Implant Business Slows as Patients Await FDA Decision

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For the past 12 years, silicone implants have only been available under limited circumstances, such as for women getting reconstructive surgery, or those replacing existing silicone implants.


But in September, the Food and Drug Administration informed the two leading makers of silicone and saline implants, Mentor Corp. and Inamed Corp., both based in Santa Barbara, that their improved versions of silicone implants could be approved once conditions to reduce medical errors and enable long-term tracking of patients were worked out.


That news has repercussions both on Wall Street where takeover battles involving the companies are raging and in doctors’ offices, where the fast-growing breast implant market slowed in the third quarter.


The market has recently grown at an annualized rate of 15 percent a year but that fell by more than half, to 7 percent, in the third quarter, a fall that analysts attribute to patients taking a wait-and-see approach to an elective surgery.


“It’s clear patients are waiting.” said CIBC World Markets analyst John Calcagnini, who covers both Mentor and Inamed. “At the same time, the companies who want in on the market aren’t waiting. Everyone realizes that the silicone market is going to take off, even with the implants being more than twice the price of saline.”



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The full story

is available in the Dec. 5 edition of the Business Journal.

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