Goleta Corporations to Benefit from Cosmetic Implants’ FDA Approval
by Martha Sadler
Goleta Valley will once again provide larger breasts for American women through the magic of silicone, after the FDA announced that it will lift a 14-year ban on the chemical gel implants for cosmetic use. Mentor Corporation and Inamed Corporation — the latter acquired last June by Irvine-based Allergan Corporation — both ceased production of silicone implants for the U.S. market in 1992, when the FDA ordered more product testing. Both continued to be global leaders in the silicone-implant industry in countries without the ban. Meanwhile, American women had to make do with saline-solution implants unless they traveled overseas. The only exception were women undergoing reconstructive surgery for medical reasons — such as mastectomies — and women enrolled in testing programs.
While the moratorium’s end is certainly a bonanza for the two companies, the effect on the local economy is less clear. Because the companies’ business is wholesale, the county derives no direct taxes from their sales. Additional retail sales taxes would, however, be forthcoming if new plastic surgery offices set up shop in Santa Barbara to meet the demand for the silicone breasts, which have a more natural look and feel.
The Goleta Valley’s research-and-development industries have long been considered an economic boon, largely because of the positive economic impact made by their well-paid workforces. The demographic picture has changed over the past decade, however, and now the question becomes whether a company’s workforce — much less an expanded workforce — can compete in a pricier housing market. Mentor, headquartered on Hollister Avenue, currently has 200 employees engaged in research and development, clinical studies administration, marketing, and customer service. Representatives would not speculate on whether the administrative operations will expand.
Allergan representatives also said they will not speculate on their company’s future in the county. Citing the need to guard business secrets, Allergan also declined to state how many employees work at the company’s offices on Ekwill Avenue, or to characterize their jobs or salaries. However, according to a number of sources, some 450 Allergan employees are engaged in research and development, customer support, and other administrative duties.
Controversy continues to stalk silicone implants, despite the FDA’s recent clean bill of health. A whistle-blowing Mentor engineer has raised concerns that the implant leaks gel from a one-inch patch that seals a hole created during manufacture — though not on the samples that patients handle, an allegation the company does not deny. Even more disturbingly, a series of investigative articles in the Los Angeles Times has illustrated the Food and Drug Administration’s credibility problems, based on the fact that their scientists sometimes receive jobs and honoraria from the very companies whose products they are assessing.
If the FDA is to be believed, however, women with the implants have no greater incidence of cancer, connective tissue diseases, rheumatic diseases, or neurological diseases — all of which silicone breast implants had been accused of causing — than women without them. Moreover, the FDA concluded that there was “no evidence of elevated silicone in breast milk.” As a condition of approval, however, the FDA is requiring another 10 years of epidemiological studies on 400,000 customers. The patient literature provided by the companies acknowledges some downsides to the implants: Mammograms become problematic, nipples may lose their erogenous sensitivity, scar tissue may form, rupture is not unusual, and breastfeeding can lead to complications, especially if the surgical incision encircles the nipple. The American Society of Plastic Surgeons reported 265,000 cosmetic breast enlargements last year, up 10 percent from 2004.