Texas Implant Factory Adjusts to Silicone Rule - KLTV.com - Tyler, Longview, Jacksonville |ETX News

01/22/07 - Dallas, Texas

Texas Implant Factory Adjusts to Silicone Rule

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 145,000 square-foot factory that is home to the nation's only breast implant manufacturing facility and anecdotally known as one of the augmentation capitals of the United States.

The recent FDA approval of silicone-gel implants _ ending a 14-year virtual ban _ has far-reaching ramifications 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 FDA 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 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 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.

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

Mentor officials, predicting that 40 percent of American women 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 retail for about $800 to $900 and double that for silicone, 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 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, said plant manager Andrew G. Tymkiw, Mentor's vice president of global manufacturing operations.

So it remains business as usual for the plant's 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 - looking very much like Florida elections officials scrutinizing ballots for hanging chads.

Story courtesy of the Associated Press.

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