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By W.D. Crotty
October 17, 2003
Medical device maker Inamed (Nasdaq: IMDC) won a victory recently when
an FDA advisory panel recommended that the company be approved to sell
its silicone breast implants. But does the slim 9-to-6 panel margin
portend problems for this profitable and quickly growing company?
To be sure, breast implants are big business. Between 1992 and 2001,
the number of operations increased by 533%, and doctors performed
236,888 breast enlargement operations in 2002 alone.
Prior to 1992, when silicone implants were outlawed, they were
manufactured by Baxter (NYSE: BAX), Bristol-Myers Squibb (NYSE: BMY),
3M (NYSE: MMM), and Dow Corning, a subsidiary of Dow Chemical (NYSE:
DOW).
Complications arose, and all four companies fell victim to multiple
lawsuits. In March 1994, they agreed to a $4.25 billion settlement --
the largest class action settlement at that time.
Unfortunately, a safer saline product proved inferior to the softer,
more natural feel of silicone gel, as evidenced by the fact that, in
Europe, women select silicone 9 to 1 over saline. By being first to
market with the new silicone, Inamed expects to steal share from
leader Mentor (NYSE: MNT). Both have been manufacturing breast implant
products for decades, and neither was swamped by litigation.
Should Inamed shareholders be concerned about silicone? Yes! The
company acknowledges that in-place implants can rupture or simply
leak. The company's latest quarterly filing acknowledges that it has
not found a carrier willing to provide "risk-shifting liability
insurance on terms and conditions which are acceptable to the
Company."
Then there's always the risk the FDA will not green-light its advisory
panel's recommendation. High-profile women's groups and others are
still trying to prevent approval.
A full 55% of Inamed's sales are derived from breast implant products.
So, yes, the company's top-line growth of 14.5% will accelerate if FDA
approval is granted. But even with the increased sales -- and one
other interesting product for obesity -- at 46 times earnings,
Inamed's uninsured risks are a bit too much.
W.D. Crotty can be reached at [email hidden].
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For more information on the silicone implant debacle ... you are
welcome to visit www.BreastImplantAwareness.org