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Breast implants made of silicone back on US market

In many spots, the factory looks like an especially clean industrial kitchen. Workers are covered from head to toe in surgical scrubs. Stacked on stainless steel rolling trays are mounds of various sizes and shapes, all resembling risen pizza dough.

Mentor Corp. has its global manufacturing operations at this 13,050-square-meter factory that is home to the nation's only breast implant manufacturing facility and anecdotally known as one of the augmentation capitals of the US.

The recent FDA approval of silicone-gel implants -- ending a 14-year virtual ban -- has far-reaching ramifications in Texas. All made-in-the-USA breast implants begin here, the starting point for nearly a quarter million breast augmentation surgeries a year.

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.

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

The factory is located in an industrial office park near the Dallas/Fort Worth International Airport. But the California-based company prohibits photographs of most parts of the manufacturing process and declined to identify certain employees lest any rivals divine trade secrets.

This reticence comes at a time when implant manufacturers stand to make additional millions of dollars, thanks to the FDA approval two months ago.

In a jubilant conference call with shareholders and analysts after the FDA announcement, Mentor President and CEO Josh Levine 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 women around the world choose silicone over saline between 80 percent and 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."

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

The 41-year-old Dallas massage therapist eventually switched to silicone implants, a choice she expects more will make.

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