Thursday, June 30, 2005
Anne T. Denogean :: www.tucsoncitizin.com

New Thinking on Silicon Gel Breast Implants

It seems such an innocuous thing when held in the palm of the hand - just a clear, nicely squishy, gel-filled sac. But the silicone breast implant is among the most controversial medical devices ever invented. It's been debated, litigated, evaluated, banned, politicized, lauded, loved, vilified and hated.

Soon, perhaps early in July, the next milestone in its history will be charted.

The U.S. Food and Drug Administration is expected to rule whether silicone implants made by Mentor Corporation and Inamed Aesthetics, both of Santa Barbara, Calif., are safe and should be available to women for both breast reconstruction and augmentation. An FDA advisory panel earlier this year recommended in favor of Mentor's application but not Inamed's.

While saline breast implants are on the market, silicone implants are available only through controlled studies. The FDA restricted most uses of silicone implants in 1992 amid widespread claims by women that the implants made them sick when ruptures or leaks sent silicone into their bodies.

At stake are women's health and women's right to a choice of implants, as well as the boost to the big business of big breasts that the FDA's golden seal would deliver.

About 327,000 American women got implants in 2004 - primarily saline-filled. Silicone implants have a superior feel and the destigmatization of them through FDA approval would likely mean an increased market for both the manufacturers and plastic surgeons.

"I believe that in the future, they are going to approve the silicone implants and they probably will be the primary implant of choice for augmentation," said local plastic surgeon Dr. Christopher Maloney Jr. of The Institute for Plastic Surgery.

The research has vindicated them as safe, and most reconstruction patients choose silicone after doing their own research on the Internet, he said.

"I tell people quite honestly if I were going to get implants I would want to get the silicone gels because they are more natural," said Dr. Gwen Maxwell of Maxwell Aesthetics Cosmetic Surgery. "They feel better and I think most female plastic surgeons would get gels."

Those who oppose FDA approval of the gels say the companies haven't adequately answered the most basic of questions. How often do the implants rupture and what are the health consequences when they do? asked Diana Zuckerman, president of the National Research Center for Women & Families in Washington, D.C.

Mentor reported a 1.4 percent rupture rate, but its data covers only two years. Inamed reported a 4.8 percent rate over three years. Both companies estimated 10-year rates of about 15 percent, but the FDA questioned their reliability.

"You cannot draw any conclusions about rupture in the 10th year based on rupture in the first two years because everybody knows that breast implants rarely break during the first two years," Zuckerman said.

"When they do break, how often do they leak? If they leak what are the implications of that, for health and also for appearance?" she asked.

The quest for bigger and prettier breasts dates back to at least the 1880s when, according to the Institute of Medicine, materials inserted in breasts included "ivory, glass balls, ground rubber, ox cartilage, and sponges, sacs and tapes made from various substances."

Starting in the 1940s, various liquid substances were injected into breasts to make them larger, including paraffin, petroleum jelly and industrial silicone.

The results were almost uniformly disastrous, the institute said, with women suffering pain, infection, disfigurement, liver and respiratory problems and, in some cases, death.

Dow Corning Corporation introduced the first silicone gel-filled implant in 1963. The Tucson Citizen ran a story in 1976 noting that a pair could be had "for the price of two weeks in the Bahamas."

But silicone implants came under fire in the early 1990s when very sick women began to ask whether their illnesses - connective tissue diseases, rheumatic conditions and cancers - were caused by their implants.

Major studies were initiated. Women flocked to surgeons' offices to have their implants removed. Lawsuits were filed and won, including $3.2 billion from Dow Corning to settle the claims of 170,000 women. Lisa Hickey of Phoenix testified before the FDA panel in April that she had four surgeries due to implant complications and suffered systemic illness.

In 1999, the Institute of Medicine Committee on the Safety of Silicone Breast Implants, after reviewing thousands of scientific and industry reports, concluded there was no evidence that silicone implants cause any major diseases.

But breast implants of all types are by no means an innocuous medical device.

Complications in or near the implant - "local complications" - are common, the institute and the FDA say.

They include pain, hardening, hematomas, infection, implant displacement, rupture of silicone implants, deflation of saline implants and "capsular contracture" or the buildup and tightening of the scar tissue that normally forms around the implant.

"Breast implants will not last a lifetime," the FDA warns in its 2004 consumer guide to implants. "You are likely to have the implants removed, with or without replacement, because of one or more complications over the course of your life."

Despite the risks, Tucson cancer survivor Juenn Shigetani found silicone implants to be a blessing after a bilateral mastectomy last year.

During her mastectomy, she was implanted with "expanders," devices similar to implants, that would be filled with saline over a period of months to stretch the breast skin for permanent implants.

The saline was awful and never felt right, Shigetani said. She has little fat to spare on her 4-foot-11-inch frame, so she didn't have enough tissue to hold the expander properly. There was dimpling, and the breast felt hard. The saline became a constant reminder of the cancer and the loss of her breasts, she said.

"I felt depressed that I was going to have to live with it... . I wasn't comfortable to even give anyone a hug because of the difference in how it felt," she said.

When it came time to replace the expander with implants, Shigetani and her plastic surgeon, Dr. Kian Samimi of University Physicians Healthcare, opted for silicone.

Shigetani said they are comfortable and feel close to her natural breast.

"Now I can hug people and I feel normal, not like I'm giving them a chest compression or something," Shigetani said.

Most Americans understand why a woman would be willing to incur limited health risks to feel restored after a mastectomy.

But the majority of women get implants as a purely elective procedure - 264,000 breast augmentations in 2004 - and are incurring the risks for the sake of a cultural standard of beauty set by such celebrities as Pamela Anderson and Carmen Electra.

Maxwell, the Tucson plastic surgeon, said it's legitimate to view the risks of a cosmetic surgery through a different lens than than those of a medically necessary surgery.

She is brutally honest in explaining to her patients that implants, like any consumer product, are fallible. She has created a book of graphic photos of complications that every patient must look at.

The larger the breast, the more it will fall and possibly disturb the skin, she warns. They can get hard or cause a chest wall deformity. There could be rippling.

"They're not perfect and they are not permanent," Maxwell said she tells her patients. "You have to weigh the risks to have bigger breasts."