IRVING – At the nation's only factory for saline and silicone implants, plant manager Andrew G. Tymkiw is serious about the big business of making bigger breasts.

Associated Press

Silicone gel breast implants are being produced in Irving.

"It's not cocktail party talk," said Mr. Tymkiw, vice president of global manufacturing operations for Mentor Corp., a California-based company.

The recent FDA approval of silicone implants – ending a 14-year virtual ban – has far-reaching ramifications in Texas, home to the country's only breast implant factory and anecdotally known as one of the augmentation capitals of the United States.

All made-in-the-U.S.A. breast implants start at a 145,000-square-foot factory in an industrial office park near Dallas/Fort Worth International Airport.

The saying that everything is bigger in Texas rings true at the implant factory, the starting point for nearly a quarter-million breast augmentation surgeries a year. In many spots, the factory looks like an especially clean industrial kitchen, with breast implants resembling risen pizza dough stacked on stainless steel rolling trays.

The implants come in a variety of sizes and two main shapes: round and teardrop. A combination of factory workers, machines and robots produces about 2,100 a day and more than half a million a year in a process that the company protects as if it were nuclear missile launch codes.

The company prohibits photographs of most parts of the manufacturing process and declined to identify certain employees lest any rivals divine trade secrets.

Implant manufacturers stand to make additional millions of dollars, thanks to the FDA approval of the silicone implants. (The only other U.S. manufacturer is California-based Allergan, but its factories are outside the United States.)

In a jubilant conference call with shareholders and analysts after the FDA announcement, Mentor president and chief executive Josh Lavine referred to the FDA approval as a "historic moment."

When silicone implants were banned in 1992, saline became the only option, unless women agreed to be part of a clinical study or were undergoing breast reconstruction. Under the new ruling, the FDA allows women 22 and older to choose silicone for augmentation.

Last year, nearly 300,000 patients underwent breast augmentation surgery, according to the American Society of Plastic Surgeons. Industry experts say that women around the world choose silicone over saline 80 percent to 90 percent of the time. The reason is simple:

"Silicone looks more natural, and it feels more natural, and that's it," said Dr. Robert Schwartz, a Dallas plastic surgeon. "But that's huge."

Dr. Schwartz says he's seeing an increase in two kinds of patients: women with saline implants who want to switch to silicone and women who were waiting for FDA approval to get silicone.

Since the FDA approval, "we haven't had to put up velvet ropes, but definitely there's an uptick in calls and people scheduling appointments to get it done," he said.

Breast augmentation patient Holly Brooks' first pair of implants were saline and "looked fake and felt terrible, like a balloon filled up with water," she said.

The suburban Dallas massage therapist eventually switched to silicone implants, a choice she expects more women will soon make.

"I'm just excited for all the women who have had bad boob jobs," said Ms. Brooks, 41.

Mentor officials, predicting that 40 percent of American women will choose silicone over saline within the first year of approval, have already adjusted their revenue projections for 2007 by as much as $25 million. With silicone, Mentor stands to make twice as much on a per-implant basis, company officials said.

A pair of saline implants retail for about $800 to $900, and it's double that for silicone, Dr. Schwartz said. Including the costs for the surgery, breast augmentation procedures typically cost patients between $5,000 and $7,000 for saline implants and an additional $1,000 for silicone, Dr. Schwartz said.

The impact of FDA approval at the implant factory has been minimal. The plant has been cutting saline implant production and boosting silicone implant production to meet the expected market shifts, Mr. Tymkiw said.

So it's business as usual for the plant's 350 employees, many of them factory workers covered from head to toe in surgical scrubs. During the manufacturing process, employees help cure, vacuum seal, wash, heat, package, sterilize and store the implants. They take careful thickness measurements, working under signs that read "Stuffing Area" and "Gel Fill Area."

Throughout the process, workers inspect the implants for air pockets, tears and other imperfections – looking very much like Florida election officials scrutinizing ballots for hanging chads.

The daily grind of making implants might not change much – but what workers are doing here will affect hundreds of thousands of women a year.

"It's not often you have big news stories in plastic surgery," Dr. Schwartz said. "This is big. This has been the biggest break in a long time."

1962: Breast implants introduced.

1974: Congress grants the FDA the authority to regulate medical devices.

1990: A nationally televised report generates publicity and concern about the safety of silicone implants.

1992: The FDA bans silicone implants unless used in clinical studies or for breast reconstruction.

1995: Three major silicone implant makers settle a class-action lawsuit for $3 billion.

1998: The FDA issues a booklet about the risks of breast implants.

2004: Six former silicone implant makers pay the government $11 million over Medicare costs for women who became ill after receiving implants.

2006: The FDA approves the use of silicone implants for breast augmentation.

SOURCE: Associated Press