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Apr. 01, 2007
Copyright © Las Vegas Review-Journal


Silicone or saline argument goes on

Breast implantation surgery popular either way

By PAUL HARASIM
REVIEW-JOURNAL



Anna Capurro talks Tuesday with Dr. Michael Edwards about her recent silicone implant surgery, which Edwards performed.
Photo by Craig L. Moran.



Charlotte Mahlum in January 1999 describes the problems she had after one of her silicone breast implants ruptured. The number of silicone implants increased 18 percent in 2006 after FDA approval.
Photo by Clint Karlsen.

These are the best of times for 38-year-old Anna Capurro, who is recovering from breast implantation surgery.

"I never would have gotten implants if I couldn't have had silicone," Capurro said as she sat in the Summerlin office of plastic surgeon Michael Edwards.

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"I'm sure they are safe, or the FDA wouldn't have reapproved them. They make me feel more complete about my physical appearance. I'm incredibly happy."

These are the worst of times for 57-year-old Charlotte Mahlum. "I wish I could go back to 1985 and never get silicone implants," the former Las Vegan said by phone from her Texas home.

"Now I've got multiple sclerosis ... incontinence, headaches all the time," said Mahlum, who won a multimillion-dollar lawsuit against an implant manufacturer. "I wish I had one day where I felt good. Women who get silicone implants are making a horrendous mistake."

It has been five months since the federal Food and Drug Administration ended a 14-year virtual ban on silicone-gel breast implants. Until November, they were available only as part of research studies.

And even though the consumer now has a choice between saline and silicone implants, a heated debate over the safety of silicone lingers.

That debate is spawned in part by the FDA's own warnings that breast implants are not lifetime devices and that a woman will likely need one or more reoperations over the course of her life due to rupture or other complications.

Because the rupture of a silicone gel-filled implant is most often silent, the FDA suggests that women undergo an MRI three years after the initial implant surgery and then every two years thereafter.

Edwards and most plastic surgeons say findings by some of the country's most prestigious scientific organizations, including the National Academy of Science's Institute of Medicine, support the safety of silicone implants.

Yet Dr. Sidney Wolfe of Public Citizen, the Ralph Nader-founded consumer advocacy group based in Washington, D.C., calls the implants "the most defective medical device FDA has ever approved."

There is no debate over whether there is a demand for the implants, whose proponents say are more natural in look and feel than those filled with saline, or saltwater.

Silicone implant procedures often cost about $6,000, around $1,000 more than saline.

Largely because of an 18 percent jump in silicone implants in 2006, the American Society for Aesthetic Plastic Surgery reported that for the first time breast augmentation procedures surpassed liposuction as the most sought after surgery for women.

"The FDA approval of silicone breast implants in late 2006 seems to have made an impact," said Dr. James Stuzin, ASAPS president.

Though statistics for cosmetic surgery are not kept by city or state officials, they are kept regionally by the American Society of Plastic Surgeons.

With more than 117,000 breast augmentation procedures in 2006, ASAPS's region 5, which includes Nevada, California and Arizona, leads all areas.

A distant second is the region that includes Florida, South Carolina and North Carolina, with fewer than 62,000 implant surgeries.

"Las Vegas is considered the mecca for breast augmentation," said Kathy Keithley-Johnston, executive director of Toxic Discovery.

The Missouri-based consumer advocacy group supports individuals seeking assistance with silicone-related injuries.

Capurro, a medical supply sales specialist who had her implant procedure three weeks ago, believes she knows why: "There is much more of a premium in physical beauty here because of the entertainment industry. Women in all walks of life have to be more conscious of their appearance in Las Vegas."

Las Vegas plastic surgeons say lifting the FDA ban on silicone implants has changed the focus of their practices.

"My patients are definitely favoring the silicone implants," said Edwards, who says more than half of the eight breast augmentations he will perform this week will be with silicone implants. "Many women simply believe it is more natural."

Las Vegas plastic surgeon Julio Garcia said he expects silicone-gel implants to take a much larger share of the augmentation market, but he also expects saline implant procedures to remain the choice of some women because of the perception they're safer.

Garcia said he understands the skittishness of some women who don't want silicone implants, given that some people and organizations refer to them as "ticking time bombs."

No one makes that argument more vigorously than Mahlum. In 1995, the former Nevadan won a $14.2 million jury verdict in Reno against Dow Chemical, a 50 percent shareholder of the largest implant manufacturer, Dow Corning.

In 1999, Nevada's Supreme Court stripped her of a $10 million award for punitive damages, but let her $4.2 million compensatory judgment stand.

Mahlum said she often has seizures and difficulty walking, in addition to nerve damage and brain lesions because of silicone poisoning.

She got her silicone implants after a double mastectomy in 1985.

By 1990, she was seriously ill. She had the implants removed, one of which had ruptured, but she said the damage had been done.

So much silicone remains in her system, she said, she cannot donate blood.

"The silicone has played havoc with my entire central nervous system," she said. "It has attached itself to my spine."

The gist of Mahlum's complaint, that leaking silicone from her ruptured plastic sac caused a host of connective tissue illnesses, was powerful in the courtroom, despite the fact that the science backing such claims was largely theoretical.

In writing for the majority, Nevada Supreme Court Justice Bob Rose recognized the lack of science backing the claim of Mahlum and her husband.

"We are aware that causation is a scientifically controversial component of the plaintiff's case in breast implant litigation," Rose wrote. "The Mahlums, however, did not need to wait until the scientific community developed a consensus that breast implants caused her diseases."

During the 1990s, even while juries around the country were returning similar multimillion-dollar verdicts for women, epidemiological studies failed to establish a connection between implants and autoimmune and connective tissue illnesses.

In fact, epidemiology found in general that women with implants do not get sick more often than women without them.

Public Citizens' Wolfe, however, has long said the epidemiological studies haven't been done over a long enough period of time. No one, he says, has done more than five years of follow-up study for a product that hit the market in the '60s.

"That is inexcusable," he said. "They are now doing an experiment using thousands of women as guinea pigs."

Wolfe said saline implants aren't as heavily scrutinized as silicone implants, because "when they rupture, you're talking about water going into the body."

By contrast, he said, there are studies showing silicone to be harmful to the body.

Toxic Discovery's Keithley-Johnston, who said she was once sick from silicone implants until she had them removed, thinks the thousands of women who appeared to get sick from silicone shows studies should be done to see if a subset of women are genetically susceptible to the substance.

"More study should have been done before it was put back on the market," she said, adding that the FDA is bending to corporate pressure rather than representing consumers. "We should be seeing if there is an environmental trigger for these women."

Both Wolfe and Keithley-Johnston believe the FDA has recognized the lack of sufficient study by ordering the two companies marketing silicone-gel filled breast implants, Allergan Corp. and Mentro Corp., to conduct a post-approval study following about 40,000 women for 10 years after receiving breast implants.

FDA representatives, however, say the agency often requires postmarket studies to answer questions that can only be answered once a product is in broader use.

Edwards and Garcia agree that the silicone breast implant surgery, which the FDA has limited to women 22 and older because the breasts of younger women are still developing, should not be taken lightly.

They note that the FDA warns consumers that local complications can occur, including hardening of the area around the implant, breast pain, change in nipple sensation, implant rupture and the need for additional surgery.

The agency also notes that the majority of women with implants who have participated in studies are satisfied with the results.

Garcia said he tells patients that the initial implantation could be the least expensive part of breast augmentation.

Corrective procedures, along with $2,000 MRIs every two years, could run the tab for a woman in her 20s upwards of $50,000 over a lifetime to keep breast implants in proper form.

The cost and prospect of further surgeries doesn't bother Capurro, who said she readily signed off on legal documents that warned of possible complications.

"I went into this realizing there could be other monetary costs, that I could have to have other operations," she said. "That is a choice I make to look the way I want to look.

"Let's face it: Looking this way can help me in my work. That's a fact of life. I know things can break or wear out. These consumer groups who say they are speaking for women aren't speaking for me and a whole lot of other women. Studies have been done showing illnesses are not caused by silicone implants. I'm not stupid. I did my homework before doing this."


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