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Friday, February 23, 2007

By LESLIE PALMA-SIMONCEK STATEN ISLAND ADVANCE

STATEN ISLAND, N.Y. -- Forty-six years ago, a surgical resident at Baylor University in Texas squeezed a plastic blood bag and remarked on how much it felt like a breast.

The silicone breast implant was born.

A year later, according to author Teresa Riordan, Timmie Jean Lindsey received the first silicone implants and reported that "things began to look up after that."

Implants quickly became big business and for 30 years the vast majority of American women unhappy with their breasts opted for silicone gel over saline implants.

But in 1992, amid allegations that silicone implants were unhealthy, the federal Food and Drug Administration placed a moratorium on their use for cosmetic augmentation until definitive studies could be performed.

The moratorium did not apply to breast cancer patients undergoing reconstructive surgery, but for American women who just wanted to stretch the tape measure farther, the only other option was saline implants.

They proved an imperfect fit for many.

"Big and bigger, that's saline," said Dr. Patrick Maxwell, a plastic surgeon in Nashville.

Last November, silicone implants were again approved for use in the United States and those in the business predict that "big and round" is about to give way to "shaped and subtle," according to image-enhancement consultant Wendy Lewis,

"FDA approval of silicone gel is really momentous," said Ms. Lewis.

"We now have options in terms of form and dimension," Dr. Maxwell said.

Ms. Riordan, Dr. Maxwell and Ms. Lewis last week took part in a panel discussion in Manhattan hosted by Allergan, the California-based company whose INAMED Silicone-Filled Breast Implants were one of two implants approved by the FDA in November.

The other approved implants are manufactured by Mentor Corp., also based in California.

FDA approval was based on studies performed by both companies and a review of independent studies. Allergan and Mentor now must conduct 10-year follow-up studies of 40,000 women who receive the implants.

Since the moratorium was imposed in 1992, studies performed by governmental and private entities concluded there is no link between breast cancer risk and implants, although in a study of 13,500 women, the National Cancer Institute did find that breast cancer was detected somewhat later in women with implants.

In approving the silicone implants, the FDA noted the devices are not risk-free.

"Breast implants are not lifetime devices and a woman will likely need additional surgeries on her breast at least once over her lifetime," according to an FDA statement released on Nov. 17, 2006.

The statement also noted that "rupture of a silicone gel-filled breast implant is most often silent, which means that usually neither the woman nor her surgeon will know that her implants have ruptured; and a woman will need regular screening MRI examinations over her lifetime to determine if silent rupture has occurred."

Breast implants can cost between $5,000 and $10,000 and, except in the case of reconstructive surgery following breast cancer, are not covered by insurance. Women would also have to foot the bill for their follow-up MRIs and any subsequent surgeries.

But despite the cost and the lingering risks, demand for silicone implants is expected to surge.

"The U.S. market is expected to increase 50 percent" by 2009, according to Ms. Lewis.

"Today the women of America can have the same options as women in the rest of the world," said Dr. Maxwell, who took part in the development of the Allergan implants.

The desire for bigger breasts is nothing new.

In her 2004 book "Inventing Beauty," Ms. Riordan wrote that "the female impulse to artificially enhance the breasts is ancient." Some Greek scholars believed the goddess Hera donned some sort of push-up device to distract Zeus and keep him from "meddling in the Trojan War."

But it's in the last 150 years that the urge to augment coupled with the development of new technologies really began to change the topography of the female form. The de-volution of the corset led to the invention of the brassiere.

In the last quarter of the 19th century, Ms. Riordan said, work on breast-building devices began in earnest, and many of the inventors were women.

Next came potions, massagers and suction gadgets designed to increase the size of the natural breasts. While they did a brisk business, they provided little result. Falsies of wire, rubber and cork were employed, with limited success until the 1930s and 40s, when serious curves came into vogue and innovators got busy.

Breast-enhancement surgery was progressing as well. A physician in Vienna came up with the idea for paraffin injections in the 1890s. In the 1920s and 30s, doctors began transplanting fatty tissue from the buttocks and belly into the breasts. After that came insertables made of polyurethane, glass balls, wood, sponges, even Teflon, according to Ms. Riordan's research.

Silicone, an industrial lubricant prized because it does not break down at high temperatures, began to be injected into the breasts of prostitutes in post-World War II Japan.

And then in 1961, Thomas Gerow, the Baylor resident, altered the breast enhancement landscape forever when he squeezed the blood bag.

It can't be disputed that many women want bigger breasts and are willing to pay dearly for them. Just flip through the premium cable channels any late night and you're likely to encounter more saline breasts than natural ones -- it's not hard to tell the difference.

Whether they should just be content with what nature provided is a question every woman must answer for herself.

"Mental health professionals used to take a dim view of cosmetic surgery," said David Sarwer, a clinical psychologist who also spoke at the Allergan luncheon at The Modern last week.

But now, he said, there's a realization that "how we look matters."

For many, he said, cosmetic surgery has become "another extension of a healthy lifestyle."

Leslie Palma-Simoncek is the religion editor for the Advance. She may be reached at palma@siadvance.com

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