dangers of implants, said Dr. Richard Rosenblum , a plastic surgeon with offices in Norfolk and Virginia Beach. “We always believed it was safe.”
Still, critics think the FDA acted too hastily. They say questions remain about how long the implants typically last. And, they say, the long-term health consequences of silicone are not yet clear.
“I just want there to be good answers to the safety questions,” said Amy Allina , program director at the National Women’s Health Network , a nonprofit group in Washington .
Even before silicone came back on the market, cosmetic breast implant surgeries had become increasingly popular, growing 55 percent between 2000 and 2006 , according to the American Society of Plastic Surgeons . Last year, 329,396 breast augmentations were done nationwide. That made it the most common cosmetic surgery procedure, ahead of nose reshaping and liposuction.
Rosenblum said most of his breast augmentation patients seek a more proportionate figure. Or they’re like Kristina Doerr of Chesapeake, and want to get back the figures they had when they were younger.
“After having kids, I didn’t feel as good on the outside as I did on the inside,” said Doerr, 36 , who received silicone breast implants in January .
The silicone implants available now have a stronger shell and are filled with a more cohesive gel than those taken off the market in the early 1990s, Rosenblum said.
“The stuff was like toothpaste,” and after a rupture, “it would creep down in the tissues,” said Dr. James Carraway , head of the plastic surgery division at Eastern Virginia Medical School . “It made it difficult to remove.”
Even then, Carraway said, studies did not find a link between silicone and disease. He said he has no qualms about the safety of today’s implants.
The implants gained popularity because silicone has a consistency that is more like the fatty tissue of the breast.
“It’s softer,” Moore said of choosing silicone. “Saline is really like a water balloon.”
Saline implants also can have ripples along the seam, which can show through on women with very thin skin or with little breast tissue.
Saline does have its advantages. It’s cheaper, something that may be important because insurance plans typically don’t cover cosmetic procedures. Rosenblum said patients should expect to pay $5,500 for the surgery with saline implants and $6,500 with silicone.
Saline is easier to adjust in the operating room. The saline shell is filled after it is implanted and only requires an inch long incision. Silicone implants come pre-filled and need about a 2½-inch incision.
Both types of implants carry similar risks. They can rupture, or too much fibrous tissue that forms around them after surgery can contract and distort the shape and feel of the breast.
When a saline implant ruptures, it’s easily evident. The shell deflates as the salt-water solution pours out and is absorbed by tissue.
When a silicone implant breaks, the woman may not notice because the more cohesive gel will probably stay in the shell, Rosenblum said.
One of the approval conditions the FDA set for silicone implants was that patients become part of a study and agree to have MRIs done at regular intervals to detect ruptures – a cost also unlikely to be covered by insurance.
Another condition of FDA approval was in the product labeling; women are to be told that the implants are not “lifetime devices,” meaning they should assume they will have to be replaced at some point.
“This is a serious financial commitment,” Allina said. Even if they have to be replaced every 10 years, “that’s a lot of surgeries.”
Allina said that her biggest concern is the unknown long-term effects of having silicone leak into body tissues, and patients should keep track of ongoing research.
“I do worry that the FDA approval gives women false reassurance,” she said.
For now, Moore and Doerr said they’re happy with their silicone implants.
Yet on Friday , Rosenblum said his breast implant surgery patients on that day went with saline.
“They’re still choosing,” he said.
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