Despite FDA lift on ban, some still fear silicone implants

Audra Scott knows a thing or two -- or perhaps four -- about breast implants.

She's had four different augmentations, she said.

The first were silicone gel-filled implants in 1992. Then came saline implants in 1997, then again in 2002; and, most recently, "high-profile" silicone implants at a clinic overseas.

"The insides are like gummy bears," she explained of her high-profile implants, which boosted her from a C cup to an E.

She would've preferred silicone over saline, Scott said. But that wasn't an option for her and other women seeking breast augmentation from 1992 to fall 2006.

It's been about one year since the U.S. Food and Drug Administration lifted its moratorium on virtually all silicone breast implant surgeries.

What's changed in 14 years of implant surgery? And how are silicone implants different from saline?

An unfounded fear

Silicone implants were first banned in the early '90s, said Dr. John A. Grossman, a plastic surgeon with private practices in both Beverly Hills, Calif., and Denver, whose clientele includes A-list celebrities and top executives.

It started with reports to the FDA by a Southern California woman and several others alleging they developed diseases after discovering their implants had ruptured, Grossman explained during a recent phone interview.

After various reports and negative press, the FDA set up an advisory panel

Exceptions for use of silicone implants during the ban were for use in clinical trials, reconstruction or ruptured silicone implants, traumatic injury and congenital defects (such as underdeveloped breasts), said Dr. Joey Manduano, a plastic surgeon with his own practice on 21st Street near Lewis Avenue.

Since then, various independent studies have looked at whether silicone gel-filled breast implants were linked to connective tissue disease or cancer, according to information on the FDA's Web site (visit www.tulsaworld.com/fdasilicone).

"The studies, including a report by the Institute of Medicine, have concluded there is no convincing evidence that breast implants are associated with either of these diseases," the FDA reported. That approval extends to women of all ages for reconstructive surgery, as well as women ages 22 and older for breast augmentation.

However, these issues are to be addressed further in post-approval studies conducted by the companies producing silicone implants: Allergan Corp. (formerly Inamed Corp.) of Irvine, Calif., and Mentor Corp. of Santa Barbara, Calif., according to the FDA. Each company will be required to lead the studies, which will follow about 40,000 women for 10 years after they've received implants.

Despite the FDA's reversal on silicone's safety, there is still "an unfounded fear," said Dr. Bryan Whitlock of Whitlock Plastic Surgery in Tulsa.

Misconceptions abound about silicone, he said. The majority of implants he does are saline, but he maintains there is "no association seen" between silicone and health problems.

Of course, there are risks with any implant surgery, according to information from BreastImplantSafety.org.

It offers factual, scientific information on the pros and cons of saline implants -- the only devices currently approved for all uses by the FDA -- as well as the advantages and disadvantages of silicone implants.

Weighing the options

Potential risks and complications for all implants include bleeding, capsular contracture (excessive firmness of the breasts -- the most common problem), implant ruptures, infection, visible skin wrinkling and rippling, to name a few, according to BreastImplantSafety.org.

The subject of risks and potential complications of surgery is best discussed on a personal basis between patient and physician.

These risks don't happen for the majority of implant patients, though. Capsular contracture, for example, can happen in 10-15 percent of cases, Whitlock said.

Whitlock's patients are usually back at work in a few days; some even go back the next day or go out dancing the same night.

Scott never had a problem with any of her implants, and she only experienced minimal pain. "It was more discomfort with the wrappings than it was anything else," she said of both her saline and silicone implants. "I found them to be extremely comfortable."

Each option has its own advantages and disadvantages, according to Breast Implant Safety's online information:

• Saline implant ruptures are easier to detect than silicone implant ruptures. When saline implants rupture, they deflate, and the results are usually seen almost immediately. When silicone implants rupture, the breast often looks and feels the same because the silicone gel may leak into surrounding areas of the breast without a visible difference.
• Many surgeons and patients with breast implants think that silicone implants have a more natural look and feel than saline implants, due to the fact that silicone gel has a texture similar to breast tissue.

"(Silicone implants) have a more realistic feel to them," Scott said. "They don't gurgle. They don't sound like a balloon with water in them.

"You can hear (saline implants), especially if you're jogging. You can hear them slosh."

Aside from silicone fears, price is the second-biggest reason women choose saline over silicone, Whitlock said. Silicone usually costs three times the price of saline implants.

In Tulsa, silicone implants are about $4,000-$4,200, Whitlock said. They're a little more expensive in Wichita, Kan., and even more so in Dallas -- $7,000 and up.

Silicone implants have evolved, Whitlock said. The silicone is becoming more cohesive (more solid, less liquid), meaning it doesn't leak out if there's a perforation in the shell.

Keep in mind, though, that anyone getting implants will more than likely need a second surgery, Whitlock said. And 15 percent will need a second surgery within the first three years.

Size matters

When deciding whether or not you want implants, "do a lot of research," Scott suggested.

Make sure the surgeon you use is certified with organizations such as the American Society of Plastic Surgeons or the American Board of Plastic Surgery, both of which have Web sites with information and tools to find certified surgeons in your area.

It's a good idea to talk with a physician or two, Whitlock said. When you visit to ask questions, gauge the confidence of the staff, and ask them questions.

As for determining size, everyone starts with a different volume, Whitlock said. He said his average implant is 390 cubic centimeters (a measurement of liquid volume). A can of Coke has approximately 355 cubic centimeters, he added.

"The larger you go, the more likely that the implant will become visible," Whitlock warned. Larger implants will put pressure on the skin and cause ripples.

He has patients try on different sizes of implants in their bras to see which ones they like best. Often, if a patient is deciding between two sizes, he recommends they pick the bigger one.

Whitlock said fewer than 10 patients have come back wanting larger breasts; none have asked for a smaller size.

Jason Ashley Wright 581-8483
jason.wright@tulsaworld.com