Silicone Boobs Bounce Back

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.