SEC investigation targets Inamed
This article was originally published in The Gray Sheet
Executive Summary
Adequacy of disclosures concerning firm's silicone gel-filled breast implants is under Securities and Exchange Commission review, Inamed reports in 10-K filing March 16. "We believe that our disclosures regarding our silicone gel-filled breast implant products have been and are in compliance with federal securities laws," Inamed maintains, adding that those disclosures represent $3.4 mil., or less than 1% of its 2004 revenue. FDA's General & Plastic Surgery Devices Panel is slated to consider Inamed and Mentor's respective silicone gel breast implant premarket applications April 11-13 (1"The Gray Sheet" March 7, 2005, In Brief)...
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Securities and Exchange Commission staffers recommend halting the investigation of Inamed's disclosures for its silicone gel-filled breast implants, after advising that no enforcement action be taken, the firm reports in a Nov. 9 10-K filing. The firm has repeatedly claimed it is in compliance with federal securities laws since the probe began in February (1"The Gray Sheet" March 21, 2005, In Brief)...
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FDA's General & Plastic Surgery Devices Panel will hear public presentations on breast implants April 11, according to a Feb. 28 Federal Register notice. The advisory committee will then discuss and vote on Inamed and Mentor silicone gel breast implant premarket applications April 12-13 (1"The Gray Sheet" Jan. 24, 2005, In Brief). Those who wish to make oral presentations during the meeting should contact FDA prior to March 28. [Editors' note: To order a webcast, videoconference or DVD of the meeting, visit 2www.FDAAdvisoryCommittee.com]...
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