INAMED'S CUI EXITING BREAST IMPLANT MARKET, the firm announced in a Sept. 7 release. CUI has set Sept. 10 as the cut-off date for orders of saline-filled breast implants for already scheduled surgeries, after which the company will no longer manufacture or distribute the devices. The firm ceased marketing and distribution of silicone gel-filled implants after FDA requested a moratorium on the further distribution of all silicone gel breast implants in January 1992 ("The Gray Sheet" Jan. 13, 1992, p. 2). Acquired in 1989 by Inamed, CUI (previously called Cox-Uphoff) will continue to distribute its line of soft tissue expanders, facial implants, wound drains, TopiGel for scar management and other accessory products. CUI's breast implant production was an "insignificant" percentage of Inamed's total involvement in the breast implant market, according to Inamed. Inamed's McGhan subsidiary will continue to manufacture saline-filled breast implants and related products at its California and Ireland facilities and will simultaneously "concentrate on the development" of its "businesses outside of plastic surgery products, particularly in the bariatric market." McGhan currently has no plans to resume sales of silicone gel- filled breast implants. The firm had ceased gel-filled breast implant production after two FDA inspections of its Santa Barbara facility conducted between January and April 1992 resulted in a warning letter and two 483 adverse inspection reports ("The Gray Sheet" May 4, 1992, p. 8). Subsequently, from November 1992 to April of this year, the firm provided gel breast implants on a limited basis while its supplies lasted under FDA's "urgent need" policy ("The Gray Sheet" April 19, p. 3). The company has been actively working to address FDA concerns at its Santa Barbara facility and has requested a broad reinspection, which it expects to take place "relatively soon." Inamed also announced that it is selling its Specialty Silicone Fabricators, Inc. subsidiary, a manufacturer of non- proprietary silicone medical device components, to a private investment group led by SSF management. The deal is valued at about $10.8 mil. "Inamed has received a combination of $2.7 mil. in cash and short-term and long-term notes" from the investment group, called Innovative Specialty Silicone Acquisition Corp., the release says. Also under the deal, 450,000 to 500,000 shares of Inamed's common stock currently held by SSF management will be retired; the value of the stock will be applied against balances outstanding on short-term notes. SSF's sales last year totaled approximately $10 mil.
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