Sandra laliberte s_laliberte_2001@yahoo.com

Mentor Corp.'s Texas plant prepares to meet demand after 14-year ban is lifted.

By Jeff Carlton

ASSOCIATED PRESS

Saturday, January 06, 2007

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

"It's not cocktail party talk," said Tymkiw, the vice president of global manufacturing operations for Mentor Corp.

Donna McWilliam

ASSOCIATED PRESS

Mentor Corp.'s breast implant factory in Irving has been boosting production of silicone implants since the government ended a 14-year ban on them Nov. 17. Company officials predict that 40 percent of U.S. women who want implants will choose silicone over saline within the first year after approval.

The recent federal approval of silicone implants, ending a 14-year virtual ban, has far-reaching ramifications in Texas, home to the nation's only breast implant manufacturing facility.

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

The implant factory is the starting point for almost 250,000 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 produce about 2,100 a day and more than 500,000 a year. The California-based Mentor company protects the process 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.

This reticence comes at a time when implant manufacturers stand to make additional millions, thanks to approval by the Food and Drug Administration. (The only other U.S. manufacturer is California-based Allergan Inc., but its factories are outside the United States.)

In a jubilant conference call with shareholders and analysts after the FDA announcement, Mentor President and CEO 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, almost 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 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."

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 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," Schwartz said.

Mentor officials, predicting that 40 percent of U.S. women who want implants will choose silicone over saline within the first year of approval, already have 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 retails for about $800 to $900, and silicone sets cost twice as much, Schwartz said. Including the costs for the surgery, breast augmentation procedures typically cost patients between $5,000 and $7,000 for saline implants and another $1,000 for silicone, Schwartz said.

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

So it remains business as usual for the 350 employees. 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 closely inspect the implants for air pockets, tears and other imperfections.
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," Schwartz said. "This is big. This has been the biggest break in a long time."

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Sure this has been the biggest break on plastic surgery they lied through there teeth to the FDA and Health Canada they got bought expert testimony from plastic surgeons all so they could make millions.