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Lone U.S. breast implant factory adjusts to silicone approval Slight upturn in implant interest follows repeal of 14-year ban

ASSOCIATED PRESS An inspector is shown at work at Mentor Corp., a breast implant manufacturing facility in Irving, Texas.

IRVING, TEXAS (Jan 18, 2007)

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 13,470-square-metre factory that is home to the only breast implant manufacturing facility in the United States.

In October, Health Canada lifted restrictions on the use of silicone implants. Mentor Corp. and Allergan Inc. make products that are approved for the Canadian market.

In the U.S., the Food and Drug Administration also recently approved silicone-gel implants -- ending a 14-year virtual ban.

And there are far-reaching ramifications at this facility in Texas. All made-in-the-U.S.A. 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 agency approval in November. (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 agency announcement, Mentor president and chief executive Josh Levine referred to the agency 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 Food and Drug Administration 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 between 80 per cent and 90 per cent 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."

Schwartz said he is seeing an increase in two kinds of patients: women with saline implants who want to switch to silicone and women who were waiting for agency approval to get silicone.

Since the approval was granted "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,"

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All made-in-the-USA breast implants begin here, the starting point for nearly a quarter million breast augmentation surgeries a year. ... -- but what workers are doing here will affect hundreds of thousands of women a year.

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It certainly will these, woman will become deathly ill from; Mentor's new Implants just like they have from Mentor's old ones that rupture. We have women writing us; that are al ready Ill from; the new gummy bear implants. Don't Do it is my best advise as a BI victim, the PS